Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group.

PURPOSE: To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous (IV) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin. PATIENTS AND METHODS: Patients were randomized to receive either IV paclitaxel 135 mg/m(2) over 24 hours followed by IV cisplatin 75 mg/m(2) every 3 weeks for six courses or IV carboplatin (area under curve 9) every 28 days for two courses, then IV paclitaxel 135 mg/m(2) over 24 hours followed by intraperitoneal (IP) cisplatin 100 mg/m(2) every 3 weeks for six courses. RESULTS: Of the 523 patients who entered this trial, 462 were determined to be assessable, with prognostic factors well balanced between the treatments. Neutropenia, thrombocytopenia, and gastrointestinal and metabolic toxicities were greater in the experimental arm. As a result, 18% of the patients received < or = two courses of IP therapy. Progression-free survival was superior for patients randomized to the experimental treatment arm (median, 28 v 22 months; relative risk, 0.78; log-rank P =.01, one-tail). There was a borderline improvement in overall survival associated with this regimen (median, 63 v 52 months; relative risk, 0.81; P =.05, one-tail). CONCLUSION: An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is not recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.

Cervical carcinoma: determination of recurrent tumor extent versus radiation changes with MR imaging.

PURPOSE: To evaluate the effectiveness of magnetic resonance (MR) imaging for assessment of the present and extent of tumor recurrence as determined with pathologic and surgical findings. MATERIALS AND METHODS: MR findings were retrospectively examined in 37 patients with a history of cervical carcinoma. Inter- and intraobserver variability was analyzed. Surgical or pathologic results were acquired in 34 of these patients; the remaining three patients were clinically followed up for at least 4 years. RESULTS: MR imaging allowed correct detection of recurrent tumor in 18 of 21 patients who had histologically documented recurrence. It helped correctly exclude recurrent disease in 15 of 16 patients. Sensitivity and specificity for detection of recurrence was 86% and 94%, respectively. Good intra- and interobserver agreement was demonstrated. CONCLUSION: MR imaging is a useful modality for differentiation of recurrent cervical carcinoma from radiation changes. Determination of the extent of recurrence with MR imaging may offer clinical assistance in the selection of optimal therapy.

A controlled trial of two low-dose heparin regimens for the prevention of postoperative deep vein thrombosis.

Venous thromboembolism is a serious complication following gynecologic surgery and is particularly common in patients with malignancy. A previous study of subcutaneous low-dose heparin given as one dose preoperatively and every 12 hours postoperatively failed to show a benefit in gynecologic oncology patients. In the present study, two more intense regimens of low-dose heparin were evaluated. Three hundred four patients were assigned randomly to receive no prophylaxis (controls), subcutaneous heparin 5000 units 2 hours before surgery and every 8 hours postoperatively (low-dose heparin) (regimen I), or 5000 units heparin subcutaneously every 8 hours preoperatively (between two and nine doses) and every 8 hours postoperatively (regimen II). All patients had thromboembolism surveillance with the fibrinogen uptake test and clinical evaluation. Eighty-four percent had a malignancy. Thromboemboli were diagnosed in 19 of 103 control patients, ten of 104 regimen I patients, and six of 97 regimen II patients, a statistically significant difference (P less than .008). When compared with the control group, the study groups had no evidence of increased bleeding complications or alteration of laboratory coagulation indicators.