Postsurgical Keytruda Has Little Impact on Quality of Life in Melanoma

Receiving Keytruda (pembrolizumab) as adjuvant (after surgery) treatment did not significantly affect health-related quality of life in patients with stage 3 melanoma when compared with placebo (inactive drug).

In the recent KEYNOTE-054 study published in The Lancet, 514 patients with stage 3 melanoma were randomly assigned to receive Keytruda and 505 patients were assigned placebo. At baseline (before patients started treatment in the study), the patients in both groups exceeded the health-related quality of life evaluation by 90%. However, evaluations ranged from 60% to 90% for post-baseline timepoints, the researchers noted.

“In the KEYNOTE-054 study, [Keytruda] did not significantly affect long-term [health-related quality of life],” the study researchers wrote. “[Overall health status and quality of life] returned to baseline in the long term for patients from the [Keytruda] group and exceeded baseline by values smaller than the threshold of clinical relevance for patients from the placebo group.”

Patients in the Keytruda group had their overall health status or quality of life return to baseline in the long term and exceeded baseline for patients in the placebo group, the researchers established. On average, changes from baseline to long-term regarding overall health status or quality of life were –0.56 in the Keytruda group and 1.63 in the placebo group. Of note, changes at 0 or greater indicate an improvement in quality of life compared with baseline.

In terms of physical functioning, the average change in quality of life from baseline to long-term was –0.46 in the Keytruda group and 0.10 in the placebo group, the researchers reported.

“Physical functioning scores remained similar to baseline at all long-term evaluation points in both groups,” they wrote.

READ MORE: Presurgical Targeted Therapy, Immunotherapy Show Responses in Melanoma

Side Effects from Postsurgical Keytruda in Stage 3 Melanoma

Side effects among 481 patients in the Keytruda group included immune-related side effects, according to the study. The most common side effects were underactive thyroid (73 patients), overactive thyroid (51 patients), vitiligo (causes patches of skin to lose pigment; 24 patients), colitis (inflamed colon; 18 patients) and pneumonitis (inflammation in your lung tissues; 17 patients).

Twenty-four of the 481 patients in the Keytruda group had complete recovery from these side effects after two years, the researchers determined. In 92 of the 481 patients, a full recovery was not reported within two years from the beginning of treatment in the study. Specifically, the most common immune-related side effects without a report of recovery were underactive thyroid in 53 patients and vitiligo in 20 patients.

“Among 481 patients from the [Keytruda] group with a baseline [health-related quality of life] questionnaire available, 34 patients had grade 3 or 4 (severe or life-threatening) immune-related [side effects] during the adjuvant treatment,” the researchers wrote.

Interestingly, the associations between the immune-related side effects and long-term health-related quality of life in patients from the Keytruda group were not statistically significant nor clinically relevant, the researchers stated.

Patients who experienced distant metastasis (distant spreading of cancer) were associated with worsened health-related quality of life outcomes, according to the study.

“Patients with immune-related [side effects] from the [Keytruda] group did not have clinically relevant or statistically significant worse long-term [health-related quality of life],” the researchers wrote. “By contrast, the occurrence of distant metastasis negatively affected long-term [health-related quality of life].”

Nevertheless, effects that were clinically relevant for overall health status and quality of life were role and social functioning and fatigue.

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