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Objectives: To evaluate the safety and efficacy of cisplatin plus gemcitabine in persistent or recurrent platinum-resistant ovarian and primary peritoneal cancer., Study Design: Eligible, consenting subjects with measurable disease and one prior platinum-based regimen, but no prior gemcitabine, were to receive intravenous cisplatin followed by gemcitabine on days 1 and 8 every 28 days., Results: Between December 2000 and March 2003, 59 patients were enrolled from 24 institutions; two were ineligible. During the first stage of accrual, 27 subjects received cisplatin 30 mg/m2 and gemcitabine 750 mg/m2. In the second stage, gemcitabine was reduced to 600 mg/m2 because of hematologic toxicity at the higher dose. There were 4 complete and 5 partial responses for an overall response rate of 16% (9/57). Thirty-one women (54%) had stable disease. Median time to progression was 5.4 months. Overall survival was 14.9+ months. Grade 4 toxicities were hematologic, except one cutaneous reaction., Conclusions: Cisplatin plus gemcitabine, in the doses and schedule employed, has modest activity in this patient population.

Objectives: This trial was conducted to evaluate the safety and efficacy of cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix., Subjects and Methods: All women had measurable histologically confirmed squamous cell cervical cancer and a GOG performance status less than or equal to 2. The women were to receive cisplatin at 30 mg/m(2) plus gemcitabine at 800 mg/m(2) day 1 and day 8 every 28 days., Results: Between February 2001 and May 2002, 32 eligible patients were entered. All women had received prior chemotherapy and 29 had received radiation. Twenty patients received platinum previously twice. The median time from primary treatment to recurrence was 21 months, but the median time from last prior chemotherapy was less than 2 months. A second phase of accrual was not indicated per the established stopping rules. There were 7 (21.9%) partial responses and median response duration was 2.1 months. Twelve additional women (37.5%) had stable disease. Nine women (28.1%) had increasing disease. Median time to progression was 3.5 months. There were no treatment-related deaths. Six women had grade 4 neutropenia, three had grade 4 anemia, and two had grade 4 thrombocytopenia. Grade 4 gastrointestinal toxicity occurred in two women and grade 4 anorexia occurred in one., Conclusions: This study suggests modest activity for the gemcitabine plus cisplatin doublet in previously treated squamous cell carcinoma of the cervix. The objective response rate of 22% is comparable to that of other active agents and combinations tested in this setting. Toxicities were primarily hematologic and generally manageable with dose reductions.

Objectives: The aim was to determine the safety and efficacy of gemcitabine plus cisplatin for patients with relapsed ovarian carcinoma and to compare ex vivo drug sensitivity profiles with clinical outcomes., Patients and Methods: Previously treated patients with ovarian carcinoma received cisplatin (30 mg/m(2)) plus gemcitabine (600-750 mg/m(2)) on Days 1 and 8 of each 21-day cycle. Seventeen of the 27 patients underwent ex vivo analyses for correlation with clinical response., Results: Of 27 patients, there were 7 (26%) complete and 12 (44%) partial responses, for an overall response rate of 70% (95% CI: 53-87%). Toxicities included neutropenia Grade III in 51.9%, Grade IV in 29.6%; anemia Grade III in 18.5 %; thrombocytopenia Grade III in 66.7 %, Grade IV in 29.6%; nausea and vomiting Grade III in 14.8 %; peripheral neuropathy Grade III in 3.7%; and alopecia Grade IV in 11.1% of patients. The median time to progression for objective responders was 7.9 months with a range of 2.1 to 13.2 months. There were no treatment-related deaths. Ex vivo results correlated with response, time to progression, and survival, remaining significant when adjusted for platin-resistance and number of prior therapies. Adjustment for platin-free interval decreased the significance but did not, in and of itself, predict significantly for progression-free survival., Conclusions: Cisplatin plus gemcitabine is active for patients with relapsed ovarian cancer. Toxicities, primarily hematologic, are manageable with dose modifications. Responses observed in heavily pretreated and platin-resistant patients indicate activity in drug-refractory patients. The results of the ex vivo analyses correlate with clinical outcomes.

Objective: Morbidity associated with radical hysterectomy is significant. Utilizing the endoscopic stapler for transection of the cardinal ligaments and uterosacral ligaments is a possible method to decrease operative time and blood loss., Methods: Two groups of patients, one group with the stapler used (n = 21) and the other with the traditional method utilized (n = 18), were compared in regard to operative and postoperative morbidity, operative time, and surgical margins. The groups were similar in regard to medical condition, age, and weight., Results: Median (243 min versus 284 min) and mean (246 min versus 287 min) operative times were significantly less in the stapler group than in the control group (P < 0.002). Median blood loss was reduced by 20% in the stapler group (400 ml versus 500 ml, P < 0.03). There was no significant difference in febrile morbidity, surgical complications, or length of hospital stay., Conclusion: Our data suggest significant reduction in blood loss and operative time with the use of the endoscopic stapler., (Copyright 1998 Academic Press.)

We present a case report of a patient with a IB1 cervical squamous cell cancer which recurred in a transposed ovary 8 years following radical parametrectomy. The patient was initially treated with a simple vaginal hysterectomy for apparent CIS but was found to have an invasive squamous cell cancer to a depth of 7 mm into the stroma. She was treated with a radical parametrectomy, pelvic lymphadenectomy, and ovarian transposition. There was no evidence of residual disease. The patient then had an apparent isolated recurrence in her left ovary 8 years later. Although there are a few cases of stage IB squamous cell cancer metastatic to a transposed ovary, this is the first case with such minimal primary disease and delayed isolated recurrence.

The MN protein is a newly described biomarker found to be overexpressed in most cervical carcinomas. This study was an effort to evaluate the prognostic importance of tumor MN expression, HPV status, and the presence of other biomarkers in cervical cancers. Tumor DNA and protein for study were extracted from archived frozen tissue. Tumor tissues and controls were evaluated by Western blot analysis for MN, intestinal alkaline phosphatase (IAP), c-myc, and p53 protein overexpression. Immunohistochemistry was performed for MN quantification and the study of expression patterns in histologic subtypes of cervical cancer. HPV data were obtained by PCR amplification of extracted DNA using consensus and type-specific primers. Clinical data were obtained from the patients' records and from the cancer registry. Clinical and molecular data were correlated by chi2, Fisher's exact test, and logistic regression. The results demonstrate that IAP is not overexpressed in clinical specimens of cervical carcinoma, although in somatic cell hybrid experiments, overexpression of IAP correlates with the malignant state. None of 47 tumors, including those which were HPV negative, overexpressed p53. c-myc protein overexpression occurred in 11 of 52 tumors, most of which contained HPV 16, but this was not significantly different from the tumors as a whole. There was no apparent association between MN protein expression and the overexpression of c-myc protein. MN was overexpressed in all cancers and quantitatively varied with the histologic subtype. Specifically, lower expression of MN correlated with adenosquamous and less-differentiated histology (P < 0.01 for grade 3 tumors). Low expression of MN protein also correlated with HPV negativity (P < 0.05). In stage IB and IIA cancers, low expression of MN was associated with deeper cervical stromal invasion (P < 0.03). Further, low expression of MN correlated with lymph node metastases in small (<3.5 cm) IB and IIA cervical cancers (P < 0.04). These data suggest that MN is emerging as a potentially important new biomarker for cervical carcinoma. The overexpression commonly seen in cervical cancer is possibly associated with loss of a critical tumor suppressor gene located on chromosome 11. Low expression of MN antigen appears to correlate with several adverse prognostic features and further prospective study is warranted.