Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study
dc.contributor.author | Mansoor, Was | |
dc.contributor.author | Kulkarni, A. S. | |
dc.contributor.author | Kato, K. | |
dc.contributor.author | Sun, J. M. | |
dc.contributor.author | Shah, M. A. | |
dc.contributor.author | Enzinger, P. C. | |
dc.contributor.author | Adenis, A. | |
dc.contributor.author | Doi, T. | |
dc.contributor.author | Kojima, T. | |
dc.contributor.author | Metges, J. P. | |
dc.contributor.author | Li, Z. G. | |
dc.contributor.author | Kim, S. B. | |
dc.contributor.author | Cho, B. C. | |
dc.contributor.author | Sunpaweravong, P. | |
dc.contributor.author | Alsina, M. | |
dc.contributor.author | Goekkurt, E. | |
dc.contributor.author | Suryawanshi, S. | |
dc.contributor.author | Norquist, J. | |
dc.contributor.author | Shah, S. | |
dc.contributor.author | Shen, L. | |
dc.date.accessioned | 2021-05-18T08:48:03Z | |
dc.date.available | 2021-05-18T08:48:03Z | |
dc.date.issued | 2021 | en |
dc.identifier.citation | Mansoor W, Kulkarni AS, Kato K, Sun J-M, Shah MA, Enzinger PC, et al. Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study. JCO. 2021 Jan 20;39(3_suppl):168–168. | en |
dc.identifier.doi | 10.1200/JCO.2021.39.3_suppl.168 | en |
dc.identifier.uri | http://hdl.handle.net/10541/623994 | |
dc.description.abstract | Background: In the randomized, international, double-blind, placebo-controlled KEYNOTE-590 (NCT03189719) study, pembrolizumab (pembro) + chemotherapy (chemo) provided statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs placebo + chemo as first-line therapy for patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). Here we report HRQoL outcomes in KEYNOTE-590. Methods: 749 pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2y + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires were administered at baseline, every 3 weeks (Q3W) up to week 24, and then Q9W up to 1 year or end of treatment, and at the 30-d safety follow-up visit. HRQoL was assessed in all treated patients who completed ≥1 HRQoL assessment (N = 711: 356 for pembro + chemo; 355 for chemo). Change from baseline to week 18 in EORTC-QLQ-C30 global health status (GHS)/QoL and physical functioning, and in QLQ-OES18 scores were prespecified secondary endpoints. Change from baseline to week 18 in EQ-5D scores was an exploratory endpoint. Time to deterioration (TTD) was evaluated for all endpoints. Least square mean (LSM) change from baseline (95% CI) was compared using a constrained longitudinal data analysis model. TTD was compared using a stratified log rank test and Cox proportional hazards model. P-values are nominal and two-sided. Results: QLQ-C30, QLQ-OES18 and EQ-5D-5L compliance was ≥90% in both arms at baseline and at week 18. There was no significant difference in least squares mean (LSM) change from baseline to week 18 in GHS/QoL status between arms (LSM difference [95% CI] -0.10 [-3.40-3.20]; P = 0.9530). Median TTD in GHS/QoL was similar between arms (HR, 0.86 [95% CI, 0.66-1.13]; P = 0.2864). Outcomes were similar in ESCC PD-L1 CPS ≥10, ESCC, and PD-L1 CPS ≥10 patient populations. LSM change from baseline to week 18 for QLQ-OES18 pain subscale was better for pembro + chemo (-4.78) vs chemo (-1.85 ) (-2.94, -5.86 to -0.02; P = 0.0487). There was no significant difference in LSM change from baseline to week 18 between arms for reflux (-1.19; -4.49-2.10; P = 0.4781) or dysphagia (-2.35; -7.78-3.07; P = 0.3945). VAS LSM change from baseline to week 18 was similar between arms (1.20, -1.61-4.01; P = 0.4016). Conclusions: HRQoL was stable and similar over 18 weeks in the pembro + chemo and chemo arms. Together with superior OS, PFS, and ORR and a manageable safety profile with pembro + chemo, these results support the clinically meaningful benefit of pembro + chemo in patients with advanced esophageal cancer including EGJ adenocarcinoma | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1200/JCO.2021.39.3_suppl.168 | en |
dc.title | Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | The Christie NHS Foundation Trust, Manchester, United Kingdom | en |
dc.identifier.journal | Journal of Clinical Oncology | en |
dc.description.note | en |