- Email: [email protected]
Other diagnoses discovered at exploration for presumed ovarian cancer
98
SOCIETY
OF GYNECOLOGIC
SON, J. JONES, AND C. D. RUNOWICZ, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York 10461.
The management of women with endometrial cancer with suspected or documented cervical involvement is controversial. Preoperative radiotherapy (RT) needs reassessment in view of the current FIG0 surgical staging. Radical hysterectomy as primary therapy in this medically high risk group may be associated with excess morbidity and is usually not appropriate in most cases. To evaluate the role of a primary extrafascial hysterectomy (TAH), a review of 238 medical records of patients (pts) with endometrial cancer treated (tx) at our institution from 3/86 to 3/91 was performed. Thirty-one pts were selected based on histopathologic documentation of cervical involvement in the surgical specimen. Twenty-one pts had stage II (5 stage IIA; 16 stage IIB) and 10 pts had stage III disease. Two pts were excluded as they were tx with preoperative RT. Of the remaining 29 pts, 25 had a TAH, with or without pelvic and paraaortic lymph node sampling. Four pts did not have a TAH: 3 had a radical hysterectomy as mandated by the intraoperative findings and 1 pt had a subtotal hysterectomy for technical reasons. At a median follow-up of 17 months (range 3-5.5) the actuarial survival for pts tx with TAH was 78% in stage II pts and 42% in stage III. Our data indicate that 86% of patients with cervical involvement may be safely and effectively tx with an extrafascial hysterectomy, without preoperative RT or radical surgery, allowing tailored postoperative tx. Dose Rate Brachytherapy in Endometrial Cancer. J. FANNING, P. J. NANAVATI, AND R. D. HILCERS, Southern Illinois University, Springfield, Illinois 62794.
90. High
Sixty-two patients (pts) with endometrial adenocarcinoma were treated with postoperative high dose rate brachytherapy (HDRB) to determine efficacy and toxicity. Forty-one pts with poor prognosis Stage I and Stage II tumors received 4500 cGy external radiation (XRT) followed by 1500 cGy of HDRB. Twenty-one pts with good prognosis Stage I tumors received 2100 cGy of HDRB. Dose was calculated at 0.5 cm from the surface of the applicator. HDRB was given in three fractions, 2 weeks apart, as outpatient therapy with no anesthesia. Median follow-up is 2 years. XRT/HDRB was associated with seven acute complications (diarrhea, 4; intestinal hemorrhage, 2; urinary hemorrhage, 1); four chronic complications (diarrhea, 1; vaginal stenoses, 3); and one complication requiring surgery (rectal stenosis). There was one acute complication (diarrhea) and no chronic complications in the 21 pts receiving HDRB only. Three of 62 pts recurred (liver, bone, abdomen) but there were no vaginal recurrences. Postoperative HDRB is well-tolerated and may decrease the risk of vaginal recurrence. The major advantages of HDRB are: (1) outpatient administration, (2) reduced treatment time (1 hr versus 72 hr), and (3) protection of personnel from radiation exposure. 91. Strategies to Evaluate Postmenopausal Bleeding: A Cost-Effectiveness Analysis with Consideration of Age and Disease Prevalence. S. FELDMAN, R. BERKOWITZ, AND A. TOSTESON, Brigham and Wom-
en’s Hospital, Harvard School of Public Health, Harvard Medical School, Boston, Massachusetts 02115. We performed a cost-effectiveness analysis using a decision-analytic computer model to evaluate office endometrial biopsy, dilation and curettage (D&C), or close observation for assessing postmenopausal bleeding. We considered the probability of insufficient tissue, the sensitivity, specificity, and complication rate for each sampling method, and various treatment options. We varied both the patient’s age and the underlying risk of cancer and hyperplasia. We found that the appropriate sampling strategy depends on the patient’s age. In all cases of postmenopausal bleeding, office endometrial biopsy is the preferred initial sampling technique. In a 60-year-old woman, however, office
ONCOLOGISTS-ABSTRACTS biopsy is costly (greater than $20,000 per year life saved) for combined risks of hyperplasia and cancer below 20%. Furthermore, the combined risks of hyperplasia and cancer should exceed 50% before performing a D&C if insufficient tissue is obtained on an endometrial biopsy. We conclude that until other safe, less-expensive diagnostic strategies are proven to be both sensitive and specific, patients with postmenopausal bleeding should be evaluated by office biopsy, with consideration of close observation for patients at very low risk for cancer or hyperplasia. Further evaluation with a D&C should be reserved only for patients with a high risk for cancer or hyperplasia. 92.
