A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.
A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study.
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DOI：
10.1038/sj.bjc.6602241
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发表时间：
2004-12-13
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
多西他赛（75 mg m−2，每周3次）是晚期非小细胞肺癌（NSCLC）的标准二线治疗，具有显著毒性。为了验证每周一次方案（33.3 mg m−2，持续6周）是否改善了生活质量（QoL），在220例年龄≥ 75岁、ECOG PS ≥ 2的晚期NSCLC患者中进行了一项III期研究。通过EORTC问卷和每日日记卡（DDC）评估QoL。3周时总体QoL评分无差异。疼痛、咳嗽和脱发明显有利于每周一次的时间表，而腹泻则更严重。DDC分析显示，在第一周，3周组的食欲不振和总体状况显著更差，而在第三周，每周组的恶心和食欲不振更严重。缓解率和生存率相似，每周一次组的死亡风险比为1.04（95% CI 0.77-1.39）。多西他赛3周1次治疗对白细胞减少症、中性粒细胞减少症、发热性中性粒细胞减少症和脱发的毒性更大;标准组中任何3-4级血液学毒性的发生率显著更高（25 vs 6%）。对于接受多西他赛作为晚期NSCLC二线治疗的患者，每周一次给药方案可能是首选，因为其具有某些QoL优势、毒性较低且无证据表明对生存期的影响存在显著差异。
Docetaxel (75 mg m−2 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m−2 for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, ⩽75 years, ECOG PS ⩽2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77–1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3–4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.
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影响因子：
8.4
作者：
BERGMAN, B;AARONSON, NK;SULLIVAN, M
通讯作者：
SULLIVAN, M
影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
45.3
作者：
Shepherd, FA;Dancey, J;Berille, J
通讯作者：
Berille, J
影响因子：
3.7
作者：
KAPLAN, EL;MEIER, P
通讯作者：
MEIER, P
影响因子：
5.3
作者：
Leu, KM;Kim, KM;Schiller, JH
通讯作者：
Schiller, JH