Dr Taieb on the Safety Proline of TAS-102/Bevacizumab in Refractory mCRC

Julien Taieb, MD, PhD, professor of medicine, Université Paris Cité, The Hôpital Européen Georges-Pompidou, Université de Paris, discusses the safety profile associated with trifluridine/tipiracil (TAS-102; Lonsurf) with bevacizumab (Avastin) in refractory metastatic colorectal cancer (mCRC).

At the 2023 ASCO Annual Meeting, Taieb and colleagues presented data from a post-hoc analysis of the phase 3 SUNLIGHT trial (NCT04737187), showing that TAS-102 plus bevacizumab prolonged overall survival (OS) in patients with mCRC in patients who maintained their ECOG performance status compared with TAS-102 alone. Notably, these results were consistent with what was previously reported in the intent-to-treat population. Previous efficacy and safety data from the phase 3 trial presented at the 2023 Gastrointestinal Cancers Symposium showed that the median OS was improved with the addition of bevacizumab to TAS-102 (10.8 months) vs TAS-102 alone (7.5 months; HR, 0.61; 95% CI, 0.49-0.77; P < .001).

Although TAS-102 is associated with low clinical toxicities, hematological toxicities can be a concern, Taieb says. One of the primary adverse effects associated with TAS-102 is neutropenia, which can create issues when attempting to continue the treatment regimen, Taieb explains. However, from a patient perspective, they may not necessarily be aware that their white blood cells are low, making it important to monitor, he adds, noting that granulocyte colony–stimulating factor could be used to combat instances of neutropenia. In the previously reported data from SUNLIGHT, the rates of any-grade neutropenia were 62% in the combination arm vs 51% for TAS-102 alone.

When adding bevacizumab to treatment with TAS-102, it is important to be aware of the AEs associated with bevacizumab; however, this is also a generally well-tolerated drug, Taieb emphasizes. The main AE associated with bevacizumab is hypertension; however, in rare cases, proteinuria may be observed, he concludes.