|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
FOLFOXIRI plus bevacizumab followed by the reintroduction of the same treatment after progressive disease may yield better progression-free survival (PFS) outcomes compared with FOLFIRI plus bevacizumab followed by repeat of the same medication after progressive disease in patients with unresectable metastatic colorectal cancer (mCRC), according to the results of a phase 3, randomized strategy study conducted in Italy. The findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.1
Researchers enrolled 679 patients with unresectable metastatic colorectal cancer to participate in the study, which lasted from February 2015 to May 2017 (ClinicalTrials.gov Identifier: NCT02339116). Of all the patients, 340 received up to 8 cycles of FOLFOX plus bevacizumab followed by FOLFIRI plus bevacizumab after progressive disease (PD), and 339 received up to 8 cycles of FOLFOXIRI plus bevacizumab followed by the reintroduction of the same treatment after progressive disease. Median patient age was 61 years in the first group and 60 years in the second group.
The primary end point of the study was progression-free survival 2 (PFS2) — the time from randomization to “PD2” was defined as either progressive disease on any treatment administered after the first progressive disease or death. Secondary end points included response rate; first progression-free survival (1st-PFS), defined as the time from randomization to the first evidence of progressive disease or death (PD1); second progression-free survival (2nd-PFS), defined as the time from PD1 to PD2; and overall survival.
After progression, FOLFOXIRI plus bevacizumab yielded superior results compared with the other treatment; PFS2 in the study arm that received FOLFOXIRI plus bevacizumab was 19.1 months compared with 17.5 months in the other arm (HR 0.74, 95% CI 0.62-0.88, P <.001). Response rate was 62% in the FOLFOXIRI plus bevacizumab group versus 50% in the other group (OR 1.61, 95% CI 1.19-2.18, P =.002). First progression-free survival (1st-PFS) was 12.0 months in the FOLFOXIRI plus bevacizumab arm compared with 9.8 months in the other arm (HR 0.75, 95% CI 0.63-0.88, P <.001). Overall survival in the FOLFOXIRI plus bevacizumab arm was 27.6 months compared with 22.6 months in the other arm. Second progression-free survival (2nd-PFS) was also longer in the FOLFOXIRI plus bevacizumab group, at 6.5 months compared with 5.8 months in the other group (HR 0.76, 95% CI 0.60-0.97, P =.025).
As expected, FOLFOXIRI plus bevacizumab treatment was linked to a higher incidence of certain grade 3 and grade 4 adverse events compared with the other treatment, noted lead study author Chiara Cremolini, MD, an oncology researcher at the University of Pisa in Italy. Examples included diarrhea, neutropenia, and febrile neutropenia, she said.
Based on data from patients who received second-line therapy, the safety profiles were comparable between both treatment arms. The only exception was a higher rate of neurotoxicity in the FOLFOXIRI plus bevacizumab arm, Dr Cremolini noted.
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- Cremolini C, Antoniotti C, Lonardi S, et al. Updated results of TRIBE2, a phase III, randomized strategy study by GONO in the first- and second-line treatment of unresectable mCRC. Presented at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 3508.