The use of the anti-PD-L1 monoclonal antibody durvalumab after concurrent chemoradiation in locally advanced, unresectable non-small cell lung cancer (NSCLC) patients was shown to improve progression-free survival (PFS) as reported at ESMO 2017 Annual Congress and simultaneously published in the NEJM. Furthermore, the PACIFIC investigators showed at the IASLC 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer from 15-18 October 2017, in Yokohama, Japan that quality of life (QoL) measures are maintained. The patient-reported outcomes were presented by Dr. Rina Hui of the University of Sydney and Westmead Hospital in Australia.
This study is the first randomised, global, blinded assessment of patient-reported outcomes with consolidation durvalumab treatment after chemoradiation in locally advanced NSCLC. The researchers viewed patient-reported QoL data as imperative to better informing the decision of whether or not to administer durvalumab in this patient population.
The researchers randomised 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 twelve months, while the control group was treated with placebo.
The study participants completed questionnaires at baseline and at different points throughout the study. To measure changes among the participants, the researchers analyzed variations from the baseline, time to deterioration and odds of improvement.
Compliance with completing the questionnaires was high in both durvalumab and placebo groups (>80% up to week 48). There were no differences between groups at baseline in symptoms, function or global health status/QoL. A mixed model for repeated measures analysis showed no statistically significant differences between treatment groups in adjusted mean changes from baseline (average over 12 months) in the prespecified symptoms of dyspnoea, cough, chest pain, fatigue and appetite loss, and for global health status/QoL and physical functioning.
Clinically relevant improvements from baseline were observed throughout the study in both durvalumab and placebo groups for dysphagia and alopecia. There were no differences in median time to deterioration between groups except ‘other pain’. The only difference in improvement rates between groups was for appetite loss. Other symptoms, function and health-related QoL remained stable throughout with no between-group differences in time to deterioration or improvement rates.
The authors concluded that the results of the study showed that patients treated with durvalumab did not experience worsening of symptoms, function or health-related QoL, which was similar to patients who received placebo. Clinically relevant improvement in alopecia and dysphagia with durvalumab and placebo was likely due to resolution of toxicities related to prior chemoradiation.
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of “Synergy to Conquer Lung Cancer”, the conference covered a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit wclc2017.iaslc.org