Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study
<i>Background and Objectives:</i> The comparative efficacy and safety of nivolumab plus ipilimumab (Nivo-Ipi) combination therapy between patients with either postoperative recurrent non-small cell lung cancer (NSCLC) or inoperable stage III/IV NSCLC have yet to be conclusively determine...
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2025-05-01
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| author | Yuhei Kurata Atsuto Mouri Hisao Imai Satoshi Endo Kasumi Tsukamoto Kenji Masaki Kosuke Hashimoto Yu Miura Ayako Shiono Ou Yamaguchi Junichi Nakagawa Kyoichi Kaira Kunihiko Kobayashi Hiroshi Kagamu |
| author_facet | Yuhei Kurata Atsuto Mouri Hisao Imai Satoshi Endo Kasumi Tsukamoto Kenji Masaki Kosuke Hashimoto Yu Miura Ayako Shiono Ou Yamaguchi Junichi Nakagawa Kyoichi Kaira Kunihiko Kobayashi Hiroshi Kagamu |
| author_sort | Yuhei Kurata |
| collection | DOAJ |
| description | <i>Background and Objectives:</i> The comparative efficacy and safety of nivolumab plus ipilimumab (Nivo-Ipi) combination therapy between patients with either postoperative recurrent non-small cell lung cancer (NSCLC) or inoperable stage III/IV NSCLC have yet to be conclusively determined. <i>Materials and Methods:</i> This retrospective study reviewed the medical records of consecutive patients diagnosed with either postoperative recurrent NSCLC or inoperable stage III/IV NSCLC. Both groups, referred to as the postoperative and inoperable cohorts respectively, underwent Nivo-Ipi therapy at four Japanese medical institutions between December 2020 and November 2022. The study’s primary aim was to evaluate and compare the efficacy and safety outcomes across these two groups. <i>Results:</i> A total of 161 patients received Nivo-Ipi therapy (postoperative group, <i>n</i> = 30; inoperable group, <i>n</i> = 131). The objective response rate was comparable between the postoperative and inoperable groups (36.7% vs. 32.1%, <i>p</i> = 0.67). Median progression-free survival did not differ significantly between groups (8.9 months vs. 6.5 months, <i>p</i> = 0.14). However, median overall survival was significantly longer in the postoperative group (not reached vs. 13.0 months, <i>p</i> = 0.012). The incidence of grade ≥ 3 adverse events in the postoperative group included lung injury (13.3%), liver dysfunction (10.0%), adrenal insufficiency (6.7%), and colitis (6.7%). No significant difference was observed in the frequency of grade ≥ 3 treatment-related adverse events between the groups, and no treatment-related deaths occurred in the postoperative group. <i>Conclusions:</i> Patients with postoperative recurrent NSCLC treated with Nivo-Ipi demonstrated significantly longer overall survival compared to those with inoperable NSCLC. Given its favorable efficacy and acceptable toxicity profile, postoperative recurrent disease may warrant consideration as a stratification factor in clinical trials for advanced NSCLC. Nivo-Ipi therapy could serve as a preferred first-line treatment option for patients with postoperative recurrent NSCLC. |
| format | Article |
| id | doaj-art-453af5bab4ee459fbb2a0044c0073a79 |
| institution | Kabale University |
| issn | 1010-660X 1648-9144 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
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| series | Medicina |
| spelling | doaj-art-453af5bab4ee459fbb2a0044c0073a792025-08-20T03:27:33ZengMDPI AGMedicina1010-660X1648-91442025-05-0161699410.3390/medicina61060994Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational StudyYuhei Kurata0Atsuto Mouri1Hisao Imai2Satoshi Endo3Kasumi Tsukamoto4Kenji Masaki5Kosuke Hashimoto6Yu Miura7Ayako Shiono8Ou Yamaguchi9Junichi Nakagawa10Kyoichi Kaira11Kunihiko Kobayashi12Hiroshi Kagamu13Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota 373-8550, Gunma, JapanDivision of Respiratory Medicine, National Hospital Organization Disaster Medical Center, Tachikawa 190-0014, Tokyo, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDivision of Respiratory Medicine, National Hospital Organization Takasaki General Medical Center, Takasaki 370-0829, Gunma, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, JapanDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka 350-1298, Saitama, Japan<i>Background and Objectives:</i> The comparative efficacy and safety of nivolumab plus ipilimumab (Nivo-Ipi) combination therapy between patients with either postoperative recurrent non-small cell lung cancer (NSCLC) or inoperable stage III/IV NSCLC have yet to be conclusively determined. <i>Materials and Methods:</i> This retrospective study reviewed the medical records of consecutive patients diagnosed with either postoperative recurrent NSCLC or inoperable stage III/IV NSCLC. Both groups, referred to as the postoperative and inoperable cohorts respectively, underwent Nivo-Ipi therapy at four Japanese medical institutions between December 2020 and November 2022. The study’s primary aim was to evaluate and compare the efficacy and safety outcomes across these two groups. <i>Results:</i> A total of 161 patients received Nivo-Ipi therapy (postoperative group, <i>n</i> = 30; inoperable group, <i>n</i> = 131). The objective response rate was comparable between the postoperative and inoperable groups (36.7% vs. 32.1%, <i>p</i> = 0.67). Median progression-free survival did not differ significantly between groups (8.9 months vs. 6.5 months, <i>p</i> = 0.14). However, median overall survival was significantly longer in the postoperative group (not reached vs. 13.0 months, <i>p</i> = 0.012). The incidence of grade ≥ 3 adverse events in the postoperative group included lung injury (13.3%), liver dysfunction (10.0%), adrenal insufficiency (6.7%), and colitis (6.7%). No significant difference was observed in the frequency of grade ≥ 3 treatment-related adverse events between the groups, and no treatment-related deaths occurred in the postoperative group. <i>Conclusions:</i> Patients with postoperative recurrent NSCLC treated with Nivo-Ipi demonstrated significantly longer overall survival compared to those with inoperable NSCLC. Given its favorable efficacy and acceptable toxicity profile, postoperative recurrent disease may warrant consideration as a stratification factor in clinical trials for advanced NSCLC. Nivo-Ipi therapy could serve as a preferred first-line treatment option for patients with postoperative recurrent NSCLC.https://www.mdpi.com/1648-9144/61/6/994advanced non-small cell lung cancerimmune checkpoint inhibitoripilimumabnivolumabpostoperative recurrence |
| spellingShingle | Yuhei Kurata Atsuto Mouri Hisao Imai Satoshi Endo Kasumi Tsukamoto Kenji Masaki Kosuke Hashimoto Yu Miura Ayako Shiono Ou Yamaguchi Junichi Nakagawa Kyoichi Kaira Kunihiko Kobayashi Hiroshi Kagamu Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study Medicina advanced non-small cell lung cancer immune checkpoint inhibitor ipilimumab nivolumab postoperative recurrence |
| title | Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study |
| title_full | Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study |
| title_fullStr | Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study |
| title_full_unstemmed | Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study |
| title_short | Efficacy and Safety of First-Line Nivolumab Plus Ipilimumab in Patients with Postoperative Recurrent and Inoperable Non-Small Cell Lung Cancer: A Real-World Retrospective Observational Study |
| title_sort | efficacy and safety of first line nivolumab plus ipilimumab in patients with postoperative recurrent and inoperable non small cell lung cancer a real world retrospective observational study |
| topic | advanced non-small cell lung cancer immune checkpoint inhibitor ipilimumab nivolumab postoperative recurrence |
| url | https://www.mdpi.com/1648-9144/61/6/994 |
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