Blank, Christian U. and Lucas, Minke W. and Scolyer, Richard A. and van de Wiel, Bart A. and Menzies, Alexander M. and Lopez-Yurda, Marta and Hoeijmakers, Lotte L. and Saw, Robyn P. M. and Lijnsvelt, Judith M. and Maher, Nigel G. and Pulleman, Saskia M. and Gonzalez, Maria and Torres Acosta, Alejandro and van Houdt, Winan J. and Lo, Serigne N. and Kuijpers, Anke M. J. and Spillane, Andrew and Klop, W. Martin C. and Pennington, Thomas E. and Zuur, Charlotte L. and Shannon, Kerwin F. and Seinstra, Beatrijs A. and Rawson, Robert V. and Haanen, John B. A. G. and Ch'ng, Sydney and Naipal, Kishan A. T. and Stretch, Jonathan and van Thienen, Johannes V. and Rtshiladze, Michael A. and Wilgenhof, Sofie and Kapoor, Rony and Meerveld-Eggink, Aafke and Grijpink-Ongering, Lindsay G. and van Akkooi, Alexander C. J. and Reijers, Irene L. M. and Gyorki, David E. and Gruenhagen, Dirk J. and Speetjens, Frank M. and Vliek, Sonja B. and Placzke, Joanna and Spain, Lavinia and Stassen, Robert C. and Amini-Adle, Mona and Lebbe, Celeste and Faries, Mark B. and Robert, Caroline and Ascierto, Paolo A. and van Rijn, Rozemarijn and van den Berkmortel, Franchette W. P. J. and Piersma, Djura and van der Westhuizen, Andre and Vreugdenhil, Gerard and Aarts, Maureen J. B. and Stevense-den Boer, Marion A. M. and Atkinson, Victoria and Khattak, Muhammad and Andrews, Miles C. and van den Eertwegh, Alfons J. M. and Boers-Sonderen, Marye J. and Hospers, Geke A. P. and Carlino, Matteo S. and de Groot, Jan-Willem B. and Kapiteijn, Ellen and Suijkerbuijk, Karijn P. M. and Rutkowski, Piotr and Sandhu, Shahneen and van der Veldt, Astrid A. M. and Long, Georgina V. (2024) Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. NEW ENGLAND JOURNAL OF MEDICINE, 391 (18). pp. 1696-1708. ISSN 0028-4793, 1533-4406
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND In phase 1-2 trials in patients with resectable, macroscopic stage III melanoma, neoadjuvant immunotherapy was more efficacious than adjuvant immunotherapy. METHODS In this phase 3 trial, we randomly assigned patients with resectable, macroscopic stage III melanoma to two cycles of neoadjuvant ipilimumab plus nivolumab followed by surgery or surgery followed by 12 cycles of adjuvant nivolumab. Only patients in the neoadjuvant group with a partial response or nonresponse received adjuvant treatment. The primary end point was event-free survival. RESULTS A total of 423 patients underwent randomization. At a median follow-up of 9.9 months, the estimated 12-month event-free survival was 83.7% (99.9% confidence interval [CI], 73.8 to 94.8) in the neoadjuvant group and 57.2% (99.9% CI, 45.1 to 72.7) in the adjuvant group. The difference in restricted mean survival time was 8.00 months (99.9% CI, 4.94 to 11.05; P<0.001; hazard ratio for progression, recurrence, or death, 0.32; 99.9% CI, 0.15 to 0.66). In the neoadjuvant group, 59.0% of patients had a major pathological response, 8.0% had a partial response, 26.4% had a nonresponse (>50% residual viable tumor), and 2.4% had progression; in 4.2%, surgery had not yet been performed or was omitted. The estimated 12-month recurrence-free survival was 95.1% in patients in the neoadjuvant group who had a major pathological response, 76.1% among those with a partial response, and 57.0% among those with a nonresponse. Adverse events of grade 3 or higher that were related to systemic treatment occurred in 29.7% of patients in the neoadjuvant group and in 14.7% in the adjuvant group. CONCLUSIONS Among patients with resectable, macroscopic stage III melanoma, neoadjuvant ipilimumab plus nivolumab followed by surgery and response-driven adjuvant therapy resulted in longer event-free survival than surgery followed by adjuvant nivolumab.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ADJUVANT NIVOLUMAB; DOUBLE-BLIND; IV MELANOMA; OPACIN-NEO; SURVIVAL; IMMUNOTHERAPY; EFFICACY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 23 Jul 2025 10:10 |
| Last Modified: | 23 Jul 2025 10:10 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65743 |
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