A phase II study of docetaxel in paclitaxel-resistant ovarian and peritoneal carcinoma: a Gynecologic Oncology Group study

作者: Peter G Rose , John A Blessing , Harrison G Ball , James Hoffman , David Warshal

DOI: 10.1016/S0090-8258(02)00091-4

关键词: CarcinomaGynecologic oncologyDocetaxelRegimenSurgeryChemotherapyPaclitaxelInternal medicineMedicineChemotherapy regimenPhases of clinical researchOncology

摘要: Abstract Objectives Docetaxel is an inhibitor of microtubule depolymerization and has demonstrated activity in paclitaxel-resistant breast cancer gynecologic cancer. The Gynecologic Oncology Group (GOG) conducted a study docetaxel ovarian peritoneal carcinoma to determine its activity, nature degree toxicity, this cohort patients. Methods Patients with platinum- or carcinoma, defined as progression while on within 6 months therapy, were eligible if they had measurable disease not received more than one chemotherapy regimen. at dose 100 mg/m 2 was administered iv over 1 h every 21 days. A prophylactic regimen oral dexamethasone 8 mg bid begun 24 before administration continued for 48 thereafter. Hepatic function strictly monitored. Results Sixty patients entered treated total 256 courses, all 60 evaluable toxicity 58 response. Responses observed 22.4% patients, 5.2% achieving complete response 17.2% partial (95% CI, 12.5–35.3%). median duration 2.5 months. likelihood observing did appear be related the length prior paclitaxel-free interval paclitaxel infusions. principal adverse effect grade 4 neutropenia occurred 75% There treatment-related death. Dose reductions required 36% Conclusions active but, view significant hematologic further warranted ascertain optimal schedule.

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