Infiltrative carcinoma of the vulva: Results of surgical treatment

Infiltrative carcinoma of the vulva: Results of surgical treatment GEORGE W. MORLEY, M.D.

Ann Arbor, Michigan

During a 40 year period 374 patients with infiltrative carcinoma of the vulva were evaluated. Some forrn of radical surgery was the treatment chosen for 278 patients. The absolute 5 year survival rates for all clinical stages treated with some forrn of radical surgery was 66.8 per cent with a corrected rate of 73.9 per cent. The corrected 5 year survival rate for patients treated with radical vulvectomy and groin lymphadenectomy approximated 80 per cent and if the regional lymph nodes were negative, it approximated 93 per cent. The size of the pritnary lesion and the incidence of regionall_vmph node metastases seemed directly related. Lymph node involvement itself significantly reduced the rhance for survival. Furthermore, the inaccuracy of preoperative evaluation of the groin lymph nodes approximated 25 per cent. The assumption that a lesion is "early" does not justify less than radical surgery. Conversely, the "advanced" lesion when geographically localized can be treated quite satisfactorily with pelvic exenteration. The treatment of choice is discussed.

women with cancer of the vulva are usually past middle age and often have associated medical problems, they show remarkable tolerance for the radical vulvectomy and regional lymphadenectomy required for effective treatment of the malignant lesion. This surgical method came into wide use after the studies of Taussig1 and Waf demonstrated its superiority, and it has now been tested for well over a quarter of a century. 3- 6 The result is that since 1940 a 5-year survival rate of about 10 per cent 7 has increased to about 90 per cent, among patients with vulvar carcinoma promptly and adequately treated by radical surgery. When the lesion is detected reasonably early, appropriate treatment is applied without delay, and rehabilitation problems are handled to the patient's benefit, the patient's chance for a disease-free existence in the future is often more favorable than for a number of other malignant neoplasms seen by the practicing

physician. Unfortunately, patient delay and physician mismanagement, despite concerted educational efforts, still act to decrease the chance of survival for many of these patients. 8 • 9 This report covers 374 cases of infiltrative carcinoma of the vulva recorded at the University of Michigan Medical Center in the 40 years from January, 1935. to July, 1975. All charts were reviewed by the author, and the T-N-M* and clinical staging system as most recently published by FIG0 10 was applied to all cases studied. 11 From this series, the major issues arising for discussion include the over-all survival rates as related to the various radical surgical procedures used, the significance of regional lymph node metastases, the error in preoperative evaluation of groin lymph-nodebearing regions in relation to the postoperative findings, the interpretation of the "early" and "advanced" lesions of the vulva and the benefits and limitations of bilateral pelvic lymph-node dissection.

EVEN THOUGH

Cllnlcat evaluation and histopatholOgic features From the Departrrumt of Obstetrics and Gynecology (Director, Gynecologic Oncology), University of Michigan Medical Center.

Although a total of 404 patients with infiltrative vulvar malignancies were seen on the Gynecology Service at the University of Michigan Medical Center during the specified period, 30 of these were excluded

Presented by invitation at the Eighty-sixth Annual Meeting of the American Association of Obstetricians and Gynecologists, Hot Springs, Virginia, September 4-6, 1975.

*T-N-M designates the pretreatment evaluation of the primary Tumor, regional lymph Nodes, and remote Metastases: FIGO is the International Federation of Gynecology and Obstetrics.

Reprint requests: Dr. George W. Morley, Department of

Obstetrics and Gynecology, University of Michigan Medical Center, Ann Arbor, Michigan 48104.

874

Volume 124 Number 8

from our final analysis because their invasive lesions were other than carcinoma. Of the 374 patients with infiltrative carcinoma, 278 were treated with some form of radical pelvic surgery and are evaluated in this report (Table 1). The ages of the patients ranged from 20 to 94; the median age was 63. Age itself is not considered a basic deterrent to the operation, nor do we rule out formerly designated "high-risk" patients with medical conditions such as a combination of hypertension, obesity, and diabetes mellitus. On the other hand, these medical illnesses must of course be taken into account in the over-all management of a given case-diabetes mellitus, for example, poses a threat because of its frequency of occurrence and its inherent effect on wound healing. Of the patients in our series, 14.4 per cent were under treatment for diabetes mellitus. When the patients were seen in our hospital, the initial complaint in most cases (74.8 per cent) was the presence of a mass or growth in the vulvar area. Pruritus vulvae (38.8 per cent), localized pain ( 19.8 per cent), perineal bleeding ( 12 per cent), and a mass in the groin ( l. 9 per cent) were also complaints reported. With respect to associated vulvar disease, it was estimated that almost half the malignant lesions were related to some type of previously existing chronic vulvar dystrophy (Table II). It was also disconcerting to note that even though carcinoma of the vulva is a surface lesion which is readily accessible to early diagnosis and treatment, still more than 30 per cent of the patients had conditions such as a sore, discharge, or itching for more than a year before seeking medical attention. Hopefully, patients now entering the "older age group" will not be hampered by the same embarrassment, sensitivity, and modesty in seeking medical advice that marked previous generations of women. Even more disconcerting was the fact that the first physician to see the patient often was responsible for delay in diagnosis and treatment. About a third of the patients were su~jected to topical therapy for 3 to 6 months before a biopsy of the lesion was performed. Moreover, a significant number of patients had been treated inappropriately, with a modified surgical approach, before they were seen in our hospital. The concept that small and therefore more favorable lesions can be treated with lesser surgical therapy was probably responsible for preventable deaths in many instances. The different histologic types of infiltrative carcinoma of the vulva were also studied. Approximately 85 per cent of the lesions were histologically graded as well-differentiated, cornifying, infiltrative, squamous-

Infiltrative carcinoma of vulva

875

Table I. Four types of radical surgery used in treatment of infiltrative carcinoma of the vulva

T_ype of surgery Radical vulvectomy only Radical vulvectomy plus groin lymphadenectomy Radical vulvectomy plus groin and pelvic lymphadenectomy Pelvic exenteration Total

1935-1970

1935-1975

No.j

No.j

%

%

37 157

16.2 68.6

42 193

15.1 69.4

23

10.0

29

10.4

12 229

5.2 100

14 278

5.1 100

Table II. Incidence of associated vulvar diseases in 374 patients with infiltrative carcinoma of vulva Percent of patients

Associated vulvar disease "Leukoplakia,· "Kraurosis" Condyloma acuminatum Lymphopatheum venereum Lymphogranuloma inguinale Total

137 31 18 4

36.6 8.3 4.8

2

0.5 51.3

192

1.1

cell carcinoma of the vulva. Microinvasive disease, as such, was not considered as a pathologic entity in this study. A more detailed analysis of this material has been reported elsewhere. 12

The treatment method Preoperative care. After an initial complete medical evaluation, the patients are presented to the Gynecology Tumor Conference for final diagnosis, preoperative staging, and recommended disposition. Almost all patients are given prophylactic heparin therapy, and some are given antibiotics prophylactically if this seems indicated. Operative technique. In performing this operation one must adhere to the basic principles of cancer surgery as originally set forth by Basset 13 in 1912 and later modified by others 1• 14- 16 by carrying out en bloc dissection and insuring adequate borders around the neoplastic mass. Whereas the technical details are the subject of another paper, some of the surgical principles should be presented at this time. One must be familiar with the surgical anatomy of the various areas so that "accidents of surgery" can be avoided. On the other hand, one must be careful not to confuse the surgical approach with that of an anatomic dissection. Anatomists describe the planes, layers, and locations in differentiating the various lymph-node groups; surgeons must simply keep in mind two designated areas

876 Morley

April 15, 1976 Am . .f. Obstet. Gynecol.

