Effects of tislelizumab on health‐related quality of life in patients with recurrent or metastatic nasopharyngeal cancer

Background This study evaluated health‐related quality of life (HRQoL) in the RATIONALE‐309 (NCT03924986) intent‐to‐treat (ITT) population and in a subgroup of patients with liver metastases. Methods Patients were randomized 1:1 to tislelizumab + chemotherapy or placebo + chemotherapy. As the secondary endpoint, HRQoL was evaluated using seven selected scores from the EORTC QLQ‐C30 and QLQ Head and Neck Cancer module (QLQ‐H&N35). Results Of 263 randomized patients in the ITT population (tislelizumab + chemotherapy n = 131, placebo + chemotherapy n = 132), 43% had liver metastases (tislelizumab + chemotherapy n = 56; placebo + chemotherapy n = 57). No differences in change in selected scores on the QLQ‐C30 from baseline to cycle 4 or cycle 8 were observed for the ITT or liver metastases subgroup. No differences in selected QLQ‐H&N35 scores were observed between the arms from baseline to cycle 4. In the ITT population and the liver metastases subgroup, a greater reduction from baseline to cycle 8 was observed in the tislelizumab + chemotherapy arm than the placebo + chemotherapy arm in QLQ‐H&N35 pain score. At cycle 8 in the liver metastases subgroup, the tislelizumab + chemotherapy arm experienced greater improvement in the QLQ‐H&N35 senses problems score than the placebo + chemotherapy arm. Differences in time to deterioration between arms were not observed. Conclusions The current findings, along with improved survival and favorable safety, suggests that tislelizumab + chemotherapy represents a potential first‐line treatment for recurrent or metastatic nasopharyngeal cancer.