Cadaver
Dissection
for
VISELLI, AND C. GRANAI, Rhode Island 02905.
Oncologist, G. FEUER, A. Women & Infants’ Hospital, Providence,
the Gynecologic
Debulking surgery in the upper abdomen requires the gynecologic oncologist (g.0.) to have surgical skills beyond the pelvis. It was hypothesized that cadaver dissection would provide an initial means toward obtaining expertise at these surgical procedures as well as teaching fellows and residents operations and anatomy infrequently encountered. Dissection of the abdomen, pelvis, groin, perineum, and upper thigh was performed on a female cadaver by a g.o. and senior gynecology (gyn) residents. Emphasis was on the surgical approach, but basic anatomic relationships were also appreciated. Multiple procedures were possible on each anatomic site by leaving the organs in situ and carefully ordering the sequence of operations. For reinforcement purposes, each procedure was reviewed two to seven times. A total of 44 procedures were done. There were 13 gastrointestinal, 22 related gyn oncology, and 9 others. Operations performed that the g.o. may be unfamiliar with included liver mobilization, diaphragmatic resection, splenectomy, Kocher maneuver, distal pancreatectomy, and partial and total gastrectomy. Procedures infrequently performed by the g.o. included total supralevator exenteration, single incision radical vulvectomy, gracilis, and tensor lata flaps. Examples of important anatomic relationships that were discerned are the mesenteric, splenic, gastric, and all branches of the iliac vessels; and the common duct and the porta hepatis. Survey of the physician-dissectors found that the exercise was enjoyable and greatly improved their surgical and anatomic knowledge from pre- to postdissection. It was concluded that cadaver dissection is an effective educational tool to familiarize the g.o. with new surgical procedures, to practice infrequently performed surgeries, to teach fellows and residents, and to attain a more complete understanding of anatomy. 93.
Other Diagnoses Discovered at Exploration for Presumed Ovarian Cancer. G. FEUER, 0. ABULARA, C. GRANAI, AND J. BOYCE, Women
& Infants’ Hospital, Providence, Rhode Island 02905. The gynecologic (gyn) oncologist has patients referred for presumed ovarian carcinoma (ca) who ultimately have different diagnoses. Perioperative and intraoperative assessment often fails to recognize these patients. Over a 33-month period on a gyn oncology service, 30 patients were inaccurately assumed to have ovarian ca based upon history, physical findings, or radiologic evidence. The control group was 34 other patients with a final diagnosis of ovarian ca. Diagnosis from the former group included gastrointestinal (gi) malignancies (5), diverticulitis (l), breast ca (l), malignancies resembling ovarian ca (4), other gyn cancers (6) gyn infections (4), benign gyn pathology (7) and other pathology (I). Patients with inflammatory or benign lesions were younger (median 37.5 years; P < 0.005) than those with ovarian ca (57 years) or other malignancies (63 years). Otherwise, the groups had similar presentations, physical findings, and X-ray results. Only those patients with gyn infections had fevers preoperatively. Retrospectively, exploration was unavoidable for 26 of 30 patients without ovarian ca despite extensive preoperative evaluation. Four patients with nonovarian gyn cancers might have avoided exploration if endometrial sampling had been per-
SOCIETY
OF GYNECOLOGIC
ONCOLOGISTS-ABSTRACTS
99
formed. Preoperative diagnosis of gi pathology was not possible for all but 1 patient, despite adequate gi investigation. We concluded that, for patients less than 37 years or with preoperative fevers, a benign process should be considered. Preoperative endometrial sampling may obviate exploration for some patients. Due to the limitations of preoperative evaluation, prolonged delays are not warranted. Gyn oncologists cannot escape encountering cancers outside their specialty. This dictates need for expertise in the exploration for and management of advanced gi cancers.
