دورية أكاديمية
Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma.
| العنوان: | Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. |
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| المؤلفون: | Hamid, Omid, Robert, Caroline, Daud, Adil, Hodi, F Stephen, Hwu, Wen-Jen, Kefford, Richard, Wolchok, Jedd D, Hersey, Peter, Joseph, Richard W, Weber, Jeffrey S, Dronca, Roxana, Gangadhar, Tara C, Patnaik, Amita, Zarour, Hassane, Joshua, Anthony M, Gergich, Kevin, Elassaiss-Schaap, Jeroen, Algazi, Alain, Mateus, Christine, Boasberg, Peter, Tumeh, Paul C, Chmielowski, Bartosz, Ebbinghaus, Scot W, Li, Xiaoyun Nicole, Kang, S Peter, Ribas, Antoni |
| المصدر: | The New England journal of medicine, vol 369, iss 2 |
| بيانات النشر: | eScholarship, University of California |
| سنة النشر: | 2013 |
| المجموعة: | University of California: eScholarship |
| مصطلحات موضوعية: | Humans, Melanoma, Brain Neoplasms, Skin Neoplasms, Antineoplastic Agents, Antibodies, Monoclonal, Drug Administration Schedule, Dose-Response Relationship, Drug, Adult, Aged, 80 and over, Middle Aged, Female, Male, Humanized, Programmed Cell Death 1 Receptor, Human Genome, Genetics, Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Cancer, Medical and Health Sciences, General & Internal Medicine |
| جغرافية الموضوع: | 134 - 144 |
| الوصف: | BackgroundThe programmed death 1 (PD-1) receptor is a negative regulator of T-cell effector mechanisms that limits immune responses against cancer. We tested the anti-PD-1 antibody lambrolizumab (previously known as MK-3475) in patients with advanced melanoma.MethodsWe administered lambrolizumab intravenously at a dose of 10 mg per kilogram of body weight every 2 or 3 weeks or 2 mg per kilogram every 3 weeks in patients with advanced melanoma, both those who had received prior treatment with the immune checkpoint inhibitor ipilimumab and those who had not. Tumor responses were assessed every 12 weeks.ResultsA total of 135 patients with advanced melanoma were treated. Common adverse events attributed to treatment were fatigue, rash, pruritus, and diarrhea; most of the adverse events were low grade. The confirmed response rate across all dose cohorts, evaluated by central radiologic review according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was 38% (95% confidence interval [CI], 25 to 44), with the highest confirmed response rate observed in the cohort that received 10 mg per kilogram every 2 weeks (52%; 95% CI, 38 to 66). The response rate did not differ significantly between patients who had received prior ipilimumab treatment and those who had not (confirmed response rate, 38% [95% CI, 23 to 55] and 37% [95% CI, 26 to 49], respectively). Responses were durable in the majority of patients (median follow-up, 11 months among patients who had a response); 81% of the patients who had a response (42 of 52) were still receiving treatment at the time of analysis in March 2013. The overall median progression-free survival among the 135 patients was longer than 7 months.ConclusionsIn patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects. (Funded by Merck Sharp and Dohme; ClinicalTrials.gov number, ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | unknown |
| العلاقة: | qt3bc5s56x; https://escholarship.org/uc/item/3bc5s56xTest; https://escholarship.org/content/qt3bc5s56x/qt3bc5s56x.pdfTest |
| DOI: | 10.1056/nejmoa1305133 |
| الإتاحة: | https://doi.org/10.1056/nejmoa1305133Test https://escholarship.org/uc/item/3bc5s56xTest https://escholarship.org/content/qt3bc5s56x/qt3bc5s56x.pdfTest |
| حقوق: | public |
| رقم الانضمام: | edsbas.5ED465C1 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/nejmoa1305133 |
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