Dabrafenib plus trametinib is effective in the treatment of BRAF V600-mutated metastatic melanoma patients: analysis of patients from the dabrafenib plus trametinib Named Patient Program (DESCRIBE II)

ATKINSON, V., S. SANDHU, G. HOSPERS, G. V. LONG, M. AGLIETTA, P. F. FERRUCCI, S. TULYTE, G. C. A. CAPPELLINI, V.. SORIANO, S. ALI, Alexandr POPRACH, A. CESAS, D. RODRIGUEZ-ABREU, M. LAU, E. DEJONG, P. LEGENNE, D. STEIN, B. KING and J. V. VAN THIENEN. Dabrafenib plus trametinib is effective in the treatment of BRAF V600-mutated metastatic melanoma patients: analysis of patients from the dabrafenib plus trametinib Named Patient Program (DESCRIBE II). MELANOMA RESEARCH. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS, 2020, vol. 30, No 3, p. 261-267. ISSN 0960-8931. Available from: https://dx.doi.org/10.1097/CMR.0000000000000654.

Basic information

Original name

Dabrafenib plus trametinib is effective in the treatment of BRAF V600-mutated metastatic melanoma patients: analysis of patients from the dabrafenib plus trametinib Named Patient Program (DESCRIBE II)

Authors

ATKINSON, V., S. SANDHU, G. HOSPERS, G. V. LONG, M. AGLIETTA, P. F. FERRUCCI, S. TULYTE, G. C. A. CAPPELLINI, V.. SORIANO, S. ALI, Alexandr POPRACH (203 Czech Republic, belonging to the institution), A. CESAS, D. RODRIGUEZ-ABREU, M. LAU, E. DEJONG, P. LEGENNE, D. STEIN, B. KING and J. V. VAN THIENEN

Edition

MELANOMA RESEARCH, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2020, 0960-8931

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Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30204 Oncology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.599

RIV identification code

RIV/00216224:14110/20:00116009

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1097/CMR.0000000000000654

UT WoS

000532204900005

Keywords in English

BRAF; chart review; dabrafenib; MEK; melanoma; trametinib

Tags

14110811, rivok

Tags

International impact, Reviewed

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Abstract

V originále

In clinical trials, dabrafenib plus trametinib improved overall survival (OS) compared with single-agent BRAF inhibitors (BRAFi) in patients with BRAF V600-mutant unresectable or metastatic melanoma. We investigated dabrafenib plus trametinib therapy in a compassionate-use setting [Named Patient Program (NPP); DESCRIBE II]. A retrospective chart review of patients with BRAF V600-mutated unresectable stage III/IV melanoma receiving dabrafenib plus trametinib as compassionate use was conducted. Treatment patterns and duration, clinical outcomes, and tolerability were evaluated. Of 271 patients, 92.6% had stage IV melanoma, including 36.5% with brain metastases. Overall, 162 patients (59.8%) were BRAFi naive and 171 (63.1%) received first-line dabrafenib plus trametinib. Among BRAFi-naive patients, the overall response rate (ORR) was 67.3%, median OS (mOS) was 20.0 months, and median progression-free survival (mPFS) was 7.5 months. In BRAFi-naive patients with known brain metastases (n = 62), ORR was 61.3%, mOS was 15.5 months, and mPFS was 6.2 months. Eighty-four patients received BRAFi monotherapy for >30 days and switched to dabrafenib plus trametinib prior to progression. Of these 84 patients, 63 had known disease status at the time of switch, and 22 improved with the combination therapy. No new safety signals were identified, and dabrafenib plus trametinib was well tolerated. Dabrafenib plus trametinib showed substantial clinical activity in NPP patients with BRAF V600-mutated unresectable or metastatic melanoma. Analysis of treatment patterns demonstrated the effectiveness of the combination in patients with brain metastases and across lines of therapy with a well tolerated and manageable safety profile.