alive and disease-free 140 to 164 months after therapy. Three additional pts have subsequently died of other diseases without evidence of recurrent ovarian cancer. All long-term disease-free survivors had surgically documented complete response at second-look laparotomy. Treatment with intensive, brief duration H-CAP chemotherapy has produced long-term survival in a subset of pts. The uncensored survival rate is 13% for the entire group, 45% for those with limited residual (IIIb), and 3% for those with extensive residual (111~) disease. There have been no late relapses at 11 + years follow-up.
94. Peritoneal Adenocarcinoma of Miillerian Type: Cisplatin (CDDP)Based Chemotherapy Associated with Long-Term Survival. J. M. FOWLER, R. K. NIEBERG, T. SCHOOLER, AND J. S. BEREK, UCLA
96. Quality Control (QC) in Multicentric Clinical Trials (MCT). FAVALLI, J. B. VERMORKEN, J. RENARD, K. VANTONGELEN, VAN OOSTEROM, L. FALLO, AND S. PECORELLI, E.O.R.T.C.
School of Medicine, Los Angeles, California 90024. Peritoneal adenocarcinoma of mtillerian type (PAMT) is frequently misclassified as another primary tumor. Peritoneal carcinomatosis in women without evidence of a primary site may occur secondary to a number of processes. Confusion regarding the nomenclature has made it difficult to determine the incidence and natural history of this unique malignancy. Other terms used for this tumor include mesothehoma, peritoneal papillary serous carcinoma, extra-ovarian serous carcinoma, and normal-sized ovarian carcinoma syndrome. Thirty-four patients were identified with PAMT during 1976 through 1988. One hundred thirty-seven patients underwent primary cytoreductive surgery at the study institution for a preoperative diagnosis consistent with ovarian cancer. Twenty-nine (21.2%) were classified as PAMT (5 of the 34 had their initial surgery at other institutions). The mean age was 61.4 years. The primary symptoms and signs were abdominal pain (68%) and ascites (52%). Twenty-five (73%) had a preoperative diagnosis of ovarian cancer while the postoperative diagnosis was unknown (44%), PAMT (29%), and ovarian cancer (27%). Univariate and multivariate survival analyses were performed. Survival was independent of age, residual disease, grade, ascites, type of chemotherapy, and second-look results. In patients with residual disease < 1.5 cm, extended survival was found in those with ascites < 1000 cc, residual disease in pelvis only, and small residual volume but statistical significance was not obtained. Twenty-eight patients received 2 4 courses of chemotherapy after primary surgery. Twelve of 21 patients (57%) who received CDDP survived between 23 and 92 months, while no patient receiving other chemotherapeutic regimens survived more than 25 months. The 2- and 3-year survival rate for CDDP was 47 and 33% vs 14 and 0% for other regimens. Optimal cytoreductive surgery was not an independent prognostic factor as found in ovarian cancer, probably secondary to unresectable peritoneal carcinomatosis. PAMT is sensitive to chemotherapy but only the use of CDDP was associated with long-term survival. Based on these results, women with peritoneal carcinomatosis consistent with PAMT should receive a CDDP-based regimen after primary surgery. 95. Extended Follow-up of Patients with Advanced Ovarian Cancer Treated with H-CAP Chemotherapy: (Hexamethylmelamine, Cyclophosphamide, Doxorubicin, Cisplatin). G. C. GARROW, J. D. HAINSWORTH, L. S. BURNETT, H. W. JONES, L. L. WILLIAMS, AND F. A. GRECO, Vanderbilt University, Nashville, Tennessee 37232-5536.
