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23. Treatment of Ovarian Germ Cell Tumors wirh Cisplatin + Vinblastine + Bleomycin: LongTerm Results of Therapy. STEPHEN D. WILLIAMS, HOWARLI HOMESLEY, ROBERT SLAYTON, AND JOHN BLESSING, Indiana University, Indianapolis, Indiana 46223, and the Gynecologic Oncology
Group, Philadelphia, Pennsylvania. Sixty patients with stage III, IV, or recurrent ovarian germ cell tumors were treated with three or four courses of cisplatin 20 mg/m’ daily x 5, vinblastine 12 mg/m’ Day 1, and bleomycin 20 units /m2 (maximum 30 units) weekly (PVB) after surgical cytoreduction. After induction, second-look surgery was performed when appropriate. Patients with persistent or recurrent disease were treated with vincristine + actinomycin D + cyclophosphamide (VAC). Nine are ineligible or inevaluable and five too early, leaving 46 evaluable patients. Approximately one-half had received previous chemotherapy or radiation. Of 16 patients with measurable disease, there were 10complete responses. Twenty-eight second-look procedures have been done (15 negative, 3 mature teratoma, 10 positive). Twenty-two patients are progression-free with 13 having been followed for 24-43 months. Results by cell type are: Progression-free/total Immature teratoma Endodermal sinus, embryonal, and mixed Chorio
4/11 11133 l/2
Three other patients are clinically disease-free with second therapy (2 VAC, 1 cisplatin + VP-16 at 20, 44, and 47 months). No patient relapsed later than I5 months. Toxicity was substantial with two deaths related to PVB. PVB will induce a substantial number of durable CRs in patients with advanced ovarian germ cell tumors, including previously treated patients. 24. Tamoxifen and Endometrial Carcinoma: Alterations in Estrogen and Progesterone Receptors in Untreated Patients and Combination Hormonal Therapy in Advanced Neoplasia. JOHN A. CARLSON, JR., M.D.,* JOSEPHC. ALLEGRA, M.D.,? THOMAS G. DAY, JR., M.D.,* AND JAMES L. WITTLIFF,
PH.D.,S *Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, and Departments of tIntema1 Medicine and $Biochemistry, University of Louisville School of Medicine, Louisville, Kentucky 40292. Metastatic endometrial carcinoma is frequently treated with progestins. Preliminary data suggest that response to progestin therapy occurs predominantly in tumors which are progesterone receptor (PR) positive. Since tamoxifen citrate can induce PR in normal endometrium and since PR in normal and carcinomatous endometrium has been shown to be essentially identical, the influence of tamoxifen citrate on PR status was studied in patients with primary endometrial carcinoma. On initial biopsy, 13 of 25 (52%) tumors were PR positive (3 of 6 grade 1, 8 of 11 grade 2, and 2 of 8 grade 3), while, after receiving tamoxifen for 5 days, 21 of 25 (84%) were PR positive, including 6 of 6 grade I, 11 of 11 grade 2, and 4 of 8 grade 3 neoplasms (P < 0.05). Considering these results, a phase II clinical trial of tamoxifen plus progestin was instituted for patients with recurrent endometrial carcinoma. Thus far, however, the 33% total response rate achieved with combination therapy is not superior to standard progesterone therapy. 25. Recurrence in Endometrial Carcinoma as a Function of Extended Surgical Staging Data. C. P. MORROW, W. T. CREASMAN, H. HOMESLEY, G. WILBANKS, AND BRIAN BUNDY.
