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Prospective study of the quality of life of cancer patients after intraoral tumor surgery
J Oral Maxillofac Surg 54:664-669, 1996
Prospective Study of the Quality of Life of Cancer Patients After Intraoral Tumor Surgery HENNING
SCHLIEPHAKE, MD, DDS, PHD,* KARSTEN AND THOMAS SCHNELLER, DIPL PSYCH,
RUFFERT, PHD$
DDS,t
Purpose: The aim of this prospective study was to determine the quality of life of patients with oral cancer after intraoral ablative surgery. Patients and Methods: Eighty-five consecutive patients with squamous cell carcinoma of the floor of the mouth were enrolled in the study. Reconstruction of intraoral soft tissues was accomplished by local tissue (67.8%), jejunal grafts (16.9%), and cutaneous and myocutaneous flaps (15.3%). Soft tissue resections were combined with resections of the alveolar process of the mandible in 35.0% and mandibular discontinuity resections in 31.7% of the cases. A self-administered, standard questionnaire consisting of 22 visual analog scale items with a maximum index value of 154 was used to determine the physical functional status, the psychological status, and social functioning of cancer patients (Functional Living Index -Cancer). The questionnaire was administered preoperatively and 3, 6, and 12 months postoperatively. Results: The Functional Living Index score increased significantly toward the end of the first postoperative year because of an increase in all three factors of the scale. All modes of soft tissue reconstruction achieved nearly equal levels of life quality in patients with median or lateral defects at the end of the observation period. Only patients with large bilateral defects exhibited lower preoperative and postoperative values because of extensive loss of functionally important soft tissue. Patients with discontiunuity resections of the mandible took longer to regain the same level of life quality as patients without bone resections. Persistence of dysphagia, reflux of fluids, limitations to liquid food, and sleep disorders had a significant negative effect on the score. Conc/usions: It is concluded that rehabilitation of oral cancer patients is particularly difficult in the case of large soft tissue defects and is not always accomplished completely even with primary microsurgical tissue repair.
The goal of cancer therapy achievement of a disease-free and an acceptable quality of cause the curative resection
associated with the loss of functionally unique tissues, and thus may result in considerably decreased oral function, a successful treatment strategy is not always readily attainable without missing at least one part of the goal. Advances in orofacial reconstruction allow for the removal of even larger tumors and immediate reconstruction by a variety of reliable techniques.lm5 The benefit of this improvement in reconstructive procedures is supposed to be a higher quality of life after completion of surgical rehabilitation. To determine life quality of cancer patients in general, and those with head and neck cancer in particular, a number of new measures of life quality have been developed over the past decade.““’ One major concern in measuring quality of life is the validity and the
may be described as the physical state of health life after treatment. Beof oral cancer is often
Received from the University Medical School, Hannover, many. * Associate Professor, Department of Oral and Maxillofacial
GerSur-
gery.
t Research Fellow, Department of Oral and Maxillofacial Surgery. $ Associate Professor, Department of Medical Psychology. Address correspondence and reprint requests to Dr Schliephake: Department of Oral and Maxillofacial Surgery, University Medical School, Konstanty-Gutschow-Str. 8, D-3000 Hannover 1, Germany. 0 1996 American Association 027%2391/96/5406-0002$3.00/O
of Oral and Maxillofacial
Surgeons
664
SCHLIEPHAKE, ROFFERT, AND SCHNELLER
Tumor stage
665 MEASUREMENTOF LIFE QUALITY
Defect location bilateral median+
T3
lateral
T2
lateral
Tl
median
08 FIGURE
40 1,
80 Tumor
0
40
stages and location
80 of intraoral
% defects.
reliability of the instrument used.” It is generally accepted that measuring quality of life should rely on patient self-reports and be multidimensional, reflecting the physical, functional, psychological, and social health of the individual.12 However, only a few reports have been published that used a validated instrument in measuring the actual quality of life of head and neck cancer patients. The aim of the current study was therefore to determine the postoperative life quality of patients having undergone ablative surgery for oral squamous cell carcinomas with regard to surgical parameters such as tumor stage, extent of soft tissue surgery and bone resections, and the mode of reconstruction by using a well-validated self-administered questionnaire in a prospective trial. Materials
and Methods
STUDY POPULATION Eighty-five consecutive patients with a squamous cell carcinoma of the floor of the mouth and the adjacent regions were enrolled in the study. The mean age of the study population (69 men, 18 women) was 55.8 years (range, 32 to 86). The T-stages were fairly equally distributed except for a slightly smaller number of T3 tumors (Fig 1). The defects resulting from surgery were located mainly unilaterally and anteriorly, with only a small percentage of large bilateral defects. Reconstruction of intraoral soft tissues was accomplished mainly by local tissue for small defects (67.8% of all patients), whereas jejunal grafts (16.9%) and cutaneous and myocutaneous flaps (15.3%) were used to cover larger defects. Soft tissue resections were combined with resection of the alveolar process of the mandible in 35.0% and mandibular discontinuity resections in 3 1.7% of all cases. Mandibular continuity was restored immediately after tumor resection by metal plates, followed by secondary osseous reconstruction after a disease-free interval of 12 to 18 months.