Fig. 1. Trapezoid or butterfly incision.

as they relate to the surgical treatment of infiltrative carcinoma of the vulva, and consider bilateral groin and pelvic lymphadenectomy as two distinct areas of dissection. In most cases the entire operation can be performed as a one-stage procedure. At operation, the patient is placed in the so-called "ski position" 17 so that the lower abdominal and perineal regions can be dissected without repositioning the patient. A trapezoid or butterfly-like incision is utilized (Fig. I) in performing the en bloc dissection. A full-thickness block of tissue is dissected off the underlying fascial areas and one must remember that the rectus abdominis fascia of the abdominal wall, the fascia lata of the thigh, and the inferior fascia of the urogenital diaphragm are all in the same fascial plane and are in contact with each other at the symphysis pubis and rami. This full-thickness dissection is designed to maintain circulation in the remaining flaps. We no longer undermine the skin flaps, because in our experience this led to unsatisfactory wound healing. The groin dissection is simplified by elevating the fibroadipose tissue off the underlying fascia lata in the following manner. A medial incision at the top of the labiocrural line is carried down onto the fascia overlying the adductor longus muscle. By blunt dissection the fibroadipose tissue is separated off the fascia lata from medially to laterally and anterior to the cribriform fascia overlying the femoral triangle. This anterior block of tissue contains the superficial inguinal lymph-node-bearing tissue and the greater saphenous vein. The elevation of this tissue allows for easier dissection of the area, since the femoral vessels are

posterior to the dissecting finger. The femoral sheath is then incised longitudinally in opening the femoral triangle. The fascia lata is removed only if the nodes or the cancer are adherent to it. The femoral triangle is cleared of the deep inguinal (femoral) lymph nodes, including Cloquet's node, which anatomically speaking is considered the sentinel node. It is not necessary to clean the femoral nerve and its branches since it lies outside the femoral sheath. The great vessels of the femoral triangle must be protected either by closure of the femoral sheath at the site of the previous incision or by transplantation of the sartorius muscle medially with fixation to the inguinal ligament. When possible, the bilateral groin lymphnode dissections are carried out simultaneously by "double-teaming" the procedure as an operative timesaving step. The necessity for bilateral groin lymph-node dissection is well documented. 18 • 19 The area is rich with lymphatic vessels, and liberal anastomosis across the midline allows for contralateral drainage of the vulvar tissues and resultant metastasis in some cases. The groin dissection is carried out bilaterally before any consideration is given to pelvic lymphadenectomy. At this point a decision must be made concerning pelvic lymphadenectomy. On occasion, an exploration of the pelvic lymph nodes may be all that is indicated. But if pelvic lymphadenectomy is planned, a parallel incision of the aponeurosis of the external oblique muscles is made along the inguinal ligament. The peritoneum is then reflected superiorly and medially to give adequate retroperitoneal exposure for dissec-

Volume 124 Number 8

tion of the iliac, hypogastric, obturator, and common iliac lymph nodes. Seldom is there an indication for drainage of the retroperitoneal space. The en bloc resection is continued down onto the inferior fascia of the urogenital diaphragm and into the ischiorectal fossa to include the vulvar and perineal tissues; whether cautery or sharp dissection is used depends on the surgeon's preference. This completes the dissection and once hemostasis is obtained, the wound is ready for closure. The portions of the urethra and vaginal wall are included in the en bloc dissection when indicated. The wound is closed in a variety of ways. In over 90 per cent of our cases the perineal, vulvar, and groin wounds are closed primarily; however, there is an area of about 7 by 8 em. located suprapubically that cannot be covered without unusual tension on the suture material. This area is allowed to heal secondarily by granulation, rather than by skin grafting. Usually no drains are inserted in the wounds, but a pressure dressing is applied so as to eliminate possible "dead spaces" with the tendency to retain secretions. This compression dressing is left in place for 1~ to 48 hours. Postoperative care. Most important for the patient is the expert care which is provided by our interested and dedicated nursing staff. After the operation, the patients are kept in a semi-Fowler's position and allowed only "log rolling" for 48 hours. After the initial dressing change at about 48 hours, the wound is left exposed and the patient is gradually ambulated. Sitz baths and whirlpool physiotherapy are started shortly thereafter and urinary catheter drainage can be discontinued in 4 or 5 days. Primarily, we depend on pressure dressings; however, if Hemovac or Penrose drains have been used, they are removed within 72 hours. Complications The incidence of major complications is not particularly significant. The complication encountered most frequently was wound breakdown which occurred to some degree in over 50 per cent of the cases. Occasionally a major bleeding episode is encountered during the postoperative period; however, the great vessels are not involved, because, if necessary, the sartorius muscle has been transplanted as a roof over this otherwise unprotected area. In our series, six patients experienced blood loss of hemorrhagic proportions postoperatively which was thought to be related either to infection involving lesser vessels or to an untoward response to prophylactic anticoagulant therapy. Lymphedema of the lower extremities is encountered quite frequently but is usually not of major

Infiltrative carcinoma of vulva

100 80

3 Years

r-(184/229) (164/211)

~ 60

;;; a:: 1;; ;It

71.6% 71.1%

5 Years

877

10 Years

.......(153/229) (153/2011

66.8% 73.9%

r--

'(9iii78i (91/142)

51.1% 64.1%

40 20 0

CRUDE CORIIECTEO

CRUDE CORRECTED

CRUDE CORRECTED

Fig. 2. Survival rates (3, .5, and I 0 years) for all stages treated with radical pelvic surgery.

consequence; it can best be corrected by the use of elastic stockings for 3 to 6 months. It is thought that even though lymph nodes can never regenerate, the lymphatic channels themselves can regenerate very quickly. Nevertheless, if conservative therapeutic measures are not carried out the lymphedema may become chronic and perhaps permanent. The development of a lymphocyst in the groin area is an infrequent occurrence, but we suspect it occurred in our series more often than was recorded on the charts. It probably can be prevented by careful ligation of all the lymph-bearing tissue during the groin dissection. It is treated by the application of pressure dressings to the area, with intermittent aseptic aspiration of the fluid. Seromas and hematomas which occasionally develop are treated in a similar manner. Of considerable importance among these patients is the occurrence of late complications-difficulties that arise some weeks or months after the operation. Sometimes, patients complain of perineal numbness or stiffness, lack of control over urinary direction at micturition, and pulling of the scar around the vaginal opening. Occasionally a patient complains of dyspareunia, because of significant vaginal stenosis. Symptoms related to stress incontinence and the development of a cystocele or rectocele are sometimes reported by these patients. These conditions reflect the loss of the supports of the lower end of the vagina, and consequent enlargement of the introitus. One must remember that these findings may simply reflect the increased frequency of pelvic visceral prolapse among older women. In five cases in our series the urethral orifice became obliterated by the development of severe cicatricial changes around the vaginal opening. The resuitant urinary blockage was significant in two cases, and was easily corrected by vaginal dilation and external

April 15, 1976

878 Morley

100

Am. J. Obstet. Gvnecol.

Table IV. Crude and corrected 5 year survival rates for all stages combined when related to specific form of radical surgery

Positive Nodes

Negative Nodes

Crude 5 yr.

80

survival rate.\

(1091130) (109/118)

83.8% 92.4% ....J

<

> >

60

a::

:::::>

"'

'Cf!.

40 (24/84) (24/62)

37.5% 38.7%

20 0

CRUll CORR£CTEO

CRUDE CMRECTED

Fig. 3. Groin lymph node status: 5 year survival rate.

Type 'ifswgery

No .

Radical vulvectomy only Radical vulvectomy plus groin lymphadenectomy Radical vulvectomy plus groin and pelvic lymphadenectomy

I

No.

