Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial
| العنوان: | Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial |
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| المؤلفون: | Rutger H. T. Koornstra, Sandrine Marreaud, Victoria Atkinson, Andrey Meshcheryakov, Christian U. Blank, Piotr Rutkowski, Jean-Jacques Grob, Leonel Hernandez-Aya, Clemens Krepler, Michal Kicinski, Dirk Schadendorf, Paolo A. Ascierto, Caroline Robert, Mario Mandalà, Susana Puig, Nageatte Ibrahim, Alexander C.J. van Akkooi, Adnan Khattak, Stéphane Dalle, Georgina V. Long, James Larkin, Shahneen Sandhu, Rahima Jamal, Matteo S. Carlino, Alfonsus J M van den Eertwegh, Ralf Gutzmer, Anna Maria Di Giacomo, Andrew Haydon, Alexander M.M. Eggermont, Stefan Suciu, Paul Lorigan |
| المساهمون: | CCA - Cancer Treatment and quality of life, Medical oncology |
| المصدر: | Journal of Clinical Oncology, 38, 3925-3936 Eggermont, A M M, Blank, C U, Mandala, M, Long, G V, Atkinson, V G, Dalle, S, Haydon, A M, Meshcheryakov, A, Khattak, A, Carlino, M S, Sandhu, S, Larkin, J, Puig, S, Ascierto, P A, Rutkowski, P, Schadendorf, D, Koornstra, R, Hernandez-Aya, L, di Giacomo, A M, van den Eertwegh, A J M, Grob, J-J, Gutzmer, R, Jamal, R, Lorigan, P C, van Akkooi, A C J, Krepler, C, Ibrahim, N, Marreaud, S, Kicinski, M, Suciu, S & Robert, C 2020, ' Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial ', Journal of Clinical Oncology, vol. 38, no. 33, pp. 3925-3936 . https://doi.org/10.1200/JCO.20.02110Test Journal of Clinical Oncology, 38(33), 3925-3936. American Society of Clinical Oncology Journal of Clinical Oncology Eggermont, A M M, Blank, C U, Mandala, M, Long, G V, Atkinson, V G, Dalle, S, Haydon, A M, Meshcheryakov, A, Khattak, A, Carlino, M S, Sandhu, S, Larkin, J, Puig, S, Ascierto, P A, Rutkowski, P, Schadendorf, D, Koornstra, R, Hernandez-Aya, L, Di Giacomo, A M, van den Eertwegh, A J M, Grob, J J, Gutzmer, R, Jamal, R, Lorigan, P C, van Akkooi, A C J, Krepler, C, Ibrahim, N, Marreaud, S, Kicinski, M, Suciu, S & Robert, C 2020, ' Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma : Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 38, no. 33, pp. 3925-3936 . https://doi.org/10.1200/JCO.20.02110Test Journal of Clinical Oncology, 38, 33, pp. 3925-3936 |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Medizin, Pembrolizumab, Placebo, law.invention, Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Original Reports, medicine, Stage III melanoma, Melanoma, Chemotherapy, Manchester Cancer Research Centre, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, Cancer, medicine.disease, Clinical trial, 030104 developmental biology, 030220 oncology & carcinogenesis, business, Adjuvant |
| الوصف: | PURPOSE We conducted the phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. On the basis of 351 recurrence-free survival (RFS) events at a 1.25-year median follow-up, pembrolizumab prolonged RFS (hazard ratio [HR], 0.57; P < .0001) compared with placebo. This led to the approval of pembrolizumab adjuvant treatment by the European Medicines Agency and US Food and Drug Administration. Here, we report an updated RFS analysis at the 3.05-year median follow-up. PATIENTS AND METHODS A total of 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were randomly assigned to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity. The two coprimary end points were RFS in the overall population and in those with programmed death-ligand 1 (PD-L1)–positive tumors. RESULTS Pembrolizumab (190 RFS events) compared with placebo (283 RFS events) resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7% v 44.1% for pembrolizumab v placebo, respectively; HR, 0.56; 95% CI, 0.47 to 0.68) and in the PD-L1–positive tumor subgroup (HR, 0.57; 99% CI, 0.43 to 0.74). The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and BRAF mutation status (HR, 0.51 [99% CI, 0.36 to 0.73] v 0.66 [99% CI, 0.46 to 0.95] for V600E/K v wild type). CONCLUSION In resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups. |
| وصف الملف: | application/pdf |
| تدمد: | 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::19c8d8800862ec580f808001677c9a85Test https://hdl.handle.net/2066/228545Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....19c8d8800862ec580f808001677c9a85 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 0732183X |
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