Patient-reported outcomes from a phase 2 PLATINUM trial of nivolumab combination therapy sparing concurrent cisplatin in nasopharyngeal carcinoma.

BACKGROUND In the PLATINUM (ClinicalTrials.gov: NCT03984357) trial, nivolumab plus chemoradiotherapy sparing concurrent cisplatin demonstrated efficacy and safety in nasopharyngeal carcinoma (NPC). Herein, patient-reported outcomes (PROs) on quality of life (QoL), tolerability, and social reintegration are reported.

METHODS Patients with T4N1M0/T1-4N2-3M0 NPC were assessed for general and head-and-neck-specific QoL (using the European Organization for Research and Treatment of Cancer and the Functional Assessment of Cancer Therapy) and tolerability (using the PRO-specific Common Terminology Criteria for Adverse Events). Analyses included change over time, effect of the treatment phase on QoL, time-to-event analysis, and a comparison of PROs and clinician-reported outcomes (CROs) in toxicity.

FINDINGS Among 152 patients, 44.1% achieved social reintegration, and 51.3% were satisfied with their current life. Radiotherapy dominated QoL deterioration rather than induction chemotherapy (pooled mean difference, -18.51; 95% confidence interval [CI], -29.50 to -7.52; p = 0.001), and its removal dominated QoL improvement rather than that of nivolumab (pooled mean difference, -7.62; 95% CI, -10.05 to -5.19; p < 0.001). Patients without social reintegration had greater deterioration in speech (hazard ratio [HR], 0.60; 95% CI, 0.38 to 0.94; p = 0.027) and swallowing functions (HR, 0.59; 95% CI, 0.39 to 0.89; p = 0.011). Under-reporting of decreased appetite severity by CROs vs. by PROs in all three treatment phases was associated with poorer social reintegration (p = 0.002) and reduced failure-free survival (3 years, 86.1% vs. 95.0%; p = 0.021).

CONCLUSIONS Social reintegration is a practical composite indicator of favorable PROs in NPC. Interventions targeting speech, swallowing, and decreased appetite might promote better recovery.

FUNDING This study was funded by the Academician Workstation of Jun Ma (YSGZZ2024001), the Specific Research Fund of the Innovation Platform for Academicians of Hainan Province (YSPTZX202501), the National Natural Science Foundation of China (82573549, 82172870), the Guangdong Special Support Program for Young Top Talents (TZ09B0046), and the Guangzhou Science and Technology Program (2023A04J1786).