吉西他滨联合长春瑞滨双周给药治疗老年晚期非小细胞肺癌：多中心II期试验

Bi-weekly administration of gemcitabine plus vinorelbine in elderly patients with advanced non-small-cell lung cancer: multicenter phase II trial.

作者信息

Araya Tomoyuki, Kasahara Kazuo, Kimura Hideharu, Shibata Kazuhiko, Kita Toshiyuki, Shirasaki Hiroki, Hara Johsuke, Yoshimi Yuzo, Sone Takashi, Oribe Yoshitaka, Nobata Kouichi, Nishi Kouichi, Fujimura Masaki, Nakao Shinji

机构信息

Respiratory Medicine, Kanazawa University Hospital, Takara-machi 13-1, Kanazawa 920-8641, Japan.

出版信息

Lung Cancer. 2007 Jun;56(3):371-6. doi: 10.1016/j.lungcan.2007.01.001. Epub 2007 Feb 14.

DOI:10.1016/j.lungcan.2007.01.001

PMID:17300851

Abstract

PURPOSE

Gemcitabine (GEM) and vinorelbine (VNR) have demonstrated activity as a first-line treatment in elderly patients with advanced non-small-cell lung cancer (NSCLC). We conducted a multicenter phase II trial to evaluate the efficacy and toxicity of bi-weekly administration of GEM plus VNR in elderly patients with advanced NSCLC.

PATIENTS AND METHODS

Forty-six chemotherapy-naive elderly (age: >or=70 years) NSCLC patients were enrolled. Patients were eligible if they had histologically or cytologically confirmed unresectable NSCLC with measurable and/or assessable disease. Patients received GEM (1000 mg/m2) and VNR (25 mg/m2) every 2 weeks.

RESULTS

The objective response rate of this treatment was 22.7% (95% confidence interval (CI), 10.3-35.1%), median survival time was 310 days, and median time to progression was 133 days. The one-year survival rate was 40.9% (95% CI, 26.3-55.4%), and most adverse events were mild. Only three (6.8%) patients needed to omit GEM because of grade 4 neutropenia or due to physician judgment. No patients suffered treatment-related death.

CONCLUSIONS

Bi-weekly administration of GEM plus VNR in elderly patients was an effective, feasible and well-tolerated treatment schedule.

摘要

目的

吉西他滨（GEM）和长春瑞滨（VNR）已被证明可作为老年晚期非小细胞肺癌（NSCLC）患者的一线治疗药物。我们进行了一项多中心II期试验，以评估每两周一次给予GEM加VNR对老年晚期NSCLC患者的疗效和毒性。

患者与方法

纳入46例未接受过化疗的老年（年龄≥70岁）NSCLC患者。如果患者经组织学或细胞学确诊为不可切除的NSCLC，且疾病可测量和/或可评估，则符合入选标准。患者每2周接受一次GEM（1000 mg/m²）和VNR（25 mg/m²）治疗。

结果

该治疗的客观缓解率为22.7%（95%置信区间（CI），10.3 - 35.1%），中位生存时间为310天，中位疾病进展时间为133天。一年生存率为40.9%（95% CI，26.3 - 55.4%），且大多数不良事件为轻度。仅3例（6.8%）患者因4级中性粒细胞减少或医生判断需要停用GEM。无患者死于治疗相关原因。