21/37

56.8

21/29

72.4

1151157

73.2

1151146

78.8

9/23

39.1

9/20

45.0

Stage I II III

No.

66/85 54/62 32/81

I

Corrected 5 rr. survival rates

%

No.

77.6 87.1 39.5

66/77 54/57 32/72

I

% 85.7 94.7 44.4

urethral meatotomy. One patient developed a rectovaginal fistula two months after the operation.

Results of analysis All statistical analyses were carried out in the University of Michigan Computer Center. It is important to note that the results are given in both "crude" (uncorrected) and "corrected" form. Because of the age of these patients and the associated death rates in the general population for this age group, special attention was directed toward correcting our data for "intercurrent deaths'-that is, deaths among these patients that were not related to the carcinoma for which they had received surgical treatment. Survival rates. It was determined that 229 of the 278 patients were treated before January, 1970, and thus could be analyzed for 3. 5, and 10 year survivals (Fig. 2). Considering the over-all survival, including all stages of disease and all four forms of radical surgery, !53 of the 229 patients or 66.8 per cent were living at 5

'7c

Table V. Crude and corrected 5 year survival rates for Stage I disease treated by radical vulvectomy only vs. radical vulvectomy plus groin lymphadenectomy Crude 5 yr.

Crude 5 ~r. survival rates

I

o/r

survival ~ales

Table III. Crude and corrected 5 year survival rates for Stages I, II, and III when related to all forms of radical surgery

Correctnl 5 yr. survival rates

I%

Corrected 5 >r. survival rates

I

%

Stage I treatment

No.

Radical vulvectomy only Radical vulvectomy plus groin lymphadenectomy Total no. of patients

13/22*

!19.1

13116t

81.3

s:l/62

85.5

53/60

88.3

84

No.

76

0.0133. *Difference at significance level of p tDifference not significant at p 0.3516.

years. When corrected for intercurrent deaths, the total number was 153 of 207 patients, with a 5 year survival rate of 73.9 per cent. In considering those patients at 5 years who were disease·free, 137 of 212, 64.2 per cent were alive and well; the corrected rate was 139 of 190 patients or 71.6 per cent. The over-all 3 and I 0 year survival rates are similarly recorded. The crude 5 year survival rate for patients having negative lymph nodes (Fig. 3) (either groin or pelvic) was I 09 of 130 patients or 83.8 per cent. with a corrected rate of 92.4 per cent. For patients having positive lymph nodes, the crude 5 year survival rate was 24 of 64 or 37.5 per cent; the corrected value was 38.7 per cent. These figures are statistically significant at the I per cent confidence level by Fisher's Exact Binomial Test. Evaluation of the size of the primary lesion initially suggests that there is no significant association with decade of detection and institution of therapy; however, this material is biased, since only those patients

Infiltrative carcinoma of vulva 879

Volume 124 Number 8

Table VI. Crude and corrected 5 year survival rates for Stage II disease treated by radical vulvectomy plus groin lymphadenectomy vs. radical vulvectomy plus groin and pelvic lymphadenectomy Crude 5 yr. survival rates

I%

Crude 5 yr. survival rates

Corrected 5 yr. survival rates

Stage II treatment

No.

Radical vulvectomy plus groin lymphadenectomy Radical vulvectomy plus groin and pelvic lymphadenectomy Total no. of patients

43/47*

91.5

43/44*

3/5

60.0

3/4

52

Table VII. Crude and corrected 5 year survival rates for Stage III disease treated by radical vulvectomy plus groin lymphadenectomy vs. radical vulvectomy plus groin and pelvic lymphadenectomy

No.

_I % 97.7 75

48

Stage Ill treatment

No.

Radical vulvectomy plus groin lymphadenectomy Radical vulvectomy plus groin and pelvic lymphadenectomy patients Total no. of

I

Corrected 5 yr. survival rates

I%

%

No.

19/48*

39.6

19/42*

45.2

6/17

35.3

6/15

40.0

65

57

*Neither crude nor corrected 5 year survival rates were significantly different: p = 0.0958 and p = 0.1613, respectively.

*Neither crude nor corrected 5 year survival rates were significantly different: p 0.4955 and p 0.4834, respectively.

treated with some form of radical surgery were statistically analyzed in this way. It is of some interest, however, to note that more patients were treated with palliative vulvectomy or had lesions too extensive for surgical therapy in the 1940's than in the 1960's, implying that lesions seen today are somewhat smaller than those seen 20 to 30 years ago. The mean diameter of T 2 lesions treated surgically in the decade 1940-49 was 5.5 em., and the mean for 1960-69 was 4.2 em. Clinical stages and radical surgical procedures. When cases of clinical Stages I, II, and III lesions were analyzed for 5 year survival rates in relation to all forms of radical surgery combined (Table Ill), 66 of 85 patients in Stage I, or 77.6 per cent (uncorrected), and 85.7 per cent (corrected) survived 5 years. In Stage II, 54 of 62 or 87.1 per cent (uncorrected) and 94.7 per cent (corrected) survived 5 years. In Stage III, the respective figures were 39.5 per cent, and 44.4 per cent surviving 5 years. When the specific surgical operations were analyzed in relation to all clinical stages combined (Table IV), the crude 5 year survival rate was 56.8 per cent and the corrected rate was 72.4 per cent for the 37 patients treated with radical vulvectomy alone. Of the 157 patients treated with radical vulvectomy and groin lymph node dissection, 115 or 73.2 per cent survived 5 years; the corrected ratio was 78.8 per cent. For the 23 patients treated with radical vulvectomy plus groin lymph node and pelvic lymph node dissection, the 5 year survival was 39.1 per cent uncorrected and 45.0 per cent corrected. Of 84 patients in Stage I, 22 were treated with radical vulvectomy alone, and 62 by radical vulvectomy and groin lymph node dissection (Table V). The crude 5

year survival rates were 59.1 and 85.5 per cent, respectively. This is significantly different at the 2 per cent level by Fisher's test (P == 0.0133). However, the corrected rates were 81.3 and 88.3 per cent, respectively, and this difference between operations was not significant. The higher intercurrent death rate among patients undergoing only vulvectomy suggests that many of these patients were "at risk" for various reasons. Of 52 patients in Stage II, 47 were treated with radical vulvectomy and groin lymph node dissection, and five with radical vulvectomy plus both groin and pelvic lymph node dissection (Table VI). The uncorrected 5 year survival rates were 91.5 and 60.0 per cent, respectively. The corrected rates were 97.7 and 75 per cent, respectively. Neither the crude nor the corrected rates differed significantly for the two types of operation, but the numbers are small in the latter group. We must remember without getting lost in the statistics, that when Stage I and Stage II disease were treated with radical vulvectomy and groin lymph node dissection that the corrected 5 year survival rate approximately 90 to 95 per cent. Of 65 patients in Stage Ill, 48 were treated by radical vulvectomy and groin lymph node dissection and 17 by radical vulvectomy and both groin and pelvic lymph node dissection (Table VII). The uncorrected 5 year survival rates were 39.6 and 35.3 per cent, respectively; the corrected rates were 45.2 and 40.0 per cent. The survival rates for the two types of operation did not differ significantly, which would suggest that there is very little promise for improved chance of survival when pelvic lymph node dissection is added to the procedure. Four of the 11 postoperative deaths

880 Morley

April 15, l!J7ti

Am.

100

80

Over-all Gr:oup

(41/50) (41/48)

Negative NOdes

'!3i'iW

Positive Nodes

100

r-(39/40)

92.9% 97.5%

80

82.0% 85.4% ~

No Positive Nodes

roooiiiSi

(2/8)

0

(2/8)

CRlllf ~TEO

CRill£ COMECTEO

CRill£ CORRECTED

Fig. 4. T 1 N0 M0-groin lymph node status: 5 year survival rate. Over-oil

100

Group

Negative Nodes

80

.---

~ 60

rooiiiT (10113) 62.5% 76.9%

~ "' .,.

