A Retrospective Analysis of Dabrafenib and/or Dabrafenib Plus Trametinib Combination in Patients with Metastatic Melanoma to Characterize Patients with Long-Term Benefit in the Individual Patient Program (DESCRIBE III)

. 2021 May 18 ; 13 (10) : . [epub] 20210518

Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid34070224

Grantová podpora
None Novartis

The dabrafenib plus trametinib (dab + tram) combination has demonstrated durable long-term efficacy in patients with BRAF V600-mutant metastatic melanoma. However, real-world data characterizing patients with long-term benefit are limited. DESCRIBE III was a global, observational, retrospective, chart review study in patients with unresectable or metastatic melanoma treated with dab monotherapy and/or dab + tram combination therapy as part of the Named Patient Program or Individual Patient Program. Overall, 509 patients were enrolled. Patients were categorized into three groups based on their observed treatment duration: long-term (on therapy ≥12 months), intermediate (on therapy ≥6 months and <12 months), and short-term (on therapy <6 months) duration of benefit. More patients in the short-term duration of benefit group had baseline characteristics associated with poor prognosis compared with the other two groups. Median lactate dehydrogenase (LDH) levels (368 U/L) at baseline were also higher in the short-term duration of benefit group. No new safety signals were identified. DESCRIBE III identified baseline characteristics associated with long-term benefit of dab + tram. Lower LDH level and <3 metastatic sites at baseline were associated with a longer duration of benefit, confirming that the findings from COMBI-d and COMBI-v are relevant to patients treated in a real-world setting.

Department of Dermatovenerology University Hospital Prague Charles University 12808 Prague Czech Republic

Department of Internal Medicine Laiko General Hospital National and Kapodistrian University of Athens School of Medicine 11527 Athens Greece

Department of Medical Oncology Candiolo Cancer Institute FPO IRCCS 10060 Candiolo Italy

Department of Medical Oncology Hospital Clinic of Barcelona 08036 Barcelona Spain

Department of Medical Sciences Section of Dermatology University of Turin 10124 Turin Italy

Department of Oncology and Hematology University of Modena and Reggio Emilia 41121 Modena Italy

Department of Oncology University of Torino 10124 Turin Italy

Division of Cancer Services Princess Alexandra Hospital University of Queensland Brisbane QLD 4102 Australia

Hematology Oncology and Transfusion Medicine Center Vilnius University 08410 Vilnius Lithuania

Medical Oncology ASST Spedali Civili 25123 Brescia Italy

Medical Oncology Metropolitan Hospital 18547 Athens Greece

Medical Oncology Universitair Ziekenhuis Brussel 1090 Brussels Belgium

Melanoma Unit Cancer Immunotherapy and Innovative Therapies Istituto Nazionale Tumori IRCCS Fondazione G Pascale 80131 Naples Italy

Novartis AG 4057 Basel Switzerland

Novartis Pharmaceuticals Corporation East Hanover NJ 07936 USA

Oncology Unit ASST Sette Laghi 21100 Varese Italy

Tumor Biotherapy Unit Department of Experimental Oncology IEO Istituto Europeo di Oncologia IRCCS 20141 Milan Italy

Unit of Melanoma Medical Oncology Department of Medical Oncology and Hematology Fondazione IRCCS Istituto Nazionale dei Tumori 20133 Milan Italy

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