From August 1977 to March 1980, 5.5 patients (pts) with advanced ovarian carcinoma were treated with H-CAP regimen: hexamethylmelamine (150 mg/m’ orally Days 1 to 14), cyclophosphamide (350 mg/m* intravenously (iv) Days 1 and 8), doxorubicin (20 mg/m’ iv Days 1 and 8), and cisplatin (60 mg/m’ iv Day 1). Courses were repeated at I-week intervals, with 41 pts (75%) completing six courses. Results of treatment at a minimum follow-up of 83 months, previously reported (Ann. Intern. Med. 108,165-170, 1988), described 10 pts (18%) diseasefree at a minimum follow-up of 83 months. Extended follow-up of these pts, with a minimum follow-up of 140 months, includes 7 pts who remain
G.
A. T. Gynecologic Cancer Cooperative Group (G.C.C.G.) and Data and Chemotherapy Q.C. Subcommittee of E.O.R.T.C., Brussels, Belgium.
E.O.R.T.C.-G.C.C.G. protocol Nr 55863 in a randomized phase III trial of vindesine, cisplatin, bleomycin, and mitomycin-C (BEMP) versus cisplatin (P) in disseminated squamous cell carcinoma of the uterine cervix (opened in 1986,248 pts randomized, still ongoing). A QC study has been developed in order to evaluate the main aspects that may limit the chances of reaching correct conclusions in a MCT. A procedure to examine the administration of chemotherapy has been tested through a questionnaire covering the main aspects of drug prescription, local facilities, and procedure for preparation and administration. “Data QC” has been based on site visits by comparing data on case report forms (CRFs) with the medical record at the visited center. Eleven centers have been site visited by a constant team. Striking differences were noted in the organization of chemotherapy administration and between the type and quality of hospital files. Overall correctness of data was 80.5% (range 51-97%), incorrect data 6.5% (2-14%) data missing on form 3.5% (O-12%), and data on form but not in file 9.5% (0.7-18%). Causes of incorrectness resulted mainly from incorrect transfer by data managers (94%), but were also due to unclearness of the protocol and/or CRFs (4.2%). Training and supervising data managers, accuracy in writing treatment protocols, standardization of some aspects of CRFs, and the use of a checklist for chemotherapy data and treatment toxicities are mandatory in MCT. The need for QC for all collaborative groups performing MCT is emphasized. (Supported by the European Community, Directorate XII, Gth Medical and Health Research Program: Europe Against Cancer.) 97. Pelvic Exenteration for the Treatment of Vulvar Cancer. M. KINS, AND G. W. MORLEY, University of Michigan Medical
P. HOPCenter,
Ann Arbor, Michigan 48109. From 19.50to 1989 a total of 19 patients underwent pelvic exenteration for advanced or recurrent squamous cell cancer of the vulva. The mean age was 10 years, median 50 years, and range 40-74 years. The cumulative 5-year survival was 60%. The types of exenteration included posterior 14, anterior 2, and total 3. The survival was significantly influenced by lymph node status. When lymph nodes were negative, 10 to 14 survived 5 or more years while all five patients with positive lymph nodes died of disease (P = 0.002). When exenteration was performed as primary therapy, 7 of 11 patients survived while 3 of 8 survived when performed for recurrent disease (P = 0.4). The extent of vulvar involvement did not influence survival (P = 0.99). There was no mortality but 10 patients developed complications which included: vesicovaginal tistula, 3; stoma1 hernia, 2; abscess, 1; complete stress urinary incontinence, 1; deep venous thrombosis, 1; conduit leak, 1; enterocutaneous fistula, 1; and small bowel obstruction, 1. Acceptable survival for advanced or recurrent vulvar cancer can be achieved with pelvic exenteration but the presence of metastatic disease to lymph nodes markedly decreases the survival.
