Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: A randomized, phase-II study

详细信息    查看全文

• 作者：Hideki Kusagaya ; Naoki Inui ; Masato Karayama ; Yutaro Nakamura ; Shigeki Kuroishi ; Koshi Yokomura ; Mikio Toyoshima ; Toshihiro Shirai ; Masafumi Masuda ; Takashi Yamada ; Kazumasa Yasuda ; Takafumi Suda ; Kingo Chida
• 关键词：Biweekly ; Carboplatin ; Elderly patients ; Gemcitabine ; Non-small-cell lung cancer ; Phase-II trial
• 刊名：Lung Cancer
• 出版年：2012
• 出版时间：September, 2012
• 年：2012
• 卷：77
• 期：3
• 页码：550-555
• 全文大小：274 K

文摘

Introduction

The strategy of chemotherapy in the elderly is controversial. We wanted to evaluate the efficacy and safety of biweekly gemcitabine and low-dose carboplatin combination therapy in elderly patients with advanced non-small-cell lung cancer (NSCLC).

Methods

In this phase-II trial, chemotherapy-naive elderly patients (aged ¡Ý76 years) with NSCLC were randomly treated with biweekly combination therapy with gemcitabine and carboplatin (1000 mg/m² gemcitabine and carboplatin at an area under the curve (AUC) of 3 on days 1 and 15, every 4 weeks) or gemcitabine monotherapy (1000 mg/m² on days 1, 8 and 15, every 4 weeks). The primary endpoint was overall response rate and analysis was based on intention-to-treat.

Results

Thirty-one patients were randomly assigned combination therapy and 30 were assigned monotherapy. The median age was 79.0 years. Response rate was 22.6 % (95 % confidence interval (CI): 11.4-39.8 % ) for biweekly combination therapy and 10.0 % (95 % CI: 3.5-25.6 % ) for monotherapy. Median progression-free survival in combination chemotherapy was 3.9 months (95 % CI: 0.5-8.5 months), which was significantly longer that that in monotherapy (2.4 months, 95 % CI: 0.5-6.7 months). The prevalence of hematological and non-hematological adverse events reaching grade 3/4 was not significantly different between combination therapy and monotherapy.

Conclusions

Biweekly gemcitabine and low-dose carboplatin combination chemotherapy showed acceptable efficacy, toxicity, and tolerability in those aged ¡Ý76 years with NSCLC. Further investigations with a large population are required to confirm our results.