A self-administered standard questionnaire with 22 items was used to determine the physical functional status, the psychological status, and social functioning of cancer patients (Functional Living Index-Cancer; FLIC).’ The questionnaire was applied preoperatively at the time of hospital admission and 3, 6, and 12 months after the operation. The patients were carefully instructed how to use the questionnaire and at each interval, they were accompanied by hospital personnel to assist in any problem arising during its completion. Patients were asked to answer all 22 questions by marking with a vertical slash that point on a horizontal line of a linear visual analog scale that best represented their response. The scale ranged from 1 to 7, with higher numbers representing a better quality of life; the maximum value of the questionnaire was 154. The overall score was separated into three factors: physical well-being (factor l), psychological state (factor 2), and family interaction and sociability (factor 3), according to the factor analysis of Schipper et al.’ In addition to the postoperative quality of life, the postoperative functional state was assessed by a second questionnaire asking about dysphagia, drooling, type of diet, appetite, sleep, and pain at the surgical site. The Kamowsky Performance Index (KPI) was used as a reference scale. The results of the FLIC were related to the following surgical parameters: tumor stage (T, to T4), defect size (<40 mm, 40 to 70 mm, >70 mm, as determined from the maximum diameter of the resection specimen), defect location (midline, lateral, midline + lateral, bilateral, hypopharynx), intraoral soft tissue reconstruction (local tissue, microvascular jejunal grafts, myocutaneous flaps), and mandibular resection (loss of continuity, y/n). The parameters of oral function, which were related to the FLIC values, were defined as dysphagia: (y/n), reflux of fluids: (y/n), type of diet: (normal, purreed/ Soft, liquids, nasogastric tube), sleep disorders (y/n), and chronic pain at the surgical site (y/n). During the duration of the study, 26 of the 85 patients died of disease-related, general cachexia and respiratory failure (Table 1). Another 4 patients refused to continue the study or had to be excluded because of improper or incomplete answers at one of the intervals. A Kaplan-Meier survival analysis” showed that the overall survival of the study population at the end of the study was 68.5%. STATISTICAL METHODS A linear regression analysis was performed to test for correlations between the KPI and the FLIC and the three study factors. For each surgical variable, there was a table with the number of rows corresponding to
666
LIFE
Table
1.
Study
Population
A
Preoperative Patients Deceased Survivors Drop-outs Evaluated
85
85
3 mo
6 mo
12 mo
85 15 70 2 68
68 3 63 2 63
63 8 55
QUALITY
AFIXR
TUMOR
FLIC - Overall Scores
(P = O.OCW
I
55
the number of variable categories and four columns representing the four administrations of the questionnaire. A one-way analysis of variance was used to compare the differences in vertical direction (ie, between the different categories of one variable at each of the four intervals). A Friedman Test was calculated to test in the horizontal direction (ie, for differences in life quality during the observation period). All analyses were performed at a probability level of 5%. ”
B
Factor Analysis 0
Physical
well being
0 Psychological
state
A Sociability
c)
p = 0.0001
Results The FLIC exhibited a significant correlation with the KPI (r = .4111, P = .OOOl). This was attributable to a correlation between the KPI and factor 1 values (physical well-being) (r = 3464, P = .OOOl), whereas the psychological state and the sociability were not significantly correlated with the KPI (r = .0791, P = .5560, r = .0158, P = .4000) (Fig 2). Quality of life changed significantly during the first year after the operation. At the first postoperative follow-up, there was no significant difference compared with the preoperative score (Fig 3A). A significant change, however, came during the second half of the year, with an increase in the score from 118.6 to 126.3 (P = .0007). The individual values of the score varied between 58 and 148 at the beginning of the obeservation period and between 81 and 148 at the end of the first postoperative year. An analysis of the three separate factors showed that a distinct increase occurred in the physical state (Factor 1: P = .OOOl), whereas the psychological state and sociability changed signih-
FLIC 160
_
Factor
140-
1 (r=O.3464)
Factor 2 (r=O.O791) Factor 3 (r=O.O158)
120IOO-
40-
:
.
l
’
0
2.
I I
I,
12
3
Correlation
i .
l
.
:
8 .
.
. I I,,,,
20-
FIGURE
:
.
60-
:i
b .
80-
4
5
of FLIC
6
RESECTION
7
8
910
Karnowsky
and KPI (r = .4111, P = .0001).
p = 0.0010
30 i
*-u I +-w--f%
--
m
-___co
-A p = 0.0016
1
10 c ~---I preop. 3 Months
6 Months
/ 12 Months
FIGURE 3. A, Changes in FLIC scores during the first postoperative year. B, Analysis of the three different factors of life quality.
cantly, but not as clearly as the physical well-being (factor 2: P = .OOlO; factor 3: P = .0016) (Fig 3B). The increase in quality of life was limited to the group of survivors; the scores of the patients who died during the follow-up period started from a significantly lower preoperative level and showed a gradual decrease during the study (Fig 4). The analysis of the individual surgical parameters showed that the T-stage had no significant effect on the quality of life, either on the preoperative values or on the score after the first postoperative year. However, patients with T, tumors were the only ones to show a significant increase in their rating of life quality (P = .0177). Likewise, the size of the soft tissue defect alone was not correlated with the postoperative quality of life, exhibiting a gradual increase in the FLIC score in all three categories of defect size without statistically significant differences. By contrast, the location of the defect appeared to have some effect on postoperative life quality. Those patients who had undergone bilateral resections had the lowest values preoperatively (P = .OlOS), which remained low during the follow-up period. However,
SCHLIEPHAKE,
RiiFFERT,
AND
SCHNELLER
FLIC-Score
FLIC - Scores 0 Survivors
150
0 Deceased
0 Local flaps ci Jejunal graft
Myocut. flap
150 140
140 130 120 110 100 90
90
0.0173
0.0413
0.0277
“.S
80
80
preop. FIGURE FIGURE
4.
FLIC
scores in relation
FLIC-Score 0 lateral
0 median
FLIC
12 Months
6 Months
scores in relation
to mode of soft tissue repair.
nificantly decreased preoperative and postoperative values in this population (Fig 8). Reflux of liquids also had some effect, because a significant increase in life quality was registered only in patients without reflux. Likewise, the type of diet, which significantly decreased scores in patients who are limited to liquid food, and sleep disorders, had a significantly negative effect. Discussion The Functional Living Index-Cancer of Schipper et al7 has proved to be suitable for measuring quality of life of oral cancer patients, providing a good correlation with the Kamowsky Index and a satisfactory reflection of differences in quality of life with regard to surgical procedures and functional sequelae in retrospective trials.14.15 The current prospective trial has likewise shown the validity of this instrument in that only the score representing physical ability, but not the psychosocial factors, correlated with the KPI. The study showed a significant increase in quality of life occurring during the first year after surgical treatment for oral cancer. The range of variation of
FLIC-Score
/ Defect location 0 med.+lat.
