Add-on bevacizumab improves efficacy of trifluridine/tipiracil in mCRC
Adding bevacizumab to trifluridine/tipiracil (FTD/TPI) significantly improves progression-free survival (PFS) and overall survival (OS) compared with FTD/TPI in patients with chemorefractory metastatic colorectal cancer (mCRC), according to a study presented at ESMO GI 2019.
“The combination [of FTD/TPI and bevacizumab] … is a new option in patients with chemorefractory mCRC and could be practice-changing,” said lead author Dr Per Pfeiffer from the Department of Oncology at Odense University Hospital in Odense, Denmark.
This trial involved 93 patients with chemorefractory mCRC who were randomized to receive either oral FTD/TPI (35 mg/m2 twice daily on days 1–5 and 8–12; n=47) or FTD/TPI + bevacizumab (5 mg/kg on days 1 and 15; n=46) for a treatment cycle of 28 days. [ESMO GI 2019, abstract O-014]
Patients treated with FTD/TPI + bevacizumab experienced a significantly longer PFS compared with FTD/TPI only (median, 4.6 vs 2.6 months, hazard ratio [HR], 0.45, 95 percent confidence interval [CI], 0.29–0.72; p=0.001).
Similarly, patients who received FTD/TPI + bevacizumab achieved a significantly higher OS than those who had FTD/TPI only (median, 9.4 vs 6.7 months, HR, 0.55, 95 percent CI, 0.32–0.94; p=0.03). Thirty-seven patients were still alive after a median follow-up of 11 months, as of February 2019.
Serious adverse events occurred in 21 patients in the FTD/TPI only arm and 19 patients in the FTD/TPI + bevacizumab arm.
Grade 3–4 neutropenia was more frequent in the FTD/TPI + bevacizumab group compared with the FTD/TPI only group (67.0 percent vs 38.0 percent; p<0.05). In particular, the incidence of febrile neutropenia was higher in the FTD/TPI + bevacizumab group than in the FTD/TPI only group (events, 3 vs 1).
“[Nevertheless, the FTD/TPI + bevacizumab] therapy was well tolerated with adverse events as expected,” Pfeiffer noted.
“This trial showed for the first time that [the] addition of bevacizumab to [FTD/TPI] significantly prolonged PFS and OS [in patients with chemorefractory mCRC] … compared with FTD/TPI monotherapy, with a favourable safety profile,” he concluded.