Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality of Life (HRQoL) Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Author(s)
Ying Cheng, MD1, Tai Qin, MD2, Yolanda Chen, MA2, Gisoo Barnes, PhD3, Bryant Barnes, BS3.
1Jilin Cancer Hospital, Changchun, China, 2BeiGene, Ltd, Beijing, China, 3BeiGene, USA, San Mateo, CA, USA.
1Jilin Cancer Hospital, Changchun, China, 2BeiGene, Ltd, Beijing, China, 3BeiGene, USA, San Mateo, CA, USA.
Presentation Documents
OBJECTIVES: RATIONALE-312 (NCT04005716) demonstrated that tislelizumab plus chemotherapy (n=227) led to a significant improvement in overall survival versus placebo plus chemotherapy (n=230), as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Here, we report patient-reported outcomes (PROs) at final analysis.
METHODS: Eligible adult patients in China with previously untreated ES-SCLC were randomized 1:1 to receive 4 cycles of tislelizumab 200 mg or placebo, with etoposide plus carboplatin or cisplatin intravenously every 3 weeks, followed by tislelizumab 200 mg or placebo as maintenance. PROs assessed health-related quality of life (HRQoL) using the Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer module (QLQ-LC13). A mixed model for repeated measures (MMRM) was performed, using PRO endpoints at baseline, Cycle 4, and Cycle 6. Time to deterioration (TTD) was also examined.
RESULTS: Baseline PRO scores were similar in both arms. MMRM analyses demonstrated that patients in each arm improved on the majority of PRO endpoints, in particular global health status/QoL (GHS/QoL), coughing, chest pain, hemoptysis, and dyspnea. Patients in the tislelizumab arm showed a greater improvement in least squares (LS) mean for the QLQ-C30 GHS/QoL domain at Cycle 6 compared with those in the placebo arm (LS mean difference, 4.20, 95% confidence interval [CI]: 0.76-7.64). Only 16-26% of patients in both arms experienced a deterioration event and TTD analysis showed that tislelizumab plus chemotherapy did not increase the risk of clinically meaningful worsening of physical functioning, coughing, or chest pain.
CONCLUSIONS: PRO outcomes between the treatment arms were comparable in this population of patients with previously untreated ES-SCLC, with improvements observed in the tislelizumab arm on the key GHS/QoL domain. These results, along with previous efficacy and safety data, support tislelizumab plus chemotherapy as first-line treatment for ES-SCLC.
METHODS: Eligible adult patients in China with previously untreated ES-SCLC were randomized 1:1 to receive 4 cycles of tislelizumab 200 mg or placebo, with etoposide plus carboplatin or cisplatin intravenously every 3 weeks, followed by tislelizumab 200 mg or placebo as maintenance. PROs assessed health-related quality of life (HRQoL) using the Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer module (QLQ-LC13). A mixed model for repeated measures (MMRM) was performed, using PRO endpoints at baseline, Cycle 4, and Cycle 6. Time to deterioration (TTD) was also examined.
RESULTS: Baseline PRO scores were similar in both arms. MMRM analyses demonstrated that patients in each arm improved on the majority of PRO endpoints, in particular global health status/QoL (GHS/QoL), coughing, chest pain, hemoptysis, and dyspnea. Patients in the tislelizumab arm showed a greater improvement in least squares (LS) mean for the QLQ-C30 GHS/QoL domain at Cycle 6 compared with those in the placebo arm (LS mean difference, 4.20, 95% confidence interval [CI]: 0.76-7.64). Only 16-26% of patients in both arms experienced a deterioration event and TTD analysis showed that tislelizumab plus chemotherapy did not increase the risk of clinically meaningful worsening of physical functioning, coughing, or chest pain.
CONCLUSIONS: PRO outcomes between the treatment arms were comparable in this population of patients with previously untreated ES-SCLC, with improvements observed in the tislelizumab arm on the key GHS/QoL domain. These results, along with previous efficacy and safety data, support tislelizumab plus chemotherapy as first-line treatment for ES-SCLC.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR221
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Oncology, STA: Biologics & Biosimilars