1. A phase 2 trial of consolidation pembrolizumab following concurrent chemoradiation for patients with unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN 14-179
- Author
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Bamidele A. Adesunloye, Ebenezer A. Kio, Shadia I. Jalal, Karen L. Reckamp, Michael L. Titzer, Robert M. Langdon, Robin Zon, Greg Andrew Durm, Goetz H. Kloecker, Sandra Althouse, Wael A. Harb, Ryan D. Gentzler, Radhika V. Walling, Ziyue Liu, Nasser H. Hanna, Salma K. Jabbour, Michael J. Williamson, and Ahad Ali Sadiq
- Subjects
Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,Programmed Cell Death 1 Receptor ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Carcinoma, Non-Small-Cell Lung ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Etoposide ,Pneumonitis ,Aged ,Neoplasm Staging ,Cisplatin ,Aged, 80 and over ,business.industry ,Chemoradiotherapy ,Middle Aged ,medicine.disease ,Carboplatin ,Confidence interval ,Pemetrexed ,Oncology ,chemistry ,030220 oncology & carcinogenesis ,business ,medicine.drug - Abstract
BACKGROUND Five-year overall survival (OS) for patients with unresectable stage III non-small cell lung cancer (NSCLC) is poor. Until recently, a standard of care was concurrent chemoradiation alone. Patients with metastatic NSCLC treated with anti-programmed death 1 antibodies have demonstrated improved OS. This trial evaluated pembrolizumab as consolidation therapy after concurrent chemoradiation in patients with unresectable stage III disease. METHODS Patients with unresectable stage III NSCLC received concurrent chemoradiation with cisplatin and etoposide, cisplatin and pemetrexed, or carboplatin and paclitaxel and 59.4 to 66.6 Gy of radiation. Patients with nonprogression of disease were enrolled and received pembrolizumab (200 mg intravenously every 3 weeks for up to 12 months). The primary endpoint was the time to metastatic disease or death (TMDD). Secondary endpoints included progression-free survival (PFS) and OS. RESULTS The median follow-up for 93 patients (92 for efficacy) was 32.2 months (range, 1.2-46.6 months). The median TMDD was 30.7 months (95% confidence interval [CI], 18.7 months to not reached), which was significantly longer than the historical control of 12 months (P
- Published
- 2020