The Effect of Ipilimumab on Health-Related Quality of Life in Patients With Unresectable Advanced Melanoma

Patients diagnosed with melanoma are typically affected psychologically. Treatment usually causes impaired physical functioning and fatigue. Researchers summarized health-related quality of life (HRQOL) during the 12-week ipilimumab induction period in previously treated patients diagnosed with advanced stage III or IV melanoma.

Patients in the study were randomized to receive one of three treatments: ipilimumab plus gp100 vaccine, gp100 vaccine plus placebo, or ipilimumab plus placebo. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was utilized to assess HRQOL. This tool entails global health status, and physical, emotional, role, cognitive, and social functioning. Higher scores are indicative of better functioning. Differences in scores were subgrouped into four categories (“no change” [0-5 points], “a little” [5-10 points], “moderate” [10-20 points], and “very much” [>20 points]). A score differential of 0 to 10 points was interpreted as no or minimal impact on patient HRQOL.

The researchers reported that after 12 weeks, most patients reported that changes to HRQOL outcomes were no greater than minimal. The only statistically significant difference in score was for constipation, in a comparison of the ipilimumab plus gp100 and the gp100 alone groups. Scoring indicating “moderate” function and global health status score were role function in the ipilimumab alone group and role function and global health in the gp100 group. Symptom scoring rating a “moderate” were fatigue in the ipilimumab plus gp100 group; fatigue, sleep disturbances, and appetite loss in the ipilimumab alone group; and fatigue, pain, sleep disturbances, appetite loss, and constipation in the gp100 alone group.

Patients older than age 65 years tended to have more “moderate” changes in health status than the patients younger than 65 years. The greatest differences, albeit moderate, were observed for role function, social function, global health, dyspnea, sleep disturbance, appetite loss, and diarrhea. It is difficult to fully appreciate the importance of the findings owing to the small sample size of the age >65 years group, as the mean age was 55.6 years to 57.4 years across all of the study groups.

Treatment within all three treatment groups resulted in minimal changes in HRQOL. Therefore, the authors concluded that HRQOL changes should not be a concern for those patients with advanced melanoma and their physicians considering ipilimumab treatment.

Revicki DA, van den Eertwegh AJM, Lorigan P, et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012;10:66.