As reported in The Lancet Oncology by Hui et al, no clinically important differences in patient-reported outcomes were observed among patients receiving durvalumab vs placebo after chemoradiation for stage III unresectable non–small cell lung cancer (NSCLC) in the phase III PACIFIC trial.
The PACIFIC trial has shown significantly improved progression-free and overall survival with durvalumab vs placebo in patients with unresectable stage III NSCLC with no disease progression after at least two cycles of platinum-based chemoradiotherapy.
In the double-blind trial, 476 patients were assigned to receive durvalumab at 10 mg/kg and 237 were assigned to receive placebo every 2 weeks for up to 12 months following chemoradiotherapy. Patient-reported outcomes were assessed by the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-Lung Cancer 13 (QLQ-LC13) at randomization, at weeks 4 and 8, every 8 weeks until week 48, and then every 12 weeks until disease progression.
Higher scores on symptom scales and items represent greater symptom severity and higher scores on global health status/quality of life and functioning scales indicate better status/function. Changes from baseline to 12-month follow-up in key symptoms were analyzed using a mixed model for repeated measures (MMRM) and time-to-event analyses. Clinically relevant changes were defined as 10-point or greater changes from baseline.
Median follow-up was 25.2 months. More than 79% of patients treated with durvalumab and more than 82% of patients treated with placebo completed questionnaires up to week 48. The investigators reported:
The investigators concluded: “Our findings suggest that a clinical benefit with durvalumab can be attained without compromising patient-reported outcomes. This result is of note because the previous standard of care was observation alone, with no presumed detriment to patient-reported outcomes.”
Disclosure: The study was funded by AstraZeneca. For full disclosures of the study authors, visit thelancet.com.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.