A comparison of the patient-reported outcomes (PROs) of the 2 study arms from the PACIFIC trial, a phase 3 study of patients with stage III unresectable non-small cell lung cancer (NSCLC) previously treated with chemoradiation therapy, showed no significant differences for those randomly assigned to received subsequent treatment with durvalumab, a programmed cell death-ligand 1 (PD-L1) inhibitor, or placebo. These study results were published in Lancet Oncology.1
In the PACIFIC trial (ClinicalTrials.gov Identifier: NCT02125461), 713 patients with unresectable NSCLC without disease progression after 2 or more cycles of platinum-based chemoradiation therapy were randomized in a 2:1 ratio to receive either durvalumab or matching placebo every 2 weeks for up to 12 months. Previous reports showed both progression-free survival and overall survival, the 2 primary study end points, were significantly longer for those patients receiving durvalumab. Furthermore, the safety profiles of the 2 interventions were similar. 2,3
Evaluations of patient-reported symptoms, functioning, and global health status/quality of life (QOL) were prespecified secondary study end points of the PACIFIC trial, and were assessed using validated measures at baseline, weeks 4 and 8, every 8 weeks until week 48, and then every 12 weeks until disease progression.
At a median follow-up of 25.2 months, approximately 80% of patients in both study arms completed paper-based PRO questionnaires through week 48.
Notably, baseline symptom scores were low for patients in both study arms. Furthermore, no clinically important differences for time to deterioration or time to improvement between the 2 study arms were found with respect to most symptoms, functioning, or global health status/QOL. One exception was a significantly longer time to deterioration of the symptom of “other pain,” defined as pain other than shoulder, chest, or arm pain, in those receiving durvalumab compared with placebo.
In their concluding remarks, the study authors commented that their findings “suggest that a clinical benefit with durvalumab can be attained without compromising PROs. This result is of note because the previous standard of care was observation alone, with no presumed detriment to PROs.”
1. Hui R, Özgüroğlu M, Villegas A, et al. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study [published online October 7, 2019]. Lancet Oncol. doi: 10.1016/S1470-2045(19)30519-4
2. Antonia SJ, Villegas A, Daniel D, et al; PACIFIC Investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350.
3. Antonia SJ, Villegas A, Daniel D, et al; PACIFIC Investigators. Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929.