Highlights
- •Adjuvant therapy with ipilimumab significantly improved the outcomes.
- •Compared with placebo, it prolonged RFS (hazard ratio [HR], 0.75), DMFS (HR, 0.76) and (OS; HR, 0.73).
- •The estimated absolute increase in the 7-year OS rate was 8.7%.
- •The benefit was sustained long term and consistent across subgroups.
Abstract
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 0.63–0.88; P < 0.001), DMFS (HR 0.76, 0.64–0.90; P = 0.002) and OS (HR 0.73,
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.
Keywords
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Article info
Publication history
Published online: August 07, 2019
Accepted:
July 5,
2019
Received:
July 4,
2019
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
