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Adding Bevacizumab to TAS-102 Potentially Practice-Changing for Metastatic CRC
Trifluridine-tipracil (TAS-102) plus bevacizumab was associated with a clinically significant improvement in progression-free survival (PFS) compared with TAS-102 monotherapy in patients with metastatic colorectal cancer (CRC), according to findings from a phase 2 clinical trial (Lancet Oncol. 2020 Jan 27. Epub ahead of print).
“We aimed to compare the efficacy of TAS-102 plus bevacizumab versus TAS-102 monotherapy in patients receiving refractory therapy for metastatic [CRC],” explained Per Pfeiffer, PhD, Odense University Hospital, Odense, Denmark, and colleagues, who saw encouraging results in the small, phase 1-2 C-TASKFORCE study.
A total of 93 patients were enrolled in the study from August 2017 to October 2018 and randomized to receive TAS-102 35 mg/m2 alone (n = 47) or with bevacizumab 5 mg/kg (n = 46). TAS-102 was administered twice daily on days 1 to 5 and 8 to 12 every 28 days, with bevacizumab given on days 1 and 15.
The primary end point of the study was investigator-evaluated PFS, and follow-up lasted for a median of 10.0 months.
The median PFS was 2.6 months in the TAS-102 monotherapy arm versus 4.6 months in the TAS-102 plus bevacizumab arm (hazard ratio, 0.45; 95% CI, 0.29–0.72; P= .0015).
Neutropenia was the most common grade ≥3 adverse event; 45% of patients in the TAS-102 arm had serious adverse events versus 41% in the TAS-102 plus bevacizumab arm.
Compared with TAS-102 monotherapy, TAS-102 plus bevacizumab was tied to a significant and clinically relevant improvement in PFS and had tolerable toxicity in patients with chemorefractory metastatic CRC, Dr Pfeiffer et al said.
“The combination of TAS-102 plus bevacizumab could be a new treatment option for patients with refractory metastatic colorectal cancer and could be a practice-changing development,” they concluded.—Kaitlyn Manasterski