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Purpose: In 1986, a protocol comparing primary radiation therapy (RT) plus hydroxyurea (HU) to irradiation plus fluorouracil (5-FU) and cisplatin (CF) was activated by the Gynecologic Oncology Group (GOG) for the treatment of patients with locally advanced cervical carcinoma. The goals were to determine the superior chemoradiation regimen and to quantitate the relative toxicities., Methods: All patients had biopsy-proven invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix. Patients underwent standard clinical staging studies and their tumors were found to be International Federation of Gynaecology and Obstetrics stages IIB, III, or IVA. Negative cytologic washings and para-aortic lymph nodes were required for entry. Patients were randomized to receive either standard whole pelvic RT with concurrent 5-FU infusion and bolus CF or the same RT plus oral HU., Results: Of 388 randomized patients, 368 were eligible; 177 were randomized to CF and 191 to HU. Adverse effects were predominantly hematologic or gastrointestinal in both regimens. Severe or life-threatening leukopenia was more common in the HU group (24%) than in the CF group (4%). The difference in progression-free survival (PFS) was statistically significant in favor of the CF group (P = .033). The sites of progression in the two treatment groups were not substantially different. Survival was significantly better for the patients randomized to CF (P = .018)., Conclusion: This study demonstrates that for patients with locally advanced carcinoma of the cervix, the combination of 5-FU and CF with RT offers patients better PFS and overall survival than HU, and with manageable toxicity.

Previous clinical investigations using interferons (IFNs) have shown activity against epithelial ovarian cancer. The objective of this study was to determine the maximum tolerated dose of intraperitoneal (ip) IFN-alpha 2b which could be administered in combination with intravenous (iv) cis-platinum plus cyclophosphamide chemotherapy. After comprehensive surgical staging and maximal cytoreduction, previously untreated patients with primary ovarian adenocarcinoma were entered at one of five IFN dose levels. IFN-alpha 2b (5-30 x 10(6) units) was administered ip on Day 1 (+/- Day 8). cis-Platinum (75 mg/m2) plus cyclophosphamide (750 mg/m2) were administered iv on Day 2 with prophylactic hydration and anti-emetics. Courses were repeated every 3 weeks for 8 cycles. Adverse effects were recorded using standard Gynecologic Oncology Group toxicity scales. Fifteen patients with mean age 56 years (range 43-73) were entered and received a combined total of 100 treatment cycles. Catheter-related complications occurred in 8 patients, and in three cases lead to catheter removal and discontinuation of ip therapy. Two patients experienced grade 2-3 nephrotoxicity and 1 experienced grade 2 peripheral neuropathy. There was a single episode of chemical peritonitis. Myelosuppression was the dose-limiting toxicity with grade 3-4 leukopenia complicating 6, 5, 12, 11, and 17 cycles at dose levels 1-5, respectively. No patient completed planned treatment without interruption or dose reduction. Planned cis-platinum dose intensity was most compromised at the fifth IFN-alpha 2b dose level. The maximum tolerated dose of IFN-alpha 2b was determined to be 20 x 10(6) units repeated on Days 1 and 8 of this 21-day cis-platinum plus cyclophosphamide chemotherapy cycle.

An analysis of 41 patients with histologically documented Stage II adenocarcinoma of the endometrium treated between 1969 and 1974 is presented. The 3-year survival for all patients was 46%. Patients treated with radiation therapy alone (tandem, ovoids, and external radiation therapy) had 29% survival while patients treated with radiation therapy and surgery had a 71% survival. For all patients, survival by grade was 80% (Grade I), 36% (Grade II), and 20% (Grade III). Among those patients with recurrent disease, 40% of cases were in the pelvis while 20% were isolated distal recurrences. Patients with stromal invasion of the cervix had a 30% survival while patients without stromal invasion had a 67% survival. An analysis of these data, along with a review of the literature, reveals that 1) hysterectomy plays a critical role in survival, 2) invasion of the cervical stroma would appear to be a requisite criteria for the establishment of Stage II disease, and 3) aggressive radiation therapy with uterine packings (Heyman capsules) should be attempted in those patients who are not surgical candidates.

The clinical data of 22 patients with clear cell adenocarcinoma of the endometrium treated at the University of North Carolina Memorial Hospital are reported. In addition, the data with particular reference to survival, site of recurrence, and treatment are combined with information from two previous reports of clear cell adenocarcinoma of the endometrium to better define survival. It is noted that the patients with clear cell adenocarcinoma of the endometrium were older and had an overall poorer survival than is reported for adenocarcinoma of the endometrium (nonclear cell). Patients with Stage I clear cell carcinoma of the endometrium, however, had a similar five-year survival to Stage I adenocarcinoma of the endometrium. The paper also examines treatment methods and correlates these with site of recurrence as well as survival.

A prospective flow cytometric examination of ovarian epithelial tumors was undertaken to further characterize aneuploid (including triploid and tetraploid) tumor cell populations according to expression of ovarian tumor antigen CA125 and to expression of class I (normally present in ovarian epithelium) and class II (normally absent in ovarian epithelium) major histocompatibility complex antigens. Samples from thirty-two of 42 patients (76%) exhibited at least one aneuploid population of tumor cells. Separate analysis of the aneuploid and diploid components of samples with aneuploid populations revealed between-tumor variation: seven of 23 aneuploid populations (30%) were positive for CA125; eight of 22 aneuploid populations (40%) exhibited substantial decreases in major histocompatibility complex class I expression, compared with corresponding diploid components of the same samples; and eight of 22 aneuploid populations (36%) exhibited substantial expression of major histocompatibility complex class II antigens. The frequencies of aneuploid populations and of the foregoing antigen expression categories were independent of tumor cell type, stage, and grade. The significance of these results for prognosis remains to be determined.

Four cases of clear cell adenocarcinoma of the genital tract in young women are presented. All patients were treated with radiation therapy. Two of the patients subsequently developed chest metastases. Three patients have died of the disease, and the other is without evidence of disease. Two patients were treated with chemotherapy, and a positive response to the chemotherapy was observed. Because this is an aggressive disease, one should consider the use of chemotherapeutic agents as a part of the primary therapy.