TY - JOUR
T1 - Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma
T2 - long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial
AU - Eggermont, Alexander M.M.
AU - Chiarion-Sileni, Vanna
AU - Grob, Jean Jacques
AU - Dummer, Reinhard
AU - Wolchok, Jedd D.
AU - Schmidt, Henrik
AU - Hamid, Omid
AU - Robert, Caroline
AU - Ascierto, Paolo Antonio
AU - Richards, Jon M.
AU - Lebbe, Celeste
AU - Ferraresi, Virginia
AU - Smylie, Michael
AU - Weber, Jeffrey S.
AU - Maio, Michele
AU - Hosein, Fareeda
AU - de Pril, Veerle
AU - Kicinski, Michal
AU - Suciu, Stefan
AU - Testori, Alessandro
N1 - Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/9
Y1 - 2019/9
N2 - Background: 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. Patients, methods and results: 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 < 0.001), DMFS (HR: 95% CI: 0.76, 0.64–0.90; P = 0.002) and OS (HR: 0.73, 95% CI: 0.60–0.89; P = 0.002) benefit observed in the ipilimumab group was durable with an 8.7% absolute difference at 7 years for OS. The benefit was consistent across subgroups. Conclusions: Adjuvant therapy with ipilimumab prolongs RFS, DMFS and OS significantly. The benefit is sustained long term and consistent across subgroups.
AB - Background: 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. Patients, methods and results: 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 < 0.001), DMFS (HR: 95% CI: 0.76, 0.64–0.90; P = 0.002) and OS (HR: 0.73, 95% CI: 0.60–0.89; P = 0.002) benefit observed in the ipilimumab group was durable with an 8.7% absolute difference at 7 years for OS. The benefit was consistent across subgroups. Conclusions: Adjuvant therapy with ipilimumab prolongs RFS, DMFS and OS significantly. The benefit is sustained long term and consistent across subgroups.
KW - Adjuvant therapy
KW - Ipilimumab
KW - Long-term results
KW - Melanoma
KW - Phase III trial
KW - Stage III
UR - http://www.scopus.com/inward/record.url?scp=85070237543&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2019.07.001
DO - 10.1016/j.ejca.2019.07.001
M3 - Article
C2 - 31400634
AN - SCOPUS:85070237543
SN - 0959-8049
VL - 119
SP - 1
EP - 10
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -