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

被引：155

作者：

Butts, Charles ^{[1
]}

Maksymiuk, Andrew ^{[2
]}

Goss, Glenwood ^{[3
]}

Soulieres, Denis ^{[4
]}

Marshall, Ernie ^{[5
]}

Cormier, Yvon ^{[6
]}

Ellis, Peter M. ^{[7
]}

Price, Allan ^{[8
]}

Sawhney, Ravinder ^{[9
]}

Beier, Frank ^{[10
]}

Falk, Martin ^{[10
]}

Murray, Nevin ^{[11
]}

机构：

[1] Cross Canc Inst, Edmonton, AB T6G 1Z2, Canada

[2] CancerCare Manitoba, Winnipeg, MB, Canada

[3] Ottawa Hosp Canc Ctr, Ottawa, ON, Canada

[4] Ctr Hos Univ Montreal, Montreal, PQ, Canada

[5] Clatterbridge Ctr Oncol, Bebington, England

[6] Univ Laval, Ste Foy, PQ G1K 7P4, Canada

[7] Juravinski Canc Ctr, Hamilton, ON, Canada

[8] Western Gen Hosp, Edinburgh EH4 2XU, Midlothian, Scotland

[9] Fraser Valley Canc Ctr, Surrey, BC, Canada

[10] Merck KGaA, Darmstadt, Germany

[11] Vancouver Canc Ctr, Vancouver, BC, Canada

来源：

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY | 2011年 / 137卷 / 09期

关键词：

Survival; Non-small-cell lung cancer; Therapeutic cancer vaccine; L-BLP25; MUC1; CLINICAL-PRACTICE GUIDELINES; CISPLATIN; RADIATION; ETOPOSIDE; DIAGNOSIS; DOCETAXEL; ONCOLOGY;

D O I：

10.1007/s00432-011-1003-3

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1337 / 1342

页数：6

共 23 条

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