Introduction: In this observational, retrospective, multicenter study, we aimed to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy (IT) in a cohort of advanced non–small-cell lung cancer (aNSCLC) patients. Material and Methods: We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD-1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first or last administration of immunotherapy, or within two consecutive cycles of ICI. All adverse events apparently related to RT and/or IT were graded according to the Common Terminology Criteria for Adverse Events, version 4.0, and reported in terms of incidence and severity as immune related or RT related, or combined. Results: We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median overall survival was 16.5 months (range, 3-162). Thirteen patients developed pure RT-related side effects, and 43 patients (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect. Conclusion: This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent. This study aimed to evaluate the tolerability of the combination of radiotherapy and immunotherapy for patients with advanced lung cancer. We retrospectively analyzed data for 187 patients who received the combined treatment in seven Italian centers from September 2015 to June 2019. After a median follow-up of 23 months, the majority of patients recovered from the adverse events; one patient experienced grade 5 lung toxicity. Our analysis indicates that the combination of immunotherapy and radiotherapy.
The NIPRO Study: An Observational, Retrospective, Multicenter Study on the Safety of the Radiotherapy and Immunotherapy Combination for Advanced-Stage NSCLC / Perna, M.; Scotti, V.; Ciammella, P.; Borghetti, P.; D'Angelo, E.; Levra, N. G.; Fozza, A.; Mariotti, M.; Salvestrini, V.; Bertolini, F.; Vagge, S.; Taraborrelli, M.; Falcinelli, L.; Taddeo, A.; Rossi, R.; Costantino, G.; Frassinelli, L.; Filippi, A. R.; Greco, C.; Franceschini, D.; Genovesi, D.; Lohr, F.; Magrini, S. M.; Alongi, F.; Livi, L.; Bruni, A.. - In: CLINICAL LUNG CANCER. - ISSN 1525-7304. - 22:5(2021), pp. E767-E773. [10.1016/j.cllc.2021.02.005]
The NIPRO Study: An Observational, Retrospective, Multicenter Study on the Safety of the Radiotherapy and Immunotherapy Combination for Advanced-Stage NSCLC
Bertolini F.;Frassinelli L.;Lohr F.;
2021
Abstract
Introduction: In this observational, retrospective, multicenter study, we aimed to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy (IT) in a cohort of advanced non–small-cell lung cancer (aNSCLC) patients. Material and Methods: We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD-1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first or last administration of immunotherapy, or within two consecutive cycles of ICI. All adverse events apparently related to RT and/or IT were graded according to the Common Terminology Criteria for Adverse Events, version 4.0, and reported in terms of incidence and severity as immune related or RT related, or combined. Results: We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median overall survival was 16.5 months (range, 3-162). Thirteen patients developed pure RT-related side effects, and 43 patients (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect. Conclusion: This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent. This study aimed to evaluate the tolerability of the combination of radiotherapy and immunotherapy for patients with advanced lung cancer. We retrospectively analyzed data for 187 patients who received the combined treatment in seven Italian centers from September 2015 to June 2019. After a median follow-up of 23 months, the majority of patients recovered from the adverse events; one patient experienced grade 5 lung toxicity. Our analysis indicates that the combination of immunotherapy and radiotherapy.
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