Durvalumab NSCLC clinical benefit achieved without negative impact on PROs
medwireNews: Analysis of data from the PACIFIC trial shows that levels of key patient-reported outcomes (PROs) such as cough, fatigue, and quality of life, do not differ significantly between patients with advanced non-small-cell lung cancer (NSCLC) treated with durvalumab after chemoradiotherapy and those who received placebo.
Rina Hui (Westmead Hospital, Sydney, New South Wales, Australia) and colleagues explain that the ongoing PACIFIC trial has already found that “durvalumab (an anti-PD-L1 antibody) increased progression-free survival and overall survival (the primary endpoints) compared with placebo in patients with stage III, locally advanced, unresectable non-small-cell lung cancer who had not progressed after two or more cycles of platinum-based concurrent chemoradiotherapy.”
The current preplanned secondary analysis suggests that “a clinical benefit with durvalumab can be attained without compromising PROs,” the authors write in The Lancet Oncology.
They add: “This result is of note because the previous standard of care was observation alone, with no presumed detriment to PROs.”
During the trial, PROs were assessed regularly using the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, QLQ-LC13. At week 48, approximately 79% of the 476 patients given durvalumab and more than 82% of the 237 given placebo had completed the questionnaires at the protocol-specified times.
Hui and team report that at baseline symptom scores were low overall and remained stable throughout the study in both groups.
Furthermore, between baseline and 12 months there were no clinically relevant differences between patients in the durvalumab and placebo groups in levels of cough (mixed model for repeated measures-adjusted mean change of 1.8 vs 0.7), dyspnea (3.1 vs 1.4), chest pain (−3.1 vs −3.5), fatigue (−3.0 vs −5.2), appetite loss (−5.8 vs −7.0), physical functioning (0.1 vs 2.0), and global health status or quality of life (2.6 vs 1.8).
The changes from baseline within either group for each outcome were also not considered clinically relevant as they all fell below the 10-point threshold for deterioration or improvement.
Hui et al conclude: “We found that up to 12 months of durvalumab treatment had no clinically important detrimental effect on symptoms, functioning, or global health status or quality of life, which was comparable to placebo, further supporting its benefit after concurrent chemoradiotherapy in patients with stage III, unresectable non- small-cell lung cancer.”
In an accompanying comment, Amélie Anota and Virginie Westeel, both from University Hospital of Besançon in France, said: “With an adequate method of PRO analysis that was based on current standards, the PRO results of the PACIFIC study confirm that adjuvant durvalumab is a drug of interest after chemoradiotherapy for stage III non-small-cell lung cancer.”
However, they also point out that the EORTC questionnaires used in the current trial are not specific to immunotherapy. They say: “[T]he toxicity profile of immunotherapy is different to that of non- immunotherapy interventions, and new approaches might be necessary to capture specific immunotherapy-related changes in [health-related quality of life].”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group