Adding durvalumab to neoadjuvant chemotherapy maintains quality of life in resectable NSCLC

Dr Giulia Pasello - University of Padova, Padua, Italy

Today I am here to report the patient-reported outcomes from the AEGEAN study that I recently presented at the European Lung Cancer Conference in Paris. AEGEAN is a global phase III randomised placebo-controlled study in patients with resectable stage 2a-3b non-oncogene-addicted non-small cell lung cancer patients which previously showed that perioperative durvalumab combined with neoadjuvant chemotherapy significantly improved the pathological complete response and event free survival compared to neoadjuvant chemotherapy alone.

What was the study design?

This was a global placebo-controlled phase III randomised clinical trial. 802 patients were randomised 1:1 to an experimental arm of perioperative durvalumab combined with neoadjuvant chemotherapy or to standard of care, which was platinum-based chemotherapy plus placebo before surgery and placebo after surgery. Among the secondary endpoints of the study patients in both arms completed also the EORTC QLQ-C30 and the EORTC QLQ-C13 questionnaires to assess changes from baseline in scores for key prespecified symptoms of interest, physical [??] functioning, global health status, quality of life at five timepoints up to week 12 during the neoadjuvant period and up to twelve timepoints up to week 44 during the adjuvant period. Moreover, time to deterioration of these outcomes was assessed during the adjuvant period only. Finally, as an exploratory endpoint patients completed the PRO-CTCAE questionnaire to report different levels of burden from specific treatment -related symptoms during both treatment periods.

What were the results of this study?

In AEGEAN adding perioperative durvalumab to neoadjuvant chemotherapy  did not adversely impact the patient-reported health-related quality of life, functioning or symptoms compared with the neoadjuvant chemotherapy alone. No clinically meaningful changes from baseline in patient-reported outcome scores were observed in either arm during the neoadjuvant or adjuvant treatment periods and during the adjuvant period time to deterioration of core functioning skills, global health status, quality of life and key symptoms were similar between treatment arms.

Finally, there were no apparent between-arm differences in the proportion of patients reporting treatment-related symptoms, except patients reporting rash which was more prevalent in the durvalumab versus placebo arm.

What do you think is the clinical significance of these results?

Together with the significant efficacy improvements and the well-tolerated safety profile of this regimen in the perioperative setting, patient-reported outcomes further support perioperative durvalumab as a new treatment option for patients with non-oncogene-addicted resectable non-small cell lung cancer patients.

Is there anything else you would like to add?

I think the evaluation of patient-reported outcomes, and particularly the addition of the PRO-CTCAE questionnaire, adds some value to this study because we evaluated not only the impact of the cancer disease on quality of life of the patients but also directly their perception of adverse events strictly related to the treatment.