• Sung-Bae Kim, Eric Van Cutsem, Jaffer Ajani, Lin Shen, Gisoo Barnes, Ningning Ding, Aiyang Tao, Tianyu Xia, Lin Zhan, and Ken Kato.
• Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
• Curr Med Res Opin. 2024 Jan 1; 40 (1): 697569-75.

ObjectivePost-hoc analysis examined health-related quality of life and esophageal squamous cell carcinoma (ESCC) symptoms in the Asian subgroup of patients in RATIONALE-302 (NCT03430843).MethodsPatients were randomized 1:1 to either tislelizumab or investigator-chosen chemotherapy (paclitaxel, docetaxel, or irinotecan). Health-related quality of life was measured using the EORTC QLQ-C30 and the QLQ-OES18. Least-squares mean score changes from baseline to weeks 12 and 18 in health-related quality-of-life scores were assessed using a mixed model for repeated measurements. Reported nominal p-values are for descriptive purposes only.ResultsOf the 512 patients, this analysis was conducted in 392 Asian patients (tislelizumab, n = 192; investigator-chosen chemotherapy, n = 200). The tislelizumab arm had stable global health status/quality of life, but fatigue scores worsened in both arms. The change from baseline was similar for physical functioning in both arms at weeks 12 and 18. Eating and dysphagia scores remained stable in the tislelizumab arm. Reflux improved at week 12 in the tislelizumab arm and worsened in the investigator-chosen chemotherapy arm.ConclusionsOverall, the health-related quality of life and ESCC-related symptoms of patients receiving tislelizumab in the Asian subgroup remained stable or improved, while patients receiving investigator-chosen chemotherapy experienced worsening. These results in Asian patients corroborate the findings in the intent-to-treat population, suggesting tislelizumab is a potential new second-line treatment option for patients with advanced or metastatic ESCC.Trial RegistrationThe RATIONALE-302 study is registered on clinicaltrials.gov as NCT03430843.

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