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

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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.

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Acknowledgements

Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Rick Flemming PhD, CMPP at Aspire Scientific Limited (Bollington, UK) and was funded by CELLTRION Healthcare Co., Ltd. (Incheon, Republic of Korea). We thank all patients involved in this study.

Funding

This work was supported by the Dong-A University Research Fund.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea

    Sung Yong Oh, Suee Lee & Seok Jae Huh

  2. Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Jeeyun Lee, Seung Tae Kim, Se Hoon Park, Ho Yeong Lim & Won Ki Kang

  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

    Byung Woog Kang & Jong Gwang Kim

  4. Division of Hematology–Oncology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea

    Hyo Jin Lee

  5. Division of Hematology/Oncology, Department of Internal Medicine, School of Medicine, Gyeongsang National University, Jinju, Republic of Korea

    Jung Hoon Kim & Jung Hun Kang

  6. CELLTRION Healthcare Co. Ltd, Incheon, Republic of Korea

    HoUng Kim

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  1. Sung Yong Oh
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Contributions

SYO and JGK were involved in study conception and design, acquisition of data, and analysis/interpretation of data. SJH, BWK, HJL, and JHK were involved in acquisition of data, and analysis/interpretation of data. JL, SL, STK, SHP, JHK, HYL, and WKK were involved in acquisition of data. HK was involved in analysis and interpretation of data. All authors had full access to all the data in the study, reviewed drafts of the manuscript, approved the final version, had final responsibility for the decision to submit for publication, and agree to be accountable for the work.

Corresponding author

Correspondence to Jong Gwang Kim.

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Conflict of interest

HoUng Kim is an employee of CELLTRION Healthcare Co., Ltd. All other authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study formal consent is not required.

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Oh, S.Y., Lee, S., Huh, S.J. et al. Safety and efficacy of trastuzumab administered as a 30-min infusion in patients with HER2-positive advanced gastric cancer. Cancer Chemother Pharmacol 83, 501–508 (2019). https://doi.org/10.1007/s00280-018-3753-y

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