40

Positive Nodes

r---

09/49) (19/45)

20 0

38.8% 42.2%

(9/33)

(9/32)

27.3% 28.1% CRUDE CORRECTED

CRU!i CORRECTED

em:

ClRfCTEO

Fig. 5. T 2 N2 M0 lesions-groin lymph node status: 5 year survival rate.

occurred in the group undergoing pelvic lymphadenectomy. Lymph node metastasis. Although not always directly related, the size of the primary lesion and the incidence of regional lymph node involvement seems important. T 1 lesions showed a 20.7 per cent incidence of lymph node involvement; for T 2 lesions the incidence more than doubled-44.8 per cent. The over-all incidence of positive groin lymph nodes was 37 per cent. In addition, the presence or absence of lymph node metastases seems to have an important impact on 5 year survival (Fig. 4). Of the 50 patients classified preoperatively as T 1 N0 M0 ("early lesions"), the corrected 5 year survival rate was 85.4 per cent. Regional lymph nodes were negative in 42 of these patients, so that the corrected survival rate was 97.5 per cent. For the eight patients with positive nodes, the survival rate was 25.0 per cent. This difference was

Bilateral Positive Nodes

1100/105)

87.0% 95.2%

60 03/34)

(13/33)

55.9% 57.9%

.,."' 40 25.0% 25.0%

Obstet. Gynecol.

-

~ ::::>

20

Unilateral Positive Nodes

J.

20 0

r(3118) r3/15) ,, 18.81 20.0%

CIUf CORRECTED

CRUDE CORRECTED

CRUilf Cle!ECT£0

Fig. 6. T 1 and T 2 lesions-groin lymph node status: 5 year survival rate.

statistically significant at the 0.5 per cent confidence level. Classified preoperatively as T 2 N2 M0 ("late lesions") were 49 patients (Fig. 5). The corrected 5 year survival rate was 42.2 per cent. For the 13 patients with negative groin lymph nodes the rate was 76.9 per cent and for the 32 patients with positive nodes the rate was 28.1 per cent. The difference associated with lymph node metastases was significant at the 2.5 per cent confidence level. Looking at it from a different point of view, the combined T 1 T 2 lesions were evaluated in regard to no groin lymph node involvement. unilateral groin involvement, and bilateral groin involvement. Of 165 patients with a T 1 or T 2 lesion, 115 had no groin lymph node involvement, 34 had unilateral involvement, and 16 had bilateral involvement (Fig. 6). Of those patients with no groin lymph node involvement 100 or 87.0 per cent survived 5 years; the corrected rate was 95.2 per cent. Of the 34 patients with unilateral nodal involvement. 55.9 per cent survived 5 years; the corrected rate was 57.6 per cent. Twenty-one of these patients had just one positive groin lymph node and in this specific group there was an 81 per cent uncorrected 5 year survival rate. Of the 16 patients with bilateral nodal involvement, the corrected 5 year survival was 20.0 per cent. Twelve of these patients had only a unilateral primary lesion. A relative small number of patients (excluding those undergoing pelvic exenteration) were treated by pelvic lymphadenectomy in addition to radical vulvectomy and groin lymph node dissection. Of these 29 patients, 23 were treated before January 1970, and only six in this group or 26 per cent had positive pelvic lymph nodes. All six of the patients who had pelvic lymph node involvement also had groin lymph node involve-

Volume 124 Number 8

Infiltrative carcinoma of vulva 881

Table VIII. Errors in "T-N-M system" when related to pathology review of regional lymph nodes: 234 patients analyzed T-N-M classification (234 patients)

Per cent error

Total-120 patients: T,N 0 M0 Tz No Mo Ta No Mo Over-all error

50 38 9

Totai-34 patients: T,N 1 M0 T 2 N 1 Mo T 3 N 1 Mo Over-all error

10 13 4

11 10 2 23/120

18.0 20.8 18.2 19.2

4 3 0

28.6 18.8 0.0 20.6

7/34

Total-80 patients: T, N 2 M0 T 2 N 2 M0 T 3 N 2 Mo Over-all error Over-all error and total

5 18 4

2 43 8 27/80 57/234

71.4 29.5 33.3 33.8 24.4

Table IX. Errors in clinical staging system when related to pathology review of regional lymph nodes: 205 patients were analyzed % Clinical staging

Stage I Stage II Stage Ill (excluding T 3 lesions) Total Over-all error

Error

58 51 22

15 13 46 205 50/205

20.5 20.3 32.4 24.4

ment. The uncorrected 5 year survival rate for these six patients was 1 of 6, or 16.7 per cent. The corrected rate was 25 per cent. For the 17 patients \vith no lymph node involvement the crude 5 year survival rate was 47.1 per cent and the corrected rate was 57.1 per cent. The inaccuracy of preoperative interpretation of nodal involvement has been recognized for some time. The "N" portion of the "T-N-M" system (N0-no groin lymphadenopathy; N 1-no suspicious groin adenopathy; Nz-suspicious groin adenopathy) was analyzed for accuracy in all cases where nodal tissue was available for pathology review (Table VIII). Of the 234 cases analyzed, the over-all error for groin lymph node invoivment in preoperative T-N-M classification of patients undergoing radical surgery with regional lymph node dissection was 24.4 per cent. The preoperative clinical staging system outlined in the FIGO classification also was analyzed for accuracy

Table X. Analysis of 14 patients treated with some type of pelvic exenteration Type of surgery

No.

Per cent
A

Total pelvic exenteration Posterior pelvic exenteration Anterior pelvic exenteration

3 9

2

64.3 14.3

Over-all 5 year survival rates

8/12

66.6

"-1.""1"

Table XI. Postoperative mortality rate in the series of 278 patients Type of death

No.

Per cent

Surgical Radical vulvectomy only Radical vulvectomy plus groin and pelvic Iymphadenectomy

5

l.S

Hospital Radical vulvectomy only Radical vulvectomy plus groin lymphadenectomy Radical vulvectomy plus groin and pelvic lymphadenectomy

6

Cause of death Septicemia Pulmonary embolization Cerebral vascular accident

3

2

2.1

1 3

2

11 5 3 3

in 205 cases (Table IX). The over-all error for groin lymph node involvement in preoperative clinical staging was 24.4 per cent. "Early" and "advanced" lesions. Since some controversy exists in regard to the appropriate treatment of the so-called "early" lesion, patients classified as T 1 N 0 M0 were specifically analyzed. Over the 40 year period 61 patients in this category were treated with radical vulvectomy and groin lymph node dissection even though regional lymph node involvement was thought not to exist at the time of preoperative evaluation. Eleven or 18 per cent of these patients had positive groin lymph nodes either unilaterally or bilaterally. Conversely, 14 patients had such "advanced" lesions that some type of pelvic exenteration was considered the appropriate treatment (Table X). Nine patients were treated with posterior peivic exenteration; three were treated with total pelvic exenteration and two with anterior pelvic exenteration. Of the 12 patients operated upon 5 or more years ago, eight were alive and well at 5 years for a 5 year survival rate of 66.6 per cent. The other four patients died with disease within 5 years.

