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Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.

Publication ,  Journal Article
Ready, N; Farago, AF; de Braud, F; Atmaca, A; Hellmann, MD; Schneider, JG; Spigel, DR; Moreno, V; Chau, I; Hann, CL; Eder, JP; Steele, NL ...
Published in: J Thorac Oncol
February 2019

INTRODUCTION: For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC. METHODS: In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety. RESULTS: Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5-19.5) with a median duration of response of 17.9 months (range 3.0-42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events. CONCLUSIONS: Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.

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Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

February 2019

Volume

14

Issue

2

Start / End Page

237 / 244

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Small Cell Lung Carcinoma
  • Retreatment
  • Progression-Free Survival
  • Oncology & Carcinogenesis
  • Nivolumab
  • Middle Aged
  • Male
  • Lung Neoplasms
 

Citation

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Ready, N., Farago, A. F., de Braud, F., Atmaca, A., Hellmann, M. D., Schneider, J. G., … Antonia, S. J. (2019). Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. J Thorac Oncol, 14(2), 237–244. https://doi.org/10.1016/j.jtho.2018.10.003
Ready, Neal, Anna F. Farago, Filippo de Braud, Akin Atmaca, Matthew D. Hellmann, Jeffrey G. Schneider, David R. Spigel, et al. “Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.J Thorac Oncol 14, no. 2 (February 2019): 237–44. https://doi.org/10.1016/j.jtho.2018.10.003.
Ready N, Farago AF, de Braud F, Atmaca A, Hellmann MD, Schneider JG, et al. Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. J Thorac Oncol. 2019 Feb;14(2):237–44.
Ready, Neal, et al. “Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.J Thorac Oncol, vol. 14, no. 2, Feb. 2019, pp. 237–44. Pubmed, doi:10.1016/j.jtho.2018.10.003.
Ready N, Farago AF, de Braud F, Atmaca A, Hellmann MD, Schneider JG, Spigel DR, Moreno V, Chau I, Hann CL, Eder JP, Steele NL, Pieters A, Fairchild J, Antonia SJ. Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. J Thorac Oncol. 2019 Feb;14(2):237–244.
Journal cover image

Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

February 2019

Volume

14

Issue

2

Start / End Page

237 / 244

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Small Cell Lung Carcinoma
  • Retreatment
  • Progression-Free Survival
  • Oncology & Carcinogenesis
  • Nivolumab
  • Middle Aged
  • Male
  • Lung Neoplasms