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未经治疗的非鳞状非小细胞肺癌患者在基于卡铂诱导化疗后继续培美曲塞维持/巩固治疗的 II 期临床试验

Phase II trial of pemetrexed continuation--maintenance after carboplatin-based induction in untreated non-squamous non-small cell lung cancer.

机构信息

Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan.

出版信息

Anticancer Res. 2013 Dec;33(12):5535-42.

Abstract

AIM

We conducted a phase II study to evaluate the efficacy and safety of pemetrexed continuation-maintenance after carboplatin-based induction for advanced non-squamous non-small cell lung cancer (NSCLC).

PATIENTS AND METHODS

Thirty-four patients with advanced or recurrent non-squamous NSCLC received carboplatin (area under the concentration-time curve 6 mg/ml×min) plus pemetrexed (500 mg/m(2)) on day 1 tri-weekly. After four cycles of induction, patients without disease progression received pemetrexed maintenance until disease progression or unacceptable toxicity.

RESULTS

Twenty-five patients completed induction and 22 received maintenance. The 1-year survival, objective response and disease control rates were 70.3%, 32.4% and 88.2%, respectively. The median progression-free survival and overall survival of all patients were 5.2 and 23.3 months. The incidental rates of grade 3 or more severe adverse events were low.

CONCLUSION

This regimen appears to be an appropriate option for chemonaïve patients with advanced non-squamous NSCLC.

摘要

目的

我们进行了一项 II 期研究,以评估培美曲塞维持治疗在含卡铂诱导化疗后用于晚期非鳞状非小细胞肺癌(NSCLC)患者中的疗效和安全性。

患者和方法

34 例晚期或复发性非鳞状 NSCLC 患者接受卡铂(浓度-时间曲线下面积 6 mg/ml×min)联合培美曲塞(500 mg/m²),每 3 周 1 次,第 1 天给药。4 个周期诱导治疗后,无疾病进展的患者接受培美曲塞维持治疗,直至疾病进展或出现不可接受的毒性。

结果

25 例患者完成了诱导治疗,22 例患者接受了维持治疗。患者的 1 年生存率、客观缓解率和疾病控制率分别为 70.3%、32.4%和 88.2%。所有患者的中位无进展生存期和总生存期分别为 5.2 和 23.3 个月。≥3 级严重不良事件的发生率较低。

结论

该方案似乎是晚期非鳞状 NSCLC 患者的一种合适选择。

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