Phase II Trial of Carfilzomib Plus Irinotecan in Patients With Small-cell Lung Cancer Who Have Progressed on Prior Platinum-based Chemotherapy

Susanne M. Arnold, Kari Chansky, Maria Q. Baggstrom, Michael A. Thompson, Rachel E. Sanborn, John L. Villano, Saiama N. Waqar, John Hamm, Markos Leggas, Maurice Willis, Joseph Rosales, John J. Crowley

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4 Scopus citations

Abstract

Introduction: The purpose of this study was to evaluate the efficacy and tolerability of carfilzomib plus irinotecan (C/I) in patients with relapsed small-cell lung cancer (SCLC). Patients and Methods: Patients with SCLC who progressed after 1 platinum-containing regimen for recurrent or metastatic disease were eligible. Patients were stratified as: sensitive (SS) (progressive disease > 90 days after chemotherapy) or refractory (RS) (progressive disease 30 to 90 days after chemotherapy) and received up to 6 cycles of C/I; imaging was performed every 2 cycles. The primary endpoint was 6-month overall survival (OS). Results: All 62 patients enrolled were evaluable for efficacy and adverse events. 6-month OS was 59% in the platinum SS and 54% in the platinum RS. The overall response rate was 21.6% (2.7% complete response, 18.9% partial response) in SS (n = 37) and 12.5% (all partial response) in RS (n = 25). The disease control rate was 68% (SS) and 56% (RS). Progression-free survival and OS were 3.6 months (95% confidence interval [CI], 2.6-4.6 months) and 6.9 months (95% CI, 4.3-12.3 months) in SS, and 3.3 months (95% CI, 1.8-3.9 months) and 6.8 months (95% CI, 4.1-11 months) in RS. Twenty-nine (47%) patients experienced ≥ grade 3 adverse events; 8 (12.9%) subjects had grade 4 toxicities. Three treatment-related deaths occurred: myocardial infarction (possible), lung infection (possible), and sepsis (probable). Conclusion: In patients with relapsed SCLC, C/I was effective in the treatment of SS and RS. With 4.8% grade 5 toxicity, C/I is a viable option for relapsed patients with SCLC with performance status 0 to 1, particularly in platinum-resistant patients, or subjects who cannot receive immunotherapy. This study's objective was to evaluate the efficacy and tolerability of carfilzomib plus irinotecan in patients with relapsed small-cell lung cancer. This was a single-arm phase II trial of 62 patients with small-cell lung cancer who progressed after 1 platinum-containing regimen for recurrent or metastatic disease. The 6-month overall survival was 59% in platinum-sensitive patients and 54% in platinum-refractory patients.

Original languageEnglish
Pages (from-to)357-364.e7
JournalClinical Lung Cancer
Volume21
Issue number4
DOIs
StatePublished - Jul 2020

Keywords

  • Camptothecin combination
  • Chemotherapy
  • Proteasome inhibition
  • Relapse
  • Small cell lung cancer

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