HRQoL Benefits Indicated With Pembrolizumab For Advanced Melanoma

Pembrolizumab is associated with a smaller deterioration of health-related quality of life than chemotherapy for the treatment of advanced treatment-refractory melanoma

medwireNews: Health-related quality of life (HRQoL) findings from the KEYNOTE-002 trial add support for the use of pembrolizumab in patients with advanced melanoma refractory to ipilimumab therapy.

The results follow the initial report from the phase II study showing that the programmed cell death protein 1 (PD-1) inhibitor offers better progression-free survival (PFS) than investigator’s choice of chemotherapy and is better tolerated by patients.

HRQoL at baseline, as measured by the EORTC Quality-of-Life Questionnaire-Core 30 (QLQ-C30) assessment, was comparable between the 180 patients given pembrolizumab 2 mg/kg on a 3-week schedule, the 181 patients given the PD-1 inhibitor at the higher 10 mg/kg dose and the 179 patients who received a chemotherapy regimen.

The participants were also asked to complete the QLQ-C30 on weeks 3, 6, 12, 24 and 36, and again after treatment discontinuation, and compliance with the patient-reported outcome assessment at week 12 was 82.3% and 86.4% for the pembrolizumab groups and 76.6% for controls.

Between baseline and week 12, the pembrolizumab treatment groups experienced a significantly smaller decline in baseline HRQoL scores than those given chemotherapy, with a decline of –2.6 for both doses versus –9.1.

Pembrolizumab was also associated with “consistently smaller” longitudinal declines across the QLQ-C30 scales measuring physical, role, emotional, cognitive and social functioning, as well as those detailing individual symptoms, such as fatigue, pain, and nausea and vomiting.

Responder analyses showed that patients given pembrolizumab 2 mg/kg and 10 mg/kg were less likely to experience deterioration of their baseline global health score at the 12-week checkpoint than those given chemotherapy, at 31.8% and 26.6% versus 38.3%, respectively.

This was also true for scales separately assessing individual functioning and symptoms, report Dirk Schadendorf, from University Hospital Essen in Germany, and co-authors in the European Journal of Cancer.

The researchers emphasize that HRQoL scores were “generally worse in the presence of disease progression than in its absence” for patients regardless of treatment received.

And they caution that, as there were fewer patients without disease progression in the chemotherapy arm than the pembrolizumab groups, “the HRQoL outcomes reported here are likely associated with tumour progression in addition to chemotherapy-related side-effects.”

Nevertheless, they conclude: “Taken together, these findings suggest that pembrolizumab is well tolerated and either improves or maintains HRQoL or symptoms when compared with chemotherapy.

“Furthermore, they support the reported clinical benefit of pembrolizumab over chemotherapy with respect to PFS. Therefore, delaying disease progression or extending PFS appears to help to maintain or improve HRQoL in these patients”, the team says. 


Schadendorf D, Dummer R, Hauschild A, et al. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J Cancer 2016; 67: 46–54, Advance online publication 2 September. DOI:

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