Browsing by Author "Gadgeel, Shirish"

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    24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non–Small Cell Lung Cancer
    (Elsevier, 2018) Borghaei, Hossein; Langer, Corey J.; Gadgeel, Shirish; Papadimitrakopoulou, Vassiliki A.; Patnaik, Amita; Powell, Steven F.; Gentzler, Ryan D.; Martins, Renato G.; Stevenson, James P.; Jalal, Shadia I.; Panwalkar, Amit; Yang, James Chih-Hsin; Gubens, Matthew; Sequist, Lecia V.; Awad, Mark M.; Fiore, Joseph; Saraf, Sanatan; Keller, Steven; Gandhi, Leena; Medicine, School of Medicine
    Introduction Cohort G of KEYNOTE-021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed-carboplatin (PC) versus PC alone as first-line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow-up time 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression-free survival (PFS); the hazard ratio (HR) for overall survival (OS) was 0.90 (95% confidence interval [CI]: 0.42‒1.91). Herein, we present an updated analysis. Methods A total of 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR and/or ALK receptor tyrosine kinase gene (ALK) aberrations were randomized 1:1 to four cycles of PC with or without pembrolizumab, 200 mg every 3 weeks. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC-alone group with radiologic progression could cross over to pembrolizumab monotherapy. p Values are nominal (one-sided p < 0.025). Results As of December 1, 2017, the median follow-up time was 23.9 months. The ORR was 56.7% with pembrolizumab plus PC versus 30.2% with PC alone (estimated difference 26.4% [95% CI: 8.9%‒42.4%, p = 0.0016]). PFS was significantly improved with pembrolizumab plus PC versus PC alone (HR = 0.53, 95% CI: 0.33‒0.86, p = 0.0049). A total of 41 patients in the PC-alone group received subsequent anti‒programmed death 1/anti‒programmed death ligand 1 therapy. The HR for OS was 0.56 (95% CI: 0.32‒0.95, p = 0.0151). Forty-one percent of patients in the pembrolizumab plus PC group and 27% in the PC-alone group had grade 3 to 5 treatment-related adverse events. Conclusions The significant improvements in PFS and ORR with pembrolizumab plus PC versus PC alone observed in the primary analysis were maintained, and the HR for OS with a 24-month median follow-up was 0.56, favoring pembrolizumab plus PC.
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    Second-line treatment options in Non-Small Cell Lung Cancer (NSCLC): report from an International Experts Panel Meeting of the Italian Association of Thoracic Oncology
    (Elsevier, 2018) Gridelli, Cesare; Baas, Paul; Barlesi, Fabrice; Ciardiello, Fortunato; Crinò, Lucio; Felip, Enriqueta; Gadgeel, Shirish; Papadimitrakopoulou, Vali; Paz-Ares, Luis; Planchard, David; Perol, Maurice; Hanna, Nasser; Sgambato, Assunta; Casaluce, Francesco; de Marinis, Filippo; Medicine, School of Medicine
    Non-small-cell lung cancer (NSCLC) patients inevitably progress to first-line therapy and further active treatments are warranted. In the last few years, new second-line therapies, beyond chemo-agents, have become available in the clinical practice. To date, several options for the second-line treatment of non-oncogene-addicted NSCLC patients ranging from chemotherapy in combination with anti- vascular endothelial growth factor receptor to immunotherapeutics are available. In oncogene-driven tumors, the better knowledge of mechanisms of acquired resistance to earlier TKIs is leading to novel active inhibitors now available/in development. The second-line algorithm treatment of NSCLC becomes very intricate and the selection of proper patients with one of the new available therapeutic options is of paramount importance to personalize and optimize the treatment. This review will discuss the second-line treatment opportunities of both addicted and not-addicted NSCLC.