882 Morley Am

Recurrence. In evaluating the success or failure of the surgical procedures the recurrence rates must be evaluated. Of the 229 patients treated before 1970, 71 or 31 per cent had a recurrence of disease within the first 5 years after the operation. Moreover, from 1935 to 1950 the recurrence rate was 37.7 per cent and from 1960 to 1970 (when more radical en bloc dissection was instituted) the recurrence rate dropped to 26.4 per cent. Vital statistics. The operating time for the three major radical procedures ranged from I Y2 to .>i hours, with a median of 2 hours and 45 minutes. Estimated blood loss ranged from 300 to 3,500 mi., with a median of 1,125 mi. Postoperative hospital stay ranged from 9 to 58 days with a median of 21 days. In the series of 278 patients there were 11 postoperative deaths. (Table XI). There were five deaths within the first 30 days; three patients died from pulmonary embolism. one from cerebrovascular accident, and one from septicemia, thus yielding a 1.8 per cent surgical mortality rate. Six patients died before discharge from the hospital; four of whom died from septicemia and two from cerebrovascular accident. Therefore, there was a 2.1 per cent hospital mortality rate. Since 1968, however. there have been no surgical or hospital deaths following radical operations on the vulva.

Comment Compared with the total number of gynecology patients with infiltrative malignant tumors considered by the Gynecology Tumor Conference since January, 1935, the 404 patients with infiltrative vulvar malignancy represent an incidence of 4 per cent. Previously reported conclusions are confirmed through this report, and it is suggested that they form the basis for criteria for the future treatment of infiltrative carcinoma of the vulva. Analysis of this 40 year series discloses a well-defined interrelation between infiltrative carcinoma of the vulva and chronic vulvar dystrophy, since almost half of the patients had a history of pre-existing chronic vulvitis. Chronic vulvar dystrophies, therefore, should be considered precancerous lesions. Patient delay and physician mismanagement still must be stressed in our educational efforts. if we are to reduce the time between onset of symptoms and institution of therapy. In the study reported here, about a third of the patients had had symptoms for over a year, and an equal number had been treated medically with various lotions, potions, and ointments for 3 to 6 months before biopsy study was carried out. If premalignant lesions were routinely managed aggressively and followed carefully, the incidence of malig-

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April 15. 1976 Obstet. Gynecol.

nant tumors of the vulva could probably be reduced by about half Corollary to this is the possibility that reduced patient delay and earlier diagnosis of disease might significantly raise the sunival rate for this disease. While it is generally agreed that neither radiation therapy alone nor conservative surgical procedures can effectively control infiltrative carcinoma of the vulva. controversies still exist as to exactly what does constitute adequate therapy. Some authors 20 • 21 advocate a relatively conservative and individualized approach to the so-called early lesion, the treatment being tailored to meet the needs of the patient. Age in itself. however. and the presence of medical complications usually associated with older patients have not been regarded as strong contraindications to radical surgery. Many authors 5 • 22 recommend radical vulvectomy and bilateral groin lymph node dissection as the fundamental form of therapy and usuallv as a one-stage procedure. Whether the pelvic lymph nodes should be removed is another matter-some autbors 4 · 15 suggest that bilateral pelvic lymph node dissection be carried out only when certain criteria are met, but others 6 • 23 believe this dissection should be part and parcel of the surgical treatment, routinely. Whatever the specific philosophy one teaches, the principle of radical surgery must be endorsed if we are to significantly improve the chances of survival. At the University of Michigan radical vulvectomy and bilateral groin lymph node dissection, with or without pelvic lymph node exploration. is the fundamental therapeutic approach to most infiltrative lesions of the vulva. Up to now. pelvic lymph node dissection has been considered only in patients with clitoral lesions. groin lymph node involvement, melanoma of the vulva, adenocarcinoma of the vulva. and vaginal or urethral extension of the vulvar disease. Of course, pelvic lymph node dissection was performed in all patients treated with pelvic exenteration. The 278 patients with infiltrative carcinoma of the vulva were treated with one of four types of radical surgery to include: radical vulvectomy only. radical vulvectomy with groin lymph node dissection, radical vulvectomy plus groin lymph node and pelvic lymph node dissection, and some form of pelvic exenteration during the 40 year period from Januarv 1, 1935, to july I, 1975. Thus, 229 patients are the subject of 5 year review. In our series of 229 patients treated with some form of radical surgery prior to January, 1970, the over-all 5 year survival rate (corrected for intercurrent deaths) was 73.9 per cent. For all stages of disease with negative regional nodes, the rate was 92.4 per cent; for cases

Volume 124 Number 8

with positive regional nodes the rate was 28.7 per cent. This in itself suggests the paramount importance of the method of evaluating and treating regional lymph nodes. The over-all corrected 10 year survival rate was 64.1 per cent. When radical vulvectomy and groin lymph node dissection was the treatment of choice for Stage I and Stage II disease, the corrected 5 year survival rate was approximately 95 per cent; for Stage III the rate was 45 per cent. Moreover, when Stage I patients were treated with radical vulvectomy alone the survival rate was about 60 per cent. Such figures leave little room for doubt that the patient's best chance lies with the radical procedure mentioned here and described in detail above. Although the series in which pelvic lymphadenectom_~ was added to the procedure was small (only 23 patients), it should be pointed out that of the six patients with positive nodes only one lived 5 years or more and none of these patients had positive pelvic lymph nodes without also having groin lymph node involvement. Three died of the disease within 5 years, and the other two died in the postoperative period. This suggests that the pelvic lymph node dissection added significantly to the operating time and the risk to the patient, without contributing significantly to the chance of survival. Some authors 24 • 25 have reported the successful use of postoperative radiotherapy to the pelvic lymphatic system without the obvious risk of surgical or hospital death. One has three options, then, in regard to the presence of positive groin lymph nodes or other existing indications for pelvic lymph node treatment: ( 1) extra peritoneal exploration and/ or dissection of the pelvic lymph nodes, as part of the one-stage procedures; (2) transperitoneal pelvic lymphadenectomy at a later date, if indicated; or (3) postoperative pelvic irradiation, at dosage levels approximating 5,000 or 5,500 rads, to the whole pelvis. It appears to be an either-or program: Either you do the pelvic lymph node dissection, or you recommend postoperative irradiation. We must remember that pelvic irradiation is still regarded as an accepted treatment for infiltrative carcinoma of the cervix, and since cervical and vulvar malignancies are usually of the squamous-cell variety, there is good reason to also consider irradiation to the pelvic lymph nodes in infiltrative carcinoma of the vulva. It is proposed, therefore, that a radical vulvectomy and groin lymph node dissection be the initial therapeutic approach to carcinoma of the vulva. If the groin lymph nodes (either superficial or deep) are positive, or if other existing criteria dictate, the patient

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should then undergo either pelvic lymphadenectomy or pelvic irradiation, according to the surgeon's viewpoint. Those recommending pelvic lymphadenectomy endorse the philosophy that infiltrative carcinoma of the vulva is a surgically treated disease; those recommending pelvic irradiation should adopt the belief that the external disease is treated by radical vulvectomy and bilateral groin lymphadenectomy and the internal disease by pelvic irradiation. Whereas there is probably a direct relationship between the size of the primary lesion and the chance survival, the status of the regional lymph nodes seems to be an even more important prognostic indicator. The accuracy of physical diagnosis, however, is limited in determining the true nature of enlarged groin nodes and their appraisal by palpation has been controversial and subject to error. The over-all error of lymph node assessment in the T-N-M system and in the preoperative clinical staging approximated 25 per cent. Clinical speculation is intriguing, and pathologic confirmation is rewarding; however, in this medically sophisticated era, it is time to restrict this evaluation as follows: The preoperative descriptive T-N-M system should be considered an observation only and the definitive clinical staging should be reserved until all the facts are in postoperatively. This is not without precedence; carcinoma of the ovary and sometimes carcinoma of the endometrium are staged after surgical treatment! Simply stated, should a patient with T 1 N0 M0 disease who actually has positive regional lymph nodes be classified T 1 N0 M0 rather than T 1 N2 M0? Conversely, should a patient classified T 1 N2 M0 and thus Stage III disease, who actually has negative groin lymph nodes, be classified Stage III rather than Stage I? As shown in our study, the presence or absence of lymph node metastases is directly related to patient survival when adequate surgical therapy has been instituted. It is therefore recommended that some type of postoperative staging be given serious consideration. Recently much attention has been focused on the so-called "early" lesion of the vulva, with the suggestion that lesser surgery be performed for lesser disease. In our review of T 1 N 0 M0 lesions we found an approximate 20 per cent error in the preoperative classification of the regional lymph node status as compared to postoperative pathology examination. One must, therefore, continue to caution against the injudicious use of lesser surgical procedures in these patients. On the other hand the "advanced" lesions should not be considered hopeless. 25 • 27 Because of the extent and geographic location of the primary lesion in 14 of the patients in this study, some type of pelvic exenterative surgery was considered appropriate in an attempt to