SOCIETY
OF GYNECOLOGIC
SON, J. JONES, AND C. D. RUNOWICZ, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York 10461.
The management of women with endometrial cancer with suspected or documented cervical involvement is controversial. Preoperative radiotherapy (RT) needs reassessment in view of the current FIG0 surgical staging. Radical hysterectomy as primary therapy in this medically high risk group may be associated with excess morbidity and is usually not appropriate in most cases. To evaluate the role of a primary extrafascial hysterectomy (TAH), a review of 238 medical records of patients (pts) with endometrial cancer treated (tx) at our institution from 3/86 to 3/91 was performed. Thirty-one pts were selected based on histopathologic documentation of cervical involvement in the surgical specimen. Twenty-one pts had stage II (5 stage IIA; 16 stage IIB) and 10 pts had stage III disease. Two pts were excluded as they were tx with preoperative RT. Of the remaining 29 pts, 25 had a TAH, with or without pelvic and paraaortic lymph node sampling. Four pts did not have a TAH: 3 had a radical hysterectomy as mandated by the intraoperative findings and 1 pt had a subtotal hysterectomy for technical reasons. At a median follow-up of 17 months (range 3-5.5) the actuarial survival for pts tx with TAH was 78% in stage II pts and 42% in stage III. Our data indicate that 86% of patients with cervical involvement may be safely and effectively tx with an extrafascial hysterectomy, without preoperative RT or radical surgery, allowing tailored postoperative tx. Dose Rate Brachytherapy in Endometrial Cancer. J. FANNING, P. J. NANAVATI, AND R. D. HILCERS, Southern Illinois University, Springfield, Illinois 62794.
90. High
Sixty-two patients (pts) with endometrial adenocarcinoma were treated with postoperative high dose rate brachytherapy (HDRB) to determine efficacy and toxicity. Forty-one pts with poor prognosis Stage I and Stage II tumors received 4500 cGy external radiation (XRT) followed by 1500 cGy of HDRB. Twenty-one pts with good prognosis Stage I tumors received 2100 cGy of HDRB. Dose was calculated at 0.5 cm from the surface of the applicator. HDRB was given in three fractions, 2 weeks apart, as outpatient therapy with no anesthesia. Median follow-up is 2 years. XRT/HDRB was associated with seven acute complications (diarrhea, 4; intestinal hemorrhage, 2; urinary hemorrhage, 1); four chronic complications (diarrhea, 1; vaginal stenoses, 3); and one complication requiring surgery (rectal stenosis). There was one acute complication (diarrhea) and no chronic complications in the 21 pts receiving HDRB only. Three of 62 pts recurred (liver, bone, abdomen) but there were no vaginal recurrences. Postoperative HDRB is well-tolerated and may decrease the risk of vaginal recurrence. The major advantages of HDRB are: (1) outpatient administration, (2) reduced treatment time (1 hr versus 72 hr), and (3) protection of personnel from radiation exposure. 91. Strategies to Evaluate Postmenopausal Bleeding: A Cost-Effectiveness Analysis with Consideration of Age and Disease Prevalence. S. FELDMAN, R. BERKOWITZ, AND A. TOSTESON, Brigham and Wom-
en’s Hospital, Harvard School of Public Health, Harvard Medical School, Boston, Massachusetts 02115. We performed a cost-effectiveness analysis using a decision-analytic computer model to evaluate office endometrial biopsy, dilation and curettage (D&C), or close observation for assessing postmenopausal bleeding. We considered the probability of insufficient tissue, the sensitivity, specificity, and complication rate for each sampling method, and various treatment options. We varied both the patient’s age and the underlying risk of cancer and hyperplasia. We found that the appropriate sampling strategy depends on the patient’s age. In all cases of postmenopausal bleeding, office endometrial biopsy is the preferred initial sampling technique. In a 60-year-old woman, however, office
ONCOLOGISTS-ABSTRACTS biopsy is costly (greater than $20,000 per year life saved) for combined risks of hyperplasia and cancer below 20%. Furthermore, the combined risks of hyperplasia and cancer should exceed 50% before performing a D&C if insufficient tissue is obtained on an endometrial biopsy. We conclude that until other safe, less-expensive diagnostic strategies are proven to be both sensitive and specific, patients with postmenopausal bleeding should be evaluated by office biopsy, with consideration of close observation for patients at very low risk for cancer or hyperplasia. Further evaluation with a D&C should be reserved only for patients with a high risk for cancer or hyperplasia. 92.
