Phase I and II trials of vinorelbine with carboplatin for patients 75 years of age or older with previously untreated non-small-cell lung cancer.
Phase I and II trials of vinorelbine with carboplatin for patients 75 years of age or older with previously untreated non-small-cell lung cancer.
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长春瑞滨联合卡铂治疗 75 岁或以上患有既往未经治疗的非小细胞肺癌患者的 I 期和 II 期试验。
DOI：
10.1016/j.cllc.2011.11.007
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发表时间：
2012
期刊：
影响因子：
3.6
通讯作者：
et al.
中科院分区：
文献类型：
--
作者：
Takatani H;Nakamura Y;Nakatomi K;et al.
背景以铂类为基础的联合化疗方案治疗老年晚期非小细胞肺癌（NSCLC）的安全性和有效性尚不清楚。我们进行了I期和II期临床试验的长春瑞滨和卡铂的组合为≥75岁的患者和晚期NSCLC.Patients and MethodsPreviously untreated patients（≥75岁）与IIIB或IV期NSCLC的患者入组。基于4周周期，长春瑞滨在第1天和第8天给药，卡铂在第1天给药。剂量限制性毒性被定义为4级血液学毒性，持续4天或更长时间，发热性中性粒细胞减少症; 3级或更严重的非血液学毒性;或长春瑞滨给药的第8天，在第一个cycle.ResultsThirteen患者参加了I期。剂量限制性毒性为4级中性粒细胞减少症，持续4天或更长时间，在4级4例患者中观察到2例。II期研究使用水平3的剂量（20 mg/m2长春瑞滨，4 mg/mL/min卡铂的曲线下面积）。入组了42例患者。41例可评估患者的缓解率为14.6%（95% CI，3.8-25.4）。中位至进展时间为98天（95% CI，61-135天），中位生存时间为366天（95% CI，321-411天）。所有毒性反应均为轻度和manage.ConclusionUse长春瑞滨20 mg/m2的第1和第8天，然后卡铂的曲线下面积4 mg/mL/min的第1天，每4周保证了III期研究的老年晚期NSCLC患者。
BackgroundThe safety and efficacy of platinum-based combination chemotherapy for elderly patients with advanced non–small-cell lung cancer (NSCLC) remains unclear. We conducted phase I and phase II trials of a combination of vinorelbine and carboplatin for patients ≥75 years of age and with advanced NSCLC.Patients and MethodsPreviously untreated patients (≥75 years of age) with stage IIIB or IV NSCLC were enrolled. Based on a 4-week cycle, vinorelbine was given on days 1 and 8, and carboplatin was given on day 1. Dose-limiting toxicity was defined as grade 4 hematologic toxicity that lasted 4 days or more, febrile neutropenia; grade 3 or worse nonhematologic toxicities; or the omission of vinorelbine administration on day 8 in the first cycle.ResultsThirteen patients were enrolled in phase I. dose-limiting toxicity was grade 4 neutropenia that lasted 4 days or more, observed in 2 of 4 patients at level 4. Phase II study used the dose of level 3 (20 mg/m2vinorelbine, area under the curve of 4 mg/mL/min carboplatin). Forty-two patients were enrolled. The response rate was 14.6% of 41 assessable patients (95% CI, 3.8-25.4). The median time to progression was 98 days (95% CI, 61-135 days), and the median survival time was 366 days (95% CI, 321-411 days). All toxicities were mild and manageable.ConclusionUse of 20 mg/m2vinorelbine on days 1 and 8, followed by carboplatin area under the curve of 4 mg/mL/min on day 1 every 4 weeks warrants a phase III study for elderly patients with advanced NSCLC.