학술논문
Real-world outcomes with ipilimumab and nivolumab in advanced melanoma: a multicentre retrospective study.
Document Type
Academic Journal
Author
Serra-Bellver P; Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, United Kingdom. Electronic address: p.serra@nhs.net.; Versluis JM; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Oberoi HK; Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, United Kingdom; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.; Zhou C; Cancer Research UK Manchester Institute Cancer Biomarker Centre, University of Manchester, United Kingdom.; Slattery TD; Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, United Kingdom.; Khan Y; Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, United Kingdom.; Patrinely JR; Department of Medical Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.; Pires da Silva I; Melanoma Institute Australia, The University of Sydney and the Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Department of Medical Oncology, Westmead and Blacktown Hospital, Sydney, Australia.; Martínez-Vila C; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.; Cook N; Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, United Kingdom; Division of Cancer Sciences, University of Manchester, United Kingdom.; Graham DM; Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, United Kingdom; Division of Cancer Sciences, University of Manchester, United Kingdom.; Carlino MS; Melanoma Institute Australia, The University of Sydney and the Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Department of Medical Oncology, Westmead and Blacktown Hospital, Sydney, Australia.; Menzies AM; Melanoma Institute Australia, The University of Sydney and the Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Department of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, Australia.; Arance AM; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Johnson DB; Department of Medical Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.; Long GV; Melanoma Institute Australia, The University of Sydney and the Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Department of Medical Oncology, Royal North Shore and Mater Hospitals, Sydney, Australia.; Pickering L; Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, United Kingdom.; Larkin JMG; Department of Medical Oncology, Royal Marsden NHS Foundation Trust, London, United Kingdom.; Blank CU; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Lorigan P; Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, United Kingdom; Division of Cancer Sciences, University of Manchester, United Kingdom.
Source
Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: To assess efficacy and toxicity of combination immunotherapy with ipilimumab plus nivolumab in routine practice in a retrospective multicentre cohort of patients with advanced melanoma.
Patients and Methods: This retrospective analysis included patients with advanced melanoma treated with ipilimumab and nivolumab between October 2015 and January 2020 at six centres in Australia, Europe and the United States of America. We describe efficacy outcomes (overall survival [OS], progression-free survival [PFS] and objective response rate [ORR]) in treatment-naïve and pre-treated patients, with and without brain metastases, plus treatment-related adverse events (trAEs) in all patients treated.
Results: A total of 697 patients were identified; 472 were treatment-naïve of which 138 (29.2%) had brain metastases, and 225 were previously treated of which 102 (45.3%) had brain metastases. At baseline, 32.3% had stage M1c and 34.4% stage M1d disease. Lactate dehydrogenase was high in 280 patients (40.2%). With a median follow-up of 25.9 months, median OS in the 334 treatment-naïve patients without brain metastases was 53.7 months (95% confidence interval [CI] 40.8-NR) and 38.7 months (95% CI 18.6-NR) for the 138 treatment-naïve patients with brain metastases. For the entire cohort the ORR was 48%, for treatment-naïve patients without brain metastases ORR was 56.6% with a median PFS of was 13.7 months (95% CI 9.6-26.5). Median PFS was 7.9 months (95% CI 5.8-10.4) and OS 38 months (95% CI 31-NR) for the entire cohort. Grade 3-4 trAE were reported in 44% of patients, and 4 (0.7%) treatment-related deaths (1 pneumonitis, 2 myocarditis and 1 colitis) were recorded.
Conclusion: The outcome and toxicity of combination immunotherapy with ipilimumab and nivolumab in a real-world patient population are similar to those reported in pivotal trials.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Patients and Methods: This retrospective analysis included patients with advanced melanoma treated with ipilimumab and nivolumab between October 2015 and January 2020 at six centres in Australia, Europe and the United States of America. We describe efficacy outcomes (overall survival [OS], progression-free survival [PFS] and objective response rate [ORR]) in treatment-naïve and pre-treated patients, with and without brain metastases, plus treatment-related adverse events (trAEs) in all patients treated.
Results: A total of 697 patients were identified; 472 were treatment-naïve of which 138 (29.2%) had brain metastases, and 225 were previously treated of which 102 (45.3%) had brain metastases. At baseline, 32.3% had stage M1c and 34.4% stage M1d disease. Lactate dehydrogenase was high in 280 patients (40.2%). With a median follow-up of 25.9 months, median OS in the 334 treatment-naïve patients without brain metastases was 53.7 months (95% confidence interval [CI] 40.8-NR) and 38.7 months (95% CI 18.6-NR) for the 138 treatment-naïve patients with brain metastases. For the entire cohort the ORR was 48%, for treatment-naïve patients without brain metastases ORR was 56.6% with a median PFS of was 13.7 months (95% CI 9.6-26.5). Median PFS was 7.9 months (95% CI 5.8-10.4) and OS 38 months (95% CI 31-NR) for the entire cohort. Grade 3-4 trAE were reported in 44% of patients, and 4 (0.7%) treatment-related deaths (1 pneumonitis, 2 myocarditis and 1 colitis) were recorded.
Conclusion: The outcome and toxicity of combination immunotherapy with ipilimumab and nivolumab in a real-world patient population are similar to those reported in pivotal trials.
(Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)