Buda A, Floriani I, Rossi R, Colombo N, Torri V, Conte P F, Fossati R, Ravaioli A, Mangioni C
Laboratory of Clinical Research in Oncology, Mario Negri Institute of Pharmacological Research, Via Eritrea 62, 20157 Milan, Italy.
Br J Cancer. 2004 Jun 1;90(11):2112-7. doi: 10.1038/sj.bjc.6601787.
The aim of the study was to evaluate the role of epidoxorubicin plus paclitaxel combination (ET) vs single agent paclitaxel (T), as second-line chemotherapy treatment in advanced ovarian cancer patients in early progression within 12 months after platinum-based chemotherapy. From October 1994 up to June 1999, 234 patients from 34 Italian hospitals were randomised to receive: (A) epidoxorubicin (E) 80 mg m(-2) + paclitaxel (T) 175 mg m(-2) (3 h infusion), every 21 days for 4-6 cycles. (B) Paclitaxel 175 mg m(-2) (3 h infusion) every 21 days for 4-6 cycles. Evaluable for survival analysis were 106 and 106 patients in ET and T arm, respectively. Platinum-based monochemotherapy was the first-line treatment in 43% patients, while polichemotherapy containing anthracyclines was the preferred first-line therapy in 22% patients. The median time from the end of first-line therapy to randomisation was 3 months. Treatment was completed in 87 and 85% of T and ET arm, respectively. Haematological toxicity was significantly more common in ET group (ECOG grade 3-4 neutropenia: 37.4% in ET vs 18.2% in T arm). Neuropathies were similar in both arms (sensory: ECOG grade 2-3: 12.1% in ET vs 14.7% in T arm, motor: 6.1% in ET vs 5.3% in T arm). Objective response was achieved in 37.4% of patients in ET group and in 46.9% of patients in T arm. At a median follow-up of time of 48 months, a total of 180 patients progressed and 163 patients died. Survival analysis showed no difference between ET and T (median time to progression: 6 months for both regimens, median survival: 12 and 14 months for ET and T, respectively; hazard ratio for mortality of ET vs T: 1.17 (95% CI 0.86-1.59; P=0.33). The ET regimen does not seem to be more effective than T in refractory advanced ovarian cancer patients in early progression after platinum-based chemotherapy. Despite an acceptable response rate, the control of disease progression remains poor.
本研究旨在评估表柔比星联合紫杉醇（ET）方案与单药紫杉醇（T）方案作为铂类化疗后12个月内早期进展的晚期卵巢癌患者二线化疗的作用。从1994年10月至1999年6月，来自34家意大利医院的234例患者被随机分为两组：（A）表柔比星（E）80mg/m²+紫杉醇（T）175mg/m²（静脉滴注3小时），每21天1次，共4 - 6个周期。（B）紫杉醇175mg/m²（静脉滴注3小时），每21天1次，共4 - 6个周期。ET组和T组分别有106例患者可进行生存分析。43%的患者一线治疗采用铂类单药化疗，22%的患者首选含蒽环类药物的联合化疗。从一线治疗结束到随机分组的中位时间为3个月。T组和ET组分别有87%和85%的患者完成了治疗。血液学毒性在ET组更为常见（ECOG 3 - 4级中性粒细胞减少：ET组为37.4%，T组为18.2%）。两组神经病变情况相似（感觉性：ECOG 2 - 3级：ET组为12.1%，T组为14.7%；运动性：ET组为6.1%，T组为5.3%）。ET组37.4%的患者和T组46.9%的患者获得了客观缓解。中位随访时间48个月时，共有180例患者病情进展，163例患者死亡。生存分析显示ET组和T组之间无差异（中位疾病进展时间：两种方案均为6个月；中位生存期：ET组为12个月，T组为14个月；ET组与T组的死亡风险比为1.17（95%CI 0.86 - 1.59；P = 0.33）。对于铂类化疗后早期进展的难治性晚期卵巢癌患者，ET方案似乎并不比T方案更有效。尽管缓解率尚可，但疾病进展的控制仍然较差。
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