TY - JOUR
T1 - Sex-Based Differences in Treatment with Immune Checkpoint Inhibition and Targeted Therapy for Advanced Melanoma: A Nationwide Cohort Study
AU - van der Kooij, M.K.
AU - Dekkers, O.M.
AU - Aarts, M.J.B.
AU - van den Berkmortel, F.W.P.J.
AU - Boers-Sonderen, M.J.
AU - de Groot, J.W.B.
AU - Hospers, G.A.P.
AU - Piersma, D.
AU - van Rijn, R.S.
AU - Suijkerbuijk, K.P.M.
AU - Westgeest, H.M.
AU - van der Veldt, A.A.M.
AU - Vreugdenhil, G.
AU - Wilgenhof, S.
AU - Wouters, M.W.J.M.
AU - Haanen, J.B.A.G.
AU - van den Eertwegh, A.J.M.
AU - Kapiteijn, E.
N1 - Funding Information:
Funding: This research received no external funding. The Netherlands Organization for Health Research and Development funded the start-up of the Dutch Melanoma Treatment Registry (DMTR). Grant number: 836002002. This grant was awarded under the effectiveness research for high-cost medicine program. From its foundation, the DMTR has been sponsored by BMS, Novartis, Roche Nederland B.V., MSD, Pierre Fabre and the health insurance companies in the Netherlands via the Dutch Institute for Clinical Auditing (DICA).
Funding Information:
Conflicts of Interest: M.J.B.S. has served as an advisory board member for Bristol-Myers Squibb, Novartis, Merck and Pierre Fabre. A.J.M.v.d.E. has served as a speaker for Bristol-Myers Squibb and Novartis and an advisory board member for Bristol Myers Squibb, MSD oncology, Amgen, Roche, Novartis, Sanofi, Pfizer, Ipsen, Merck, Pierre Fabre and has received research grants not related to this paper from Sanofi, Roche, Bristol Myers Squibb, TEVA and Idera. J.W.B.d.G. is a paid consultant for Bristol Myers Squibb, MSD, Pierre Fabre, and Servier. G.A.P.H. is an unpaid consultant/advisory board member for Bristol Myers Squibb, MSD, Roche, and Novartis. D.P. has served as an advisory board member for Amgen, Bristol Myers Squibb and Pierre Fabre. A.A.M.v.d.V. is a paid consultant for Bristol Myers Squibb, MSD, Novartis, Roche, Pfizer, Eisai, Ipsen, Pierre Fabre, Sanofi, and Bayer. J.H. is a paid consultant for AIMM, Neon Therapeutics, Immunocore, Vaximm, and Neogene Therapeutics, and reports receiving commercial research grants from Bristol Myers Squibb, MSD, Novartis, and Neon Therapeutics. K.P.M.S. has served as a consultant and/or advisory board member for Bristol Myers Squibb, Novartis, MSD, Pierre Fabre and AbbVie and received honoraria/research support not related to this manuscript from Novartis, Roche and MSD. All paid to institution. EK has served as a consultant and/or advisory board member for Bristol Myers Squibb, Novartis, Merck, Pierre Fabre and has received research grants not related to this paper from Bristol Myers Squibb. H.M.W. received travel expenses from Ipsen and honoraria from Astellas and Roche. No potential conflicts of interest were disclosed by the other authors. Role of the Funder: The funders had no role in the design of the study; in the collection, analyses or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Simple Summary Melanoma is a malignant form of skin cancer. The overall survival of patients with advanced stages of disease were initially low. Fortunately, in recent years systemic treatment with immunotherapy has prolonged survival. We set out to answer the question whether men and women with advanced melanoma differ in prognostic factors, tumor-response to immunotherapy, and treatment-related adverse events. All patients in the Netherlands were registered between July 2013 and July 2018. We showed that although clinical and tumor characteristics differ, the safety profile of immunotherapy is comparable. Furthermore, overall, a 10% survival advantage for women was seen. Following immunotherapy there was no survival difference. Recent meta-analyses show conflicting data on sex-dependent benefit following systemic treatment for advanced melanoma patients. We examined the nationwide Dutch Melanoma Treatment Registry (July 2013-July 2018), assessing sex-dependent differences in advanced melanoma patients (stage IIIC/IV) with respect to clinical characteristics, mutational profiles, treatments initiated, grade 3-4 adverse events (AEs), treatment responses, and mortality. We included 3985 patients, 2363 men (59%) and showed that although men and women with advanced melanoma differ in clinical and tumor characteristics, the safety profile of immune checkpoint inhibition (ICI) is comparable. The data suggest a 10% survival advantage for women, mainly seen in patients >= 60 years of age and patients with BRAF V600 mutant melanoma. Following ICI there was no survival difference.
AB - Simple Summary Melanoma is a malignant form of skin cancer. The overall survival of patients with advanced stages of disease were initially low. Fortunately, in recent years systemic treatment with immunotherapy has prolonged survival. We set out to answer the question whether men and women with advanced melanoma differ in prognostic factors, tumor-response to immunotherapy, and treatment-related adverse events. All patients in the Netherlands were registered between July 2013 and July 2018. We showed that although clinical and tumor characteristics differ, the safety profile of immunotherapy is comparable. Furthermore, overall, a 10% survival advantage for women was seen. Following immunotherapy there was no survival difference. Recent meta-analyses show conflicting data on sex-dependent benefit following systemic treatment for advanced melanoma patients. We examined the nationwide Dutch Melanoma Treatment Registry (July 2013-July 2018), assessing sex-dependent differences in advanced melanoma patients (stage IIIC/IV) with respect to clinical characteristics, mutational profiles, treatments initiated, grade 3-4 adverse events (AEs), treatment responses, and mortality. We included 3985 patients, 2363 men (59%) and showed that although men and women with advanced melanoma differ in clinical and tumor characteristics, the safety profile of immune checkpoint inhibition (ICI) is comparable. The data suggest a 10% survival advantage for women, mainly seen in patients >= 60 years of age and patients with BRAF V600 mutant melanoma. Following ICI there was no survival difference.
KW - advanced melanoma
KW - immunotherapy
KW - prospective nation-wide data
KW - sex
KW - targeted therapy
KW - SURVIVAL
KW - EUROPEAN ORGANIZATION
KW - STAGE
KW - POOLED ANALYSIS
KW - BRAF
KW - EXPRESSION
KW - CLINICOPATHOLOGICAL FEATURES
U2 - 10.3390/cancers13184639
DO - 10.3390/cancers13184639
M3 - Article
C2 - 34572865
SN - 2072-6694
VL - 13
JO - Cancers
JF - Cancers
IS - 18
M1 - 4639
ER -