6.
3 Months
to survival.
direct comparison with unilateral or median defects was limited by the small number of patients with bilateral defects and the fact that none of these patients survived the study period (Fig 5). The mode of reconstruction had a significant effect on the development of postoperative quality of life during the first postoperative year. Patients with a jejunal graft initially showed a significant decrease in the score compared with those with local tissue reconstructions (P = .0431 and P = .0277). However, at the end of the observation period, the FLIC values for patients with all reconstructive techniques were nearly equal (Fig 6). Another parameter of relevance was the resection of mandibular bone. Although the score showed a constant and significant increase in postoperative life quality in those patients who had encountered only limited resection of the alveolar process (P = .0070), the FLIC values of patients with discontinuity resections increased much later (Fig 7). This late, but insignificant, increase can most likely be accounted for by the values of four patients who had received mandibular reconstruction in the meantime. From the list of postoperative functional parameters, the persistence of dyphagia was associated with sig-
‘50
/ Soft tissue reconstruction
bilateral
l Preservation
150 140 130 120 110
I
(-1 Discontinuity
resection resection
~~
•~ !
‘00
90
/ Mandibular of continuity
f:?
R “3.
“.S.
prebp.
3 Months
+ i‘
-*
0.0070 0.1122
“5
I
80
FIGURE FIGURE
5.
FLIC
scores in relation
to defect
location
bone.
7.
FLIC
6 Months
scores in relation
12 imonths to resection
of mandibular
668
LIFE
FLIC-Score 140 130 120 110 100 go 80
FIGURE
•m-~ ~
l (J
/ Dysphagia
*
~~
::
0
0.0007
/ ) lls.
” 0.0138
’ I p&p. 8.
0.0011
0.0041
0.0007
~_ ~~ 3 Months 6 Months FLIC
scores in relation
to persistence
12 ionths of dysphagia.
individual values in the preoperative state covered two thirds of the entire range of the FLIC score, indicating a reasonable reflection of individual variations in the study population. It thus correlates well with findings of Ganz et alI4 in a prospective evaluation of patients with lung cancer. In this study, the range of variation decreased at the end of the first postoperative year and was limited to the upper third of the score as a result of successful surgical therapy. Because the increase in the score was mainly accomplished by improvement of the physical state (factor l), it seems that physical recovery from surgery and its functional sequelae constitute the major aspect of life quality during the first year after intraoral tumor resection. This is in accordance with the previous results, which showed that the effect of physical symptoms dominates other indicators of quality of life in head and neck cancer patients.” It also correlates well with the findings of Mohide et al,” who, in a retrospective study, reported that patients with laryngeal cancers ranked physical consequences of surgery as the most important item. The results with regard to the effect of the surgical parameters, in general, confirm those of a previous study in which the FLIC questionnaire had been used retrospectively in oral cancer patients.‘” It appears from both the prospective and the retrospective trial that discontinuity resections of the mandible combined with large bilateral soft tissue defects are associated with the lowest postoperative quality of life. However, the differences were not as clear in the current study population as in retrospective studies on larger samples. This is perhaps because of the progressively decreasing number of patients during the observation period, which limited the analysis of this complex parameter. For the same reason, a multivariate approach for determination of interdependencies of isolated parameters had to be abandonded. Despite the fairly short duration of the study, the effect of functional impairment on the day-to-day life of cancer patients becomes evident in the poorer ratings by patients with limited capability for food intake and deglutition.
QUALITY
AFTER
TUMOR
RESECTION
One major question regarding mandibular resection would be whether the results could have been improved by immediate osseous reconstruction of the mandible. This possibility is supported by the fact that secondary mandibular reconstruction appeared to have contributed to improvement of life quality in the current population. A definite conclusion in this respect is, however, again limited by the small number of secondary reconstructions performed during the study period. By contrast, a retrospective analysis of long-term results has shown that patients who had received mandibular reconstruction with bone grafts presented no higher scores in determination of life quality than those who had refused osseous reconstruction.‘* This may reflect individual differences in the ability to cope with a mutilated facial contour or impaired oral function. Conversely, it may indicate that the benefit of restoring mandibular continuity, with the option of subsequent implant placement, is limited by the simultaneous loss of functionally valuable soft tissue, which is essential for a harmonic chewing function. Because it is impossible to assign patients randomly to a certain group of soft tissue reconstruction regardless of the location and the size of the defect to be repaired, it is not possible to measure the benefit of microvascular soft tissue reconstruction in comparison with local tissue flaps for extensive bilateral defects. It remains unclear whether the low scores in patients with large bilateral defects in the current study resulted from unsatisfactory function and esthetics or from disease-related deterioration of their general health. Retrospective evaluation of life quality of glossectomized patients after soft tissue repair using a myocutaneous rectus flap has shown that these patients have preserved at least a moderate quality of life,‘” which would have been impossible with local reconstructive measures alone. The merit of microsurgery in orofacial reconstruction is therefore great. However, it appears that even with today’s techniques of immediate microvascular reconstruction of soft tissues, it is not always possible to restore quality of life to the same level that can be achieved with primary soft tissue repair of smaller defects. References 1. Salibian AH, Rapaport I, Allison G: Functional oromandibular reconstruction with the composite groin flap. PIast Reconstr Surg 76:819, 1985 2. Swartz WM. Banis JC, Newton ED, et al: The osteocutaneous scapular flap for mandibular and maxillary reconstruction. Plast Reconstr Surg 77530, 1986 3. Vaughan ED: The radial forearm free flap in orofacial reconstruction. J Craniomaxillofac Surg 18:2, 1990 4. Towpik E, Meyza J: The “double faced” pectoralis major island flap. J Craniomaxillofac Surg 18:85, 1990 5. Sadove RC, Lute EA, McGrath PG: Reconstruction of the lower lip and chin with the composite radial forearm-palmaris longus free flap. Plast Reconstr Surg 88:209, 1991 6. Aaronson NK, Ahmedzai S, Berman B, et al: The European
669
RICHARD E. GLIKLICH
7.
