The effects of tislelizumab plus chemotherapy as first-line treatment on health-related quality of life of patients with advanced squamous non-small cell lung cancer: Results from a phase 3 randomized clinical trial.

ABSTRACT

BACKGROUND: This study assessed the effects of adding tislelizumab to first-line standard-of- care chemotherapy on the health-related quality of life (HRQoL) of patients with advanced squamous non-small cell lung cancer (sq-NSCLC). PATIENTS AND METHODS: Patients in this open-label, multicenter, phase 3 RATIONALE 307 trial were randomized to one of the three arms tislelizumab plus carboplatin and paclitaxel (Arm A), tislelizumab plus carboplatin and nab-paclitaxel (Arm B), or paclitaxel plus carboplatin (Arm C). HRQoL was measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the EORTC Quality of Life Questionnaire Lung Cancer 13-item module (QLQ-LC13). Mean score change from baseline at Weeks 6 and 12 in the QLQ-C30's global health status/quality of life (GHS/QoL), fatigue, and physical functioning scores and QLQ-LC13 lung cancer specific subscales were examined. Time to deterioration was estimated for the GHS/QoL score. RESULTS: A total of 355 sq-NSCLC patients received at least one dose of study drug and completed at least one HRQoL assessment. The GHS/QoL scores improved in Arms A and B relative to Arm C at Weeks 6 and 12. Arms A and B also experienced a reduction in most lung cancer-specific symptoms relative to Arm C. Time to deterioration of GHS/QoL was not reached by any of the three arms. CONCLUSIONS: The addition of tislelizumab to platinum-based chemotherapy is associated with improvements in sq-NSCLC patients' HRQoL, especially in GHS/QoL and most importantly in lung cancer-specific symptoms including coughing, dyspnea, and hemoptysis.