Abstract
BackgroundTreatment for stage III non‐small cell lung cancer (NSCLC) of unresectable disease mainly involves concurrent chemoradiation (CRT). Post‐CRT consolidation treatment with durvalumab is a major therapeutic advance that provides survival benefit in this group of patients. However, the performance of this treatment strategy remains to be studied in a real‐world setting.MethodsA total of 31 patients who had disease control post‐CRT were included in the durvalumab early access program (EAP) as an intent‐to‐treat cohort and retrospectively reviewed for post‐CRT progression‐free survival (PFS) and time to metastatic disease or death (TMDD). The neutrophil‐to‐lymphocyte ratio (NLR) at the initiation of durvalumab was analyzed in 29 patients.ResultsThe median time from the completion of concurrent CRT to the initiation of durvalumb was 2.8 months. The objective response was 25.8% and the 12 month PFS and TMDD‐free rate were 56.4% and 66.9%, respectively. The low NLR patients showed a significantly longer post‐CRT PFS (not reach vs. 12.0 months [95% CI: 5.5–not estimable]; P = 0.040; the hazard ratio for disease progression or death, 0.23 [95% CI: 0.05–1.00]; P = 0.048) and the 12 month post‐CRT PFS rate (82.5 vs. 42.6%). The post‐CRT TMDD (not reach vs. 12.6 months, [95% CI: 10.8–not estimable]; P = 0.010; the hazard ratio for distant metastasis or death, 0.11 [95% CI: 0.01–0.88]; P = 0.037) and 12 month post‐CRT TMDD‐free rate (90.9 vs. 57.1%) were also significantly higher in the low NLR patients.ConclusionsDurvalumab consolidation treatment in real‐world patients showed substantial efficacy and the correlation with the NLR level warrants further investigation.
Highlights
This work reported the preliminary results of the postCRT progression-free survival (PFS) and to metastatic disease or death (TMDD) with durvalumab consolidation treatment in an intent-to-treat cohort of stage III unresectable non-small cell lung cancer (NSCLC) patients who participated the durvalumab early access program (EAP) in a real-world setting
The all grade adverse events were noted in 72.4% of the on-treatment patients in which pneumonitis was found in 17.2%
As patients may experience disease progression in this window, the influence was taken into account by applying the intent-to-treat definition to the EAP cohort
Summary
Stage III NSCLC represents a heterogeneous group of disease entities that are potentially curable and are usually dealt with multimodality treatments involving radiotherapy, chemotherapy, and surgical resection.[1,2] For patients with unresectable stage III disease, definitive chemoradiation delivered either concomitantly or sequentially has long been the standard of care whereas the survival rate beyond five years remains dismal at around 15%–30%.3–5. Conclusions: Durvalumab consolidation treatment in real-world patients showed substantial efficacy and the correlation with the NLR level warrants further investigation
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