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      Call for Papers: Supportive Care - Essential for Modern Oncology

      Submit here before December 31, 2024

      About Oncology Research and Treatment: 2.0 Impact Factor I 3.2 CiteScore I 0.521 Scimago Journal & Country Rank (SJR)

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      Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study

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          Abstract

          Introduction

          SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the USA. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system.

          Methods

          This post-marketing surveillance in Korea included patients in line with approved indications, i.e., patients with early or metastatic breast cancer or metastatic gastric cancer. Safety outcomes were adverse events (AEs) and adverse drug reactions. Effectiveness outcomes were tumor response and event-free survival.

          Results

          424 patients were evaluated: 366 patients (86%) with early breast cancer, 53 patients (13%) with metastatic breast cancer, and 5 patients (1%) with metastatic gastric cancer. Among patients with breast cancer, AEs (mostly mild) and adverse drug reactions were reported by 158 (37.7%) and 57 (13.6%) patients, respectively. Most patients with an AE (141, 89.2%) had no change in treatment schedule. Treatment was temporarily suspended in 14 (8.9%) patients with an AE and completely discontinued in 7 (4.4%). Among patients with early and metastatic breast cancer who were evaluated for efficacy, objective response rates were 82.7% and 38.3%, respectively. Pathological complete response was 64.6% in patients with early breast cancer.

          Discussion/Conclusion

          Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab.

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          Most cited references34

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          Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial.

          Yung-Jue Bang, Eric Van Cutsem, Andrea Feyereislova … (2010)
          Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer. ToGA (Trastuzumab for Gastric Cancer) was an open-label, international, phase 3, randomised controlled trial undertaken in 122 centres in 24 countries. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation. Participants were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab. Allocation was by block randomisation stratified by Eastern Cooperative Oncology Group performance status, chemotherapy regimen, extent of disease, primary cancer site, and measurability of disease, implemented with a central interactive voice recognition system. The primary endpoint was overall survival in all randomised patients who received study medication at least once. This trial is registered with ClinicalTrials.gov, number NCT01041404. 594 patients were randomly assigned to study treatment (trastuzumab plus chemotherapy, n=298; chemotherapy alone, n=296), of whom 584 were included in the primary analysis (n=294; n=290). Median follow-up was 18.6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17.1 months (9-25) in the chemotherapy alone group. Median overall survival was 13.8 months (95% CI 12-16) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0.74; 95% CI 0.60-0.91; p=0.0046). The most common adverse events in both groups were nausea (trastuzumab plus chemotherapy, 197 [67%] vs chemotherapy alone, 184 [63%]), vomiting (147 [50%] vs 134 [46%]), and neutropenia (157 [53%] vs 165 [57%]). Rates of overall grade 3 or 4 adverse events (201 [68%] vs 198 [68%]) and cardiac adverse events (17 [6%] vs 18 [6%]) did not differ between groups. Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer. F Hoffmann-La Roche. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

            Dennis J Slamon, Brian Leyland-Jones, Steven Shak … (2001)
            The HER2 gene, which encodes the growth factor receptor HER2, is amplified and HER2 is overexpressed in 25 to 30 percent of breast cancers, increasing the aggressiveness of the tumor. We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer that overexpressed HER2. We randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive standard chemotherapy plus trastuzumab. Patients who had not previously received adjuvant (postoperative) therapy with an anthracycline were treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women). The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs. 4.6 months; P<0.001), a higher rate of objective response (50 percent vs. 32 percent, P<0.001), a longer duration of response (median, 9.1 vs. 6.1 months; P<0.001), a lower rate of death at 1 year (22 percent vs. 33 percent, P=0.008), longer survival (median survival, 25.1 vs. 20.3 months; P=0.01), and a 20 percent reduction in the risk of death. The most important adverse event was cardiac dysfunction of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although the cardiotoxicity was potentially severe and, in some cases, life-threatening, the symptoms generally improved with standard medical management. Trastuzumab increases the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.
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              Adjuvant trastuzumab in HER2-positive breast cancer.

              Dennis I. Slamon, Wolfgang Eiermann, Nicholas Robert … (2011)
              Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk-benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).
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                Author and article information

                Journal
                Journal ID (nlm-ta): Oncology
                Journal ID (iso-abbrev): Oncology
                Journal ID (hwp): OCL
                Journal ID (publisher-id): OCL
                Title: Oncology
                Publisher: S. Karger AG (Basel, Switzerland )
                ISSN (Print): 0030-2414
                ISSN (Electronic): 1423-0232
                Publication date (Electronic): 27 October 2023
                Publication date (Print): June 2024
                Volume: 102
                Issue: 6
                Pages: 465-475
                Affiliations
                [a ]Department of Surgery, Chief of Breast Cancer Center, Good GangAn Hospital, Busan, South Korea
                [b ]Department of Surgery, Yeungnam University College of Medicine, Daegu, South Korea
                [c ]Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
                [d ]Breast Thyroid Cancer Center, SM Christianity Hospital, Pohang, South Korea
                [e ]Department of Surgery, International St. Mary’s Hospital, Catholic Kwandong University College of Medicine, Incheon, South Korea
                [f ]Department of Surgery, CHA Bundang Medical Center, CHA University, Seongnam-si, South Korea
                [g ]Department of General Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
                [h ]Department of Surgery, Korea University Ansan Hospital, Ansan, South Korea
                [i ]Department of Surgery, Konkuk University School of Medicine, Seoul, South Korea
                [j ]Oncology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea
                [k ]Samsung Bioepis Co., Ltd., Incheon, South Korea
                [l ]Department of Surgery, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, South Korea
                Author notes
                Correspondence to: Min Ho Park, thokthok@ 123456hanmail.net

                Trial registration number: SB3-KO41-PMS.

                Article
                Publisher ID: 534626
                DOI: 10.1159/000534626
                PMC ID: 11151980
                PubMed ID: 37899039
                SO-VID: fed00cd4-3dbc-4c3c-9e95-cfad50425419
                Copyright © © 2023 The Author(s). Published by S. Karger AG, Basel
                License:

                This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC) ( http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes requires written permission.

                History
                Date received : 3 March 2023
                Date accepted : 5 September 2023
                Date: 2024
                Page count
                Figures: 2, Tables: 4, References: 45, Pages: 11
                Funding
                The study was sponsored by Samsung Bioepis.
                Categories
                Subject: Clinical Study

                Keywords: sb3,trastuzumab,biosimilar,real-world evidence,breast cancer
                Data availability:
                Keywords: sb3, trastuzumab, biosimilar, real-world evidence, breast cancer

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