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一项随机多中心 II 期研究,比较顺铂/多西他赛与奥沙利铂/多西他赛作为晚期或转移性非小细胞肺癌一线治疗的疗效。

A randomised multicentre phase II study with cisplatin/docetaxel vs oxaliplatin/docetaxel as first-line therapy in patients with advanced or metastatic non-small cell lung cancer.

机构信息

Department of Hematology and Oncology, Institute of Clinical Research (IKF) at Krankenhaus Nordwest, UCT-University Cancer Center, 60488 Frankfurt am Main, Germany.

出版信息

Br J Cancer. 2013 Feb 5;108(2):265-70. doi: 10.1038/bjc.2012.555. Epub 2013 Jan 17.

DOI:10.1038/bjc.2012.555
PMID:23329236
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3566804/
Abstract

BACKGROUND

This study was designed to compare cisplatin/docetaxel with oxaliplatin/docetaxel in patients with advanced and metastatic non-small lung cancer as a first-line treatment.

METHODS

Patients were randomly assigned to receive either cisplatin 75 mg m(-2) and docetaxel 75 mg m(-2) every 3 weeks or oxaliplatin 85 mg m(-2) and docetaxel 50 mg m(-2) every 2 weeks. The primary end point was response rate, and secondary end points were toxicity, time to progression and overall survival.

RESULTS

A total of 88 patients (median age: 65 (39-86) years; stage IV: 93%) were randomly assigned. Response rate (complete and partial response) was 47% (95% CI: 33-61%) in the cisplatin/docetaxel arm and 28% (95% CI: 17-43%) in the oxaliplatin/docetaxel arm (P=0.118). There was no significant difference in time to progression (6.3 vs 4.9 months, P=0.111) and median overall survival (11.6 vs 7.0 months, P=0.102) with cisplatin/docetaxel vs oxaliplatin/docetaxel, although slight trends favouring cisplatin were seen. Oxaliplatin/docetaxel was associated with significantly less (any grade) renal toxicity (56% vs 11%), any grade fatigue (81% vs 59%), complete alopecia (76% vs 27%), any grade leukopenia (84% vs 61%) and grade 3/4 leukopenia (44% vs 14%) and neutropenia (56% vs 27%).

CONCLUSION

Oxaliplatin/docetaxel has activity in metastatic non-small cell lung cancer, but it seems to be inferior to cisplatin/docetaxel.

摘要

背景

本研究旨在比较顺铂/多西他赛与奥沙利铂/多西他赛在晚期和转移性非小细胞肺癌患者中的一线治疗效果。

方法

患者被随机分配接受顺铂 75 mg/m² 和多西他赛 75 mg/m²,每 3 周一次,或奥沙利铂 85 mg/m² 和多西他赛 50 mg/m²,每 2 周一次。主要终点是缓解率,次要终点是毒性、无进展生存期和总生存期。

结果

共 88 例患者(中位年龄:65 岁[39-86 岁];IV 期:93%)被随机分配。顺铂/多西他赛组的缓解率(完全和部分缓解)为 47%(95%CI:33-61%),奥沙利铂/多西他赛组为 28%(95%CI:17-43%)(P=0.118)。顺铂/多西他赛组与奥沙利铂/多西他赛组的无进展生存期(6.3 个月 vs 4.9 个月,P=0.111)和中位总生存期(11.6 个月 vs 7.0 个月,P=0.102)无显著差异,尽管顺铂有轻微的优势趋势。奥沙利铂/多西他赛组的肾毒性(任何等级)(56% vs 11%)、任何等级的乏力(81% vs 59%)、完全脱发(76% vs 27%)、任何等级的白细胞减少(84% vs 61%)和 3/4 级白细胞减少(44% vs 14%)和中性粒细胞减少症(56% vs 27%)的发生率明显较低。

结论

奥沙利铂/多西他赛在转移性非小细胞肺癌中具有活性,但似乎不如顺铂/多西他赛。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e172/3566804/b942af27177e/bjc2012555f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e172/3566804/b942af27177e/bjc2012555f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e172/3566804/b942af27177e/bjc2012555f1.jpg

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