RT Journal Article
T1 Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆.
A1 Spigel, D R
A1 Vicente, D
A1 Ciuleanu, T E
A1 Gettinger, S
A1 Peters, S
A1 Horn, L
A1 Audigier-Valette, C
A1 Pardo Aranda, N
A1 Juan-Vidal, O
A1 Cheng, Y
A1 Zhang, H
A1 Shi, M
A1 Luft, A
A1 Wolf, J
A1 Antonia, S
A1 Nakagawa, K
A1 Fairchild, J
A1 Baudelet, C
A1 Pandya, D
A1 Doshi, P
A1 Chang, H
A1 Reck, M
K1 PD-1
K1 biomarkers
K1 immunotherapy
K1 small-cell lung cancer
AB 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.
YR 2021
FD 2021-02-01
LK http://hdl.handle.net/10668/17105
UL http://hdl.handle.net/10668/17105
LA en
DS RISalud
RD Apr 7, 2025