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采用三种不同的每周紫杉醇联合卡铂方案治疗老年非小细胞肺癌患者:一项随机试验的亚组分析

Treatment of elderly non-small cell lung cancer patients with three different schedules of weekly paclitaxel in combination with carboplatin: subanalysis of a randomized trial.

作者信息

Ramalingam Suresh, Barstis John, Perry Michael C, La Rocca Renato V, Nattam Sreenivasa R, Rinaldi David, Clark Ray, Mills Glenn M, Belani Chandra P

机构信息

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15232, USA.

出版信息

J Thorac Oncol. 2006 Mar;1(3):240-4. doi: 10.1016/s1556-0864(15)31574-4.

Abstract

BACKGROUND

Administration of paclitaxel on a weekly schedule in combination with carboplatin is associated with a lower incidence of neuropathy and myelosuppression. The authors conducted subgroup analysis of their randomized phase II study of three different schedules of weekly paclitaxel with carboplatin to determine the efficacy of each regimen in elderly patients (aged > or = 70 years) with advanced non-small-cell lung cancer (NSCLC).

METHODS

Patients with advanced NSCLC were randomized to one of three different weekly paclitaxel/carboplatin regimens. After four cycles of chemotherapy, those with objective response or stable disease were randomized to weekly paclitaxel or observation as maintenance therapy. Four hundred three patients were enrolled in the study, of whom 111 (28%) were aged 70 years or older.

RESULTS

The treatment regimen of weekly paclitaxel (100 mg/m for 3 of 4 weeks) and carboplatin (area under the curve = 6 mg/ml/min once every 4 weeks) (arm 1) was associated with the best therapeutic index overall. The median survival and 1-year survival rates were 11.3 months and 50% for patients in the > or =70 years cohort versus 11.2 months and 46% for the <70 years cohort in arm 1. Efficacy results were comparable between the two groups in the other arms as well. Grade 4 neutropenia and febrile neutropenia occurred in 13.6% and 2.3% in the > or =70 years cohort compared with 4.5% and 1.1% in the <70 years cohort in arm 1.

CONCLUSION

The weekly regimen of paclitaxel administered in combination with carboplatin is tolerated well by elderly NSCLC patients and has comparable efficacy with younger patients.

摘要

背景

每周使用紫杉醇联合卡铂给药与较低的神经病变和骨髓抑制发生率相关。作者对其关于三种不同的每周紫杉醇联合卡铂给药方案的随机II期研究进行了亚组分析,以确定每种方案对老年(年龄≥70岁)晚期非小细胞肺癌(NSCLC)患者的疗效。

方法

晚期NSCLC患者被随机分配至三种不同的每周紫杉醇/卡铂给药方案之一。化疗四个周期后,那些有客观缓解或疾病稳定的患者被随机分配接受每周紫杉醇治疗或观察作为维持治疗。403例患者入组该研究,其中111例(28%)年龄在70岁及以上。

结果

每周紫杉醇(100mg/m²,4周中的3周)联合卡铂(曲线下面积=6mg/ml/min,每4周一次)的治疗方案(第1组)总体上具有最佳的治疗指数。在第1组中,年龄≥70岁队列患者的中位生存期和1年生存率分别为11.3个月和50%,而年龄<70岁队列患者分别为11.2个月和46%。其他组中两组的疗效结果也具有可比性。在第1组中,年龄≥70岁队列4级中性粒细胞减少和发热性中性粒细胞减少的发生率分别为13.6%和2.3%,而年龄<70岁队列分别为4.5%和1.1%。

结论

老年NSCLC患者对每周紫杉醇联合卡铂的治疗方案耐受性良好,且与年轻患者疗效相当。

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