Gennari A, Donati S, Danesi R, Fogli S, Orlandini C, Del Tacca M, Conte P F
Dipartimento di Oncologia, Ospedale Santa Chiara e Universita, Pisa, Italy.
Semin Oncol. 2000 Feb;27(1 Suppl 2):14-9.
The purpose of this study was to determine the response rate of the gemcitabine/epirubicin/paclitaxel combination (GET) and its feasibility as induction chemotherapy before high-dose consolidation treatment in patients with metastatic breast cancer. Patients received gemcitabine 1,000 mg/m2 on days I and 4, epirubicin 90 mg/m2 on day 1, and paclitaxel 175 mg/m2 on day I every 3 weeks for up to eight courses. After six courses of GET, responding patients or those with stable disease entered a high-dose chemotherapy program. All 36 enrolled patients were evaluated for toxicity and response. The GET combination was well tolerated, with myelosuppression the being most common toxicity; grade 4 neutropenia was reported in 56% of patients. The overall response rate was 89% (95% confidence interval, 73.4% to 96.9%), with a 28% complete response rate. The high-dose chemotherapy program resulted in a response rate of 92% and a complete response rate of 44%. As a result of the promising activity demonstrated in this phase II study with GET and following high-dose chemotherapy, three related studies are planned: an in vitro study evaluating the possible synergism of paclitaxel and gemcitabine, a phase III study comparing GET with epirubicin/paclitaxel in metastatic breast cancer, and a phase II trial evaluating GET in patients with operable breast cancer.
本研究的目的是确定吉西他滨/表柔比星/紫杉醇联合方案（GET）的缓解率及其作为转移性乳腺癌患者大剂量巩固治疗前诱导化疗的可行性。患者每3周接受一次治疗，第1天和第4天给予吉西他滨1000mg/m²，第1天给予表柔比星90mg/m²，第1天给予紫杉醇175mg/m²，最多进行8个疗程。在接受6个疗程的GET治疗后，缓解患者或疾病稳定患者进入大剂量化疗方案。对所有36例入组患者进行了毒性和疗效评估。GET联合方案耐受性良好，骨髓抑制是最常见的毒性；56%的患者报告有4级中性粒细胞减少。总缓解率为89%（95%置信区间，73.4%至96.9%），完全缓解率为28%。大剂量化疗方案的缓解率为92%，完全缓解率为44%。由于在这项GET联合大剂量化疗的II期研究中显示出了有前景的活性，计划开展三项相关研究：一项评估紫杉醇和吉西他滨可能协同作用的体外研究、一项在转移性乳腺癌中将GET与表柔比星/紫杉醇进行比较的III期研究以及一项评估GET在可手术乳腺癌患者中的II期试验。
