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A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer

Authors
 Tae-Yong Kim  ;  Hye Sook Han  ;  Keun-Wook Lee  ;  Dae Young Zang  ;  Sun Young Rha  ;  Young Iee Park  ;  Jin-Soo Kim  ;  Kyung-Hun Lee  ;  Se Hoon Park  ;  Eun-Kee Song  ;  Soo-A Jung  ;  NaMi Lee  ;  Yeul Hong Kim  ;  Jae Yong Cho  ;  Yung-Jue Bang 
Citation
 GASTRIC CANCER, Vol.22(6) : 1206-1214, 2019 
Journal Title
 GASTRIC CANCER 
ISSN
 1436-3291 
Issue Date
2019
Keywords
Chemotherapy ; Gastric cancer ; HER2 ; Poziotinib ; Trastuzumab
Abstract
BACKGROUND: Poziotinib (HM781-36B) is an irreversible pan-HER tyrosine kinase inhibitor which targets EGFR, HER2, and HER4. This prospective, multicenter, open-label, phase I/II study determined the maximum tolerated dose (MTD) and evaluated the safety and efficacy of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer (GC). METHODS: Patients with HER2-positive GC previously treated with one line of chemotherapy received oral poziotinib (8 mg or 12 mg) once daily for 14 days, followed by 7 days off. Paclitaxel (175 mg/m2 infusion) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg infusion) were administered concomitantly with poziotinib on day 1 every 3 weeks. RESULTS: In the phase I part, 12 patients were enrolled (7 at dose level 1, 5 at dose level 2). One patient receiving poziotinib 8 mg and 2 receiving poziotinib 12 mg had dose-limiting toxicities (DLTs); all DLTs were grade 4 neutropenia, one with fever. The most common poziotinib-related adverse events were diarrhea, rash, stomatitis, pruritus and loss of appetite. The MTD of poziotinib was determined to be 8 mg/day and this was used in the phase II part which enrolled 32 patients. Two patients (6.3%) had complete responses and 5 (15.6%) had partial responses (objective response rate 21.9%). Median progression-free survival and overall survival were 13.0 weeks (95% CI 9.8-21.9) and 29.5 weeks (95% CI 17.9-59.2), respectively. CONCLUSIONS: The MTD of poziotinib combined with paclitaxel and trastuzumab was 8 mg/day. This combination yielded promising anti-tumor efficacy with manageable toxicity in previously treated patients with HER2-positive GC.
Full Text
https://link.springer.com/article/10.1007%2Fs10120-019-00958-4
DOI
10.1007/s10120-019-00958-4
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/173429
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