Ramucirumab with or without chemotherapy

The international, phase III, placebo-controlled, REGARD trial (NCT00917384) included 355 patients with stage IV gastric or gastroesophageal junction cancer who had progressed on a first-line 5-FU‒ or platinum-containing regimen. Patients were randomly assigned in a 2:1 fashion to receive either ramucirumab or placebo.[33]Ramucirumab is an acceptable treatment in patients with cisplatin- or 5-FU‒refractory, stage IV, gastric cancer.

The international, phase III, placebo-controlled, REGARD trial (NCT00917384) included 355 patients with stage IV gastric or gastroesophageal junction cancer who had progressed on a first-line 5-FU‒ or platinum-containing regimen. Patients were randomly assigned in a 2:1 fashion to receive either ramucirumab or placebo.[33]Ramucirumab is an acceptable treatment in patients with cisplatin- or 5-FU‒refractory, stage IV, gastric cancer.

Patients who were assigned to ramucirumab had a significantly improved median OS of 5.2 months compared with a median OS of 3.8 months in patients who were assigned to the placebo (HR, 0.776; P = .047).

The international, phase III, placebo-controlled, REGARD trial (NCT00917384) included 355 patients with stage IV gastric or gastroesophageal junction cancer who had progressed on a first-line 5-FU‒ or platinum-containing regimen. Patients were randomly assigned in a 2:1 fashion to receive either ramucirumab or placebo.[33]Ramucirumab is an acceptable treatment in patients with cisplatin- or 5-FU‒refractory, stage IV, gastric cancer.

Rates of hypertension were higher in the ramucirumab group than in the placebo group.[33][Level of evidence A1]

In the international, double-blinded, phase III RAINBOW trial (NCT01170663), 665 patients were randomly assigned to receive paclitaxel (80 mg/m2) on days 1, 8, and 15 every 28 days with either ramucirumab (8 mg/kg) added on days 1 and 15 or a placebo added on days 1 and 15.[34]The combination of paclitaxel and ramucirumab is an acceptable second-line chemotherapy regimen in patients with stage IV gastric or gastroesophageal junction cancer.

In the international, double-blinded, phase III RAINBOW trial (NCT01170663), 665 patients were randomly assigned to receive paclitaxel (80 mg/m2) on days 1, 8, and 15 every 28 days with either ramucirumab (8 mg/kg) added on days 1 and 15 or a placebo added on days 1 and 15.[34]The combination of paclitaxel and ramucirumab is an acceptable second-line chemotherapy regimen in patients with stage IV gastric or gastroesophageal junction cancer.

Patients who were assigned to ramucirumab had a significant improvement in median OS of 9.6 months compared with a median OS of 7.4 months in patients who were assigned to a placebo (HR, 0.807; P = .017).

In the international, double-blinded, phase III RAINBOW trial (NCT01170663), 665 patients were randomly assigned to receive paclitaxel (80 mg/m2) on days 1, 8, and 15 every 28 days with either ramucirumab (8 mg/kg) added on days 1 and 15 or a placebo added on days 1 and 15.[34]The combination of paclitaxel and ramucirumab is an acceptable second-line chemotherapy regimen in patients with stage IV gastric or gastroesophageal junction cancer.

Grade 3 or higher neutropenia, fatigue, hypertension, and abdominal pain were more common in the ramucirumab group.[34][Level of evidence A1]