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Randomized Phase II Study of Axitinib versus Observation in Patients with Recurred or Metastatic Adenoid Cystic Carcinoma

Authors
Kang, Eun JooAhn, Myung-JuOck, Chan-YoungLee, Keun-WookKwon, Jung HyeYang, YaewonChoi, Yoon HeeKim, Min KyoungJi, Jun HoYun, TakNam, Byung-HoKim, Sung-BaeKeam, Bhumsuk
Issue Date
1-10월-2021
Publisher
AMER ASSOC CANCER RESEARCH
Citation
CLINICAL CANCER RESEARCH, v.27, no.19, pp.5272 - 5279
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL CANCER RESEARCH
Volume
27
Number
19
Start Page
5272
End Page
5279
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/136091
DOI
10.1158/1078-0432.CCR-21-1061
ISSN
1078-0432
Abstract
Purpose: The role of chemotherapy in adenoid cystic carcinoma (ACC) is controversial because ACC is usually stable without chemotherapy and the lack of randomized trials. Here, we conducted the first randomized trial to evaluate the efficacy of axitinib as compared with 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 with observation.
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