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卡铂-培美曲塞序贯培美曲塞维持治疗老年晚期非鳞非小细胞肺癌的剂量递增研究。

Dose escalation study of carboplatin-pemetrexed followed by maintenance pemetrexed for elderly patients with advanced nonsquamous nonsmall-cell lung cancer.

机构信息

Department of Internal Medicine, Kinki-Chuo Chest Medical Center, Osaka, Japan.

出版信息

Ann Oncol. 2013 Apr;24(4):980-5. doi: 10.1093/annonc/mds544. Epub 2012 Nov 7.

DOI:10.1093/annonc/mds544
PMID:23136232
Abstract

BACKGROUND

This study was designed to determine the recommended dose of carboplatin-pemetrexed in elderly (≥75 years old), chemotherapy-naive patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC).

PATIENTS AND METHODS

Patients received escalated doses of carboplatin and pemetrexed every 3 weeks for four cycles. Patients with an objective response and stable disease continued pemetrexed therapy until disease progression or unacceptable toxicity was observed.

RESULTS

The combination of carboplatin at an area under the concentration-time curve (AUC) of 5, and 500 mg/m(2) pemetrexed, was determined to be the recommended dose for elderly patients with advanced nonsquamous NSCLC. Of 17 patients, 10 received a median of five cycles of pemetrexed maintenance therapy without unexpected or cumulative toxic effects. The study had an overall response rate of 47.1%. The median progression-free survival time was 142 days (95% confidence interval [CI] 68-216 days) and the median overall survival time was 461 days (95% CI 168-754 days).

CONCLUSIONS

This combination was a tolerable and effective regimen, and recommended dose (RD) was carboplatin [area under the curve (AUC) of 5]/pemetrexed (500 mg/m(2)) every 3 weeks, in chemotherapy-naïve, elderly (≥75 years old) patients with advanced nonsquamous NSCLC.

摘要

背景

本研究旨在确定卡铂-培美曲塞在初治的老年(≥75 岁)晚期非鳞状非小细胞肺癌(NSCLC)患者中的推荐剂量。

患者和方法

患者每 3 周接受 4 个周期的卡铂和培美曲塞递增剂量治疗。客观缓解和疾病稳定的患者继续接受培美曲塞治疗,直到疾病进展或出现不可接受的毒性。

结果

卡铂 AUC 为 5,培美曲塞 500mg/m2,联合方案被确定为老年晚期非鳞状 NSCLC 患者的推荐剂量。17 例患者中,10 例患者接受培美曲塞维持治疗中位数为 5 个周期,未出现意外或累积毒性作用。研究的总缓解率为 47.1%。中位无进展生存期为 142 天(95%置信区间 [CI]:68-216 天),中位总生存期为 461 天(95%CI:168-754 天)。

结论

该联合方案具有良好的耐受性和有效性,推荐剂量(RD)为卡铂[曲线下面积(AUC)为 5]/培美曲塞(500mg/m2),每 3 周一次,用于初治的老年(≥75 岁)晚期非鳞状 NSCLC 患者。

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