Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non–small cell lung cancer: patient-reported outcomes in the RATIONALE-315 trial

Introduction In the phase III RATIONALE-315 trial (NCT04379635), perioperative tislelizumab plus neoadjuvant chemotherapy significantly improved overall and event-free survival versus placebo plus chemotherapy in patients with resectable stage II–IIIA non–small cell lung cancer (NSCLC). Here, report prespecified patient-reported outcomes (PROs).Methods PROs were evaluated using the EORTC QLQ-C30 and QLQ-LC13 questionnaires. A mixed-effects model for repeated measures was used for PRO endpoints at neoadjuvant Cycle 3 and adjuvant Cycles 3, 5, and 7. Time to deterioration (TTD) was also analyzed.Results 453 patients were randomized to tislelizumab (n = 226) or placebo (n = 227). At adjuvant Cycles 3 and 5, chest pain was maintained with tislelizumab versus worsening with placebo (LSM difference −4.99 [95% CI: −9.06 to −0.93]; p = 0.016) and −4.15 [95% CI: −7.86 to −0.44]; p = 0.028, respectively). At adjuvant Cycle 7, greater improvement in coughing was observed in the tislelizumab arm versus placebo (−5.10 [95% CI: −9.79 to −0.40]; p = 0.034). TTD analysis showed a lower risk of chest pain with tislelizumab (HR 0.58; p = 0.004).Conclusion Perioperative tislelizumab improved coughing and chest pain compared with placebo in patients with resectable NSCLC. These data provide additional support of this regimen in this patient population.Clinical trial registration www.clinicaltrials.gov identifier is NCT04379635.