dc.creator | Mandala, Mario | es |
dc.creator | Larkin, James R. | es |
dc.creator | Ascierto, Paolo Antonio | es |
dc.creator | Del Vecchio, Michele | es |
dc.creator | Gogas, Helen | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Weber, Jeffrey | es |
dc.creator | Lobo, Maurice | |
dc.date.accessioned | 2022-09-30T13:38:14Z | |
dc.date.available | 2022-09-30T13:38:14Z | |
dc.date.issued | 2021-08-21 | |
dc.identifier.citation | Mandala, M., Larkin, J.R., Ascierto, P.A., Del Vecchio, M., Gogas, H., Cruz Merino, L.d.l.,...,Lobo, M. (2021). Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. Journal for ImmunoTherapy of Cancer, 9 (8), e003188. https://doi.org/10.1136/jitc-2021-003188. | |
dc.identifier.issn | 2051-1426 | es |
dc.identifier.uri | https://hdl.handle.net/11441/137535 | |
dc.description.abstract | Background Several 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.
Methods Patients with resected stage IIIB–C or IV
melanoma received nivolumab 3mg/kg every 2 weeks
(n=452) or ipilimumab 10mg/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.
Results From 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.
Conclusion Results 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. | es |
dc.format | application/pdf | es |
dc.format.extent | 9 p. | es |
dc.language.iso | eng | es |
dc.publisher | BMJ Publishing Group | es |
dc.relation.ispartof | Journal for ImmunoTherapy of Cancer, 9 (8), e003188. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.title | Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://jitc.bmj.com/content/9/8/e003188 | es |
dc.identifier.doi | 10.1136/jitc-2021-003188 | es |
dc.journaltitle | Journal for ImmunoTherapy of Cancer | es |
dc.publication.volumen | 9 | es |
dc.publication.issue | 8 | es |
dc.publication.initialPage | e003188 | |