Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial
Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial
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DOI：
10.1007/s00432-011-1003-3
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发表时间：
2011-09-01
影响因子：
3.6
通讯作者：
Murray, Nevin
中科院分区：
文献类型：
--
作者：
Butts, Charles;Maksymiuk, Andrew;Murray, Nevin
目的介绍BLP 25脂质体疫苗（L-BLP 25）治疗IIIB或IV期非小细胞肺癌（NSCLC）患者的开放标签、平行组、IIB期试验的最新生存分析。L-BLP 25组患者每周皮下接种L-BLP 25 930 μ g，共8周，然后每隔6周进行一次维持接种。结果接受L-BLP 25 + BSC的患者（n = 88）的中位生存时间比单独接受BSC的患者长4.2个月（n = 83;分别为17.2个月和13.0个月;风险比[HR] 0.745，95%置信区间[CI] 0.533-1.042）。接受L-BLP 25联合BSC的患者的3年生存率为31%，而接受BSC的患者为17%（P = 0.035）。在IIIB期局部区域（LR）疾病患者的分层子集中，接受L-BLP 25 + BSC的患者（n = 35）的中位生存时间比接受BSC的患者长17.3个月（n = 30;分别为30.6个月vs. 13.3个月; HR 0.548，95% CI 0.301-0.999）。在该亚组中，接受L-BLP 25联合BSC的患者的3年生存率为49%，而接受BSC的患者为27%（P = 0.070）。
Purpose To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).Methods Patients were randomized to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received subcutaneous vaccinations of L-BLP25 930 mu g weekly for 8 weeks, followed by maintenance vaccinations at 6-week intervals.Results Median survival time was 4.2 months longer in patients receiving L-BLP25 plus BSC (n = 88) than in those receiving BSC alone (n = 83; 17.2 months vs. 13.0 months, respectively; hazard ratio [HR] 0.745, 95% confidence interval [CI] 0.533-1.042). The 3-year survival rate was 31% in patients receiving L-BLP25 plus BSC and 17% in those receiving BSC (P = 0.035). In the stratified subset of patients with stage IIIB loco-regional (LR) disease, median survival time was 17.3 months longer in patients receiving L-BLP25 plus BSC (n = 35) than in those receiving BSC (n = 30; 30.6 months vs. 13.3 months, respectively; HR 0.548, 95% CI 0.301-0.999). In this subgroup, 3-year survival was 49% in patients receiving L-BLP25 plus BSC and 27% in those receiving BSC (P = 0.070).Conclusions Confirming the initial results, further follow-up continues to show that survival time for patients with stage IIIB/IV NSCLC was longer with L-BLP25 plus BSC compared with BSC alone, with the greatest difference seen in patients with stage IIIB LR disease.