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培美曲塞与吉西他滨联合用药对比卡铂与吉西他滨联合用药治疗非小细胞肺癌:一项单中心随机非劣效性II期研究

Pemetrexed and gemcitabine versus carboplatin and gemcitabine in non-small cell lung cancer: a randomized noninferiority phase II study in one center.

作者信息

Branden Eva, Hillerdal Gunnar, Kolbeck Karl, Koyi Hirsh

机构信息

Karolinska Hospital, Stockholm, Sweden.

Karolinska Hospital, Stockholm, Sweden

出版信息

Oncologist. 2015 Apr;20(4):365. doi: 10.1634/theoncologist.2014-0181. Epub 2015 Mar 2.

DOI:10.1634/theoncologist.2014-0181
PMID:25732264
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4391757/
Abstract

BACKGROUND

The standard treatment for non-small cell lung cancer (NSCLC) stages IIIb and IV is a platinum compound combined with a third-generation cytotoxic agent. We decided to conduct a phase II study to assess whether the platinum compound could be replaced with pemetrexed with similar results and without an increase in side effects.

METHODS

Consecutive eligible patients were randomized to either the standard arm of gemcitabine plus carboplatin (GC) or the experimental arm of gemcitabine plus pemetrexed (GP).

RESULTS

Fifty evaluable patients were enrolled in the GC arm, and 44 received GP. There were 10 partial responses in the GC arm and 16 in the GP arm. With GC, mean survival was 9 months compared with 15 months with GP. The side effects were similar in both groups.

CONCLUSION

Pemetrexed can replace platinum compounds in the first-line treatment of stage IIIb and IV NSCLC without increasing the side effects. A trend toward better survival was observed in the patients receiving pemetrexed instead of a platinum compound, and this should be studied further.

摘要

背景

非小细胞肺癌(NSCLC)Ⅲb期和Ⅳ期的标准治疗是铂类化合物联合第三代细胞毒性药物。我们决定开展一项Ⅱ期研究,以评估铂类化合物是否可用培美曲塞替代,且疗效相似且不增加副作用。

方法

连续入选的符合条件的患者被随机分为吉西他滨加卡铂(GC)的标准治疗组或吉西他滨加培美曲塞(GP)的试验组。

结果

50例可评估患者入组GC组,44例接受GP治疗。GC组有10例部分缓解,GP组有16例。GC组的平均生存期为9个月,而GP组为15个月。两组的副作用相似。

结论

培美曲塞可在Ⅲb期和Ⅳ期NSCLC的一线治疗中替代铂类化合物,且不增加副作用。接受培美曲塞而非铂类化合物治疗的患者生存期有改善趋势,应进一步研究。

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