Abstract | Background: Patients and methods: Key eligibility criteria included advanced non-squamous NSCLC with disease progression after treatment with platinum-based doublet chemotherapy, evidence of disease control after at least two cycles of first-line therapy, presence of measurable disease, ECOG performance status 0 or 1, adequate bone marrow and organ function, and no recent history of clinically significant bleeding. Eligible patients were randomized 1 : 1 to receive up to six 21-day cycles of docetaxel plus either weekly bavituximab 3 mg/kg or placebo until progression or toxicity. The primary end point was overall survival (OS). Results: A total of 597 patients were enrolled. Median OS was 10.5 months in the docetaxel + bavituximab arm and was 10.9 months in the docetaxel + placebo arm (HR 1.06; 95% CI 0.88-1.29; P = 0.533). There was no difference in progression-free survival (HR 1.00; 95% CI 0.82-1.22; P = 0.990). Toxicities were manageable and similar between arms. In subset analysis, among patients with high baseline serum β2GP1 levels ≥200 µg/ml, a nonsignificant OS trend favored the bavituximab arm (HR 0.82; 95% CI 0.63-1.06; P = 0.134). Among patients who received post-study immune checkpoint inhibitor therapy, OS favored the bavituximab arm (HR 0.46; 95% CI 0.26-0.81; P = 0.006). Conclusions: Clinical trial number: NCT01999673.
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Authors | D E Gerber, L Horn, M Boyer, R Sanborn, R Natale, R Palmero, P Bidoli, I Bondarenko, P Germonpre, D Ghizdavescu, A Kotsakis, H Lena, G Losonczy, K Park, W-C Su, M Tang, J Lai, N L Kallinteris, J S Shan, M Reck, D R Spigel |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 29
Issue 7
Pg. 1548-1553
(07 01 2018)
ISSN: 1569-8041 [Electronic] England |
PMID | 29767677
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Docetaxel
- bavituximab
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Topics |
- Adenocarcinoma
(drug therapy, pathology)
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Docetaxel
(administration & dosage)
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Lung Neoplasms
(drug therapy, pathology)
- Male
- Middle Aged
- Prognosis
- Prospective Studies
- Salvage Therapy
- Survival Rate
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