Author: By Hannah Kitt, medwireNews Reporter
medwireNews: Patients with clear cell renal cell carcinoma (RCC) given pembrolizumab following surgery do not experience a significant worsening of health-related quality of life (HRQoL) or physical functioning, according to KEYNOTE-564 findings presented at the ESMO Congress 2021.
Presenter Toni Choueiri, from Dana Farber Cancer Institute in Boston, Massachusetts, USA, said these patient-reported outcome results “support the reported efficacy and safety findings of the first prespecified analysis of KEYNOTE-564”, as previously reported by ESMO OncologyPRO.
He summarised: “Pembrolizumab is a potential new standard of care for patients with renal cell carcinoma in the adjuvant setting.”
The phase III study included patients with histologically confirmed clear cell RCC who had not received any prior systemic therapy before undergoing surgery. Among the 483 patients randomly assigned to receive pembrolizumab 200 mg every 3 weeks and the 492 given placebo, HRQoL was measured according to the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) and the EORTC QLQ-C30.
At 52 weeks, patients receiving pembrolizumab and placebo had similar changes in FKSI-DRS scores from baseline, with a least squares mean change of –1.12 and –0.45, respectively, which did not exceed the threshold of 3.0 or more for a meaningful change in either arm.
There was a numerically greater deterioration in EORTC QLQ-C30 HRQoL scores in the pembrolizumab arm compared with the placebo arm, but this did not translate to a clinically meaningful difference as the respective least squares mean changes of –4.25 and –1.68, respectively, were below the prespecified threshold of 10 or more.
The change in scores on the EORTC QLQ-C30 physical functioning scale also did not significantly differ between the pembrolizumab and placebo arms, with corresponding least squares mean changes of –1.61 and –0.90. Again, neither of these changes exceeded the 10-point threshold for clinically meaningful change.
These findings were supported in an exploratory analysis of empirical mean changes from baseline, with no significant difference between the pembrolizumab and placebo arms in any of the three QoL scores assessed.
Overall, a similar proportion of patients in the respective treatment arms had improved, stable and deteriorated scores on the FKSI-DRS (7.7 vs 12.2%, 49.3 vs 54.0% and 30.6 vs 23.1%, respectively), QLQ-C30 global health and QoL scale (10.5 vs 14.4%, 42.6 vs 52.3% and 34.9 v 23.1%) and the QLQ-C30 physical functioning scale (9.7 vs 10.3%, 54.3 vs 58.2% and 24.0 vs 21.3%).
Discussant Brian Rini, from Vanderbilt University Medical Center in Nashville, Tennessee, USA, said: “The decision to use [pembrolizumab] in the adjuvant RCC setting will come down to individual patient assessment of benefit/risk including pending data regarding prevention of recurrence and [overall survival] benefit via the potential for rare/serious [adverse events]”.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
653O - Choueiri TK, Tomczak P, Park SH, et al. Pembrolizumab (pembro) vs placebo as adjuvant therapy for patients (pts) with renal cell carcinoma (RCC): Patient-reported outcomes (PRO) in KEYNOTE-564. Ann Oncol 2021;32(suppl_5):S678–S724. doi: 10.1016/annonc/annonc675
medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2021 Springer Healthcare part of the Springer Nature group