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Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma

J. Bedke, BI. Rini, ER. Plimack, V. Stus, R. Gafanov, T. Waddell, D. Nosov, F. Pouliot, D. Soulières, B. Melichar, I. Vynnychenko, SJ. Azevedo, D. Borchiellini, RS. McDermott, S. Tamada, AM. Nguyen, S. Wan, RF. Perini, L. Rhoda Molife, MB....

. 2022 ; 82 (4) : 427-439. [pub] 20220715

Language English Country Switzerland

Document type Journal Article, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc22024272

BACKGROUND: In the phase 3 KEYNOTE-426 (NCT02853331) trial, pembrolizumab + axitinib demonstrated improvement in overall survival, progression-free survival, and objective response rate over sunitinib monotherapy for advanced renal cell carcinoma (RCC). OBJECTIVE: To evaluate health-related quality of life (HRQoL) in KEYNOTE-426. DESIGN, SETTING, AND PARTICIPANTS: A total of 861 patients were randomly assigned to receive pembrolizumab + axitinib (n = 432) or sunitinib (n = 429). HRQoL data were available for 429 patients treated with pembrolizumab + axitinib and 423 patients treated with sunitinib. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQoL end points were measured using the European Organisation for the Research and Treatment of Cancer Core (EORTC) 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. RESULTS AND LIMITATIONS: Better or not different overall improvement rates from baseline between pembrolizumab + axitinib and sunitinib were observed for the FKSI-DRS (-0.79% improvement vs sunitinib; 95% confidence interval [CI] -7.2 to 5.6), QLQ-C30 (7.5% improvement vs sunitinib; 95% CI 1.0-14), and EQ-5D VAS (9.9% improvement vs sunitinib; 95% CI 3.2-17). For time to confirmed deterioration (TTcD) and time to first deterioration (TTfD), no differences were observed between arms for the QLQ-C30 (TTcD hazard ratio [HR] 1.0; 95% CI 0.82-1.3; TTfD HR 0.82; 95% CI 0.69-0.97) and EQ-5D VAS (TTcD HR 1.1; 95% CI 0.87-1.3; TTfD HR 0.98; 95% CI 0.83-1.2). TTfD was not different between treatment arms (HR 1.1; 95% CI 0.95-1.3) for the FKSI-DRS, but TTcD favored sunitinib (HR 1.4; 95% CI 1.1-1.7). Patients were assessed during the off-treatment period for sunitinib, which may have underestimated the negative impact of sunitinib on HRQoL. CONCLUSIONS: Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS. PATIENT SUMMARY: Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups.

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$a Bedke, Jens $u Department of Urology, Eberhard Karls University of Tübingen, Tübingen, Germany. Electronic address: jens.bedke@med.uni-tuebingen.de
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$a Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma / $c J. Bedke, BI. Rini, ER. Plimack, V. Stus, R. Gafanov, T. Waddell, D. Nosov, F. Pouliot, D. Soulières, B. Melichar, I. Vynnychenko, SJ. Azevedo, D. Borchiellini, RS. McDermott, S. Tamada, AM. Nguyen, S. Wan, RF. Perini, L. Rhoda Molife, MB. Atkins, T. Powles
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$a BACKGROUND: In the phase 3 KEYNOTE-426 (NCT02853331) trial, pembrolizumab + axitinib demonstrated improvement in overall survival, progression-free survival, and objective response rate over sunitinib monotherapy for advanced renal cell carcinoma (RCC). OBJECTIVE: To evaluate health-related quality of life (HRQoL) in KEYNOTE-426. DESIGN, SETTING, AND PARTICIPANTS: A total of 861 patients were randomly assigned to receive pembrolizumab + axitinib (n = 432) or sunitinib (n = 429). HRQoL data were available for 429 patients treated with pembrolizumab + axitinib and 423 patients treated with sunitinib. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQoL end points were measured using the European Organisation for the Research and Treatment of Cancer Core (EORTC) 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. RESULTS AND LIMITATIONS: Better or not different overall improvement rates from baseline between pembrolizumab + axitinib and sunitinib were observed for the FKSI-DRS (-0.79% improvement vs sunitinib; 95% confidence interval [CI] -7.2 to 5.6), QLQ-C30 (7.5% improvement vs sunitinib; 95% CI 1.0-14), and EQ-5D VAS (9.9% improvement vs sunitinib; 95% CI 3.2-17). For time to confirmed deterioration (TTcD) and time to first deterioration (TTfD), no differences were observed between arms for the QLQ-C30 (TTcD hazard ratio [HR] 1.0; 95% CI 0.82-1.3; TTfD HR 0.82; 95% CI 0.69-0.97) and EQ-5D VAS (TTcD HR 1.1; 95% CI 0.87-1.3; TTfD HR 0.98; 95% CI 0.83-1.2). TTfD was not different between treatment arms (HR 1.1; 95% CI 0.95-1.3) for the FKSI-DRS, but TTcD favored sunitinib (HR 1.4; 95% CI 1.1-1.7). Patients were assessed during the off-treatment period for sunitinib, which may have underestimated the negative impact of sunitinib on HRQoL. CONCLUSIONS: Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS. PATIENT SUMMARY: Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups.
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$a Rini, Brian I $u Vanderbilt University Medical Center, Nashville, TN, USA
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$a Plimack, Elizabeth R $u Fox Chase Cancer Center, Philadelphia, PA, USA
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$a Stus, Viktor $u Dnipro State Medical University, Dnipro, Ukraine
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$a Gafanov, Rustem $u Russian Scientific Center of Roentgen Radiology, Moscow, Russia
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$a Waddell, Tom $u The Christie NHS Foundation Trust, Manchester, UK
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$a Nosov, Dimitry $u Central Clinical Hospital With Outpatient Clinic, Moscow, Russia
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$a Pouliot, Frederic $u CHU de Québec and Université Laval, Quebec City, QC, Canada
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$a Soulières, Denis $u Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada
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$a Melichar, Bohuslav $u Palacký University Olomouc, Medical School and Teaching Hospital, Olomouc, Czech Republic
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$a Vynnychenko, Ihor $u Sumy State University, Sumy Regional Oncology Center, Sumy, Ukraine
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$a Azevedo, Sergio J $u Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
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$a Borchiellini, Delphine $u Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France
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$a McDermott, Raymond S $u Adelaide and Meath Hospital, University College Dublin, Dublin, Ireland
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$a Tamada, Satoshi $u Bell Land General Hospital, Osaka, Japan
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$a Nguyen, Allison Martin $u Merck & Co., Inc., Rahway, NJ, USA
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$a Wan, Shuyan $u Merck & Co., Inc., Rahway, NJ, USA
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$a Perini, Rodolfo F $u Merck & Co., Inc., Rahway, NJ, USA
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$a Rhoda Molife, L $u MSD UK, London, UK
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$a Atkins, Michael B $u Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA
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