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)

J 2020

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 et. al.

Základní údaje

Originální název

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)

Autoři

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 Česká republika, domácí), A. CESAS, D. RODRIGUEZ-ABREU, M. LAU, E. DEJONG, P. LEGENNE, D. STEIN, B. KING a J. V. VAN THIENEN

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.599

Kód RIV

RIV/00216224:14110/20:00116009

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000532204900005

Klíčová slova anglicky

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

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 16. 7. 2020 12:34, Mgr. Tereza Miškechová

Anotace

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.

Citovat

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 a 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, roč. 30, č. 3, s. 261-267. ISSN 0960-8931. Dostupné z: https://dx.doi.org/10.1097/CMR.0000000000000654.

@article{1670495,
   author = {Atkinson, V. and Sandhu, S. and Hospers, G. and Long, G. V. and Aglietta, M. and Ferrucci, P. F. and Tulyte, S. and Cappellini, G. C. A. and Soriano, V.. and Ali, S. and Poprach, Alexandr and Cesas, A. and RodriguezandAbreu, D. and Lau, M. and deJong, E. and Legenne, P. and Stein, D. and King, B. and van Thienen, J. V.},
   article_location = {PHILADELPHIA},
   article_number = {3},
   doi = {http://dx.doi.org/10.1097/CMR.0000000000000654},
   keywords = {BRAF; chart review; dabrafenib; MEK; melanoma; trametinib},
   language = {eng},
   issn = {0960-8931},
   journal = {MELANOMA RESEARCH},
   title = {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)},
   url = {https://journals.lww.com/melanomaresearch/Abstract/2020/06000/Dabrafenib_plus_trametinib_is_effective_in_the.5.aspx},
   volume = {30},
   year = {2020}
}

TY  - JOUR
ID  - 1670495
AU  - Atkinson, V. - Sandhu, S. - Hospers, G. - Long, G. V. - Aglietta, M. - Ferrucci, P. F. - Tulyte, S. - Cappellini, G. C. A. - Soriano, V.. - Ali, S. - Poprach, Alexandr - Cesas, A. - Rodriguez-Abreu, D. - Lau, M. - deJong, E. - Legenne, P. - Stein, D. - King, B. - van Thienen, J. V.
PY  - 2020
TI  - 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)
JF  - MELANOMA RESEARCH
VL  - 30
IS  - 3
SP  - 261-267
EP  - 261-267
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 09608931
KW  - BRAF
KW  - chart review
KW  - dabrafenib
KW  - MEK
KW  - melanoma
KW  - trametinib
UR  - https://journals.lww.com/melanomaresearch/Abstract/2020/06000/Dabrafenib_plus_trametinib_is_effective_in_the.5.aspx
L2  - https://journals.lww.com/melanomaresearch/Abstract/2020/06000/Dabrafenib_plus_trametinib_is_effective_in_the.5.aspx
N2  - 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.
ER  -

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 a 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). \textit{MELANOMA RESEARCH}. PHILADELPHIA: LIPPINCOTT WILLIAMS \&{}amp; WILKINS, 2020, roč.~30, č.~3, s.~261-267. ISSN~0960-8931. Dostupné z: https://dx.doi.org/10.1097/CMR.0000000000000654.

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