8. 9. 10.
11. 12. 13.
organization for research and treatment of cancer QLQC30: A quality-of-life instrument for use in international clinical trials in oncology. J Nat] Cancer Inst 85:365, 1993 Schipper H, Clinch J, McMurray A, et al: Measuring the quality of life of cancer patients: The functional living index-cancer: Development and validation. J Clin Oncol 2472, 1984 Jones E, Lund VJ, Howard DJ, et al: Quality of life of patients treated surgically for head and neck cancer. J Laryngol Otol 106:238, 1992 Seifert E, Bier H, Ganzer U: Die Beurteilung der Lebensqualitlt van Patienten mit inkurablen Kopf-Hals-Tumoren. LaryngorhinoOto1ogie 68:285, 1989 Tilkom M, Mawick R, Sommerfeld S, et al: Lebensqualitlt von Patienten mit bosartigen Gesichts- und HauttumorenEntwicklung eines Fragebogens und erste Ergebnisse einer Studie. Rehabilitation 19:134, 1990 Cella DF, Tulska DS: Measuring quality of life today: Methodological aspects. Oncology 4:29, 1990 Aaronson NK: Quality of life research in cancer clinical trials: A need for common rules and language. Oncology 4:59, 1990 SPSS 6.0 fur Windows, BSB, Koblenz, 1994
14. Ganz PA, Haskell CM, Figlin RA, et al: Estimating the quality of life in a clinical trial of patients with metastatic klung cancer using the Kamowsky-performance status and functional-living index-cancer. Cancer 61:845, 1988 15. Schliephake H, Neukam FW, Schneller T, et al: EinfluR intraoraler Defektrekonstruktionsverfahren auf die Lebensqualitat nach Tumorresektion, in Zilch A, Schumann E: Plastischrekonstruktive Mal3nahmen bei Knochen- und Weichteildefekten. Thieme, Stuttgart, 1994, pp 37-40 16. Van Knippenberg FC, Out JJ, Tilanus HW, et al: Quality of life in patients with resected oesophageal cancer. Sot Sci Med 35:139, 1992 17. Mohide EA, Archibald SD, Tew M, et al: Postlaryngectomy quality-of-life dimensions identified by patients and health care professionals. Am J Surg 164:619, 1992 18. Schliephake H, Neukam FW, Schmelzeisen R, et al: Long-term results of life quality after ablative intraoral tumor surgery. J Craniomaxillofac Surg 23:243, 1995 19. Schliephake H, Schmelzeisen R, Neukam FW: The free revascularized rectus abdominis flap for the repair of tumor related defects in the head and neck area. Br J Oral Maxillofac Surg 34:18, 1996
J Oral Maxillofac Surg 54:669-670. 1996
Discussion Prospective Study of the Quality of Life of Cancer Patients After Intraoral Tumor Surgery Richard E. Gliklich, MD Harvard
Medical
School,
Boston,
Massachusetts
The oral cavity presents a complex interrelationship between structure and function. Consequently, the presence or treatment of oral cavity carcinomas may have considerable functional impact and lead to significant changes in patientperceived functioning and well-being, or quality of life. Despite being a small area of the oral cavity, the floor of mouth has an important role in speech, mastication, and deglutition. Changes in the floor of mouth may affect both the oral and phatyngeal phases of swallowing by tethering the anterior tongue or by displacing the anterior tongue posteriorly. Insensate areas of the floor of mouth can lead to residue with spillage. Loss of an adequate sulcus prevents dental restoration. Extensive defects, coupled with an atonic lower lip, can lead to lip malposition and lack of lip closure, with exposure and drooling. In this article, Schliephake et al have prospectively followed patients with a variety of floor of mouth carcinomas after ablative surgery and reconstruction using a psychometrically validated generic quality-of-life questionnaire (Functional Living Index-Cancer (FLIC)). Overall, this large group of patients demonstrated significant improvement in FLIC scores from preoperative status to 12-month postoperative status. Quality of life is clearly a crucial outcome to assess in patients undergoing significant life-altering procedures. In addition, the longitudinal rather than the crosssectional use of such a measure in this population is particularly noteworthy because it enables the patients to be compared against themselves rather than normative data. The authors’ comments on the need for valid and reliable in-
struments in such studies is worth emphasizing. It is not acceptable to merely create questionnaires to assess patient well-being; such instruments must pass set benchmarks of reliability and validity, and these benchmarks should be reported as they were in this investigation. This study falls in the realm of outcomes research. Outcomes research has been described as a technology of patient experience.’ That experience begins with a starting point and goes to an end point or outcome. Traditional outcomes include mortality and complication rates. However, mortality and complications, although important in tumor surgery, yield very little discerning information with regard to functional reconstruction. Functional or performance measures in the head and neck,*,’ although considered “objective,” continue to have problems of test-retest reliability and observer bias. Quality of life measures, although considered “subjective,” can be constructed to be valid and reliable, as shown in this study. Therefore, some of the best information that is relevant to the patient after ablative and reconstructive surgery is likely to come from the patient. As with any investigative methodology, quality of life outcome measures have limitations. For example, this study failed to demonstrate large differences in outcome between the reconstructive techniques performed. Although the authors suggest that this may because of the lack of a difference, its seems more likely that this study may not have had the necessary power to detect a difference between techniques, even if one was present. This study used a generic quality of life measure, the Functional Living Index-Cancer. Generic quality of life instruments may be limited in longitudinal sensitivity or the ability to demonstrate real clinical change over time.4 This lack of sensitivity has been demonstrated in other disease states when generic measures were compared with more disease-specific quality of life measures.’ It is now generally held that to portray a complete picture of quality of life for a particular disease, it is prefera-
