Abstract | BACKGROUND: METHODS: The trial had a standard 3+3 design. The dosage of irinotecan was fixed at 150 mg/m2 repeated every 2 weeks, while the daily dosage of apatinib was escalated from 250 mg, to 500 mg, to 750 mg. Dose-limiting toxicity (DLT) was defined as grade 4 hematological or grade 3-4 non-hematological adverse events (AEs). RESULTS: Twelve patients were enrolled. Three DLTs occurred, comprising a grade 3 perianal abscess and a grade 3 case of kaliopenia in the level 3 cohort, and a grade 4 leukopenia in the level 2 cohort. Based on these DLTs, the MTD of apatinib was 500 mg daily. The most common AEs were leukopenia (91.7%), fatigue (91.7%), anemia (66.7%), and diarrhea (58.3%). One case of grade 2 hematochezia and one case of grade 2 subclavian vein thrombosis were observed. In the nine evaluable cases, the disease control rate (DCR) was 66.7% (6/9). The median progression-free and overall survival (OS) times were 3.6±1.2 and 6.6±3.4 months, respectively. CONCLUSIONS: This phase 1 dose-escalation trial showed that, when combined with irinotecan, a daily dose of 500 mg apatinib was the optimum dose to treat ESCC.
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Authors | Jun Jia, Jing Yu, Zhiwei Sun, Ying Yang, Chuanling Liu, Yanjie Xiao, Xiaodong Zhang |
Journal | Translational cancer research
(Transl Cancer Res)
Vol. 10
Issue 2
Pg. 627-636
(Feb 2021)
ISSN: 2219-6803 [Electronic] China |
PMID | 35116396
(Publication Type: Journal Article)
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Copyright | 2021 Translational Cancer Research. All rights reserved. |