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Pelvic exenteration for the treatment of vulvar cancer
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.
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.