Trifluridine and tipiracil

A randomized, double-blinded, placebo-controlled, international, phase III trial (TAGS [NCT02500043]) included 507 patients with metastatic gastric or gastroesophageal junction adenocarcinoma who had progressive disease after receiving two previous regimens, including a fluoropyrimidine, a platinum agent, and a taxane and/or irinotecan. Patients were randomly assigned in a 2:1 ratio to receive either trifluridine and tipiracil (35 mg/m2 twice a day on days 1−5 and 8−12 every 28 days) or placebo.[37]

A randomized, double-blinded, placebo-controlled, international, phase III trial (TAGS [NCT02500043]) included 507 patients with metastatic gastric or gastroesophageal junction adenocarcinoma who had progressive disease after receiving two previous regimens, including a fluoropyrimidine, a platinum agent, and a taxane and/or irinotecan. Patients were randomly assigned in a 2:1 ratio to receive either trifluridine and tipiracil (35 mg/m2 twice a day on days 1−5 and 8−12 every 28 days) or placebo.[37]

The median OS was 5.7 months (95% CI, 4.8−6.2) in patients who received trifluridine and tipiracil, compared with 3.6 months (95% CI, 3.1−4.1) in patients who received placebo (HR, 0.69; 95% CI, 0.57−0.85; P = .00058).

A randomized, double-blinded, placebo-controlled, international, phase III trial (TAGS [NCT02500043]) included 507 patients with metastatic gastric or gastroesophageal junction adenocarcinoma who had progressive disease after receiving two previous regimens, including a fluoropyrimidine, a platinum agent, and a taxane and/or irinotecan. Patients were randomly assigned in a 2:1 ratio to receive either trifluridine and tipiracil (35 mg/m2 twice a day on days 1−5 and 8−12 every 28 days) or placebo.[37]

The objective response rate was 4% (disease control rate, 44%) in the trifluridine and tipiracil arm, compared with 2% (disease control rate, 14%) in the placebo arm.

A randomized, double-blinded, placebo-controlled, international, phase III trial (TAGS [NCT02500043]) included 507 patients with metastatic gastric or gastroesophageal junction adenocarcinoma who had progressive disease after receiving two previous regimens, including a fluoropyrimidine, a platinum agent, and a taxane and/or irinotecan. Patients were randomly assigned in a 2:1 ratio to receive either trifluridine and tipiracil (35 mg/m2 twice a day on days 1−5 and 8−12 every 28 days) or placebo.[37]

Grade 3 or higher adverse events occurred in 80% of patients treated with trifluridine and tipiracil, compared with 58% of patients who received placebo.