Outcomes of stage IV non-small cell lung cancer patients after failure of platinum-based chemotherapy in clinical trials and real-world settings: A literature review.

person Yu Yang Soon Department of Radiation Oncology, National University Cancer Institute Singapore, Singapore, Singapore info_outline Yu Yang Soon, Wesley Furnback, Jin Kim, Jenny Chuang, Gordon Chavez, Christina Proescholdt, Cloe Ying Chee Koh

Authors person Yu Yang Soon Department of Radiation Oncology, National University Cancer Institute Singapore, Singapore, Singapore info_outline Yu Yang Soon, Wesley Furnback, Jin Kim, Jenny Chuang, Gordon Chavez, Christina Proescholdt, Cloe Ying Chee Koh Organizations Department of Radiation Oncology, National University Cancer Institute Singapore, Singapore, Singapore, Real Chemistry, Inc., New York, NY, Novocure Inc., New York, NY, Novocure, Root, Switzerland Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Novocure Background: To report the outcomes of therapeutic regimens being evaluated for patients with stage IV non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy in clinical trial and real-world settings. Methods: A systematic literature review was undertaken to identify clinical trials and real-world studies evaluating treatments for stage IV NSCLC after progression with platinum-based chemotherapy. Studies were included in the review if they were published between September 2017 and September 2021, in English, and included an outcome of interest. The outcomes of interest were overall response rate, progression-free survival, overall survival, the incidence of grade 3-4 adverse events, and discontinuation due to adverse events. Results: A total of 23 studies were identified, comprising of 17 clinical trials and six real-world studies. The total sample size ranged from 12 to 1,253 patients in clinical trials and 11 to 383 patients in real-world studies. A total of 28 and six treatment regimens were evaluated within the clinical trials and real-world studies respectively. Six clinical trials evaluated outcomes in the second-line setting, one in the third-line, three in a mix of second-line and above, and seven did not report the specific treatment line(s). There were no real-world studies exclusively in the second-line setting, one in the third-line, three in a mix of second-line and above, and two did not report the specific treatment line(s). Ramucirumab + docetaxel was the only treatment regimen evaluated in both the clinical trial and real-world studies. In the real-world studies, nivolumab was the most common treatment evaluated (n = 3). The real-world studies were conducted in India (n = 2), China, Colombia, Germany, and the United States. The overall response rate (ORR) ranged from 3% to 66% and a rate of > 15% was reported for one or more treatment regimens in 86% (12/14) of clinical trials. ORR ranged from 10% to 36% in real-world studies. Median progression-free survival ranged from 1 to 5 months in clinical trials and 3 to 8 months in real-world studies. In clinical trials, a median PFS of > 6 months was observed in 71% (10/14) of studies. Median overall survival (OS) ranged from 5 to 15 months in clinical trials and 3 to 18 months in real-world studies. Discontinuation due to adverse events ranged from 3-15% in clinical trials and 9-20% in real-world studies. Conclusions: Patients with stage IV NSCLC that has progressed on or after platinum-based chemotherapy experienced a limited response and a high burden of adverse events with the treatment regimens evaluated in both the clinical trial and real-world settings.