PD-1 Inhibitor with or without Stereotactic Ablative Radiothera-py for Early-Stage Non-Small Cell Lung Cancer:Interpretation of an Open-Label,Randomized Controlled Phase 2 Trial
Stereotactic ablative radiotherapy(SABR)is the standard treatment for medically inopera-ble early-stage non-small-cell lung cancer(NSCLC),but regional or distant relapses,or both,are common.The study compared the efficacy and safety of SABR alone versus Ⅰ-SABR for early-stage or isolated parenchymal recurrent node-negative NSCLC.From June 2017 to March 2022,156 partici-pants were enrolled,and 141 participants received treatment as per the protocol and were treated at three different hospitals in TX,USA.Participants randomly assigned to one of two groups(ITT popu-lation:n=78 in each group).People aged 18 years or older with histologically proven treatment-naive stage Ⅰ A～Ⅰ B(tumor size ≤4 cm,N0M0),stage Ⅱ A(tumour size ≤5 cm,N0M0),or stage Ⅱ B(tumor size＞5 cm and ≤7 cm,N0M0)or isolated parenchymal recurrences(tumor size ≤ 7 cm)NSCLC were included in this trial.The primary endpoint was 4-year event-free survival(local,re-gional,or distant recurrence;second primary lung cancer;or death).Secondary endpoints included overall survival and treatment-related toxicity.The median follow-up time was 33 months(95％CI:28.7～38.1).Ⅰ-SABR significantly improved 4-year event-free survival[77％(66％～91％)vs 53％(95％CI:42％～67％);per-protocol population,HR=0.38,95％ CI:0.19～0.75,P=0.005 6;ITT popula-tion,HR=0.42;95％ CI:0.22～0.80,P=0.008 0)].There was no grade 3 or higher adverse events associated with SABR.In the Ⅰ-SABR group,ten participants(15％)had grade 3 immunologial ad-verse events related to nivolumab;none had grade 3 pneumonitis or grade 4 or higher toxicity.Com-pared with SABR alone,Ⅰ-SABR significantly improved event-free survival at 4 years in people with early-stage treatment-naive or lung parenchymal recurrent node-negative NSCLC,with tolerable toxicitv.
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