%0 Journal Article
%A Spigel, D R
%A Vicente, D
%A Ciuleanu, T E
%A Gettinger, S
%A Peters, S
%A Horn, L
%A Audigier-Valette, C
%A Pardo Aranda, N
%A Juan-Vidal, O
%A Cheng, Y
%A Zhang, H
%A Shi, M
%A Luft, A
%A Wolf, J
%A Antonia, S
%A Nakagawa, K
%A Fairchild, J
%A Baudelet, C
%A Pandya, D
%A Doshi, P
%A Chang, H
%A Reck, M
%T Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆.
%D 2021
%U http://hdl.handle.net/10668/17105
%X Patients with relapsed small-cell lung cancer (SCLC) have few treatment options and dismal survival. Phase I/II data show activity of nivolumab in previously treated SCLC. CheckMate 331 is a randomized, open-label, phase III trial of nivolumab versus standard chemotherapy in relapsed SCLC. Patients with relapse after first-line, platinum-based chemotherapy were randomized 1 : 1 to nivolumab 240 mg every 2 weeks or chemotherapy (topotecan or amrubicin) until progression or unacceptable toxicity. Primary endpoint was overall survival (OS). Overall, 284 patients were randomized to nivolumab and 285 to chemotherapy. Minimum follow-up was 15.8 months. No significant improvement in OS was seen with nivolumab versus chemotherapy [median OS, 7.5 versus 8.4 months; hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.72-1.04; P = 0.11]. A survival benefit with nivolumab was suggested in patients with baseline lactate dehydrogenase ≤ upper limit of normal and in those without baseline liver metastases. OS (nivolumab versus chemotherapy) was similar in patients with programmed death-ligand 1 combined positive score ≥1% versus  Nivolumab did not improve survival versus chemotherapy in relapsed SCLC. No new safety signals were seen. In exploratory analyses, select baseline characteristics were associated with improved OS for nivolumab.
%K PD-1
%K biomarkers
%K immunotherapy
%K small-cell lung cancer
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