884

Morley Am.

control the disease. Of the 12 patients operated on 5 or more years ago, eight or 66.6 per cenr are living and well without evidence of disease. Because of the relatively high incidence of recurrence, periodic follow-up examination is mandatory for these patients. There was an approximate 33 per cent recurrence rate within the first 5 years from initial therapy and approximately 85 per cent of these recurrences occurred within the first 3 years. Most local recurrences can be treated successfully with a wide local excision. At present there appears to be little benefit from the use of chemotherapeutic agents; however. immunotherapy using the transfer factor has shown promise in one patient who is alive and well 24 months after an exploratory operation disclosed an extensive

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April l£i. IY7ti Obstet. GynecoL

primary lesion with bilateral involvement of both groin and pelvic lymph nodes as well as the para-aortic lymph nodes. Her condition was judged inoperable at that time. and irradiation was considered of limited value; therefore. the immunotherapv was instituted. Finally. the patient must be psychologically supported not only during the immediate postoperative period but throughout the long rehabilitation period. We inflict significant injury on these patients when we do radical vulvar surgery. and it is our obligation to rehabilitate them so that they may live more nearlv normal lives in the future. Some have referred to this procedure as a disfiguring operation; others as a mutilating one. Some day in the future. hopefully, some type of plastic reconstruction or .. vulvoplasty" can be performed satisfactorily in this area.

REFERENCES 1. Taussig, F. ].: Cancer of the vulva, AM. ]. OBSTET. GYNECOL. 40: 764, 1940. 2. Way. S.: Carcinoma of the vulva, AM. J. 0BSTET. GvNECOL. 79: 692, I 940. 3. Collins. C. G., Lee, F. Y., and Roman-Lopez, J. ].: Invasive carcinoma of the vulva with lymph node metastasis, AM.]. OBSTET. GvNECOL. 109: 446, 1971. 4. Rutledge, F., Smith,]. P., and Franklin, E. K.: Carcinoma of the vulva, AM.]. 0BSTET. GYNECOL. 106: 1117. 1970. 5. McKelvey, J. L, and Adcock, L L.: Cancer of the vulva, Obstet. Gynecol. 26: 455, 1965. 6. Green, T. H., Ulfelder, H., and Meigs,]. V.: Epidermoid carcinoma of the vulva. Part II. An analysis of 238 cases, AM. J. 0BSTET. GYNECOL 75: 848, 1958. 7. Folsome, C. E.: Benign and malignant tumors of the vulva,]. A.M. A. 114: 1499, 1940. 8. Green, T H., Ulfelder, H., and Meigs,]. V.: Epidermoid carcinoma of the vulva. Part I. Etiology and diagnosis. AM. J 0BSTET. GYNECOL. 75: 843, I 958. 9. Boutselis, J G.: Radical vulvectomy for invasive squamous cell carcinoma of the vulva, Obstet. Gynecol. 39: 827, 1972. I 0. Classification and staging of malignant tumors in the female pelvis. Acta Obstet. Gynecol. Scand. 50: 1, 1971. 11. Franklin, E. W., III: Clinical staging of carcinoma of the vulva. AM. J. OBSTET. GvNECoL. 40: 277, 1972. 12. Gosling, J. R. G., Abell, M. R., Drolette, B. M., and Loughrin, T. D.: Infiltrative squamous cell carcinoma of vulva, Cancer 14: 330, 1961. 13. Basset, A.: Traitement chirugical operatoire de !'epithelioma primitif dn clitoris, Rev. Chir. 46: 546, 1912. 14. Nelson,]. H.: Atlas of Radical Pelvis Surgery, New York, 1969, Appleton-Century-Crofts Educational Division, Meredith Corp.

Discussion DR. ABRAHAM F. LASH, Chicago. Illinois. My personal experiences over the same period of time (that is, 40 years) at the Cook County Hospital of Chicago form the basis for my discussion.

15. Tovell, H. M. M., Twombly. G. H .. and Dank, L.: Gynecologic operations: Radical vulvectomy and bilateral superficial and deep groin and pelvic lymphadenectomy. Clin. Obstet. Gynecol. 18: 2, 1975. 16. deValera, E.: Radical vulvectomy, AM. ]. 0BSTET. GvNECOL. 101: 78, I 968. 17. Morley, G. W., Lindenauer, S., and Cerny, J. C.: Pelvic exenterative therapy in recurrent pelvic carcinoma. AM. j. 0BSTET. GYNECOL. 109: 1175, 197 J. 18. Parry-Jones, E.: Lvmphatks of the vulva. J Obstct. Gvnecol. Br. Commonw. 67: 919, 1960. 19. w'ay. S.: The anatomy of the lymphatic drainage of the vulva and its influences on the radical operation for carcinoma, Ann. R. Coli. Surg. Engl. 3: 187, 1948. 20. Brunschwig, A., and Brockunier. A.: Surgical treatment of squamous cell carcinoma of the vulva, Obstet. Gynecol. 29: 362, 1967. 21. Parker. R. T.: Personal communications. 22. Franklin, E. W., III, and Rutledge, F. D.: Prognostic factors in epidermoid carcinoma of the vulva, Obstet. Gynecol. 37: 892, 197 I, 23. Shingleton, H. M.. Fowler, W. C., Palumbo, L., and Koch, G. G.: Carcinoma of the vulva: Influence of radical operation on cure rate, Obstet. Gynecol. 35: 1, 1970. 24. Daly, ]. W., and Million, R. R.: Radical vulvectomy combined with elective node irradiation for T-x .\1-o squamous carcinoma of the vulva, Cancer 34: 161, 1974. 25. Helgason. N. M., Hass, A. C., and Latourette, H. B.: Radiation therapy in carcinoma of the vulva, Cancer 30: 997. 1972. 26. Daily, L. J., Kaplan. A. L, and Kaufman, R. H.: Exenteration for advanced carcinoma of the vulva, Obstet. Gynecol. 36: 845, 1970.

