Tislelizumab in advanced/metastatic esophageal squamous cell carcinoma: health-related quality of life in Asian patients

AbstractObjective Post-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). Methods: Patients 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 purpose only.Results: Of the 512 patients, this analysis was conducted in 392 Asian patients (tislelizumab n = 192; investigator-chosen chemotherapy n = 200). The tislelizumab arm had stable GHS/QoL, 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 investigator-chosen chemotherapy arm.Conclusions: Overall, 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 registration: The RATIONALE-302 study is registered on clinicaltrials.gov as NCT03430843.Keywords: chemotherapyesophageal squamous cell carcinomahealth-related quality of lifeimmunotherapyPD-1/PD-L1 inhibitorsDisclaimerAs a service to authors and researchers we are providing this version of an accepted manuscript (AM). Copyediting, typesetting, and review of the resulting proofs will be undertaken on this manuscript before final publication of the Version of Record (VoR). During production and pre-press, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal relate to these versions also.