Universität zu Köln

Spigel, D. R., Vicente, D., Ciuleanu, T. E., Gettinger, S., Peters, S., Horn, L., Audigier-Valette, C., Pardo Aranda, N., Juan-Vidal, O., Cheng, Y., Zhang, H., Shi, M., Luft, A., Wolf, J., Antonia, S., Nakagawa, K., Fairchild, J., Baudelet, C., Pandya, D., Doshi, P., Chang, H. and Reck, M. (2021). Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331. Ann. Oncol., 32 (5). S. 631 - 642. AMSTERDAM: ELSEVIER. ISSN 1569-8041

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Abstract

Background: 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. Patients and methods: 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). Results: 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 <1%. Median progression-free survival was 1.4 versus 3.8 months (HR, 1.41; 95% CI, 1.18-1.69). Objective response rate was 13.7% versus 16.5% (odds ratio, 0.80; 95% CI, 0.50-1.27); median duration of response was 8.3 versus 4.5 months. Rates of grade 3 or 4 treatment-related adverse events were 13.8% versus 73.2%. Conclusion: 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Spigel, D. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vicente, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ciuleanu, T. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gettinger, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Peters, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horn, L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Audigier-Valette, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pardo Aranda, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Juan-Vidal, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cheng, Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Shi, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Luft, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Antonia, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nakagawa, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fairchild, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baudelet, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pandya, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Doshi, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chang, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reck, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-604708
DOI:	10.1016/j.annonc.2021.01.071
Journal or Publication Title:	Ann. Oncol.
Volume:	32
Number:	5
Page Range:	S. 631 - 642
Date:	2021
Publisher:	ELSEVIER
Place of Publication:	AMSTERDAM
ISSN:	1569-8041
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SERUM LACTATE-DEHYDROGENASE; PHASE-III TRIAL; PLUS IPILIMUMAB; RECURRENT; TOPOTECAN; SURVIVAL; THERAPY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60470