The importance of the preoperative study of each patient cannot be overemphasized. The various medical conditions in the elderly patients, such as anemia. obesity, diabetes, hypertension, and myocardial infarct. properly controlled by medical consultants, may con-

Volume 124 Number 8

vert an operative risk to an acceptable surgical candidate. Also, an adequate complete study is needed to rule out asymptomatic primary malignancies as in the breast, gastrointestinal area, or other sites in the generative tract. In our series, a 5 per cent incidence of multiple primary cancers were found. Boutselis 1 reported 15 per cent coexisting malignancies. Age was no deterrent to adequate surgery since it is extraperitoneal and not shock-producing. Our age group varies from 23 to 102 years. The most common precursor or associated pathology in the younger age group were condyloma acuminatum, requiring multiple and repeated biopsies to achieve a definitive diagnosis of carcinoma. The clinical judgment for individualized therapy for a specific patient is based on an extensive surgical experience. Since carcinoma of the vulva is uncommon in the usual gynecologic practice, it seems logical to have these patients treated in well-organized cancer centers having such expertise. Dr. Morley properly emphasized the inaccuracy in determining lymph node involvement by palpation (25 per cent). Kelly3 reported that 28.8 per cent of the patients seen with apparently normal lymph nodes were found to have lymph node metastases. Lymphangiograms have not proved to be as helpful as anticipated for demonstrating involved nodes. But intrasurgical films taken after lymphangiograms before wound closure audit the completeness of the lymphatic tissue and nodes dissection. The patient is positioned over the Bucky casette and after the surgery is completed a film is taken which permits localization of any overlooked residual nodes, which may then be removed. This technique is especially advisable for those gynecologists performing their first radical vulvectomies and groin dissections. The decrease in the surgical mortality rate and increase in the 5 year survivals and cures over the last 50 years has been due to the thoroughness of surgical removal of the cancer-bearing tissue (radical vulvectomy) and the related lymphatics and nodes-(from Taussit (30 to 50 per cent) to Morley (66 to 90 per cent). The blood banks, antibiotics, and anticoagulants have contributed toward improving the 5 year cures as well as survivals. To prevent constriction of the vaginal vestibule and/or prolapse of the anterior vaginal wall and bladder or posterior wall with resulting rectocele, mobilization of the lower third or half of the vagina has been found helpful and free of fear of anoxemia of the walls. The mobile vagina may then be drawn outward in the closing of the mucosal cutaneous wound, thereby preventing constriction of the vaginal orifice, even after a proper perineorrhaphy. Cryosurgery 2 • 4 • 5 has proved effective in overcoming infection or controlling hemorrhage in the large, fungating infected malignant lesions so that surgery need not be delayed for any great length of time. It is also helpful in local recurrences, by destruction of the

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lesion, and is palliative in the neglected or inadequately treated or hopeless situation. Although we cannot prevent cancer from occurring, we can prevent the invasive stage from developing and progressing by recognizing and removing the precursors or the incipient stage of the neoplasm. REFERENCES 1. Boutselis, J. G.: Radical vulvectomy for invasive squamous cell carcinoma of the vulva, Obstet. Gynecol. 39: 827, 1972. 2. Crisp, W. E., Asadourian, L., and Romberger, W.: Application of cryosurgery to gynecologic malignancy, Obstet. Gynecol. 20: 668, 1967. 3. Kelly, J.: Malignant disease of the vulva, Obstet. Gynecol. Br. Commonw. 79: 265, 1972. 4. Lash, A. F.: The immediate control of hemorrhage from gynecological malignancies by cryosurgery, Int. J. Gynecol. Obstet. 10: 72, 1970. 5. Ostergard, D. R., and Townsend, D. E.: Malignant melanoma of the female urethra treated by cryosurgery with radical vulvectomy and anterior exenteration, Obstet. Gynecol. 31: 75, 1968. 6. Taussig, F. J.: Diseases of the Vulva: Gynecological and Obstetrical Monographs, New York, 1931, D. Appleton and Company, vol. 13, p. 170.

DR. RICHARD E. SYMMONDS, Rochester, Minnesota. I have enjoyed the opportunity to review Dr. Morley's complete manuscript, which he has summarized for us very succinctly. Most of the inadequately and haphazardly treated patients who have been excluded were seen, I would presume, in the very early years of the study that covers a 40 year period. Over the last 25 years, more or less, the surgical management of this condition has been fairly well standardized at most medical centers to include a radical vulvectomy with en bloc-incontinuity groin dissections and with somewhat selective pelvic node dissection. This remains our treatment plan, except for the early microinvasive lesions. As with the reports of Way, Green, and others, the Michigan data appear to substantiate the need for this type of operative procedure. Like Dr. Morley, in a sizeable series of cases we have yet to encounter a patient with negative groin nodes who has positive pelvic node metastasis. It appears that the pelvic node dissection can be limited rather safely to patients who are found to have positive groin nodes (preferably by frozen section study) and perhaps those patients who have clitoral-urethral involvement. When the pelvic nodes were involved by metastasis, very few patients have survived. If irradiation has anything to offer other than palliation, I presume it should be applied to the pelvis and lower aortic areas in those patients found to have pelvic node metastasis. I most certainly disagree with recent reports, referred to by Dr. Morley, suggesting that vulvar carcinoma can be better managed by radical vulvectomy followed by 4 to 5 weeks of irradiation to the groin-this to avoid the morbidity and prolonged hospitalization alleged to

886 Morley Am.

occur with groin dissection. With a properly accomplished groin dissection, the innswns heal promptly with infrequent exceptions (usually in obese patients), serious complications are rare, and hospitalization should not exceed about 20 days. What constitutes a properly accomplished groin dissection? I am no longer certain! In direct contrast to the technique advised in the manuscript, we cut rather thin skin flaps, the dissection proceeds from lateral to medial and deep to the fascia over the sartorius and adductor muscles rather than superficial, and we infrequently transplant sartorius muscle. We advocate suction drainage under the flaps as long as necessary and very early patient ambulation; Dr. Morley relics on pressure dressings and bed rest for several days. Despite these differences, our incidence of primary healing, duration of hospitalization, and the results obtained are quite comparable to those reported. This suggests that attention to good surgical principlessharp expeditious dissection. careful handling of tissues, and good hemostasis-is much more important than some of the minutiae about which we differ. In our North Central region, there appear to be three long-standing and persistent problems with this condition: l. Delay in diagnosis, for which patient and physician are about equally responsible. We might ask, hopefully, if Dr. Morley's data indicate some improvement over the years, perhaps in relation to the size of the lesions encountered. 2. Inadequate primary therapy. Of the cases of vulvar carcinomas we see, 17 per cent are referred with recurrent malignancy following a previous local excision or "skimpy" vulvectomy. I presume Dr. Morley's experience has been similar-and how does one stage these patients? 3. Despite a presumably adequate primary operation. there is a significant incidence oflocal recurrence, most often in the perivaginal-periurethral area. Dr. Morley notes a recurrence rate of 33 per cent. How many of these were local recurrences and what are his recommendations for their prevention? DR. jAMES H. NELSON,jR., Brooklyn, New York. Dr. Morley's complete paper carries a detailed description of the technique and preoperative care as he now performs the operation. This points up a problem with a retrospective study covering 40 years and particularly the past 40 years. He describes the use of prophylactic heparin therapy preoperatively and, in some patients, prophylactic antibiotics if indicated. Antibiotics, of course, were not available in 1935 and prophylactic heparin therapy is an approach used only in the past 5 cr 6 years. A retrospective study covering 40 years has value in terms of determining the incidence of lymph node involvement where the regional nodes have been removed. A discussion of survival rates, postoperative complications, and operative deaths is much less meaningful, however, because of the many changes

April 15, 1976 Gynecol.

