Vici Patrizia, Foggi Paolo, Colucci Giuseppe, Capomolla Elisabetta, Brandi Mario, Giotta Francesco, Gebbia Nicola, Di Lauro Luigi, Valerio Maria Rosaria, Paoletti Giancarlo, Belli Franca, Pizza Carmine, Giannarelli Diana, Lopez Massimo
Regina Elena Institute for Cancer Research, Via Elio Chianesi 53, 00144 Rome, Italy.
Anticancer Res. 2005 Mar-Apr;25(2B):1309-14.
This phase II study evaluated the efficacy and the tolerability of a sequential regimen of docetaxel followed by epirubicin-vinorelbine combination as first-line chemotherapy in advanced breast cancer.
Twenty-seven patients received docetaxel 100 mg/m2 (4 cycles) followed by 4 cycles of epirubicin 90 mg/m2 (day 1) combined with vinorelbine 25 mg/m2 (days 1 and 5), with cycles repeated every 3 weeks. G-CSF was administered during epirubicin-vinorelbine treatment.
There were 1 (3.7%) CR and 14 (51.9%) PR, for an overall response rate of 55.6% (95% CI, 36.9%-74.3%). Median time to response, time to progression and overall survival were 2, 9 and 25 months, respectively. The dose-limiting toxicity was neutropenia (grade 3 to 4 in 85% of the patients). There was one toxic death due to neutropenic fever. Gastrointestinal side-effects were generally mild According to the Simon two-stage design the response rate was considered unsatisfactory and patient accrual was terminated.
This sequential regimen appears to be moderately effective; possibly, a modulation of the treatment based on objective responses instead of a fixed number of cycles may be more appropriate in order to obtain better results.
本II期研究评估了多西他赛序贯表柔比星-长春瑞滨联合方案作为晚期乳腺癌一线化疗的疗效和耐受性。
27例患者接受多西他赛100mg/m²（4个周期），随后接受4个周期的表柔比星90mg/m²（第1天）联合长春瑞滨25mg/m²（第1天和第5天）治疗，每3周重复1个周期。在表柔比星-长春瑞滨治疗期间给予粒细胞集落刺激因子（G-CSF）。
有1例（3.7%）完全缓解（CR）和14例（51.9%）部分缓解（PR），总缓解率为55.6%（95%置信区间，36.9%-74.3%）。中位缓解时间、疾病进展时间和总生存期分别为2个月、9个月和25个月。剂量限制性毒性为中性粒细胞减少（85%的患者为3至4级）。有1例因中性粒细胞减少性发热导致的毒性死亡。胃肠道副作用一般较轻。根据西蒙两阶段设计，缓解率被认为不令人满意，因此终止了患者入组。
这种序贯方案似乎有中等疗效；为了获得更好的结果，可能根据客观缓解情况调整治疗方案而非固定周期数更为合适。