Prospective Study of the Quality of Life of Cancer Patients After Intraoral Tumor Surgery HENNING
SCHLIEPHAKE, MD, DDS, PHD,* KARSTEN AND THOMAS SCHNELLER, DIPL PSYCH,
RUFFERT, PHD$
DDS,t
Purpose: The aim of this prospective study was to determine the quality of life of patients with oral cancer after intraoral ablative surgery. Patients and Methods: Eighty-five consecutive patients with squamous cell carcinoma of the floor of the mouth were enrolled in the study. Reconstruction of intraoral soft tissues was accomplished by local tissue (67.8%), jejunal grafts (16.9%), and cutaneous and myocutaneous flaps (15.3%). Soft tissue resections were combined with resections of the alveolar process of the mandible in 35.0% and mandibular discontinuity resections in 31.7% of the cases. A self-administered, standard questionnaire consisting of 22 visual analog scale items with a maximum index value of 154 was used to determine the physical functional status, the psychological status, and social functioning of cancer patients (Functional Living Index -Cancer). The questionnaire was administered preoperatively and 3, 6, and 12 months postoperatively. Results: The Functional Living Index score increased significantly toward the end of the first postoperative year because of an increase in all three factors of the scale. All modes of soft tissue reconstruction achieved nearly equal levels of life quality in patients with median or lateral defects at the end of the observation period. Only patients with large bilateral defects exhibited lower preoperative and postoperative values because of extensive loss of functionally important soft tissue. Patients with discontiunuity resections of the mandible took longer to regain the same level of life quality as patients without bone resections. Persistence of dysphagia, reflux of fluids, limitations to liquid food, and sleep disorders had a significant negative effect on the score. Conc/usions: It is concluded that rehabilitation of oral cancer patients is particularly difficult in the case of large soft tissue defects and is not always accomplished completely even with primary microsurgical tissue repair.
The goal of cancer therapy achievement of a disease-free and an acceptable quality of cause the curative resection
associated with the loss of functionally unique tissues, and thus may result in considerably decreased oral function, a successful treatment strategy is not always readily attainable without missing at least one part of the goal. Advances in orofacial reconstruction allow for the removal of even larger tumors and immediate reconstruction by a variety of reliable techniques.lm5 The benefit of this improvement in reconstructive procedures is supposed to be a higher quality of life after completion of surgical rehabilitation. To determine life quality of cancer patients in general, and those with head and neck cancer in particular, a number of new measures of life quality have been developed over the past decade.““’ One major concern in measuring quality of life is the validity and the
may be described as the physical state of health life after treatment. Beof oral cancer is often
Received from the University Medical School, Hannover, many. * Associate Professor, Department of Oral and Maxillofacial
GerSur-
gery.
t Research Fellow, Department of Oral and Maxillofacial Surgery. $ Associate Professor, Department of Medical Psychology. Address correspondence and reprint requests to Dr Schliephake: Department of Oral and Maxillofacial Surgery, University Medical School, Konstanty-Gutschow-Str. 8, D-3000 Hannover 1, Germany. 0 1996 American Association 027%2391/96/5406-0002$3.00/O
of Oral and Maxillofacial
Surgeons
664
SCHLIEPHAKE, ROFFERT, AND SCHNELLER
Tumor stage
665 MEASUREMENTOF LIFE QUALITY
Defect location bilateral median+
T3
lateral
T2
lateral
Tl
median
08 FIGURE
40 1,
80 Tumor
0
40
stages and location
80 of intraoral
% defects.
reliability of the instrument used.” It is generally accepted that measuring quality of life should rely on patient self-reports and be multidimensional, reflecting the physical, functional, psychological, and social health of the individual.12 However, only a few reports have been published that used a validated instrument in measuring the actual quality of life of head and neck cancer patients. The aim of the current study was therefore to determine the postoperative life quality of patients having undergone ablative surgery for oral squamous cell carcinomas with regard to surgical parameters such as tumor stage, extent of soft tissue surgery and bone resections, and the mode of reconstruction by using a well-validated self-administered questionnaire in a prospective trial. Materials
and Methods
STUDY POPULATION Eighty-five consecutive patients with a squamous cell carcinoma of the floor of the mouth and the adjacent regions were enrolled in the study. The mean age of the study population (69 men, 18 women) was 55.8 years (range, 32 to 86). The T-stages were fairly equally distributed except for a slightly smaller number of T3 tumors (Fig 1). The defects resulting from surgery were located mainly unilaterally and anteriorly, with only a small percentage of large bilateral defects. Reconstruction of intraoral soft tissues was accomplished mainly by local tissue for small defects (67.8% of all patients), whereas jejunal grafts (16.9%) and cutaneous and myocutaneous flaps (15.3%) were used to cover larger defects. Soft tissue resections were combined with resection of the alveolar process of the mandible in 35.0% and mandibular discontinuity resections in 3 1.7% of all cases. Mandibular continuity was restored immediately after tumor resection by metal plates, followed by secondary osseous reconstruction after a disease-free interval of 12 to 18 months.
