Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study

Pivot, Xavier; Verma, Sunil; Fallowfield, Lesley; Müller, Volkmar; Lichinitser, Mikhail; Jenkins, Valerie; Muñoz, Alfonso Sánchez; Machackova, Zuzana; Osborne, Stuart; Gligorov, Joseph

doi:10.1016/j.ejca.2017.08.019

Cited by 45 publications

(52 citation statements)

References 38 publications

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“…During the conduct of the BELIS study, no new safety signals were detected for trastuzumab SC. The observed safety profile of trastuzumab SC at home and in the hospital was comparable to the safety results of two randomized studies and the single-arm study SafeHer [9][10][11][12]16].…”

Section: Discussionsupporting

confidence: 70%

“…Observed differences in AE rates between trastuzumab SC and trastuzumab IV in the large PrefHer study were driven by injection site reactions. Adverse events rates were similar between trastuzumab SC (275/479 [57.4%]) and trastuzumab IV (58/478 [54.0%]) when injection site reactions were excluded [10].…”

Section: Discussionmentioning

confidence: 86%

“…One year adjuvant treatment with trastuzumab is well established in HER2-positive eBC. The subcutaneous (SC) administration of trastuzumab over about 5 min has a pharmacokinetic profile and efficacy non-inferior to intravenous (IV) administration with a similar safety profile [9][10][11][12]. The SC administration of trastuzumab is highly preferred by the patients and this is important for treatments over prolonged periods of time [13,14].…”

Section: Introductionmentioning

confidence: 99%

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Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

Denys

Martinez-Mena

Martens

et al. 2020

Breast Cancer Res Treat

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Purpose The subcutaneous (SC) administration of trastuzumab is highly preferred by patients. At home, administration of trastuzumab SC might further improve patient benefit. The aims of the BELIS study are to evaluate the safety and tolerability of trastuzumab SC when administered at home by a healthcare professional (HCP) and to evaluate patient-reported outcomes for treatment experience of at home cancer therapy. Methods This open-label phase IIIb study enrolled HER2-positive early breast cancer patients in Belgium and Israel who completed the first six cycles of trastuzumab IV (neo)adjuvant therapy. The study consisted of three consecutive treatment periods: three cycles of trastuzumab IV and SC each at the hospital and six cycles of trastuzumab SC at home. Results Between November 2013 and December 2014, 23 centres enrolled 102 patients in the intent-to-treat population of which 101 patients entered the safety population. No new safety signals were detected with as expected, more mild administration site events with trastuzumab SC when compared to IV treatment. All patients agreed that they had benefit from at home administration to a large (18/81; 22%) or very large (63/81; 78%) extent. All HCPs (21/21) agreed that SC is the quickest method from start of preparation to finish of administration and that less resource use is needed. Conclusion The results of the BELIS study support that trastuzumab SC can be safely administered at home by a HCP and all patients considered this setting as beneficial. HCPs consider the SC formulation as the quickest method to administer trastuzumab. Trial registration EudraCT Identifier: 2013-000123-13. ClinicalTrials.gov Identifier: NCT01926886.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 86%

Section: Introductionmentioning

confidence: 99%

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Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

Denys

Martinez-Mena

Martens

et al. 2020

Breast Cancer Res Treat

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“…If rapid cytokine release is enhanced by a fast and high Cmax, which is to be expected from a pharmacological viewpoint, subcutaneous administration may reduce the incidence as well as the severity of reactions. This has in fact been demonstrated for trastuzumab (63,64) and rituximab (65,66), but appears to come at the cost of a substantial number of patients experiencing injection site reactions (63)(64)(65)(66).…”

Section: Discussionmentioning

confidence: 98%

Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment

et al. 2020

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Background: Patients with cancer who are treated with monoclonal antibodies are at risk for developing infusion reactions. However, for some monoclonal antibodies, the incidence of infusion reactions is low or can be lowered by the use of adequate premedication schedules. It is often feasible to increase the infusion rate/lower the post-administration observation time. This review gives an overview of infusion reactions and the possibility of accelerating infusion rates. Materials and Methods: Data on infusion reactions and infusion rates for all monoclonal antibodies that are licensed in the European Union for treatment of solid tumors or hematological malignancies, found by a literature search, were included in this review. Results: For 11 out of the 21 monoclonal antibodies data exceeding the registration text were found and described. Faster infusion schedules are possible for bevacizumab, ipilimumab, nivolumab, panitimumab, and rituximab. Conclusion: We propose optimal infusion schedules for each drug.

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“…This shift should provide for preference-based selection of Herceptin over biosimilar products, as supported by data from prefHER study (ClinicalTrials.gov Identifier: NCT01401166), in which 86% of patients preferred subcutaneous Herceptin over intravenous administration. [36][37][38] Anti-ErbB2 investigational products…”

Section: Trastuzumab Biosimilarsmentioning

confidence: 99%

Anti-ErbB2 immunotherapeutics: struggling to make better antibodies for cancer therapy

Santis

2020

mAbs

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Over the past 3 decades, monoclonal antibodies and their related derivatives, including recently approved antibody-drug conjugates, conquered a central role in cancer therapy because of their contribution to improve survival, time to progression and quality of life of patients compared to chemotherapy protocols. This review summarizes information on approved original and biosimilar products, as well as investigational antibody-based therapeutics, targeting ErbB2. This target has been selected as a paradigmatic example because of its relevant role in sustaining the malignancy of major cancer diseases including, breast, gastric and other chemotherapy-resistant solid tumors. This work analyzes the drivers affecting research and development of next-generation anti-ErbB2 immunotherapeutics, taking into account unmet medical needs and pharmacoeconomic issues related to sustainability. The analysis may help with the design of future research and development strategies.

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Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study

Abstract: Three-year EFS data following H SC and H IV treatment are consistent with those reported by previous trials for H in the adjuvant setting. The overall safety profile during adjuvant treatment was as expected.

Cited by 45 publications

References 38 publications

Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer

Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment

Anti-ErbB2 immunotherapeutics: struggling to make better antibodies for cancer therapy

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