Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.

Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.

Publication date: Aug 07, 2019

Since 2015, adjuvant therapy with ipilimumab is an approved treatment for stage III melanoma based on a significantly prolonged recurrence-free survival (RFS). At a median follow-up of 5.3 years, RFS, distant metastasis-free survival (DMFS) and overall survival (OS) were each significantly prolonged in the ipilimumab group compared with the placebo group, despite a 53.3% (ipilimumab) versus 4.6% (placebo) treatment discontinuation rate due to adverse events. We present now long-term follow-up results of this European Organisation for Research and Treatment of Cancer 18071 trial.

A total of 99 sites randomised 951 patients with stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis) with adequate resection of lymph nodes to receive intravenous infusions of ipilimumab 10 mg/kg or placebo, every 3 weeks for 4 doses, then every 3 months for up to 3 years. The RFS, DMFS and OS, as reported by the local investigators, were assessed by the intention-to-treat analysis. Among 431 patients randomised at 63 sites and who were still alive at the analysis reported in 2016, recent follow-up information could be obtained for 264 patients. The median OS follow-up was 6.9 years. The RFS (hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.63-0.88; P

Eggermont, A.M.M., , Chiarion-Sileni, Grob, J.J., Dummer, R., Wolchok, J.D., Schmidt, H., Hamid, O., Robert, C., Ascierto, P.A., Richards, J.M., Lebbe, C., , Ferraresi, Smylie, M., Weber, J.S., Maio, M., Hosein, F., Pril, de, Kicinski, M., Suciu, S., and Testori, A. Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial. 23710. 2019 Eur J Cancer (119):

Concepts Keywords
Adjuvant III cutaneous melanoma
Adjuvant Therapy Transit metastasis
Confidence Interval III melanoma
Double Blind Intravenous infusions
Intravenous Adjuvant therapy
Ipilimumab Clinical medicine
Lymph Node Bristol-Myers Squibb
Lymph Nodes Cancer
Melanoma RTT
Metastasis Ipilimumab
Placebo Cancer treatments
Resection Melanoma
Transit Adjuvant therapy

Semantics

Type Source Name
disease DOID cutaneous melanoma
disease MESH metastasis
disease MESH recurrence
disease DOID Cancer
disease MESH Cancer
pathway BSID Melanoma
disease DOID melanoma
disease MESH melanoma
drug DRUGBANK Ipilimumab

Original Article

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