The Gynecologic Oncology Group initiated a surgical staging study for clinical stage I and stage II (occult) endometrial carcinoma in June 1977. In this preliminary review of the data, 536 evaluable cases have been accrued with a minimum of 2 years follow-up. Each of these patients underwent pelvic and paraaortic lymph node sampling and peritoneal cytology at the time of hysterectomy and bilateral salpingo-oophorectomy. No patient had preoperative radiation. The incidence of adverse surgical-pathologic factors has been correlated with stage, histologic grade, myometrial invasion,
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and recurrence. For the patients with G3 lesions and outer one-third myometrial invasion, the incidence is: pelvic node metastases-stage IA 30%, stage IB 41.7%, stage II 55.6%; aortic nodesstage IA IS%, stage IB 20.8%, stage II 44.4%; adnexal spread-stage IA 15%. stage IB 20.8%. stage II 11.1%, positive peritoneal cytology-stage IA 20%, stage IB 29.2%, stage 11 1I. I%. The 2-year recurrence rate is 9.7%. 26. Intestinal Surgery in Advanced Epithelial Ovurian Carcinoma: The Mayo Clinic Experience 1961-1980. RAYMOND M. LUPSE,M.D., PH.D., RICHARDE. SYMMONDS,M.D., KARL C. PODRATZ, M.D., PH.D., AND PETERC. O’BRIEN, PH.D., Mayo Clinic, 200 First Street, SW, Rochester, Minnesota 55901. The purpose of this study was to determine whether interruption of the intestinal tract for removal of metastases improves survival in patients with advanced epithelial ovarian carcinoma. From 1961 to 1980, one hundred ninety-two patients underwent intestinal surgery in order to achieve maximum cytoreduction of tumor. Statistical methods included log-rank tests and Cox regression analysis. The protocols used evaluated (1) the use and results of intestinal surgery performed either at the time of, or subsequent to, initial debulking, and (2) subsequent follow-up of these patients. Twenty-one (10.9%) patients died within 60 days of intestinal surgery. Of 171 patients who survived, 127 (74.3%) died of disease but survived a mean of 17.8 months (longest survival 164 months). Fourteen (8.2%) patients who remain alive with no evidence of disease have survived a mean of 104 months (range: 23-243 months). These data indicate that (I) those patients who had no tumor residual after intestinal surgery had a much higher survival rate than those who did (P < 0.001); and (2) survival was greater in those patients who had maximum tumor reduction (P < 0.001). Interruption of the intestinal tract to achieve maximum tumor cytoreduction in advanced epithelial ovarian carcinoma is warranted. 27. The Syed-Neblett Interstitial Template in Locally Advanced Gynecological Malignancies. FRANCXO AMPUERO,M.D., University of New Mexico Medical Center, Albuquerque, New Mexico 87131. Twenty-eight patients with locally advanced malignancies of the cervix and vagina were treated with a combination of external radiation therapy and afterloading Syed-Neblett iridium template. There were 22 patients with squamous cell cancer and two patients with adenocarcinomas of the cervix. Four patients with squamous cell cancer of the vagina were treated with this method. Only patients with locally advanced disease (cervical lesion >4 in diameter) and poor vaginal anatomy were selected for this modality of therapy. In our series the incidence of distant failures of 39% seems to confirm the significance of local volume of disease as a prognostic indicator; despite a local control rate of 49%, only 33% of our patients are alive from 25 to 51 months. Complications occurred in 12 patients (42%). Six patients (22%) developed severe rectal stricture or rectovaginal fistula necessitating diverting sigmoid colostomy; five patients (18%) developed hemorrhagic proctitis with diarrhea and tenesmus; one patient developed vaginal vault necrosis. Complications occurred 7 to 24 months following therapy. Six of the twelve patients developing complications are dead of disease. On the basis of this study and because of the low cure rate and high incidence of complications, the value of the Syed-Neblett template in locally advanced gynecologic malignancies should be reconsidered. 28. Survival and Patterns of Recurrence in Cervical Cancer Metastatic to Periaortic Lymph Nodes (A Gynecologic Oncology Group Study). MICHAEL L. BERMAN, M.D., AND PHILIPJ. DISAIA, M.D., University of California, Irvine Medical Center, 101 City Drive, Orange, California 92668; HENRY KEYS, M.D., University of Rochester Medical Center, Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, New York 14642; WILLIAM T. CREASMAN, M.D., Duke University Medical Center, Durham, North Carolina 27710; JOHNBLESSING,PH.D., AND BRIAN BUNDY, M.A., COG Statistical Office, Roswell Park Memorial Institute, 666 Elm Street, Buffalo, New York 14263. Ninety-eight of six hundred twenty-one evaluable patients (16%) with cervical cancer enrolled into Gynecologic Oncology Group protocols were found to have periaortic lymph node metastases at staging laparotomy or at exploration for definitive operative management. As expected there was a progressive increase in the prevalence of periaortic metastases including 5% of 150 patients with