| Objective:In this study,77 patients with unresectable stage Ⅲ non-small-cell lung cancer(NSCLC)were retrospectively analyzed to compare the efficacy and safety of sequential chemoradiotherapy(SCRT)combined with sintilimab and SCRT alone in the real world.To provide reference for large-scale clinical trials and clinical practice of sintilimab in the treatment of unresectable stage Ⅲ NSCLC in the future.Methods:We included patients with unresectable,stage Ⅲ NSCLC who received sintilimab in combination with chemotherapy or chemotherapy alone for 3-6 cycles,followed by radiotherapy at the First Hospital of Jilin University from Dec 15th,2019 to Jul 15th,2022 in this study.The primary end point was the objective response rate(ORR).The secondary end points included progression-free survival(PFS);overall survival(OS);12-month and 18-month PFS rates;the duration of response(DoR);and safety.The Kaplan-Meier method was used to construct survival curves and estimate the PFS,OS,and DoR.The log-rank test was used to compare the difference in treatment.The hazard ratio(HR)and 95%confidence intervals(CIs)were calculated using stratified Cox regression model.The Clopper-Pearson method was used to estimate the 95%CI for ORR in each cohort.Differences in ORR between the two cohorts were assessed using Fisher’s exact test.R 4.2.0 software was used for statistical analyses.Results:1.A total of 77 patients were included in this retrospective study,among which 49 patients receiving sintilimab in combination with SCRT were assigned to cohort A,and 28 patients receiving SCRT alone were assigned to cohort B.All baseline characteristics were adequately balanced in the two cohorts.The demographic characteristics of patients revealed that a majority of the patients were male(81.8%)and former or current smokers(79.2%).More patients were with stage Ⅲ A(45.5%),ECOG performance status of 1(58.4%),the squamous histologic type(75.3%),a radiotherapy dose at 60-66Gy(77.9%)and induction treatment for 5-6 cycles(51.9%).2.The ORR was significantly higher in cohort A(79.6%,95%CI 65.7-89.8)than in cohort B(35.7%,95%CI 18.6-55.9)(P<0.001).Median DoR was not reached in cohort A(95%CI 20.2-NR)and was 17.8 months in cohort B(95%CI 12.1-NR).3.Median PFS was significantly longer in cohort A than in cohort B(median NR[95%CI 21.4-NR]vs 16.0 months[13.0-22.5];HR 0.375,95%CI 0·192-0.735;P=0.004).The PFS rates at 12 and 18 months were 84.8%(95%CI 75.0-95.9)and 71.3%(95%Cl 58.7-86.7)in cohort A,and 75.0%(95%CI 60.6-92.9)and 38.3%(95%CI 23.7-61.7)in cohort B,respectively.The sintilimab-combination cohort exhibited a superior PFS benefit than the SCRT-alone cohort across most prespecified subgroups.Median OS was not reached in cohort A(95%CI NR-NR)and was 24.4 months in cohort B(95%CI 22.4-NR).The OS was significantly longer in cohort A than in cohort B(HR 0.282;95%CI,0.100-0.792;P=0.01).4.AEs of any grade were reported in 45 patients(91.8%)in cohort A and 24 patients(85.7%)in cohort B.AEs of grade 3 or 4 were reported in 19 patients(38.8%)and 7 patients(25.0%)in two cohorts.Anemia was the most common AE of any grade in both the cohorts(59.2%and 53.6%,respectively).The most common AEs of grade 3 or 4 were pneumonitis or immune-mediated pneumonitis(10.2%)and decreased neutrophil count(10.2%)in cohort A,and decreased white blood cell count(10.7%).Grade 3 or 4 pneumonitis or immunemediated pneumonitis,radiation pneumonitis,and pneumonia occurred in 5(10.2%),4(8.2%),and 2(4.1%)patients in cohort A,and 0,2(7.1%),and 2(7.1%)patients in cohort B,respectively.Conclusions:1.Sintilimab in combination with SCRT resulted in a significantly better efficacy than SCRT alone in the real world.2.The sintilimab-combination regimen demonstrated tolerable toxicity and a manageable safety profile.3.Sintilimab combined with SCRT might increase the incidence of immune-mediated pneumonitis,compared to that observed with SCRT alone,but the incidence of radiation pneumonitis could be similar in the two regimen. |
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