Cadaver
Dissection
for
VISELLI, AND C. GRANAI, Rhode Island 02905.
Oncologist, G. FEUER, A. Women & Infants’ Hospital, Providence,
the Gynecologic
Debulking surgery in the upper abdomen requires the gynecologic oncologist (g.0.) to have surgical skills beyond the pelvis. It was hypothesized that cadaver dissection would provide an initial means toward obtaining expertise at these surgical procedures as well as teaching fellows and residents operations and anatomy infrequently encountered. Dissection of the abdomen, pelvis, groin, perineum, and upper thigh was performed on a female cadaver by a g.o. and senior gynecology (gyn) residents. Emphasis was on the surgical approach, but basic anatomic relationships were also appreciated. Multiple procedures were possible on each anatomic site by leaving the organs in situ and carefully ordering the sequence of operations. For reinforcement purposes, each procedure was reviewed two to seven times. A total of 44 procedures were done. There were 13 gastrointestinal, 22 related gyn oncology, and 9 others. Operations performed that the g.o. may be unfamiliar with included liver mobilization, diaphragmatic resection, splenectomy, Kocher maneuver, distal pancreatectomy, and partial and total gastrectomy. Procedures infrequently performed by the g.o. included total supralevator exenteration, single incision radical vulvectomy, gracilis, and tensor lata flaps. Examples of important anatomic relationships that were discerned are the mesenteric, splenic, gastric, and all branches of the iliac vessels; and the common duct and the porta hepatis. Survey of the physician-dissectors found that the exercise was enjoyable and greatly improved their surgical and anatomic knowledge from pre- to postdissection. It was concluded that cadaver dissection is an effective educational tool to familiarize the g.o. with new surgical procedures, to practice infrequently performed surgeries, to teach fellows and residents, and to attain a more complete understanding of anatomy. 93.
Other Diagnoses Discovered at Exploration for Presumed Ovarian Cancer. G. FEUER, 0. ABULARA, C. GRANAI, AND J. BOYCE, Women
& Infants’ Hospital, Providence, Rhode Island 02905. The gynecologic (gyn) oncologist has patients referred for presumed ovarian carcinoma (ca) who ultimately have different diagnoses. Perioperative and intraoperative assessment often fails to recognize these patients. Over a 33-month period on a gyn oncology service, 30 patients were inaccurately assumed to have ovarian ca based upon history, physical findings, or radiologic evidence. The control group was 34 other patients with a final diagnosis of ovarian ca. Diagnosis from the former group included gastrointestinal (gi) malignancies (5), diverticulitis (l), breast ca (l), malignancies resembling ovarian ca (4), other gyn cancers (6) gyn infections (4), benign gyn pathology (7) and other pathology (I). Patients with inflammatory or benign lesions were younger (median 37.5 years; P < 0.005) than those with ovarian ca (57 years) or other malignancies (63 years). Otherwise, the groups had similar presentations, physical findings, and X-ray results. Only those patients with gyn infections had fevers preoperatively. Retrospectively, exploration was unavoidable for 26 of 30 patients without ovarian ca despite extensive preoperative evaluation. Four patients with nonovarian gyn cancers might have avoided exploration if endometrial sampling had been per-
SOCIETY
OF GYNECOLOGIC
ONCOLOGISTS-ABSTRACTS
99
formed. Preoperative diagnosis of gi pathology was not possible for all but 1 patient, despite adequate gi investigation. We concluded that, for patients less than 37 years or with preoperative fevers, a benign process should be considered. Preoperative endometrial sampling may obviate exploration for some patients. Due to the limitations of preoperative evaluation, prolonged delays are not warranted. Gyn oncologists cannot escape encountering cancers outside their specialty. This dictates need for expertise in the exploration for and management of advanced gi cancers.
