Kidney Cancer Coverage from Every Angle

ESMO 2021: Patient-Reported Outcomes From KEYNOTE-564 With Adjuvant Pembrolizumab for Kidney Cancer

By: Vanessa A. Carter, BS
Posted: Wednesday, September 29, 2021

The phase III KEYNOTE-564 trial, which met its primary endpoint of disease-free survival with adjuvant  pembrolizumab versus placebo after surgery in patients with renal cell carcinoma, was performed by Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues. The patient-reported outcomes from this trial, presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 653O), revealed there were no clinically meaningful changes from baseline in symptom scores or health-related quality of life with adjuvant pembrolizumab or placebo. In fact, over time, the scores remained stable.

Patient-reported outcomes were assessed in all patients who received more than one dose of either pembrolizumab (n = 496) or placebo (n = 498). They completed the Functional Assessment of Cancer Therapy–Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) and European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaires throughout the study period. Questionnaires were administered electronically at cycles 1, 5, 9, 13, and 17; treatment discontinuation; 30 days after the final dose; and annually until recurrence or new therapy.

The median time from study initiation to the cutoff date was 24.1 months, and no patients remained on treatment at that time. More than 90% of patients in both the pembrolizumab and placebo groups completed each questionnaire at baseline, and more than 60% filled them out at week 52.

The least square mean change in FKSI-DRS scores was statistically insignificant for both the pembrolizumab (−1.12) and placebo (−0.45) arms. In the pembrolizumab group, the least square mean change in QLQ-C30 score was –4.25, and it was –1.68 for those in the placebo group. Physical functioning scores seemed to decline more in participants treated with pembrolizumab (–1.81) compared with placebo (–0.90), although neither change was considered by the study investigators to be statistically significant.

Disclosure: For full disclosures of the study authors, visit

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