REGARD: A phase 3, randomized, double-blind trial of ramucirumab (RAM) and best supportive care (BSC) versus placebo (PL) and BSC in the treatment of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma following disease progression (PD) on first-line platinum- and/or fluoropyrimidine-containing combination therapy: Age subgroup analysis.

Abstract:

Background:

The REGARD trial demonstrated significant improvements in overall survival (OS), progression free survival (PFS), and disease control rates in pts receiving RAM, a human IgG1 receptor targeted antibody. We examined outcomes by age (<65 and ≥65 years [yrs]). 

Methods: Pts were randomized 2:1 to receive RAM (8 mg/kg IV) plus BSC or PL plus BSC every 2 wks until PD, unacceptable toxicity, or death. Eligible patients had PD within 4 months (m) after 1^st-line therapy for metastatic disease or within 6 m after adjuvant therapy. The primary endpoint was OS. Secondary endpoints included PFS, 12-wk PFS rate, overall response rate (ORR) and safety.

Results: 355 pts. were randomized; 227 were age <65 yrs (RAM 156; PL 71) and 128 were ≥ 65 yrs (RAM 82; PL 46).Baseline characteristics were well balanced between the treatment arms and subgroups. RAM efficacy was similar in younger and older patients. Median OS was 5.3 vs 4.1 m in the RAM:PL arms for pts <65 yrs and 5.2 vs 3.8 m in the RAM:PL arms for pts ≥65 yrs. The OS HR was 0.846 (95% CI, 0.611-1.171) in pts <65 years and 0.722 (95% CI 0.471-1.106) in pts ≥65 yrs (treatment-by-age group interaction p = 0.5569). Median PFS was 1.9 vs 1.3m in the RAM:PL arm for pts <65 yrs and 2.8 vs 1.4 m for Ram:PL for pts ≥65 yrs. The PFS HR was 0.450 (95% CI, 0.327-0.620) <65 yrs and 0.490 (95% CI, 0.319-0.752) (interaction p=0.9445). The incidence of Grade ≥3 adverse events was comparable between treatment arms for both age groups (55% vs 57% pts <65 yrs; 60% pts ≥65 yrs in both arms). The most frequent grade ≥ 3 AEs in ≥ 5% of pts RAM arm were: hypertension (7.8% RAM; 1.4% PL [<65 yrs] and 7.3% RAM; 4.4% PL [≥65 yrs]), abdominal pain (7.1% RAM; 4.3% PL [<65 yrs]), fatigue (7.3% RAM; 2.2% PL ≥ 65 yrs) and anemia (9.1% RAM; 7.1% PL [<65 yrs]. No specific AE was observed at grade ≥ 3 in > 10% of patients.

Conclusions:When compared to placebo, RAM conferred similar improvements for OS and PFS between pts age < 65 yrs and those age ≥ 65; AE profiles were also similar for pts ≥ 65 and <65 yrs. Clinical trial information: NCT00917384.

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Citation:
J Clin Oncol 32:5s, 2014 (suppl; abstr 4057)