Yang Chih-Hsin, Chen Min-Chun, Cheng Ann-Lii, Hsu Chih-Hung, Yeh Kun-Huei, Yu Yu-Chie, Whang-Peng Jacqueline, Yang Pan-Chyr
Department of Oncology and Cancer Research Center, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Oncology. 2005;68(4-6):350-5. doi: 10.1159/000086974. Epub 2005 Jul 11.
High-dose epirubicin was shown to be effective in the treatment of inoperable non-small cell lung cancer (NSCLC). Paclitaxel is synergistic to a conventional dose of anthracyclines in the treatment of advanced cancer. A phase II study was designed to test the effectiveness of combining paclitaxel with a conventional dose of epirubicin in inoperable NSCLC patients.
Eligibility criteria included inoperable stage IIIB or IV NSCLC patients, Eastern Cooperative Oncology Group performance status of 0-2, measurable or evaluable disease and adequate organ function. Epirubicin 70 mg/m2 intravenous infusion for 15 min was given on day 1. Paclitaxel 175 mg/m2 intravenous infusion for 3 h was given on day 2. Cycles were repeated every 21 days. Tumor response was evaluated every two cycles. Patients received treatment until disease progression, unacceptable toxicity or stable disease after cycle 6.
Thirty-eight patients received a total of 185 cycles (median 6 cycles). Seventeen patients responded to treatment (response rate 44.7%). Twenty-six (68%) patients received second-line chemotherapy. All patients were followed until their death. Median survival was 11.9 months (95% confidence interval 9.0-14.9 months). Median time-to-treatment-failure was 4.6 months.
Conventional dose epirubicin plus paclitaxel is effective as a first-line treatment for inoperable NSCLC patients.
高剂量表柔比星已被证明在治疗无法手术的非小细胞肺癌(NSCLC)中有效。紫杉醇在治疗晚期癌症方面与传统剂量的蒽环类药物具有协同作用。一项II期研究旨在测试紫杉醇与传统剂量表柔比星联合应用于无法手术的NSCLC患者的有效性。
入选标准包括无法手术的IIIB期或IV期NSCLC患者、东部肿瘤协作组体能状态为0 - 2、可测量或可评估的疾病以及足够的器官功能。第1天给予表柔比星70 mg/m²静脉输注15分钟。第2天给予紫杉醇175 mg/m²静脉输注3小时。每21天重复一个周期。每两个周期评估肿瘤反应。患者接受治疗直至疾病进展、出现不可接受的毒性或在第6个周期后疾病稳定。
38例患者共接受了185个周期(中位值6个周期)。17例患者对治疗有反应(反应率44.7%)。26例(68%)患者接受了二线化疗。所有患者均随访至死亡。中位生存期为11.9个月(95%置信区间9.0 - 14.9个月)。中位治疗失败时间为4.6个月。
传统剂量表柔比星加紫杉醇作为无法手术的NSCLC患者的一线治疗有效。