Dataset Information

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

ABSTRACT: 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.

SUBMITTER: van Zeijl MCT

PROVIDER: S-EPMC7689762 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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

van Zeijl Michiel C T MCT Ismail Rawa K RK de Wreede Liesbeth C LC van den Eertwegh Alfonsus J M AJM de Boer Anthonius A van Dartel Maaike M Hilarius Doranne L DL Aarts Maureen J B MJB van den Berkmortel Franchette W P J FWPJ Boers-Sonderen Marye J MJ de Groot Jan-Willem B JB Hospers Geke A P GAP Kapiteijn Ellen E Piersma Djura D van Rijn Rozemarijn S RS Suijkerbuijk Karijn P M KPM Ten Tije Albert J AJ van der Veldt Astrid A M AAM Vreugdenhil Gerard G Haanen John B A G JBAG Wouters Michel W J M MWJM

International journal of cancer 20200704 12

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 surviva ...[more]

PMID: 32559817

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Dataset Information

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

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

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