Department of Respiratory Medicine and Allergy, Toyota Kosei Hospital, 500-1 Ibohara Josui-cho, Toyota, Aichi 470-0396, Japan.
Lung Cancer. 2010 Sep;69(3):319-22. doi: 10.1016/j.lungcan.2009.11.021. Epub 2010 Jan 6.
We conducted a phase II trial to evaluate the safety and efficacy of weekly paclitaxel in patients with resistant or relapsed non-small cell lung cancer (NSCLC) treated with docetaxel and carboplatin. Thirty-two NSCLC patients at a median age of 58.0 years (range 33-75) were enrolled. The Eastern Cooperative Oncology Group performance status scores (0/1/2) were 18/9/5, respectively. The majority of patients had adenocarcinoma (84%) and stage IV disease (81%). The response rate for the first-line chemotherapy was 28%. Paclitaxel was administered at a dose of 80 mg/m(2) as an intravenous infusion 60 min weekly for 6 consecutive weeks of an 8-week cycle. All patients were assessable for response and toxicity. The median number of cycles administered was two (range 1-8), and the overall response rate was 15.6%. The median survival time (MST) was 10.6 months (95% CI=8.2-12.5), while the 1-year survival rate was 37.5%, and the median progression-free survival was 4.9 months (95% CI=3.0-7.1). Hematological toxicities (grade 3 or 4) were observed in 15 patients (46.9%) with leukopenia, and in 4 (12.5%) with anemia. Non-hematological toxicity was generally mild, though grade 3 anorexia was observed in 3 patients (9.3%). No treatment-related deaths were observed. In conclusion, second-line weekly paclitaxel is effective in NSCLC patients treated with docetaxel plus carboplatin and is associated with a tolerable toxicity profile.
我们进行了一项 II 期临床试验，以评估每周紫杉醇治疗多西紫杉醇和卡铂治疗后耐药或复发的非小细胞肺癌（NSCLC）患者的安全性和疗效。32 名 NSCLC 患者的中位年龄为 58.0 岁（范围 33-75 岁）。东部合作肿瘤学组表现状态评分（0/1/2）分别为 18/9/5。大多数患者为腺癌（84%）和 IV 期疾病（81%）。一线化疗的缓解率为 28%。紫杉醇以 80mg/m²的剂量作为静脉输注，每周 60 分钟，每 8 周为一个周期，连续 6 周给药。所有患者均可评估反应和毒性。中位给药周期数为 2 个（范围 1-8），总缓解率为 15.6%。中位总生存期（MST）为 10.6 个月（95%CI=8.2-12.5），1 年生存率为 37.5%，中位无进展生存期为 4.9 个月（95%CI=3.0-7.1）。15 名患者（46.9%）出现血液学毒性（3 或 4 级），表现为白细胞减少，4 名患者（12.5%）出现贫血。非血液学毒性通常较轻，但 3 名患者（9.3%）出现 3 级厌食症。未观察到与治疗相关的死亡。总之，二线每周紫杉醇治疗多西紫杉醇加卡铂治疗后的 NSCLC 患者有效，且毒性谱可耐受。
