Trifluridine-tipiracil plus bevacizumab ‘feasible alternative’ for unresectable CRC
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Trifluridine-tipiracil plus bevacizumab was not superior to capecitabine plus bevacizumab but presented no new safety concerns in patients with unresectable metastatic colorectal cancer who are ineligible for intensive treatment.
“The standard first-line treatment for patients with unresectable metastatic colorectal cancer is full-dose doublet or triplet chemotherapy with or without targeted therapy,” Thierry André, MD, professor of medical oncology at Sorbonne University and Saint Antione Hospital in Paris, and colleagues wrote in The Lancet Gastroenterology & Hepatology. “However, some patients with metastatic colorectal cancer might not be candidates for intensive full-dose doublet or triplet first-line chemotherapy for different reasons, including advanced age, poor performance status, comorbidities and low tumor burden or patient preference.”
In an open-label, phase 3 study, André and colleagues analyzed 856 adult patients (54% men) with histologically confirmed metastatic CRC who were ineligible for full-dose doublet or triplet chemotherapy and curative resection. Patients were randomized to receive trifluridine-tipiracil plus bevacizumab (n = 426) or capecitabine plus bevacizumab (n = 430). The primary endpoint was investigator-assessed progression-free survival. Researchers noted this trial is ongoing.
After a median follow-up of 16.6 months, the HR for progression-free survival with trifluridine-tipiracil plus bevacizumab compared with capecitabine plus bevacizumab was 0.87 (95% CI, 0.75-1.02). By cohort, the median progression-free survival was 9.4 months (95% CI, 9.1-10.9) and 9.3 months (95% CI, 8.9-9.8), respectively.
The estimated probability of progression-free survival was 71% among both treatment groups at 6 months, 39% (95% CI, 34-43) vs. 31% (95% CI, 66-75), respectively, at 12 months and 19% (95% CI, 15-24) vs. 13% (95% CI, 9-17) at 18 months.
Researchers reported treatment-emergent adverse events in 94% of patients in the trifluridine-tipiracil plus bevacizumab group compared with 88% in the capecitabine plus bevacizumab group. The most common events (grade 3) were neutropenia (52% vs. 1%), decreased neutrophil count (18% vs. < 1%), anemia (14% vs. 4%) and hand-foot syndrome (0% vs. 15%). Treatment-related deaths occurred in five patients in the trifluridine-tipiracil plus bevacizumab group and four patients in the capecitabine plus bevacizumab group.
“First-line treatment with trifluridine-tipiracil plus bevacizumab was not superior to capecitabine plus bevacizumab in terms of investigator-assessed progression-free survival in patients with unresectable metastatic colorectal cancer who were not candidates for intensive therapy; however, progression-free survival was similar in both treatment groups,” André and colleagues concluded. “The safety profile differed between treatments, with more neutropenia with trifluridine-tipiracil plus bevacizumab and more hand-foot syndrome with capecitabine plus bevacizumab, but there were no new safety concerns.”
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