Health-Related Quality of Life in Pivotal Trial of Adjuvant Ipilimumab in Stage III Melanoma


Key Points

  • In patients with high-risk stage III melanoma, global health status was significantly poorer statistically with ipilimumab, but differences did not meet the criteria for clinically important differences.
  • Diarrhea and insomnia were worse with ipilimumab at 10 weeks.

As reported in The Lancet Oncology by Coens et al, there was little difference between adjuvant ipilimumab (Yervoy) vs placebo in health-related quality of life in patients with high-risk stage III melanoma in the phase III EORTC 18071 trial supporting the 2014 approval of ipilimumab in this setting. The trial showed significant prolongation of recurrence-free survival with ipilimumab vs placebo.

Study Details

In the trial, patients received ipilimumab at 10 mg/kg (n = 475) or placebo (n = 476) every 3 weeks for 4 doses and then every 3 months for up to 3 years. Health-related quality of life was assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (EORTC QLQ-C30) at baseline; at weeks 4, 7, 10, and 24; and every 12 weeks thereafter for up to 2 years irrespective of disease progression.

Summary health-related quality-of-life scores were calculated as the average score during induction and the average score after induction, with scores transformed to a 0-to-100 scale. A 10-point difference on the health-related quality-of-life scale was predefined as a clinically relevant difference. The primary endpoint of the current analysis was the QLQ-C30 global health scale. On the QLQ-C30, a higher score on global health status or function scales indicates better status, whereas higher score on symptom scales indicates worse status.

Health-Related Quality-of-Life Outcomes

Health-related quality-of-life questionnaire compliance among all patients was 94% at baseline, 75% at week 24, and 51% at week 108. Patient mean global health scores were statistically significantly worse with ipilimumab vs placebo during induction (72.96 vs 77.32, P = .00011) and after induction (72.32 vs 76.48, P = .00067), but the differences did not meet the threshold for clinically important differences.

Scores differed most between groups at week 7 (72 vs 77) and week 10 (70 vs 77). Clinically important poorer symptom status was observed in the ipilimumab group at week 10 for diarrhea (18.17 vs 7.67) and insomnia (25.60 vs 15.17).

The investigators concluded: “Despite increased toxicity, which led to treatment discontinuation for most patients during the induction phase of ipilimumab administration, overall [health-related quality of life], as measured by the EORTC QLQ-C30, was similar between groups, as no clinically relevant differences (10 points or more) in global health status scores were observed during or after induction. Clinically relevant deterioration for some symptoms was observed at week 10, but after induction, no clinically relevant differences remained.”

The study was supported by Bristol-Myers Squibb.

Corneel Coens, MSc, of EORTC Headquarters, Brussels, Belgium, is the corresponding author of The Lancet Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.