Challenges of Recruitment for Immunoconsolidation Therapy After Adaptive Chemoradiotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer
[Objective]To analyze the challenges of enrollment for immunoconsolidation therapy after adaptive chemoradiotherapy in patients with locally advanced non-small-cell lung cancer(NSCLC).[Methods]A total of 107 patients with unresectable stage Ⅲ NSCLC were treated with standard platinum-based concurrent chemoradiotherapy from November 2018 to December 2019.The prescription dose of radiotherapy was 64～66 Gy for gross tumor volume and 54 Gy for planning target volume with 30 fractions of radiation.After 20 fractions of radiotherapy,off-line adaptive re-simulated CT and replanning were performed.Before radiotherapy patients were initially asked for consensus to receive consolidation im-munotherapy after chemoradiotherapy.After radiotherapy,patients who agreed to immunoconsolidation therapy and met the enrollment criteria received sintilimab,200 mg q3w,within 45 d of completion of ra-diotherapy and maintained for one year.The primary end point was grade 2 toxicity.[Results]In 107 potentially eligible patients received off-line adaptive concurrent chemoradiotherapy,88 declined enroll-ment before chemoradiotherapy,19 agreed to receive consolidation sintilimab.Among the patients who did not agree to be enrolled,16(18.2％)patients did not meet the inclusion criteria,including 7 cases with unresolved grade 2 or higher radiation pneumonitis,5 cases with unresolved grade 2 or higher esophagitis,2 cases with both of above conditions,and 2 cases with unresolved grade 3 leukopenia.Among the pa-tients who agreed to be enrolled,4(21.1％)were ineligible,including 2 cases with unresolved grade 2 ra-diation pneumonitis,1 case with unresolved grade 3 esophagitis,and 1 case with unresolved grade 3 leukopenia.[Conclusion]The study shows that about 20％patients who agreed or refused for consolidation immunotherapy after adaptive chemoradiotherapy did not meet the inclusion criteria,the main reasons of which are acute chemoradiotherapy toxicities,especially radiation pneumonia and radiation esophagitis.
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