A phase I/II study of carboplatin plus gemcitabine for elderly patients with advanced non-small cell lung cancer: West Japan Thoracic Oncology Group Trial (WJTOG) 2905

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• 作者：Takayasu Kurata^a ; ^{t-kurata@med.kindai.ac.jp} ; Tomonori Hirashima^b ; Yasuo Iwamoto^c ; Tomoya Kawaguchi^d ; Norihiko Ikeda^e ; Masahiro Tsuboi^e ; Toshiyuki Sawa^f ; Takashi Ishiguro^f ; Takuya Aoki^g ; Yoshikazu Kotani^h ; Kazuhiko Nakagawa^a ; Masahiro Fukuoka^a
• 关键词：Combination phase I/II study ; Gemcitabine ; Carboplatin ; Elderly patients ; NSCLC
• 刊名：Lung Cancer
• 出版年：2012
• 期刊代码：187_01695002
• 类别：med
• 出版时间：July, 2012
• 卷：77
• 期：1
• 页码：110-115
• 文件大小：232 K

摘要

Introduction

Monotherapy with a third generation anticancer agent has been regarded as the standard therapy for elderly patients with advanced non-small-cell lung cancer (NSCLC). However, it is unclear whether elderly patients with a good performance status can tolerate platinum-doublet chemotherapy like younger patients.

Methods

A combination phase I/II study was conducted in chemo-naive elderly patients with NSCLC to establish the toxicity and maximum tolerated dose (MTD) and to investigate the antitumor activity of carboplatin (CBDCA) plus gemcitabine (GEM). GEM was infused on days 1 and 8, and CBDCA on day 1 every 3 weeks.

Results

Seventy-five patients were enrolled. The most frequent toxicities were hematological, especially thrombocytopenia. Three of three patients experienced a dose-limiting toxicity at dose level 3: 1000 mg/m² GEM with AUC 5 CBDCA (MTD), and one of seven patients at level 2a: 1000 mg/m² GEM with AUC 4 CBDCA (recommended dose). In the phase II study, the overall response rate was 22.2%and the median overall survival time was 14.2 months.

Conclusions

Although the recommended dosage is restricted to a lower level compared to younger patients, combination therapy using CBDCA with GEM is tolerable and promising for elderly patients with advanced NSCLC.