A phase 2 randomised study of veliparib plus FOLFIRI±bevacizumab versus placebo plus FOLFIRI±bevacizumab in metastatic colorectal cancer

Vera Gorbunova, J. Thaddeus Beck, Ralf Dieter Hofheinz, Pilar Garcia-Alfonso, Marina Nechaeva, Antonio Cubillo Gracian, Laszlo Mangel, Elena Elez Fernandez, Dustin A. Deming, Ramesh K. Ramanathan, Alison H. Torres, Danielle Sullivan, Yan Luo, Jordan D. Berlin

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Background: Metastatic colorectal cancer (mCRC) has low survival rates. We assessed if addition of veliparib, concurrent to FOLFIRI, improves survival in patients with previously untreated mCRC. Methods: This study compared veliparib (200 mg BID for 7 days of each 14-day cycle) to placebo, each with FOLFIRI. Bevacizumab was allowed in both arms. The primary endpoint was progression-free survival (PFS). Results: Patients were randomised to receive veliparib (n = 65) or placebo (n = 65) in combination with FOLFIRI. Median PFS was 12 vs 11 months (veliparib vs placebo) [HR = 0.94 (95% CI: 0.60, 1.48)]. Median OS was 25 vs 27 months [HR = 1.26 (95% CI: 0.74, 2.16)]. Response rate was 57% vs 62%. Median DOR was 11 vs 9 months [HR = 0.73 (95% CI: 0.38, 1.40)]. AEs with significantly higher frequency (p < 0.05) in the veliparib group were anaemia (39% vs 19%, p = 0.019) and neutropenia (66% vs 37%, p = 0.001) for common AEs (≥20%); neutropenia (59% vs 22%, p < 0.001) for common Grade 3/4 AEs (≥5%); none in serious AEs. Haematopoietic cytopenias were more common with veliparib (79% vs 52%, p = 0.003). Fourteen percent of patients on veliparib and 15% on placebo discontinued treatment due to AEs. Conclusion: Veliparib added to FOLFIRI ± bevacizumab demonstrated similar efficacy as FOLFIRI ± bevacizumab in frontline mCRC patients. No unexpected safety concerns occurred.

Original languageEnglish (US)
Pages (from-to)183-189
Number of pages7
JournalBritish journal of cancer
Volume120
Issue number2
DOIs
StatePublished - Jan 22 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Gorbunova, V., Beck, J. T., Hofheinz, R. D., Garcia-Alfonso, P., Nechaeva, M., Cubillo Gracian, A., Mangel, L., Elez Fernandez, E., Deming, D. A., Ramanathan, R. K., Torres, A. H., Sullivan, D., Luo, Y., & Berlin, J. D. (2019). A phase 2 randomised study of veliparib plus FOLFIRI±bevacizumab versus placebo plus FOLFIRI±bevacizumab in metastatic colorectal cancer. British journal of cancer, 120(2), 183-189. https://doi.org/10.1038/s41416-018-0343-z