A self-administered standard questionnaire with 22 items was used to determine the physical functional status, the psychological status, and social functioning of cancer patients (Functional Living Index-Cancer; FLIC).’ The questionnaire was applied preoperatively at the time of hospital admission and 3, 6, and 12 months after the operation. The patients were carefully instructed how to use the questionnaire and at each interval, they were accompanied by hospital personnel to assist in any problem arising during its completion. Patients were asked to answer all 22 questions by marking with a vertical slash that point on a horizontal line of a linear visual analog scale that best represented their response. The scale ranged from 1 to 7, with higher numbers representing a better quality of life; the maximum value of the questionnaire was 154. The overall score was separated into three factors: physical well-being (factor l), psychological state (factor 2), and family interaction and sociability (factor 3), according to the factor analysis of Schipper et al.’ In addition to the postoperative quality of life, the postoperative functional state was assessed by a second questionnaire asking about dysphagia, drooling, type of diet, appetite, sleep, and pain at the surgical site. The Kamowsky Performance Index (KPI) was used as a reference scale. The results of the FLIC were related to the following surgical parameters: tumor stage (T, to T4), defect size (<40 mm, 40 to 70 mm, >70 mm, as determined from the maximum diameter of the resection specimen), defect location (midline, lateral, midline + lateral, bilateral, hypopharynx), intraoral soft tissue reconstruction (local tissue, microvascular jejunal grafts, myocutaneous flaps), and mandibular resection (loss of continuity, y/n). The parameters of oral function, which were related to the FLIC values, were defined as dysphagia: (y/n), reflux of fluids: (y/n), type of diet: (normal, purreed/ Soft, liquids, nasogastric tube), sleep disorders (y/n), and chronic pain at the surgical site (y/n). During the duration of the study, 26 of the 85 patients died of disease-related, general cachexia and respiratory failure (Table 1). Another 4 patients refused to continue the study or had to be excluded because of improper or incomplete answers at one of the intervals. A Kaplan-Meier survival analysis” showed that the overall survival of the study population at the end of the study was 68.5%. STATISTICAL METHODS A linear regression analysis was performed to test for correlations between the KPI and the FLIC and the three study factors. For each surgical variable, there was a table with the number of rows corresponding to
666
LIFE
Table
1.
Study
Population
A
Preoperative Patients Deceased Survivors Drop-outs Evaluated
85
85
3 mo
6 mo
12 mo
85 15 70 2 68
68 3 63 2 63
63 8 55
QUALITY
AFIXR
TUMOR
FLIC - Overall Scores
(P = O.OCW
I
55
the number of variable categories and four columns representing the four administrations of the questionnaire. A one-way analysis of variance was used to compare the differences in vertical direction (ie, between the different categories of one variable at each of the four intervals). A Friedman Test was calculated to test in the horizontal direction (ie, for differences in life quality during the observation period). All analyses were performed at a probability level of 5%. ”
B
Factor Analysis 0
Physical
well being
0 Psychological
state
A Sociability
c)
p = 0.0001
Results The FLIC exhibited a significant correlation with the KPI (r = .4111, P = .OOOl). This was attributable to a correlation between the KPI and factor 1 values (physical well-being) (r = 3464, P = .OOOl), whereas the psychological state and the sociability were not significantly correlated with the KPI (r = .0791, P = .5560, r = .0158, P = .4000) (Fig 2). Quality of life changed significantly during the first year after the operation. At the first postoperative follow-up, there was no significant difference compared with the preoperative score (Fig 3A). A significant change, however, came during the second half of the year, with an increase in the score from 118.6 to 126.3 (P = .0007). The individual values of the score varied between 58 and 148 at the beginning of the obeservation period and between 81 and 148 at the end of the first postoperative year. An analysis of the three separate factors showed that a distinct increase occurred in the physical state (Factor 1: P = .OOOl), whereas the psychological state and sociability changed signih-
FLIC 160
_
Factor
140-
1 (r=O.3464)
Factor 2 (r=O.O791) Factor 3 (r=O.O158)
120IOO-
40-
:
.
l
’
0
2.
I I
I,
12
3
Correlation
i .
l
.
:
8 .
.
. I I,,,,
20-
FIGURE
:
.
60-
:i
b .
80-
4
5
of FLIC
6
RESECTION
7
8
910
Karnowsky
and KPI (r = .4111, P = .0001).
p = 0.0010
30 i
*-u I +-w--f%
--
m
-___co
-A p = 0.0016
1
10 c ~---I preop. 3 Months
6 Months
/ 12 Months
FIGURE 3. A, Changes in FLIC scores during the first postoperative year. B, Analysis of the three different factors of life quality.
cantly, but not as clearly as the physical well-being (factor 2: P = .OOlO; factor 3: P = .0016) (Fig 3B). The increase in quality of life was limited to the group of survivors; the scores of the patients who died during the follow-up period started from a significantly lower preoperative level and showed a gradual decrease during the study (Fig 4). The analysis of the individual surgical parameters showed that the T-stage had no significant effect on the quality of life, either on the preoperative values or on the score after the first postoperative year. However, patients with T, tumors were the only ones to show a significant increase in their rating of life quality (P = .0177). Likewise, the size of the soft tissue defect alone was not correlated with the postoperative quality of life, exhibiting a gradual increase in the FLIC score in all three categories of defect size without statistically significant differences. By contrast, the location of the defect appeared to have some effect on postoperative life quality. Those patients who had undergone bilateral resections had the lowest values preoperatively (P = .OlOS), which remained low during the follow-up period. However,
SCHLIEPHAKE,
RiiFFERT,
AND
SCHNELLER
FLIC-Score
FLIC - Scores 0 Survivors
150
0 Deceased
0 Local flaps ci Jejunal graft
Myocut. flap
150 140
140 130 120 110 100 90
90
0.0173
0.0413
0.0277
“.S
80
80
preop. FIGURE FIGURE
4.
FLIC
scores in relation
FLIC-Score 0 lateral
0 median
FLIC
12 Months
6 Months
scores in relation
to mode of soft tissue repair.
nificantly decreased preoperative and postoperative values in this population (Fig 8). Reflux of liquids also had some effect, because a significant increase in life quality was registered only in patients without reflux. Likewise, the type of diet, which significantly decreased scores in patients who are limited to liquid food, and sleep disorders, had a significantly negative effect. Discussion The Functional Living Index-Cancer of Schipper et al7 has proved to be suitable for measuring quality of life of oral cancer patients, providing a good correlation with the Kamowsky Index and a satisfactory reflection of differences in quality of life with regard to surgical procedures and functional sequelae in retrospective trials.14.15 The current prospective trial has likewise shown the validity of this instrument in that only the score representing physical ability, but not the psychosocial factors, correlated with the KPI. The study showed a significant increase in quality of life occurring during the first year after surgical treatment for oral cancer. The range of variation of
FLIC-Score
/ Defect location 0 med.+lat.
