Phase II randomised trial comparing docetaxel given every 3 weeks with weekly schedule as second-line therapy in patients with advanced non-small-cell lung cancer (NSCLC)
Phase II randomised trial comparing docetaxel given every 3 weeks with weekly schedule as second-line therapy in patients with advanced non-small-cell lung cancer (NSCLC)
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DOI：
10.1093/annonc/mdi018
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发表时间：
2005-01-01
影响因子：
50.5
通讯作者：
Quoix, E
中科院分区：
文献类型：
--
作者：
Gervais, R;Ducolone, A;Quoix, E
背景： 每 3 周剂量为 75 mg/m(2) 的 Taxotere(R)（多西他赛）是治疗非小细胞肺癌 (NSCLC) 的标准疗法。本研究的目的是评估两种多西他赛给药方案（每 3 周一次与每周一次）对接受过治疗的 NSCLC 患者的安全性。 患者和方法：从 2000 年 2 月到 2001 年 2 月，125 名局部晚期或转移性 NSCLC 患者在之前的铂类治疗方案失败后被随机分配接受每 3 周一次 75 mg/m(2) 的多西他赛治疗 (Dq3w) 或多西他赛 40mg/m(2) 每周给予，持续 6 周，然后休息 2 周 (Dqw)。安全性评估集中于 3-4 级中性粒细胞减少症、发热性中性粒细胞减少症、恶心呕吐和乏力。结果：各组患者的特征非常平衡。最常见的美国国家癌症研究所通用毒性标准 (NCI-CTC) 3-4 级毒性是中性粒细胞减少症，Dq3w 患者的发生率为 48.4%，而 Dqw 患者的发生率为 15.9% (P = 0.001)。此外。在 Dq3w 中观察到 6.5% 的患者出现发热性中性粒细胞减少症，而在 Dqw 中这一比例为 0%。 3-4 级无力在 Dqw 中更为常见。其他非血液学毒性非常罕见。就疗效而言，Dq3w 的疾病控制率有更好的趋势：Dqw 为 32.2%，而 Dqw 为 25.4%。两组的中位进展时间和生存时间相当相似：Dq3w 为 2.1 个月（范围 2-3.2）和 5.8 个月（范围 4.0-7.0），Dqw 为 1.8 个月（范围 1.6-2.3）和 5.5 个月（范围 3.7-6.6）。结论：虽然两种方案都具有良好的安全性，但严重中性粒细胞减少症的发生率显着较低。在每周臂中观察到。两种方案具有相似的功效。对于有严重中性粒细胞减少症风险的患者来说，每周一次的治疗方案可以被认为是一个很好的选择。
Background: Taxotere(R) (docetaxel) at the dose of 75 mg/m(2) every 3 weeks is a standard therapy for pretreated non-small-cell lung cancer (NSCLC). The aim of this study was to evaluate the safety profile of two schedules of docetaxel administration (every 3 weeks versus weekly) in patients with pretreated NSCLC.Patients and methods: From February 2000 to February 2001, 125 patients with locally advanced or metastatic NSCLC were randomised after failure of a previous platinum-based regimen to receive either docetaxel 75 mg/m(2) administered every 3 weeks (Dq3w) or docetaxel 40mg/m(2) given weekly for 6 weeks followed by 2 weeks of rest (Dqw). Safety evaluations focused on grade 3-4 neutropenia, febrile neutropenia, nausea-vomiting and asthenia.Results: Patients' characteristics were well balanced between arms. The most common National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3-4 toxicity was neutropenia, which occurred in 48.4% of Dq3w patients versus 15.9% of Dqw patients (P = 0.001). In addition. febrile neutropenia were observed in 6.5% of patients in Dq3w versus 0% in Dqw. Grade 3-4 asthenia was more frequent in Dqw. Other non-haematological toxicities were very rare. Regarding efficacy, there was a trend towards a better disease control rate in Dq3w: 32.2% versus 25.4% in Dqw. Median time to progression and survival were rather similar in both arms, respectively: 2.1 months (range 2-3.2) and 5.8 months (range 4.0-7.0) in Dq3w and 1.8 months (range 1.6-2.3) and 5.5 months (range 3.7-6.6) in Dqw.Conclusions: While both schedules had a favourable safety profile, a significant lower rate of severe neutropenia was observed in the weekly arm. Both regimens had similar efficacy. The weekly regimen could be considered as a good alternative for patients at risk of severe neutropenia.