- The addition of bevacizumab to TAS-102 leads to improved survival in metastatic colorectal cancer (CRC), with little effect on adverse events other than neutropenia.
Why this matters
- The authors suggest that the finding should change practice, but an accompanying editorial calls for more data before guidelines should be changed.
- Open-label, randomized, phase 2 trial at 4 centers in Denmark (n=93).
- Patients were randomly assigned to oral TAS-102 alone or TAS-102 combined with bevacizumab.
- Included patients had metastatic CRC refractory or intolerant to a fluoropyrimidine, irinotecan, oxaliplatin, and cetuximab or panitumumab (RAS wild-type only).
- Funding: Servier.
- Median follow-up, 10.0 months.
- Median PFS was longer in the TAS-102/bevacizumab group:
- 4.6 vs 2.6 months;
- HR, 0.45 (P=.0015).
- Median OS was longer in the TAS-102/bevacizumab group:
- 9.4 vs 6.7 months;
- HR, 0.55 (P=.028).
- Grade 3 or higher adverse events included neutropenia (38% in TAS-102 vs 67% in the TAS-102/bevacizumab group).
- Severe adverse events occurred in 45% of the TAS-102 group and 41% of the TAS-102/bevacizumab group.
- Open-label design.
- Small sample size.