6.
3 Months
to survival.
direct comparison with unilateral or median defects was limited by the small number of patients with bilateral defects and the fact that none of these patients survived the study period (Fig 5). The mode of reconstruction had a significant effect on the development of postoperative quality of life during the first postoperative year. Patients with a jejunal graft initially showed a significant decrease in the score compared with those with local tissue reconstructions (P = .0431 and P = .0277). However, at the end of the observation period, the FLIC values for patients with all reconstructive techniques were nearly equal (Fig 6). Another parameter of relevance was the resection of mandibular bone. Although the score showed a constant and significant increase in postoperative life quality in those patients who had encountered only limited resection of the alveolar process (P = .0070), the FLIC values of patients with discontinuity resections increased much later (Fig 7). This late, but insignificant, increase can most likely be accounted for by the values of four patients who had received mandibular reconstruction in the meantime. From the list of postoperative functional parameters, the persistence of dyphagia was associated with sig-
‘50
/ Soft tissue reconstruction
bilateral
l Preservation
150 140 130 120 110
I
(-1 Discontinuity
resection resection
~~
•~ !
‘00
90
/ Mandibular of continuity
f:?
R “3.
“.S.
prebp.
3 Months
+ i‘
-*
0.0070 0.1122
“5
I
80
FIGURE FIGURE
5.
FLIC
scores in relation
to defect
location
bone.
7.
FLIC
6 Months
scores in relation
12 imonths to resection
of mandibular
668
LIFE
FLIC-Score 140 130 120 110 100 go 80
FIGURE
•m-~ ~
l (J
/ Dysphagia
*
~~
::
0
0.0007
/ ) lls.
” 0.0138
’ I p&p. 8.
0.0011
0.0041
0.0007
~_ ~~ 3 Months 6 Months FLIC
scores in relation
to persistence
12 ionths of dysphagia.
individual values in the preoperative state covered two thirds of the entire range of the FLIC score, indicating a reasonable reflection of individual variations in the study population. It thus correlates well with findings of Ganz et alI4 in a prospective evaluation of patients with lung cancer. In this study, the range of variation decreased at the end of the first postoperative year and was limited to the upper third of the score as a result of successful surgical therapy. Because the increase in the score was mainly accomplished by improvement of the physical state (factor l), it seems that physical recovery from surgery and its functional sequelae constitute the major aspect of life quality during the first year after intraoral tumor resection. This is in accordance with the previous results, which showed that the effect of physical symptoms dominates other indicators of quality of life in head and neck cancer patients.” It also correlates well with the findings of Mohide et al,” who, in a retrospective study, reported that patients with laryngeal cancers ranked physical consequences of surgery as the most important item. The results with regard to the effect of the surgical parameters, in general, confirm those of a previous study in which the FLIC questionnaire had been used retrospectively in oral cancer patients.‘” It appears from both the prospective and the retrospective trial that discontinuity resections of the mandible combined with large bilateral soft tissue defects are associated with the lowest postoperative quality of life. However, the differences were not as clear in the current study population as in retrospective studies on larger samples. This is perhaps because of the progressively decreasing number of patients during the observation period, which limited the analysis of this complex parameter. For the same reason, a multivariate approach for determination of interdependencies of isolated parameters had to be abandonded. Despite the fairly short duration of the study, the effect of functional impairment on the day-to-day life of cancer patients becomes evident in the poorer ratings by patients with limited capability for food intake and deglutition.
QUALITY
AFTER
TUMOR
RESECTION
One major question regarding mandibular resection would be whether the results could have been improved by immediate osseous reconstruction of the mandible. This possibility is supported by the fact that secondary mandibular reconstruction appeared to have contributed to improvement of life quality in the current population. A definite conclusion in this respect is, however, again limited by the small number of secondary reconstructions performed during the study period. By contrast, a retrospective analysis of long-term results has shown that patients who had received mandibular reconstruction with bone grafts presented no higher scores in determination of life quality than those who had refused osseous reconstruction.‘* This may reflect individual differences in the ability to cope with a mutilated facial contour or impaired oral function. Conversely, it may indicate that the benefit of restoring mandibular continuity, with the option of subsequent implant placement, is limited by the simultaneous loss of functionally valuable soft tissue, which is essential for a harmonic chewing function. Because it is impossible to assign patients randomly to a certain group of soft tissue reconstruction regardless of the location and the size of the defect to be repaired, it is not possible to measure the benefit of microvascular soft tissue reconstruction in comparison with local tissue flaps for extensive bilateral defects. It remains unclear whether the low scores in patients with large bilateral defects in the current study resulted from unsatisfactory function and esthetics or from disease-related deterioration of their general health. Retrospective evaluation of life quality of glossectomized patients after soft tissue repair using a myocutaneous rectus flap has shown that these patients have preserved at least a moderate quality of life,‘” which would have been impossible with local reconstructive measures alone. The merit of microsurgery in orofacial reconstruction is therefore great. However, it appears that even with today’s techniques of immediate microvascular reconstruction of soft tissues, it is not always possible to restore quality of life to the same level that can be achieved with primary soft tissue repair of smaller defects. References 1. Salibian AH, Rapaport I, Allison G: Functional oromandibular reconstruction with the composite groin flap. PIast Reconstr Surg 76:819, 1985 2. Swartz WM. Banis JC, Newton ED, et al: The osteocutaneous scapular flap for mandibular and maxillary reconstruction. Plast Reconstr Surg 77530, 1986 3. Vaughan ED: The radial forearm free flap in orofacial reconstruction. J Craniomaxillofac Surg 18:2, 1990 4. Towpik E, Meyza J: The “double faced” pectoralis major island flap. J Craniomaxillofac Surg 18:85, 1990 5. Sadove RC, Lute EA, McGrath PG: Reconstruction of the lower lip and chin with the composite radial forearm-palmaris longus free flap. Plast Reconstr Surg 88:209, 1991 6. Aaronson NK, Ahmedzai S, Berman B, et al: The European
669
RICHARD E. GLIKLICH
7.
