Examining the Impact of Tislelizumab Added to Chemotherapy on Health‑Related Quality of Life (HRQoL) Outcomes in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC): The Rationale-306 Study

Speaker(s)

Xu J1, Jiménez-Fonseca P2, Kato K3, Shu Y4, Park SR5, Hubner R6, Raymond E7, Yoon HH8, Yan S9, Barnes B9, Prieto Patron A10, Mardiguian S9, Barnes G9
1Fifth Medical Center, Chinese PLA General Hospital, Beijing, Beijing, China, 2Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain, 3National Cancer Center Hospital, Tokyo, Tokyo, Japan, 4The First Affiliated Hospital of Nanjing Medical University, Nanjing, Nanjing, China, 5Asan Medical Center, University of Ulsan College of Medicine, Seoul, Seoul, Korea, Republic of (South), 6Department of Medical Oncology, The Christie NHS Foundation Trust/Division of Cancer Sciences, University of Manchester, Manchester, Manchester, UK, 7Centre Hospitalier Paris Saint-Joseph, Paris, Paris, France, 8Mayo Clinic, Rochester, MN, USA, 9BeiGene USA, Inc., San Mateo, CA, USA, 10BeiGene Switzerland GmbH, Pully, Switzerland

Presentation Documents

OBJECTIVES: In the global, randomized, phase 3 RATIONALE-306 trial (NCT03783442), first-line treatment with tislelizumab plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival versus placebo plus chemotherapy in patients with unresectable, locally advanced, recurrent, or metastatic ESCC. Here, we report patient-reported outcomes (PRO) from RATIONALE-306.

METHODS: PROs were included as secondary endpoints and HRQoL was assessed using EORTC QLQ-C30 and QLQ-OES18. Domains of interest included global health status (GHS)/QoL, physical functioning, and fatigue from QLQ-C30, and dysphagia, difficulty eating, reflux, pain symptoms, and the index score from QLQ-OES18. Mixed model for repeated measures analyses were performed using data from baseline, Cycle 6, and Cycle 8. Median time to deterioration (TTD) was examined using the Kaplan-Meier method.

RESULTS: A total of 649 patients were randomized to receive tislelizumab plus chemotherapy (n=326) or placebo plus chemotherapy (n=323). At Cycle 6, patients in the tislelizumab arm showed significantly greater improvement in mean change from baseline for GHS/QoL (3.3 [95% CI, 0.4-6.2]) and physical functioning (2.6 [95% CI, 0.0-5.1]) versus the placebo arm; they also experienced a clinically meaningful reduction in mean pain symptoms at Cycle 6 (-5.2 [95% CI, -6.7 to -3.7]). At Cycle 8, changes from baseline on these key domains were generally maintained in patients treated with tislelizumab. TTD analyses showed that patients in the tislelizumab arm were at lower risk of clinically meaningful worsening of physical functioning (HR, 0.79 [95% CI, 0.60-1.04]); risk of worsening was similar between arms in the remaining domains examined.

CONCLUSIONS: PRO outcomes between the treatment arms were comparable in this patient population with advanced or metastatic ESCC, with improvements in the tislelizumab arm on the key GHS/QoL and physical functioning domains. Importantly, patients treated with tislelizumab experienced improvement in pain at Cycle 6 and lower risk of worsening of physical functioning.

Code

PCR65

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Drugs, Oncology