Tomao Silverio, Romiti Adriana, Tomao Federica, Di Seri Marisa, Caprio Giuliana, Spinelli Gian Paolo, Terzoli Edmondo, Frati Luigi
Department of Clinical Oncology, Regina Elena Cancer Institute of Rome, Via Chianesi, 53, 00100 Rome, Italy.
BMC Cancer. 2006 May 24;6:137. doi: 10.1186/1471-2407-6-137.
Many emerging new drugs have recently been trialled for treatment of early and advanced breast cancer. Among these new agents paclitaxel and gemcitabine play a crucial role, mostly in patients with relapsed and metastatic disease after failure of chemotherapy with antracyclines.
A phase II study was started in order to evaluate the activity and toxicity of a combination of paclitaxel and gemcitabine in a biweekly schedule on metastatic breast cancer patients previously treated with antracyclines.
Twenty-five patients received paclitaxel (150 mg/mq) by 3-hours infusion, followed by gemcitabine (2000 mg/mq) given as a 60 min i.v. infusion (day 1-14) for a maximum of eight cycles. In all patients treatment was evaluated for toxicity and efficacy; four patients (16%) achieved a complete response, 12 (48%) a partial response giving an overall objective response rate of 64%. Stable disease was documented in 5 patients (20%) and progressive disease occurred in 4 patients (16%).
The schedule of treatment was safe and tolerable from a haematological and non-haematological point of view. These data confirm that the combination of gemcitabine and paclitaxel on a biweekly basis is an effective and well-tolerated regimen in breast cancer patients with prior therapeutic exposure to antracyclines.
最近许多新型药物已被试验用于治疗早期和晚期乳腺癌。在这些新药中，紫杉醇和吉西他滨发挥着关键作用，主要用于蒽环类化疗失败后的复发和转移性疾病患者。
开展一项II期研究，以评估紫杉醇和吉西他滨联合用药每两周一次给药方案对先前接受过蒽环类治疗的转移性乳腺癌患者的活性和毒性。
25例患者接受紫杉醇（150mg/m²）3小时静脉输注，随后给予吉西他滨（2000mg/m²）60分钟静脉输注（第1 - 14天），最多8个周期。对所有患者的治疗进行毒性和疗效评估；4例患者（16%）达到完全缓解，12例（48%）部分缓解，总客观缓解率为64%。5例患者（20%）疾病稳定，4例患者（16%）疾病进展。
从血液学和非血液学角度来看，该治疗方案安全且耐受性良好。这些数据证实，每两周一次的吉西他滨和紫杉醇联合方案对于先前接受过蒽环类治疗的乳腺癌患者是一种有效且耐受性良好的治疗方案。
