التفاصيل البيبلوغرافية
| العنوان: |
Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma. |
| المؤلفون: |
Bedke, Jens1 (AUTHOR) jens.bedke@med.uni-tuebingen.de, Rini, Brian I.2 (AUTHOR), Plimack, Elizabeth R.3 (AUTHOR), Stus, Viktor4 (AUTHOR), Gafanov, Rustem5 (AUTHOR), Waddell, Tom6 (AUTHOR), Nosov, Dimitry7 (AUTHOR), Pouliot, Frederic8 (AUTHOR), Soulières, Denis9 (AUTHOR), Melichar, Bohuslav10 (AUTHOR), Vynnychenko, Ihor11 (AUTHOR), Azevedo, Sergio J.12 (AUTHOR), Borchiellini, Delphine13 (AUTHOR), McDermott, Raymond S.14 (AUTHOR), Tamada, Satoshi15 (AUTHOR), Nguyen, Allison Martin16 (AUTHOR), Wan, Shuyan16 (AUTHOR), Perini, Rodolfo F.16 (AUTHOR), Rhoda Molife, L.17 (AUTHOR), Atkins, Michael B.18 (AUTHOR) |
| المصدر: |
European Urology. Oct2022, Vol. 82 Issue 4, p427-439. 13p. |
| مصطلحات موضوعية: |
*RENAL cell carcinoma, *SUNITINIB, *QUALITY of life, *PEMBROLIZUMAB, *RENAL cancer |
| مستخلص: |
First-line pembrolizumab + axitinib significantly improved overall survival, progression-free survival, and objective response rate over sunitinib, while health-related quality of life outcomes were not different between groups. 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). To evaluate health-related quality of life (HRQoL) in KEYNOTE-426. 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. 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. 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. 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. Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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