Delfino Carlos, Caccia Graciela, Riva Gonzáles Luis, Mickiewicz Elizabeth, Rodger Jeannette, Balbiani Luis, Flores Morales Daniel, Zori Comba Alberto, Brosio Celia
Hospital Privado de Comunidad, Mar del Plata, Argentina.
Oncology (Williston Park). 2003 Dec;17(12 Suppl 14):22-5.
Gemcitabine (Gemzar) and paclitaxel exhibit good activity and good safety profiles when used alone and together in the treatment of advanced breast cancer. In a phase II trial, 45 patients with metastatic breast cancer received gemcitabine at 1,200 mg/m2 on days 1 and 8 and paclitaxel at 175 mg/m2 on day 1 every 21 days. Twenty-seven patients (60.0%) had prior adjuvant therapy. Objective response was observed in 30 patients (objective response rate 66.7%, 95% confidence interval [CI] = 52%-71%), including complete response in 10 (22.2%) and partial response in 20 (44.4%). Median duration of response was 18 months (95% CI = 11-26.7 months), median time to tumor progression for the entire population was 11 months (95% CI = 7.1-18.7 months), median overall survival was 19 months (95% CI = 17.3-21.7 months), and the 1-year survival rate was 69%. Treatment was well tolerated, with grade 3/4 toxicities being infrequent. Grade 3/4 leukopenia, neutropenia, and thrombocytopenia were each observed in six patients (13.3%). No patient was discontinued from the study due to hematologic or nonhematologic toxicity. Thus, the gemcitabine/paclitaxel combination shows promising activity and tolerability when used as first-line treatment in advanced disease. The combination recently has been shown to be superior to paclitaxel alone as first-line treatment in anthracycline-pretreated advanced disease according to interim results of a phase III trial and it should be further evaluated in comparative trials in breast cancer.
吉西他滨（健择）和紫杉醇单独使用或联合使用治疗晚期乳腺癌时均显示出良好的活性和安全性。在一项II期试验中，45例转移性乳腺癌患者每21天接受一次治疗，第1天和第8天给予吉西他滨1200mg/m²，第1天给予紫杉醇175mg/m²。27例患者（60.0%）曾接受过辅助治疗。30例患者观察到客观缓解（客观缓解率66.7%，95%置信区间[CI]=52%-71%），其中完全缓解10例（22.2%），部分缓解20例（44.4%）。中位缓解持续时间为18个月（95%CI=11-26.7个月），全体患者的中位肿瘤进展时间为11个月（95%CI=7.1-18.7个月），中位总生存期为19个月（95%CI=17.3-21.7个月），1年生存率为69%。治疗耐受性良好，3/4级毒性反应不常见。6例患者（13.3%）分别出现3/4级白细胞减少、中性粒细胞减少和血小板减少。没有患者因血液学或非血液学毒性而退出研究。因此，吉西他滨/紫杉醇联合方案作为晚期疾病的一线治疗显示出有前景的活性和耐受性。根据一项III期试验的中期结果，该联合方案最近已被证明在蒽环类药物预处理的晚期疾病中作为一线治疗优于单独使用紫杉醇，并且应在乳腺癌的对比试验中进一步评估。
