Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial
Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: a report from the Central Japan Lung Study Group, CJLSG 0503 trial
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DOI：
10.1007/s10147-010-0118-x
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发表时间：
2010-12-01
影响因子：
3.3
通讯作者：
Shimokata, Kaoru
中科院分区：
文献类型：
--
作者：
Usami, Noriyasu;Yokoi, Kohei;Shimokata, Kaoru
这项II期研究的目的是评估卡铂和吉西他滨联合治疗完全切除的非小细胞肺癌（NSCLC）的可行性和安全性。病理证明完全切除的IB、II或IIIA期非小细胞肺癌患者接受卡铂和吉西他滨治疗。化疗包括卡铂在第1天5（1级）或4（2级）曲线下区域的4个周期，联合吉西他滨在第1天和第8天每3周1,000 mg/m(2)。本研究的主要终点是4个周期的完成率。20例患者接受治疗，患者的人口统计学特征为：中位年龄61岁（51-74岁），性别为男性(n = 13, 65%)/女性（n = 7, 35%）， IB期（n = 8, 40%）， IIA期（n = 1, 5%）， IIB期（n = 6, 30%）， IIIA期（n = 5, 25%）。17例患者（85%，95%可信区间64.0 ~ 94.8）每3周接受1级化疗方案计划的4个周期。在未能完成4个周期的3例患者中，停止治疗的原因分别是拒绝（n = 1）、血小板减少（n = 1）和皮疹（n = 1）。主要不良反应为血液学毒性以及3/4级中性粒细胞减少和血小板减少（分别发生在65%和40%的患者中）。卡铂和吉西他滨联合化疗方案的辅助化疗具有可接受的毒性，大多数患者完成了4个周期的治疗。
The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC).Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m(2) on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles.Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively).Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.