The first patient-reported outcomes study on durvalumab treatment after chemoradiation in locally advanced non-small cell lung cancer (NSCLC) shows patients’ quality of life is similar to that of the patients who received placebo.

The randomized, global, blinded assessment was conducted on the immunotherapy drug durvalumab – an anti-programmed death ligand 1(anti-PD-L1) new checkpoint inhibitor, which stimulates patients’ own immune system to fight against cancer. Dr Rina Hui, of the University of Sydney and Westmead Hospital in Australia, presented the findings at the International Association for the Study of Lung Cancer (IASLC) 18^th World Conference on Lung Cancer (WCLC) in Yokohama, Japan.

Previously, the PACIFIC study showed that durvalumab was superior compared to placebo with significant median progression-free survival (PFS) of over 11 months – median PFS for durvalumab and placebo was 16.8 months (13.0–18.1) and 5.6 months (4.6–7.8), respectively [Stratified hazard ratio, 0.52 (95% CI, 0.42–0.65), p<0.001]. [N Engl J Med 2017 Sep 8. Doi: 10.1056/NEJMoa1709937]

PACIFIC is the first study to bring this class of immunotherapy to earlier stage NSCLC, adding durvalumab for 12 months after the standard concurrent chemoradiation for this earlier stage patients. So, patients receiving durvalumab also had a lower incidence of new lesions including new brain metastases compared with patients receiving placebo.

“Although we found that durvalumab was well-tolerated with a manageable and tolerated safety profile, we believe it’s important to hear from the patients,” said Hui.

Therefore, Hui and fellow researchers randomized NSCLC patients who had received standard concurrent chemoradiation, but had not experienced disease progression, into two groups. The intervention group was treated with durvalumab for up to 12 months, while the control group was given placebo. They looked at patients’ reported outcomes where patients completed questionnaires at baseline and at different time points throughout the study and on 30 days after discontinuation of the study drug. To measure changes among the participants, the researchers analyzed variations from the baseline, time to deterioration and odds of improvement.

The findings showed that the scores for physical functioning and global health status/ quality of life was maintained and stable throughout the study over different time points. There was no difference between the durvalumab and placebo arms in most symptoms, said Hui.

The take home messages from the study include:
-changes from baseline for key symptoms was minimal with durvalumab and placebo.
-clinical improvements in alopecia and dysphagia were likely due to resolution of toxicities related to prior chemoradiation, which all patients received before they joined the study.
-chances of improvement for ‘appetite loss’ and time to deterioration for ‘other pain’ both favoured durvalumab vs placebo.

“So, we conclude that adding durvalumab for 12 months after chemoradiation did not compromise quality of life,” said Hui.

Alongside with the positive efficacy and safety data from PACIFIC, these patient-reported outcomes further support the clinical value of durvalumab in the early stage NSCLC, said Hui.