Dataset Information

Adjuvant therapy versus watch-and-wait post surgery for stage III melanoma: a multicountry retrospective chart review.

ABSTRACT:

Aim

To describe treatment patterns among patients with stage III melanoma who underwent surgical excision in years 2011-2016, and assess outcomes among patients who subsequently received systemic adjuvant therapy versus watch-and-wait.

Methods

Chart review of 380 patients from 17 melanoma centers in North America, South America and Europe.

Results

Of 129 (34%) patients treated with adjuvant therapy, 85% received interferon ?-2b and 56% discontinued treatment (mostly due to adverse events). Relapse-free survival was significantly longer for patients treated with adjuvant therapy versus watch-and-wait (hazard ratio = 0.63; p < 0.05). There was considerable heterogeneity in adjuvant treatment schedules and doses. Similar results were found in patients who received interferon-based adjuvant therapy.

Conclusion

Adjuvant therapies with better safety/efficacy profiles will improve clinical outcomes in patients with stage III melanoma.

SUBMITTER: Mohr P

PROVIDER: S-EPMC6923782 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adjuvant therapy versus watch-and-wait post surgery for stage III melanoma: a multicountry retrospective chart review.

Mohr Peter P Kiecker Felix F Soriano Virtudes V Dereure Olivier O Mujika Karmele K Saiag Philippe P Utikal Jochen J Koneru Rama R Robert Caroline C Cuadros Florencia F Chacón Matias M Villarroel Rodrigo U RU Najjar Yana G YG Kottschade Lisa L Couselo Eva M EM Koruth Roy R Guérin Annie A Burne Rebecca R Ionescu-Ittu Raluca R Perrinjaquet Maurice M Zager Jonathan S JS

Melanoma management 20191004 4

<h4>Aim</h4>To describe treatment patterns among patients with stage III melanoma who underwent surgical excision in years 2011-2016, and assess outcomes among patients who subsequently received systemic adjuvant therapy versus watch-and-wait.<h4>Methods</h4>Chart review of 380 patients from 17 melanoma centers in North America, South America and Europe.<h4>Results</h4>Of 129 (34%) patients treated with adjuvant therapy, 85% received interferon α-2b and 56% discontinued treatment (mostly due to ...[more]

PMID: 31871622

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Project description:BackgroundSeveral therapeutic options are now available in the adjuvant melanoma setting, mandating an understanding of their benefit‒risk profiles in order to make informed treatment decisions. Herein we characterize adjuvant nivolumab select (immune-related) treatment-related adverse events (TRAEs) and evaluate possible associations between safety and recurrence-free survival (RFS) in the phase III CheckMate 238 trial.MethodsPatients with resected stage IIIB-C or IV melanoma received nivolumab 3 mg/kg every 2 weeks (n=452) or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks (n=453) for up to 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. First-occurrence and all-occurrence select TRAEs were analyzed within discrete time intervals: from 0 to 3 months of treatment, from >3-12 months of treatment, and from the last dose (regardless of early or per-protocol treatment discontinuation) to 100 days after the last dose. Possible associations between select TRAEs and RFS were investigated post randomization in 3-month landmark analyses and in Cox model analyses (including a time-varying covariate of select TRAE), within and between treatment groups.ResultsFrom the first nivolumab dose to 100 days after the last dose, first-occurrence select TRAEs were reported in 67.7% (306/452) of patients. First-occurrence select TRAEs were reported most frequently from 0 to 3 months (48.0%), during which the most common were pruritus (15.5%) and diarrhea (15.3%). Most select TRAEs resolved within 6 months. There was no clear association between the occurrence (or not) of select TRAEs and RFS by landmark analysis or by Cox model analysis within treatment arms or comparing nivolumab to the ipilimumab comparator arm.ConclusionResults of this safety analysis of nivolumab in adjuvant melanoma were consistent with its established safety profile. In the discrete time intervals evaluated, most first-occurrence TRAEs occurred early during treatment and resolved. No association between RFS and select TRAEs was evident.Trial registration numberNCT02388906.

Dataset Information

Adjuvant therapy versus watch-and-wait post surgery for stage III melanoma: a multicountry retrospective chart review.

Aim

Methods

Results

Conclusion

Publications

Adjuvant therapy versus watch-and-wait post surgery for stage III melanoma: a multicountry retrospective chart review.

Similar Datasets

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