Cadron Isabelle, Leunen Karin, Amant Frédéric, Van Gorp Toon, Neven Patrick, Vergote Ignace
Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospitals Leuven, Katholieke Universiteit Leuven, Belgium.
Gynecol Oncol. 2007 Aug;106(2):354-61. doi: 10.1016/j.ygyno.2007.04.003. Epub 2007 May 11.
The purpose of this study was to evaluate the "Leuven" dose-dense regimen in recurrent ovarian cancer.
Six courses of paclitaxel (90 mg/m(2)) and carboplatinum (AUC 4) on d1 and d8 every 3 weeks were administered. Response rates were determined using RECIST and Gynaecological Cancer Intergroup (GCIG) CA 125 criteria. Platinum resistance was defined as progression during or within 6 months after platinum-based chemotherapy.
Thirty-three patients were included with a median number of prior treatment regimens of 2. Nine patients were platinum-resistant and 24 were platinum-sensitive. Three of 8 patients in the platinum-resistant group and 16 of 21 patients in the platinum-sensitive group achieved an evaluable response according to RECIST. According to the GCIG CA 125 criteria 3 of 7 patients in the platinum-resistant and 17 of 19 patients in the platinum-sensitive patients responded. In the entire patient population evaluable for response (n=29), the median progression-free survival (PFS) was 9 months; the median overall survival (OS) was 18 months. Median PFS was 6.75 months for the platinum-resistant and 10.5 months for the platinum-sensitive group. The median OS was 8 months in the platinum-resistant and not yet reached in the platinum-sensitive group. Toxicity was mostly bone marrow-related with neutropenia grade 3/4 in 34% and neutropenic fever in 2% of courses. Dose reduction was necessary in 25% of patients. Nausea and vomiting and fatigue were the most frequent non-hematological side effects.
Dose-dense paclitaxel and carboplatin offers a well-tolerated regimen with high response rates even in heavily pre-treated and platinum-resistant ovarian cancer.
本研究旨在评估“鲁汶”剂量密集方案用于复发性卵巢癌的疗效。
每3周在第1天和第8天给予6个疗程的紫杉醇（90mg/m²）和卡铂（AUC 4）。使用RECIST和妇科肿瘤协作组（GCIG）CA 125标准确定缓解率。铂耐药定义为在铂类化疗期间或化疗后6个月内病情进展。
纳入33例患者，既往治疗方案的中位数为2个。9例患者铂耐药，24例铂敏感。根据RECIST标准，铂耐药组8例患者中有3例、铂敏感组21例患者中有16例获得可评估的缓解。根据GCIG CA 125标准，铂耐药组7例患者中有3例、铂敏感组19例患者中有17例有反应。在可评估缓解的全部患者群体（n = 29）中，无进展生存期（PFS）中位数为9个月；总生存期（OS）中位数为18个月。铂耐药组PFS中位数为6.75个月，铂敏感组为10.5个月。铂耐药组OS中位数为8个月，铂敏感组尚未达到。毒性主要与骨髓相关，34%的疗程出现3/4级中性粒细胞减少，2%的疗程出现中性粒细胞减少性发热。25%的患者需要减量。恶心、呕吐和疲劳是最常见的非血液学副作用。
剂量密集的紫杉醇和卡铂方案耐受性良好，即使在预处理严重和铂耐药的卵巢癌中也有较高的缓解率。
