Rutika Mehta, MD, MPH
Researchers hope that the novel combination of ramucirumab (Cyramza) with TAS-102 (trifluridine/tipiracil; Lonsurf), which is under investigation in a phase II trial, will overcome the significant adverse events (AEs) seen with ramucirumab/paclitaxel in patients with advanced gastric and gastroesophageal junction (GEJ) cancer, said Rutika Mehta, MD, MPH.
The recommended frontline treatment for patients with metastatic gastric/GEJ cancer typically consists of a fluoropyrimidine with a platinum-based agent, usually oxaliplatin, which is known to induce neuropathy over time. While ramucirumab is currently FDA approved in combination with paclitaxel in the second-line setting, many patients are unable to tolerate the regimen as paclitaxel is also neurotoxic, said Mehta, a gastrointestinal medical oncologist at Moffitt Cancer Center.
In an effort to address this need, the phase II study (NCT03686488
), which is still accruing, will combine ramucirumab with TAS-102, a novel oral formulation of trifluorothymidine and a thymidine phosphorylase inhibitor.1
Those with gastric or GEJ adenocarcinoma who have received ≥1 prior line of treatment, have an ECOG performance status of 0 or 1, and have preserved organ function, are eligible for enrollment. Ramucirumab will be administered at 8 mg/kg every 2 weeks and TAS-102 at doses of 35 mg/m2
twice daily. Each cycle length will be 28 days. The primary endpoint is 6-month overall survival (OS), and secondary endpoints are safety, objective response rate, and progression-free survival.
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