Overall Survival of Patients With Unresectable or Metastatic BRAF V600-Mutant Acral/Cutaneous Melanoma Administered Dabrafenib Plus Trametinib: Long-Term Follow-Up of a Multicenter, Single-Arm Phase IIa Trial

To examine the long-term survival outcome of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic acral/cutaneous melanoma with BRAF-V600 mutation and to explore potential predictors of effectiveness. This was a long-term follow-up of Chinese patients with un...

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Published in:Frontiers in oncology 2021-08, Vol.11, p.720044-720044
Main Authors: Mao, Lili, Ding, Ya, Bai, Xue, Sheng, Xinan, Dai, Jie, Chi, Zhihong, Cui, Chuanliang, Kong, Yan, Fan, Yun, Xu, Yanjun, Wang, Xuan, Tang, Bixia, Lian, Bin, Yan, Xieqiao, Li, Siming, Zhou, Li, Wei, Xiaoting, Li, Caili, Guo, Jun, Zhang, Xiaoshi, Si, Lu
Format: Article
Language:English
Subjects:
acral melanoma
BRAF
dabrafenib
melanoma
Oncology
trametinib
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Summary:To examine the long-term survival outcome of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic acral/cutaneous melanoma with BRAF-V600 mutation and to explore potential predictors of effectiveness. This was a long-term follow-up of Chinese patients with unresectable or metastatic BRAF V600-mutant acral/cutaneous melanoma administered dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) in an open-label, multicenter, single-arm, phase IIa study (NCT02083354). Efficacy endpoints included objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). The impacts of baseline characteristics on PFS and OS were analyzed. A total of sixty patients were included. The median age was 48 years, and 24 patients (40.0%) were male. Totally 12 individuals (20.0%) had acral melanoma, and 45 (75.0%) had failed previous systemic therapy. Up to July 2020, the median duration of follow-up was 37.0 (95% confidence interval [CI] 29.1-44.9) months. The updated ORR was 71.7% (95%CI 60.3%-83.1%). The 3-year OS rate was 28.8% (95%CI 19.1-43.6%) in the overall population, and 35.7% (95%CI 15.5-82.4%) in acral melanoma patients. The median DOR was 7.5 months (95%CI 4.5 to 10.5). Baseline normal lactic dehydrogenase (LDH), metastatic organ sites
ISSN:2234-943X
2234-943X
DOI:10.3389/fonc.2021.720044