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Cancer Chemother Pharmacol. 2019 Mar;83(3):501-508. doi: 10.1007/s00280-018-3753-y. Epub 2018 Dec 8.

Safety and efficacy of trastuzumab administered as a 30-min infusion in patients with HER2-positive advanced gastric cancer.

Author information

1
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea.
2
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
3
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, 807 Hoguk-ro, Buk-gu, Daegu, 41404, Republic of Korea.
4
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, 807 Hoguk-ro, Buk-gu, Daegu, 41404, Republic of Korea. jkk21c@knu.ac.kr.
5
Division of Hematology-Oncology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea.
6
Division of Hematology/Oncology, Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju, Republic of Korea.
7
CELLTRION Healthcare Co. Ltd, Incheon, Republic of Korea.

Abstract

PURPOSE:

To investigate the safety and efficacy of 30-min maintenance infusions of trastuzumab in advanced gastric cancer positive for human epidermal growth factor receptor 2 (HER2).

METHODS:

This was a retrospective study conducted across five Korean hospitals in patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma treated with first-line, 3-weekly trastuzumab plus chemotherapy. The first dose of trastuzumab (8 mg/kg) was administered as a 90-min infusion, with all subsequent maintenance infusions (6 mg/kg) given over 30 min. The primary aim was to investigate infusion-related reactions and cardiac events with 30-min infusions of trastuzumab. Objective response rate, progression-free survival, and overall survival were secondary endpoints.

RESULTS:

The study included 128 patients (efficacy population), of whom 123 received both induction and maintenance infusions and formed the safety population. The median age was 63 years; 80% were presenting for the first time with metastatic disease, and 94% were treated with trastuzumab plus capecitabine/cisplatin. Infusion-related reactions were observed in 32 of 123 patients (26%). There were no cardiac events. The most frequent adverse events were anorexia and nausea, followed by vomiting, fatigue, mucositis, sensory neuropathy, and hand-foot syndrome. Most events were grade 1-2 and were manageable. No patient discontinued study treatment due to adverse events. The objective response rate was 63%, and included 6 complete responses.

CONCLUSIONS:

Trastuzumab 30-min maintenance infusions were well tolerated with a good safety profile, and resulted in sustained efficacy in patients with HER2-positive advanced gastric cancer.

KEYWORDS:

30-min infusion; Chemotherapy; Gastric cancer; HER2; Rapid infusion; Trastuzumab

PMID:
30535535
DOI:
10.1007/s00280-018-3753-y

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