8. 9. 10.
11. 12. 13.
organization for research and treatment of cancer QLQC30: A quality-of-life instrument for use in international clinical trials in oncology. J Nat] Cancer Inst 85:365, 1993 Schipper H, Clinch J, McMurray A, et al: Measuring the quality of life of cancer patients: The functional living index-cancer: Development and validation. J Clin Oncol 2472, 1984 Jones E, Lund VJ, Howard DJ, et al: Quality of life of patients treated surgically for head and neck cancer. J Laryngol Otol 106:238, 1992 Seifert E, Bier H, Ganzer U: Die Beurteilung der Lebensqualitlt van Patienten mit inkurablen Kopf-Hals-Tumoren. LaryngorhinoOto1ogie 68:285, 1989 Tilkom M, Mawick R, Sommerfeld S, et al: Lebensqualitlt von Patienten mit bosartigen Gesichts- und HauttumorenEntwicklung eines Fragebogens und erste Ergebnisse einer Studie. Rehabilitation 19:134, 1990 Cella DF, Tulska DS: Measuring quality of life today: Methodological aspects. Oncology 4:29, 1990 Aaronson NK: Quality of life research in cancer clinical trials: A need for common rules and language. Oncology 4:59, 1990 SPSS 6.0 fur Windows, BSB, Koblenz, 1994
14. Ganz PA, Haskell CM, Figlin RA, et al: Estimating the quality of life in a clinical trial of patients with metastatic klung cancer using the Kamowsky-performance status and functional-living index-cancer. Cancer 61:845, 1988 15. Schliephake H, Neukam FW, Schneller T, et al: EinfluR intraoraler Defektrekonstruktionsverfahren auf die Lebensqualitat nach Tumorresektion, in Zilch A, Schumann E: Plastischrekonstruktive Mal3nahmen bei Knochen- und Weichteildefekten. Thieme, Stuttgart, 1994, pp 37-40 16. Van Knippenberg FC, Out JJ, Tilanus HW, et al: Quality of life in patients with resected oesophageal cancer. Sot Sci Med 35:139, 1992 17. Mohide EA, Archibald SD, Tew M, et al: Postlaryngectomy quality-of-life dimensions identified by patients and health care professionals. Am J Surg 164:619, 1992 18. Schliephake H, Neukam FW, Schmelzeisen R, et al: Long-term results of life quality after ablative intraoral tumor surgery. J Craniomaxillofac Surg 23:243, 1995 19. Schliephake H, Schmelzeisen R, Neukam FW: The free revascularized rectus abdominis flap for the repair of tumor related defects in the head and neck area. Br J Oral Maxillofac Surg 34:18, 1996
J Oral Maxillofac Surg 54:669-670. 1996
Discussion Prospective Study of the Quality of Life of Cancer Patients After Intraoral Tumor Surgery Richard E. Gliklich, MD Harvard
Medical
School,
Boston,
Massachusetts
The oral cavity presents a complex interrelationship between structure and function. Consequently, the presence or treatment of oral cavity carcinomas may have considerable functional impact and lead to significant changes in patientperceived functioning and well-being, or quality of life. Despite being a small area of the oral cavity, the floor of mouth has an important role in speech, mastication, and deglutition. Changes in the floor of mouth may affect both the oral and phatyngeal phases of swallowing by tethering the anterior tongue or by displacing the anterior tongue posteriorly. Insensate areas of the floor of mouth can lead to residue with spillage. Loss of an adequate sulcus prevents dental restoration. Extensive defects, coupled with an atonic lower lip, can lead to lip malposition and lack of lip closure, with exposure and drooling. In this article, Schliephake et al have prospectively followed patients with a variety of floor of mouth carcinomas after ablative surgery and reconstruction using a psychometrically validated generic quality-of-life questionnaire (Functional Living Index-Cancer (FLIC)). Overall, this large group of patients demonstrated significant improvement in FLIC scores from preoperative status to 12-month postoperative status. Quality of life is clearly a crucial outcome to assess in patients undergoing significant life-altering procedures. In addition, the longitudinal rather than the crosssectional use of such a measure in this population is particularly noteworthy because it enables the patients to be compared against themselves rather than normative data. The authors’ comments on the need for valid and reliable in-
struments in such studies is worth emphasizing. It is not acceptable to merely create questionnaires to assess patient well-being; such instruments must pass set benchmarks of reliability and validity, and these benchmarks should be reported as they were in this investigation. This study falls in the realm of outcomes research. Outcomes research has been described as a technology of patient experience.’ That experience begins with a starting point and goes to an end point or outcome. Traditional outcomes include mortality and complication rates. However, mortality and complications, although important in tumor surgery, yield very little discerning information with regard to functional reconstruction. Functional or performance measures in the head and neck,*,’ although considered “objective,” continue to have problems of test-retest reliability and observer bias. Quality of life measures, although considered “subjective,” can be constructed to be valid and reliable, as shown in this study. Therefore, some of the best information that is relevant to the patient after ablative and reconstructive surgery is likely to come from the patient. As with any investigative methodology, quality of life outcome measures have limitations. For example, this study failed to demonstrate large differences in outcome between the reconstructive techniques performed. Although the authors suggest that this may because of the lack of a difference, its seems more likely that this study may not have had the necessary power to detect a difference between techniques, even if one was present. This study used a generic quality of life measure, the Functional Living Index-Cancer. Generic quality of life instruments may be limited in longitudinal sensitivity or the ability to demonstrate real clinical change over time.4 This lack of sensitivity has been demonstrated in other disease states when generic measures were compared with more disease-specific quality of life measures.’ It is now generally held that to portray a complete picture of quality of life for a particular disease, it is prefera-