Camrelizumab Plus Apatinib and Temozolomide as First-Line Treatment in Patients With Advanced Acral Melanoma
-
Published:2023-08-01
Issue:8
Volume:9
Page:1099
-
ISSN:2374-2437
-
Container-title:JAMA Oncology
-
language:en
-
Short-container-title:JAMA Oncol
Author:
Mao Lili1, Lian Bin1, Li Caili1, Bai Xue1, Zhou Li2, Cui Chuanliang2, Chi Zhihong1, Sheng Xinan2, Wang Xuan1, Tang Bixia1, Yan Xieqiao2, Li Siming2, Kong Yan1, Dai Jie1, Wei Xiaoting1, Li Juan2, Duan Rong2, Xu Huayan2, Wu Xiaowen2, Yang Yue1, Cheng Fengzhuo3, Zhang Cheng3, Xia Fangzhou3, Pang Zheng3, Guo Jun1, Si Lu1
Affiliation:
1. Department of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China 2. Department of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China 3. Department of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China
Abstract
ImportanceAcral melanoma, known for low tumor mutation burden, responds poorly to immunotherapy. A standard therapy is still lacking.ObjectiveTo investigate the activity and safety of camrelizumab (an anti–programmed cell death-1 antibody) plus apatinib (a vascular endothelial growth factor receptor 2 inhibitor) and temozolomide as first-line treatment in patients with advanced acral melanoma.Design, Setting, and ParticipantsIn this single-arm, single-center, phase 2 nonrandomized clinical trial, patients with treatment-naive unresectable stage III or IV acral melanoma were enrolled at Peking University Cancer Hospital and Institute between June 4, 2020, and August 24, 2021. The data cutoff date was April 10, 2022.InterventionsPatients received 4-week cycles of intravenous camrelizumab, 200 mg, every 2 weeks; oral apatinib 250 mg, once daily; and intravenous temozolomide, 200 mg/m2, once daily on days 1 to 5 until disease progression or unacceptable toxic effects.Main Outcomes and MeasuresThe primary end point was objective response rate as assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (version 1.1). Secondary end points included progression-free survival, time to response, duration of response, disease control rate, overall survival, and safety.ResultsA total of 50 patients (32 men [64%]; median age, 57 years [IQR, 52-62 years]) were enrolled and received treatment. The median follow-up duration was 13.4 months (IQR, 9.6-16.2 months). The objective response rate was 64.0% (32 of 50; 95% CI, 49.2%-77.1%). The median time to response and duration of response were 2.7 months (IQR, 0.9-2.9 months) and 17.5 months (95% CI, 12.0 to not reached), respectively. The disease control rate was 88.0% (44 of 50; 95% CI, 75.7%-95.5%). The estimated median progression-free survival was 18.4 months (95% CI, 10.6 to not reached). The median overall survival was not reached. The most common grade 3 or 4 treatment-related adverse events were increased gamma-glutamyltransferase levels (15 [30%]), decreased neutrophil count (11 [22%]), increased conjugated bilirubin levels (10 [20%]), and increased aspartate aminotransferase levels (10 [20%]). No treatment-related deaths occurred.Conclusions and RelevanceThe findings of this nonrandomized clinical trial suggest that camrelizumab plus apatinib and temozolomide may be a potential first-line treatment option for patients with advanced acral melanoma, which warrants further validation in a randomized clinical trial.Trial RegistrationClinicalTrials.gov Identifier: NCT04397770
Publisher
American Medical Association (AMA)
Subject
Oncology,Cancer Research
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|