The phase 3 CASPIAN trial reports that adding durvalumab (Imfinzi®, AstraZeneca) to etoposide and a platinum therapy improves overall survival in patients with extensive-stage small-cell lung cancer (ES-SCLC).
Many patients with small-cell lung cancer do not receive a diagnosis until after their disease has already reached the extensive stage, at which point the prognosis is poor. Because immunotherapy has shown some activity in ES-SCLC, the researchers of the CASPIAN trial assessed the efficacy of adding one or two immunotherapy drugs—durvalumab with or without tremelimumab—to treatment with etoposide and a platinum therapy (either cisplatin or carboplatin) in previously untreated ES-SCLC.
The open-label trial, completed at 209 sites across 23 countries, enrolled adults with previously untreated ES-SCLC who had a World Health Organization (WHO) performance status of 0 or 1 and measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients were randomized in a 1:1:1 ratio to receive durvalumab/platinum/etoposide, durvalumab/tremelimumab/platinum/etoposide, or platinum/etoposide alone. The current publication in The Lancet reports the results of a planned interim analysis for the 268 patients in the durvalumab/platinum/etoposide group compared with the 269 patients in the platinum/etoposide group.
Durvalumab/platinum/etoposide increased median overall survival compared with platinum/etoposide alone (13.0 vs 10.3 months) and increased the proportion of patients who were alive at 18 months (34% vs 25%). Grade 3/4 adverse events of any cause occurred at equal rates in both groups (62%), with a slightly higher rate of adverse events leading to death in patients receiving platinum/etoposide alone (6%) compared with those receiving durvalumab/platinum/etoposide (5%).
"First-line durvalumab plus platinum-etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group," conclude the researchers in their publication, led by first author Luis Paz-Ares, MD, Chair of Medical Oncology at the Hospital 12 de Octubre, Madrid, Spain. "Safety findings were consistent with the known safety profiles of all drugs received."
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Image credit: Scott Wilkinson and Adam Marcus. Courtesy of the National Cancer Institute (Winship Cancer Institute of Emory University)