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Thierry Andre, MD, discusses the efficacy of trifluridine/tipiracil plus bevacizumab in patients with metastatic colorectal cancer and the safety profiles of the 2 arms of the phase 3 SOLSTICE trial.
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Thierry Andre, MD, professor of medical oncology, University Pierre et Marie Curie, head, Medical Oncology Department, St. Antoine Hospital, Paris, discusses the efficacy of trifluridine/tipiracil (TAS-102; Lonsurf) plus bevacizumab (Avastin) in patients with metastatic colorectal cancer (mCRC) and the safety profiles of the 2 arms of the phase 3 SOLSTICE trial (NCT03869892).
The SOLSTICE trial evaluated the efficacy and safety of TAS-102 in combination with bevacizumab vs bevacizumab in combination with capecitabine (Xeloda) in treatment-naïve patients with unresectable mCRC who were unfit for intensive chemotherapy. In this trial, patients in the TAS-102 arm achieved a median progression-free survival (PFS) of 9.4 months (95% CI, 9.1-10.9) vs 9.3 months (95% CI, 8.9-9.8) in those in the capecitabine arm, missing the trial’s primary end point (HR, 0.87; 95% CI, 0.75-1.02). Overall survival (OS), the trial’s key secondary end point, was also not met. The median OS was 19.74 months (95% CI, 18.04-22.40) in the TAS-102 arm vs 18.59 months (95% CI, 16.82-21.39) in the capecitabine arm (HR, 1.06; 95% CI, 0.90-1.25).
Conversely, the phase 3 SUNLIGHT trial (NCT04737187), which investigated TAS-102 plus bevacizumab vs TAS-102 alone in patients with pretreated mCRC, demonstrated positive results with the TAS-102 combination in the third-line setting. In this trial, patients in the bevacizumab arm achieved a median OS of 10.8 months compared with 7.5 months in those in the TAS-102 monotherapy arm (HR, 0.61; 95% CI, 0.49-0.77; P < .001). In addition, the median PFS was 5.6 months with the combination vs 2.4 months with the monotherapy (HR, 0.44; 95% CI, 0.36-0.54; P < .001).
The findings from SUNLIGHT and SOLSTICE indicate that although TAS-102 plus bevacizumab should be the third-line standard of care in mCRC, this regimen was not superior to capecitabine plus bevacizumab in the first-line mCRC setting, and therefore should not be used as a first-line regimen, Andre says.
In the SOLSTICE trial, the most common toxicities in the TAS-102 and capecitabine arms, respectively, were neutropenia (54% vs 1%) and hand-foot syndrome (0% vs 15%), Andre explains. The toxicity profiles may differ between the 2 arms because of differences in the bevacizumab dosing schedule, Andre notes. In the TAS-102 arm, patients received TAS-102 at 35 mg/m2 twice daily on days 1 through 5 and 8 through 12 plus bevacizumab at 5 mg/kg on days 1 and 15 of each 28-day cycle. In the capecitabine arm, patients received capecitabine at 1000 mg/m2 or 1250 mg/m2 twice daily on days 1 through 14 plus bevacizumab at 7.5 mg/kg on day 1 of each 21-day cycle.