Real-world outcomes of advanced melanoma patients not represented in phase III trials

Autor: van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G, Wouters, M W J M, Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology
Přispěvatelé: Sub Algemeen Math. Inst, Afd Pharmacoepi & Clinical Pharmacology, extern UU GWS, Pharmacoepidemiology and Clinical Pharmacology, CCA - Cancer Treatment and quality of life, AII - Cancer immunology, Medical oncology, Medical Oncology, Radiology & Nuclear Medicine, Surgery, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), Guided Treatment in Optimal Selected Cancer Patients (GUTS)
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Oncology
advanced melanoma
Cancer Research
Phase iii trials
medicine.medical_treatment
ineligibility
THERAPIES
Targeted therapy
chemistry.chemical_compound
MAGNITUDE
Antineoplastic Agents
Immunological
0302 clinical medicine
METASTATIC MELANOMA
Medicine
BENEFIT
Molecular Targeted Therapy
Prospective Studies
Cancer Therapy and Prevention
AMERICAN SOCIETY
Melanoma
Netherlands
Aged
80 and over
education.field_of_study
Middle Aged
Prognosis
real-world outcomes
Treatment Outcome
030220 oncology & carcinogenesis
Female
medicine.drug
Adult
medicine.medical_specialty
Clinical Decision-Making
Population
Ipilimumab
survival
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
Young Adult
03 medical and health sciences
Lactate dehydrogenase
Internal medicine
decision tree
CLINICAL ONCOLOGY
Humans
IMMUNOTHERAPY
education
real‐world outcomes
Aged
Neoplasm Staging
Proportional Hazards Models
Advanced melanoma
business.industry
Proportional hazards model
IPILIMUMAB
Patient Selection
Immunotherapy
Survival Analysis
COMBINED NIVOLUMAB
Clinical Trials
Phase III as Topic
chemistry
business
Zdroj: International Journal of Cancer, 147(12), 3461-3470. Wiley-Liss Inc.
International Journal of Cancer
van Zeijl, M C T, Ismail, R K, de Wreede, L C, van den Eertwegh, A J M, de Boer, A, van Dartel, M, Hilarius, D L, Aarts, M J B, van den Berkmortel, F W P J, Boers-Sonderen, M J, de Groot, J-W B, Hospers, G A P, Kapiteijn, E, Piersma, D, van Rijn, R S, Suijkerbuijk, K P M, Ten Tije, A J, van der Veldt, A A M, Vreugdenhil, G, Haanen, J B A G & Wouters, M W J M 2020, ' Real-world outcomes of advanced melanoma patients not represented in phase III trials ', International Journal of Cancer, vol. 147, no. 12, pp. 3461-3470 . https://doi.org/10.1002/ijc.33162
International Journal of Cancer, 147(12), 3461. Wiley-Liss Inc.
International Journal of Cancer, 147, 3461-3470
International Journal of Cancer, 147, 12, pp. 3461-3470
International Journal of Cancer, 147(12), 3461-3470. Wiley
International Journal of Cancer, 147(12), 3461-3470. WILEY
ISSN: 0020-7136
DOI: 10.1002/ijc.33162
Popis: The aim was to provide evidence on systemically treated patients with advanced melanoma not represented in phase III trials to support clinical decision‐making. Analysis were performed on advanced melanoma patients diagnosed between 2014 and 2017 in the Netherlands, treated with immune‐ or targeted therapy, who met ≥1 trial exclusion criteria. These criteria were derived from the KEYNOTE‐006 and CHECKMATE‐067/‐066 phase III trials. Prognostic importance of factors associated with overall survival (OS) was assessed with the Kaplan‐Meier method, Cox models, predicted OS probabilities of prognostic subgroups and a conditional inference survival tree (CIST). A nationwide population‐based registry was used as data source. Of 2536 systemically treated patients with advanced melanoma, 1004 (40%) patients were ineligible for phase IIII trials. Ineligible patients had a poorer median OS (mOS) compared to eligible patients (8.8 vs 23 months). Eligibility criteria strongly associated with OS in systemically treated ineligible patients were Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≥2, brain metastases (BM) and lactate dehydrogenase (LDH) of >500 U/L. Patients with ECOG PS of ≥2 with or without symptomatic BM had a predicted mOS of 6.5 and 11.3 months and a 3‐year survival probability of 9.3% and 23.6%, respectively. The CIST showed the strongest prognostic covariate for survival was LDH, followed by ECOG PS. The prognosis of patients with LDH of >500 U/L is poor, but long‐term survival is possible. The prognosis of ineligible patients with advanced melanoma in real‐world was very heterogeneous and highly dependent on LDH value, ECOG PS and symptomatic BM.
What's new? By necessity, randomized controlled trials (RCTs) exclude many patients. However, these ineligible patients are often still treated with new systemic therapies on an individual basis. In this study, the authors examined how various subgroups of ineligible patients fared following treatment for advanced melanoma. They found that several criteria were strongly associated with prognosis in these patients, including lactate dehydrogenase (LDH) levels. These results should provide clinicians with a decision tree of prognostic factors to help guide treatment decisions.
Databáze: OpenAIRE
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