Doi H, Matsuo Y, Kishi N, Ogura M, Mitsuyoshi T, Ueki N, Ueki K, Fujii K, Sakamoto M, Atsuta T, Katagiri T, Sakamoto T, Narabayashi M, Ohtsu S, Fujishiro S, Kishi T, and Mizowaki T
Background: Although durvalumab has shown promise in improving survival rates in patients with locally advanced non-small cell lung cancer (NSCLC), the ideal duration of treatment has yet to be established., Objective: The primary objective of this study was to determine the optimal number of durvalumab cycles following definitive chemoradiotherapy for locally advanced NSCLC., Patients and Methods: A total of 178 patients who received chemoradiotherapy for stage III NSCLC at 15 institutions were retrospectively analyzed. Progression-free survival (PFS) and overall survival (OS) were assessed according to the number of consolidation durvalumab cycles by landmark analysis. Landmark analyses were performed at 3-month intervals from the start of durvalumab treatment to 9 months., Results: The median number of durvalumab cycles was 16 (range 1-27). PFS and OS were significantly better in patients who received ≥20 cycles of durvalumab than in those who did not (p < 0.001 and p < 0.001, respectively). In landmark analysis, significant differences were observed in PFS from 0 to 6 months and OS from 3 to 6 months between patients who continued durvalumab after the time point and those who did not. However, there were no significant differences in PFS or OS between patients who received 13-19 or ≥20 cycles of durvalumab at 9 months., Conclusions: Durvalumab should be administered for more than 6 months to contribute to the main benefits of consolidation therapy following chemoradiotherapy., Competing Interests: Declarations. Funding: This work was supported by JSPS KAKENHI, Grant Numbers JP22K07733 and JP24K10796. Conflicts of Interest: HD received speaker fees from AstraZeneca, Eisai, Varian Medical Systems, and Accuray. YM received speaker fees from AstraZeneca and Varian Medical Systems and has been a member of the guideline committee of the Japan Lung Cancer Society. NK received speaker fees from AstraZeneca and payments for educational events from MSD. TS received speaker fees from AstraZeneca. TM received speaker fees from Varian Medical Systems, Hitachi Ltd., Brainlab AG, Elekta KK, AstraZeneca, and Jannsen; consulting fees from Varian Medical Systems, advisory board of Novartis, grants from Varian Medical Systems, Hitachi Ltd., and Brainlab AG; and has been a member of the Board of Directors of the Japanese Society for Radiation Oncology, Japan Society of Clinical Oncology, Japan Society of Urologic Oncology, and the Board of Specially Assigned Directors. Masakazu Ogura, Takamasa Mitsuyoshi, Nami Ueki, Kazuhito Ueki, Kota Fujii, Masato Sakamoto, Tomoko Atsuta, Tomohiro Katagiri, Masaru Narabayashi, Shuji Ohtsu, Satsuki Fujishiro, and Takahiro Kishi declare that they have no conflicts of interest that might be relevant to the contents of this manuscript. Ethics Approval, Consent to Participate: The study was conducted in accordance with the principles of the Declaration of Helsinki and approved by the Institutional Review Board (IRB) of Kindai University (approval no. R06-010). Fifteen Japanese institutions of the Kyoto Radiation Oncology Study Group (KROSG) participated in this study after obtaining approval from their respective IRBs. Because of the retrospective design of the study, the requirement for written informed consent was waived. Consent for Publication: Not applicable. Availability of Data and Material: The datasets generated and analyzed in the present study are available from the corresponding author upon reasonable request. Code Availability: Not applicable. Authors' Contributions: HD: conceptualization, data curation, formal analysis, investigation, software, visualization, funding acquisition, and writing (original draft); YM: supervision, project administration, methodology, validation and writing (review and editing); NK: resources, data curation, investigation and writing (review and editing); MO: resources and writing (review and editing); TM: resources and writing (review and editing); NU: resources and writing (review and editing); KU: resources and writing (review and editing); KF: resources and writing (review and editing); MS: resources and writing (review and editing); TA: resources and writing (review and editing); TK: resources and writing (review and editing); TS: resources and writing (review and editing); MN: resources and writing (review and editing); SO: resources and writing (review and editing); SF: resources and writing (review and editing); TK: resources and writing (review and editing); TM: supervision and writing (review and editing)., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)