한빛사 논문
Eun Joo Kang1, Myung-Ju Ahn2, Chan-Young Ock3, Keun-Wook Lee4, Jung Hye Kwon5, Yaewon Yang6, Yoon Hee Choi7, Min Kyoung Kim8, Jun Ho Ji9, Tak Yun10, Byung-Ho Nam11, Sung-Bae Kim12, and Bhumsuk Keam3,*
1Korea University Guro Hospital
2Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center
3Department of Internal Medicine, Seoul National University Hospital
4Department of Internal Medicine, Seoul National University Bundang Hospital/Seoul National University College of Medicine
5Department of Internal Medicine, Chungnam National University College of Medicine
6776-1 1Sunhwan-ro Seowon-gu, Chungbuk National University Hospital
7Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences
8Division of Hematology-Oncology, Department of Internal Medicine, Yeungnam University College of Medicine
9Internal medicine, Samsung Changwon Hospital
10Center for Lung cancer, National Cancer Center
11Clinical Design Research Center, HERINGS
12Oncology, Asan Medical Center, University of Ulsan College of Medicine
* Corresponding Author:
Bhumsuk Keam, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-799, Korea (South), Republic of.
Abstract
PURPOSE: The role of chemotherapy in adenoid cystic carcinoma (ACC) is controversial because ACC is usually stable without chemotherapy and lack of randomized trials. Here, we conducted the first randomized trial to evaluate the efficacy of axitinib as compared to observation in ACC. PATIENTS AND METHODS: In this multicenter, prospective phase II trial, we enrolled patients with recurrent or metastatic ACC whose cancer had progressed within the past 9 months. Patients were randomly assigned to either axitinib (5 mg twice daily) or observation at a 1:1 ratio. Crossover from observation to axitinib was permitted after progression. The primary endpoint was a 6-month progression-free survival (PFS) rate. The secondary endpoints included objective response rate (ORR), overall survival (OS), PFS, duration of response, and adverse events. RESULTS: Sixty patients were allocated to the axitinib or observation group, with response evaluation conducted in 54 patients. With a median follow-up of 25.4 months, the 6-month PFS rate was 73.0% with axitinib and 23.0% with observation. Median PFS was longer in the axitinib arm (10.8 months vs. 2.8 months, P < 0.001). The ORR of axitinib was 0.0%, but the disease control rate was 100.0% with axitinib and 51.9% with observation. Median OS was not reached with axitinib, but was 27.2 months with observation (P = 0.226). The most frequently reported adverse events for axitinib were oral mucositis and fatigue. CONCLUSIONS: In this first randomized trial in patients with ACC, axitinib significantly increased the 6-month PFS rate as compared to observation. (ClinicalTrials.gov number, NCT02859012).
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