alive and disease-free 140 to 164 months after therapy. Three additional pts have subsequently died of other diseases without evidence of recurrent ovarian cancer. All long-term disease-free survivors had surgically documented complete response at second-look laparotomy. Treatment with intensive, brief duration H-CAP chemotherapy has produced long-term survival in a subset of pts. The uncensored survival rate is 13% for the entire group, 45% for those with limited residual (IIIb), and 3% for those with extensive residual (111~) disease. There have been no late relapses at 11 + years follow-up.
94. Peritoneal Adenocarcinoma of Miillerian Type: Cisplatin (CDDP)Based Chemotherapy Associated with Long-Term Survival. J. M. FOWLER, R. K. NIEBERG, T. SCHOOLER, AND J. S. BEREK, UCLA
96. Quality Control (QC) in Multicentric Clinical Trials (MCT). FAVALLI, J. B. VERMORKEN, J. RENARD, K. VANTONGELEN, VAN OOSTEROM, L. FALLO, AND S. PECORELLI, E.O.R.T.C.
School of Medicine, Los Angeles, California 90024. Peritoneal adenocarcinoma of mtillerian type (PAMT) is frequently misclassified as another primary tumor. Peritoneal carcinomatosis in women without evidence of a primary site may occur secondary to a number of processes. Confusion regarding the nomenclature has made it difficult to determine the incidence and natural history of this unique malignancy. Other terms used for this tumor include mesothehoma, peritoneal papillary serous carcinoma, extra-ovarian serous carcinoma, and normal-sized ovarian carcinoma syndrome. Thirty-four patients were identified with PAMT during 1976 through 1988. One hundred thirty-seven patients underwent primary cytoreductive surgery at the study institution for a preoperative diagnosis consistent with ovarian cancer. Twenty-nine (21.2%) were classified as PAMT (5 of the 34 had their initial surgery at other institutions). The mean age was 61.4 years. The primary symptoms and signs were abdominal pain (68%) and ascites (52%). Twenty-five (73%) had a preoperative diagnosis of ovarian cancer while the postoperative diagnosis was unknown (44%), PAMT (29%), and ovarian cancer (27%). Univariate and multivariate survival analyses were performed. Survival was independent of age, residual disease, grade, ascites, type of chemotherapy, and second-look results. In patients with residual disease < 1.5 cm, extended survival was found in those with ascites < 1000 cc, residual disease in pelvis only, and small residual volume but statistical significance was not obtained. Twenty-eight patients received 2 4 courses of chemotherapy after primary surgery. Twelve of 21 patients (57%) who received CDDP survived between 23 and 92 months, while no patient receiving other chemotherapeutic regimens survived more than 25 months. The 2- and 3-year survival rate for CDDP was 47 and 33% vs 14 and 0% for other regimens. Optimal cytoreductive surgery was not an independent prognostic factor as found in ovarian cancer, probably secondary to unresectable peritoneal carcinomatosis. PAMT is sensitive to chemotherapy but only the use of CDDP was associated with long-term survival. Based on these results, women with peritoneal carcinomatosis consistent with PAMT should receive a CDDP-based regimen after primary surgery. 95. Extended Follow-up of Patients with Advanced Ovarian Cancer Treated with H-CAP Chemotherapy: (Hexamethylmelamine, Cyclophosphamide, Doxorubicin, Cisplatin). G. C. GARROW, J. D. HAINSWORTH, L. S. BURNETT, H. W. JONES, L. L. WILLIAMS, AND F. A. GRECO, Vanderbilt University, Nashville, Tennessee 37232-5536.
