SRL172 (killed Mycobacterium vaccae) in addition to standard chemotherapy improves quality of life without affecting survival, in patients with advanced non-small-cell lung cancer:: phase III results
SRL172 (killed Mycobacterium vaccae) in addition to standard chemotherapy improves quality of life without affecting survival, in patients with advanced non-small-cell lung cancer:: phase III results
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DOI：
10.1093/annonc/mdh220
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发表时间：
2004-06-01
影响因子：
50.5
通讯作者：
Reck, M
中科院分区：
文献类型：
--
作者：
O'Brien, MER;Anderson, H;Reck, M
背景：这项开放的、随机的III期研究旨在进一步研究SRL 172(灭活母牛分枝杆菌混悬液)联合化疗治疗非小细胞肺癌(NSCLC)的临床活性和安全性。患者和方法：患者随机接受以铂为基础的化疗，包括最多6个周期的MVP(丝裂霉素、长春花碱、顺铂或卡铂)，每月(210例患者)或(209例患者)每月SRL 172。结果：两组在整个研究过程中的总生存期(主要疗效终点)没有统计学差异(中位总生存期223天对225天；P=0.65)。然而，化疗加SRL172组患者在15周治疗结束时存活的比例(90%)高于单纯化疗组(83%)(P=0.061)。治疗期末，联合组有效率为37%，单纯化疗组有效率为33%。单纯化疗组患者的全球健康状况评分(-14.3)比化疗+SRL172组患者(-6.6)的恶化程度更大(P=0.02)。结论：在这项非安慰剂对照试验中，在标准癌症化疗的基础上加入SRL172显著改善了患者的生活质量，而不影响总体生存时间。
Background: This open-label, randomised phase III study was designed to further investigate the clinical activity and safety of SRL 172 (killed Mycobacterium vaccae suspension) with chemotherapy in the treatment of non-small-cell lung cancer (NSCLC).Patients and methods: Patients were randomised to receive platinum-based chemotherapy, consisting of up to six cycles of MVP (mitomycin, vinblastine and cisplatin or carboplatin) with (210 patients) or without (209 patients) monthly SRL 172.Results: There was no statistical difference between the two groups in overall survival (primary efficacy end point) over the course of the study (median overall survival of 223 days versus 225 days; P = 0.65). However, a higher proportion of patients were alive at the end of the 15-week treatment phase in the chemotherapy plus SRL 172 group (90%), than in the chemotherapy alone group (83%) (P = 0.061). At the end of the treatment phase, the response rate was 37% in the combined group and 33% in the chemotherapy alone group. Patients in the chemotherapy alone group had greater deterioration in their Global Health Status score (-14.3) than patients in the chemotherapy plus SRL172 group (-6.6) (P = 0.02).Conclusion: in this non-placebo controlled trial, SRL172 when added to standard cancer chemotherapy significantly improved patient quality of life without affecting overall survival times.