medwireNews: Combination therapy with pembrolizumab plus axitinib results in similar health-related quality of life (HRQoL) outcomes to that with sunitinib monotherapy for untreated advanced renal cell carcinoma (RCC), KEYNOTE-426 study data show.
The phase 3 trial previously demonstrated that pembrolizumab plus axitinib significantly improved overall survival, progression-free survival, and objective response rate relative to pembrolizumab plus sunitinib.
“These data further support the use of pembrolizumab plus axitinib as a standard of care for the first-line treatment of patients with advanced RCC,” write Jens Bedke (Eberhard Karls University of Tübingen, Germany) and co-authors in European Urology.
Of the 861 patients included in the study, 429 randomly assigned to receive pembrolizumab plus axitinib and 423 treated with sunitinib had HRQoL data available for the current analysis.
The researchers report that most scores on the EORTC Core Quality of Life Questionnaire (QLQ-C30), EQ-5D visual analog rating scale (VAS), and Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index–Disease-Related Symptoms (FKSI–DRS) questionnaires either improved or remained stable in both treatment arms after 30 weeks of treatment.
The proportion of patients who reported a clinically meaningful improvement in QLQ-C30 (≥10 points) was a significant 7.5 percentage points higher with axitinib than with sunitinib (41 vs 34%) and a significant 9.9 percentage points higher for EQ-5D VAS (50 vs 40% with ≥7-point change from baseline). For FKSI–DRS, 35.0% of patients in both arms experienced a clinically meaningful improvement of 3 or more points.
In addition, there were no clinically meaningful between-group differences in least-squares mean scores for axitinib versus sunitinib at week 30 for the QLQ-C30 global heath score (–1.70 points), EQ-5D VAS (–1.50 points), and FKSI–DRS (–0.53 points).
The median times to confirmed deterioration of QLQ-C30 global heath score, EQ-5D VAS, and FKSI–DRS were 15.0, 8.3, and 25.0 months, respectively, with axitinib, and a corresponding 13.0 months, 10.0 months, and not reached with sunitinib. The difference between the two arms was only statistically significant, in favor of sunitinib, for the FKSI–DRS.
Median time to first deterioration with axitinib was 3.0 months for the QLQ-C30 global heath score, 2.2 months for EQ-5D VAS, and 2.8 months for FKSI–DRS. With sunitinib, the respective times were 2.3, 2.3, and 2.6 months. In this case only the difference for QLQ-C30 global heath score was statistically significant, favoring axitinib.
Bedke and team note, however, that “[p]atients receiving sunitinib demonstrated a consistent pattern of worsening HRQoL during the 4-[week] treatment period, with a rebound during the 2-[week] off-treatment period.”
As QoL was assessed at the end of the 2-weeks off-treatment, rather than during the 4-week on-treatment period for sunitinib, any negative impact that the drug had may have been underestimated, the researchers caution.
They therefore say: “The effect of the cyclical pattern of a treatment as demonstrated by sunitinib should also be considered closely when assessing HRQoL and determining the overall risk/benefit effect of a therapy.”
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Eur Urol 2022; doi:10.1016/j.eururo.2022.06.009