Long-Term Real-World Outcomes and Safety of Vemurafenib and Vemurafenib plus Cobimetinib Therapy in Patients with BRAF-Mutated Melanoma

被引：3

作者：

Piejko, Karolina ^{[1
]}

Cybulska-Stopa, Bozena ^{[1
,6
]}

Zietek, Marcin ^{[2
,3
]}

Dziura, Robert ^{[4
]}

Galus, Lukasz ^{[5
]}

Kempa-Kaminska, Natasza ^{[6
]}

Ziolkowska, Barbara ^{[7
]}

Rutkowska, Ewa ^{[4
]}

Kopcinski, Tomasz ^{[1
]}

Kubiatowski, Tomasz ^{[8
]}

Bal, Wieslaw ^{[9
]}

Suwinski, Rafal ^{[7
]}

Mackiewicz, Jacek ^{[5
,10
]}

Kaminska-Winciorek, Grazyna ^{[11
]}

Czarnecka, Anna M. ^{[4
,12
,13
]}

Rutkowski, Piotr ^{[13
]}

机构：

[1] Mar Sklodowska Curie Natl Res Inst Oncol, Dept Clin Oncol, Clin Oncol Clin, Cracow Branch, Garncarska 11, PL-31115 Krakow, Poland

[2] Wroclaw Comprehens Canc Ctr, Dept Surg Oncol, Wroclaw, Poland

[3] Wroclaw Med Univ, Dept Oncol, Wroclaw, Poland

[4] Holy Cross Canc Ctr, Clin Oncol Dept, Kielce, Poland

[5] Univ Med Sci, Dept Med & Expt Oncol, Poznan, Poland

[6] Wroclaw Comprehens Canc Ctr, Dept Clin Oncol, Wroclaw, Poland

[7] Maria Sklodowska Curie Natl Res Inst Oncol, Clin Radiotherapy & Chemotherapy 2, Gliwice Branch, Gliwice, Poland

[8] Minist Interior & Adm Hosp, Warmian Masurian Canc Ctr, Olsztyn, Poland

[9] Maria Sklodowska Curie Natl Res Inst Oncol, Gliwice Branch, Gliwice, Poland

[10] Greater Poland Canc Ctr, Dept Diagnost & Canc Immunol, Poznan, Poland

[11] Maria Sklodowska Curie Natl Res Inst Oncol, Dept Bone Marrow Transplantat & Hematol Oncol, Gliwice Branch, Gliwice, Poland

[12] Polish Acad Sci, Mossakowski Med Res Ctr, Dept Expt Pharmacol, Warsaw, Poland

[13] Maria Sklodowska Curie Natl Res Inst Oncol, Dept Soft Tissue Bone Sarcoma & Melanoma, Warsaw, Poland

来源：

TARGETED ONCOLOGY | 2023年 / 18卷 / 02期

关键词：

METASTATIC MELANOMA; MULTICENTER; SURVIVAL; PHASE-3;

D O I：

10.1007/s11523-023-00954-w

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BackgroundCombined treatment with BRAFi and/or MEK inhibitors (MEKi) improves outcomes in advanced melanoma patients in comparison with monotherapy.ObjectiveWe aim to report real-world treatment efficacy and safety of vemurafenib (V) and vemurafenib + cobimetinib (V + C) from 10 years of practice.Patients and MethodsA total of 275 consecutive patients with unresectable or metastatic BRAF mutated melanoma started first-line V or V + C treatment between 1 October 2013 and 31 December 2020. Survival analyses were performed using the Kaplan-Meier method, and Log-rank and Chi-square tests were used for comparison between groups.ResultsThe estimated median overall survival (mOS) was 10.3 months in the V group, and 12.3 months in the V + C group (p = 0.0005; HR = 1.58, 95% CI 1.2-2.1), although the latter group of patients had lactate dehydrogenase elevated numerically more often. Estimated median progression-free survival (mPFS) was 5.5 months in the V group, and 8.3 months in the V + C group (p = 0.0002; HR = 1.62, 95% CI 1.3-2.1). Complete response, partial response, stable disease, and progressive disease as best responses were recorded in the V/V + C groups in 7%/10%, 52%/46%, 26%/28%, and 15%/16% of patients, respectively. The numbers of patients with any grade of adverse effects were similar in both groups.ConclusionsWe confirmed significant improvement in the mOS and mPFS of unresectable and/or metastatic BRAF mutated-melanoma patients treated outside clinical trials with V + C as compared with V, with no major increase in toxicity for the combination.

引用

页码：235 / 245

页数：11