Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/19884
Title: Real-world efficacy and toxicity of combined nivolumab and ipilimumab in patients with metastatic melanoma.
Authors: Parakh, Sagun;Randhawa, Manreet;Nguyen, Bella;Warburton, Lydia;Hussain, Mohammad Akhtar;Cebon, Jonathan S;Millward, Michael;Yip, Desmond;Ali, Sayed
Affiliation: Department of Medical Oncology, Sir Charles Gairdner Hospital, WA, Australia
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia
ANU Medical School, Australian National University, ACT, Australia
School of Population and Global Health, University of Western Australia, WA, Australia
Western Australia Centre for Rural Health, University of Western Australia, WA, Australia
Department of Medical Oncology, Canberra Region Cancer Centre, The Canberra Hospital, ACT, Australia
Issue Date: 13-Nov-2018
EDate: 2018-11-13
Citation: Asia-Pacific journal of clinical oncology 2018; online first: 13 November
Abstract: There is limited real-world data on the efficacy and safety of combination programmed cell death protein-1 (PD-1) inhibitor, nivolumab and the cytotoxic T-lymphocyte antigen (CTLA-4) inhibitor ipilimumab. We retrospectively identified patients (pts) with metastatic melanoma treated with three-weekly nivolumab (1 mg/kg) in combination with ipilimumab (3 mg/kg) for four cycles followed by nivolumab monotherapy (3 mg/kg) fortnightly. Patient demographics and treatment parameters were collected and outcomes determined. A total of 45 pts received combination treatment with a median follow up of 8.7 months (range 0.33-25.9 months). A total of 67% were male, and BRAF V600 mutations detected in 38%. At treatment commencement, 14 (31%) pts had brain metastases, 51% had an elevated LDH and 18 (40%) were treatment-naive. Almost a third (30%) required corticosteroids for symptom control or management of prior toxicities. Nineteen (42%) patients had prior anti-PD-1 therapy. The disease control rate (DCR) was 54% and objective response rate (ORR) was 29%. Of pts treated with prior immune checkpoint inhibitors, the DCR and ORR were 50% and 33%, respectively. Intracranial responses were observed in 18% (n = 2). The median progression-free survival (PFS) was 5.8 months (95% Confidence interval (CI), 2.9-14.1 months). PFS was higher in treatment naïve patients compared to those who had prior immunotherapy (6.2 months vs 4.9 months, P = 0.59). The median OS was 17.4 months (95% CI, 7.1-NR). pts requiring corticosteroids had a shorter PFS (4.9 months vs 6.8 months) and OS (7.1 months vs NR, P = 0.01).Treatment-related adverse events of any grade were experienced by 88% of pts, with 54% having grade 3-4 adverse events. Treatment discontinuation due to adverse events occurred in 44% of pts. In this study, responses to combination immunotherapy were lower than reported. Patients treated with prior immunotherapy had similar responses as treatment-naïve pts. The toxicity profile seen in this study is similar to those reported in clinical trials.
URI: http://ahro.austin.org.au/austinjspui/handle/1/19884
DOI: 10.1111/ajco.13100
ORCID: 0000-0003-3891-2489
0000-0003-0045-6027
0000-0002-6012-3702
PubMed URL: 30426665
Type: Journal Article
Subjects: ipilimumab
metastatic melanoma
nivolumab
Appears in Collections:Journal articles

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