J. Obstet.

and improvements which have occurred over the last 40 years. Indeed, it would be interesting to see the 5 year survival rates compared between cases treated from 1935 to 1940 and those treated from 1965 to 1970, as well as a comparison of the complications and opera· tive deaths for those two periods. The foregoing is not a criticism peculiar to Dr. Morley's paper, but a growing concern of mine whenever papers are presented covering such .a long retrospective period. Dr. Morley has not made it clear as to when and why he decides to do a deep pelvic node dissection or not to do this procedure as part of the initial surgery. In our own institution we rarely do the deep pelvic node dissection as part of the initial radical vulvectomy and bilateral groin dissections. If the nodes in the groins are positive, then a deep pelvic node dissection is done 4 to 6 weeks later as a second-stage operation and is done by the transperitoneal route so that the paraaortic nodes can be examined and removed also, if necessary. I agree that the division of the inguinal ligament is unnecessary, and in my opinion, not the best approach. Dr. Morley describes a two-team approach and seems to indicate that one team does the groin dissection on one side, and the second team does the opposite groin dissection. Our own two-team approach consists of one team doing both groins and a second team doing the vulvectomy simultaneously. The use of pressure dressings is described. to eliminate dead space; they are left in place for 48 to 72 hours. I would point out to Dr. Morley that pressure dressings are apt to produce ischemia in skin edges that are already in jeopardy from lack of blood supply. We shifted several years ago at the suggestion of Stanley Way to suction drainage bilaterally which seems more physiologic. In this same regard Dr. Morley carries out the initial dressing change at 48 hours and the wound is left exposed and the patient gradually ambulated. Again, I would point out that 48 hours is too short a time if his intention is to treat the skin flaps as a graft. The tissues will continue to leak fluid and almost certainly raise the skin flaps for as long as lO or 11 days postoperatively. Suction is frequently continued in our own patients for periods of approximately 10 days. Dr. Morley states that after the operation, patients are kept in a semi-Fowler's position and allowed only "logrolling" for 48 hours. As I read this manuscript, and came upon the term "log rolling," I immediately conjured up a picture of a patient lying on her back imitating a man running on a log in the water that I used to see so commonly in newsreels. I hope Dr. Morley will define log rolling for us because it may be a very effective new Michigan method for avoiding thrombosis and embolism. In the discussion of complications, the author has indicated that the complication encountered most frequently was wound necrosis or infection and

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Infiltrative carcinoma of vulva

Table I. Incidence of lymph node metastases Author

Green et al. Way Collins et a!. Nelson

Morley

No. of cases

No. with positve nodes

Per cent

238 84 98 70 194

140 44 31 27 64

59 52.3 31.6 38.5 33

secondary disruption. He has indicated that this outcome might well be anticipated since there is a significant amount of tissue damage and that the location of the wound makes it difficult to maintain a sterile field. He then points out the measures taken to prevent these problems. One is to consider the skin flaps as skin grafts and immobilize the area as much as possible, yet he has indicated that he mobilized the patient beginning at 48 hours postoperatively. We have noted a decided improvement in the incidence of wound breakdown by following Dr. Way's suggestion of immobilizing the patients for as long as 12 days. This is extremely difficult to do with the elderly patient and, in fact, we have abandoned this practice in patients 70 years of age or older, or in patients in the 60's who appear chronologically older. We have found if one attempts to immobilize the elderly patient she is apt to develop cerebral changes such as disorientation and amnesia. In the younger patient the protracted period of immobilization has no deleterious effect that we have been able to determine and does improve the healing of the skin flaps. Surprisingly, Dr. Morley did not give actual statistics concerning complications. I realize that the title of the paper indicates the results of surgical treatment, but in my mind, complications are part of results. Dr. Morley has stated under the discussion of lymphedema that lymph nodes can never regenerate. We feel we have demonstrated quite clearly in the literature that, in fact, lymph nodes do regenerate after a pelvic node dissection. Among the results reported the most noteworthy is that of the difference of survival rates between those patients who had no lymph node metastases vs. those with lymph node metastases. It is a most impressive difference, namely, 92.4 per cent corrected 5 year survival rate for those with no lymph node metastases and 38.7 per cent for those with lymph node metastases. Dr. Morley did not tell us what the patients with lymph node metastases died of, but it certainly raises the question as to what the physician should do in the way of further treatment of those patients who have lymph node metastases. It is also of interest that Dr. Morley has one of the lowest incidences of lymph nodes metastases of any series in the literature (Table I). He also demonstrated very impressively that survival

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depended very little on whether it was aT 1 or T 2 lesion, but, as noted above, greatly depended on whether or not lymph node metastases were present. Of equal importance was Dr. Morley's finding that if a patient has either no lymph nodes involved or just one lymph node involved the prognosis is excellent, but with multiple nodes involved on one side or positive nodes bilaterally, prognosis is very markedly reduced. One of the most important facts presented by Dr. Morley in this paper was that 18 per cent of the so-called early lesions, that is TlNOMO, had lymph node metastases. I hope those people constantly advocating conservative surgery will take note of this fact for they will condemn one out of five of their patients to die of this disease if they persist in advocating conservative surgery. Dr. Morley's comments concerning surgical staging and the altering of the TNM system are pertinent. There is no question that the TNM system for vulva carcinoma as it is currently devised will not fly. One of the reasons the International Staging system in Gynecologic Oncology has been successful is because of its simplicity. Unless we simplify the vulva classification, I am afraid it will lose its usefulness. In closing I shall ask Dr. Morley if he is planning any additional therapy for that group of patients with lymph node metastases? DR. MORLEY (Closing). Fifty per cent of our cases were associated with some type of chronic vulvar dystrophy. If we can satisfactorily control the vulvar irritations then we can reduce the actual incidence of carcinoma of the vulva. What about lymphangiography intraoperatively? We have not done this, but we should in the future, especially to determine the adequacy of the dissection. Vaginal stenosis, anterior vaginal wall relaxation, and even stress urinary incontinence are delayed or remote complications. I do think that they can be treated satisfactorily by conventional methods. Time does not permit a detailed discussion of these procedures. In regard to the T 2 lesions, it is interesting to note that in the 1940's the average greatest diameter of the T 2 lesion was 5.5 em., and in the 1960's the average greatest diameter was 4.2 em. I think that is significant and it certainly shows that we are seeing these lesions a little earlier now than previously. I cannot tell you what percentage of our recurrences were distant metastases. I was primarily interested in the local recurrences; 60 per cent of them occurred in the vulvar area proper and 40 per cent of them occurred in the regional lymph node area. Our basic treatment for recurrence is simply wide local excision. We have not used cryosurgery to date. Prophylactic anticoagulants are employed. We use minidose heparin for this purose. It is obvious that this is a retrospective study and should be considered in this way. It does go back a long

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Am.

time and as a matter of fact I have only been there for the last 25 years of the study period. The study actually dates back to 1935, when a person you all know very well, Dr. Norman F. Miller, was Chairman of the Department at Michigan. The 5 year survival rates in cases from 1935 to 1940 vs. 1965 to 1970 were determined but I cannot remember the exact figures. I can say, however, that early in the series more patients had to be treated with palliative vulvectomy or no therapy at all. About pressure dressings . . . I have heard this before . . . that they do some bad! I use them primarily for hemostasis for the first 48 hours. We do a full-thickness dissection rather than a split-thickness (undermining) dissection and we think the pressure dressing serves to immobilize this tissue more effectively. The immediate complications usually were wound infection and wound breakdown, but none had serious sequelae and all responded well to conservative management.

J. Obstet. GynecoL

Lastly, about the radical surgery for external disease and pelvic irradiation for internal disease! I hope I made this point clear that I am not critical of retroperitoneal pelvic lymphadenectomy. I think that people who like to do pelvic lymph node dissection and can do pelvic lymph node dissection should do pelvic lymph node dissection! However, the thing that concerns me, and I have seen this on a number of occasions, that the lesser experienced surgeon will put his finger down into the retroperitoneal space and say, "I don't feel anything so I guess I won't do a pelvic lymph node dissection", or say, "In this case I do not think a pelvic lymph node dissection is indicated" when in actuality it probably was indicated. So, I think they are shying away from it because of the risk involved in doing a retroperitoneal dissection in this somewhat unfamiliar territory. Therefore, I am suggesting that some consideration be given to postoperative pelvic irradiation vs. pelvic lymphadenectomy for this squamous-cell malignancy, possibly as a randomized study in the future.