From August 1977 to March 1980, 5.5 patients (pts) with advanced ovarian carcinoma were treated with H-CAP regimen: hexamethylmelamine (150 mg/m’ orally Days 1 to 14), cyclophosphamide (350 mg/m* intravenously (iv) Days 1 and 8), doxorubicin (20 mg/m’ iv Days 1 and 8), and cisplatin (60 mg/m’ iv Day 1). Courses were repeated at I-week intervals, with 41 pts (75%) completing six courses. Results of treatment at a minimum follow-up of 83 months, previously reported (Ann. Intern. Med. 108,165-170, 1988), described 10 pts (18%) diseasefree at a minimum follow-up of 83 months. Extended follow-up of these pts, with a minimum follow-up of 140 months, includes 7 pts who remain
G.
A. T. Gynecologic Cancer Cooperative Group (G.C.C.G.) and Data and Chemotherapy Q.C. Subcommittee of E.O.R.T.C., Brussels, Belgium.
E.O.R.T.C.-G.C.C.G. protocol Nr 55863 in a randomized phase III trial of vindesine, cisplatin, bleomycin, and mitomycin-C (BEMP) versus cisplatin (P) in disseminated squamous cell carcinoma of the uterine cervix (opened in 1986,248 pts randomized, still ongoing). A QC study has been developed in order to evaluate the main aspects that may limit the chances of reaching correct conclusions in a MCT. A procedure to examine the administration of chemotherapy has been tested through a questionnaire covering the main aspects of drug prescription, local facilities, and procedure for preparation and administration. “Data QC” has been based on site visits by comparing data on case report forms (CRFs) with the medical record at the visited center. Eleven centers have been site visited by a constant team. Striking differences were noted in the organization of chemotherapy administration and between the type and quality of hospital files. Overall correctness of data was 80.5% (range 51-97%), incorrect data 6.5% (2-14%) data missing on form 3.5% (O-12%), and data on form but not in file 9.5% (0.7-18%). Causes of incorrectness resulted mainly from incorrect transfer by data managers (94%), but were also due to unclearness of the protocol and/or CRFs (4.2%). Training and supervising data managers, accuracy in writing treatment protocols, standardization of some aspects of CRFs, and the use of a checklist for chemotherapy data and treatment toxicities are mandatory in MCT. The need for QC for all collaborative groups performing MCT is emphasized. (Supported by the European Community, Directorate XII, Gth Medical and Health Research Program: Europe Against Cancer.) 97. Pelvic Exenteration for the Treatment of Vulvar Cancer. M. KINS, AND G. W. MORLEY, University of Michigan Medical
P. HOPCenter,
Ann Arbor, Michigan 48109. From 19.50to 1989 a total of 19 patients underwent pelvic exenteration for advanced or recurrent squamous cell cancer of the vulva. The mean age was 10 years, median 50 years, and range 40-74 years. The cumulative 5-year survival was 60%. The types of exenteration included posterior 14, anterior 2, and total 3. The survival was significantly influenced by lymph node status. When lymph nodes were negative, 10 to 14 survived 5 or more years while all five patients with positive lymph nodes died of disease (P = 0.002). When exenteration was performed as primary therapy, 7 of 11 patients survived while 3 of 8 survived when performed for recurrent disease (P = 0.4). The extent of vulvar involvement did not influence survival (P = 0.99). There was no mortality but 10 patients developed complications which included: vesicovaginal tistula, 3; stoma1 hernia, 2; abscess, 1; complete stress urinary incontinence, 1; deep venous thrombosis, 1; conduit leak, 1; enterocutaneous fistula, 1; and small bowel obstruction, 1. Acceptable survival for advanced or recurrent vulvar cancer can be achieved with pelvic exenteration but the presence of metastatic disease to lymph nodes markedly decreases the survival.