Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer.

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Citation: European Journal of Cancer. 178:70-81, 2022 Oct 07.PMID: 36410207Department: MedStar HealthForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022ISSN:
  • 0959-8049
Name of journal: European journal of cancer (Oxford, England : 1990)Abstract: AIM: To characterise risk of anaphylaxis/hypersensitivity with intravenous pertuzumab plus trastuzumab (PH IV), the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) or concomitant chemotherapy to support potential administration of PH FDC SC by healthcare professionals outside clinics.CONCLUSION: PH IV and PH FDC SC were well tolerated, with few grade >=3 anaphylaxis/hypersensitivity events reported with PH IV and no grade >=3 related events with PH FDC SC. Most events occurred during chemotherapy. Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.METHODS: A cumulative search for anaphylaxis/hypersensitivity (Roche Standard Adverse Event Group Terms) was performed for all pivotal trials cited in the current EMA P IV/PH FDC SC summaries of product characteristics: MBC: NCT00567190, NCT02402712; EBC: NCT01358877, NCT00545688, NCT00976989, NCT02132949, NCT03493854 and NCT03674112. Occurrence, incidence and severity of events were analysed and a time-trend analysis (by cycle) was performed.RESULTS: This analysis includes 4772 patients who received PH IV and/or PH FDC SC. Incidence of all-grade (grade >=3) anaphylaxis/hypersensitivity events: 3-11% (<=2%) for PH IV MBC trials; 1-13% (0-3%) for PH IV EBC trials; and 2-3% (<1%; not related to PH FDC SC) for PH FDC SC EBC trials. Discontinuations due to anaphylaxis/hypersensitivity were rare for PH IV (generally <1% except two arms of TRYPHAENA: 1% and 3%); no discontinuations of PH FDC SC have been recorded so far. Time-trend analysis showed that most events were reported during the first 6-8 cycles with concurrent chemotherapy, with a decrease in later cycles (except MetaPHER).All authors: Aguila C, Dang CT, Gianni L, Heeson S, Kuemmel S, Liu H, Loibl S, Macharia H, O'Shaughnessy J, Restuccia E, Schneeweiss A, Swain SM, Tan AR, Yang KFiscal year: FY2023Digital Object Identifier: Date added to catalog: 2022-12-13
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Journal Article MedStar Authors Catalog Article 36410207 Available 36410207

AIM: To characterise risk of anaphylaxis/hypersensitivity with intravenous pertuzumab plus trastuzumab (PH IV), the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) or concomitant chemotherapy to support potential administration of PH FDC SC by healthcare professionals outside clinics.

CONCLUSION: PH IV and PH FDC SC were well tolerated, with few grade >=3 anaphylaxis/hypersensitivity events reported with PH IV and no grade >=3 related events with PH FDC SC. Most events occurred during chemotherapy. Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

METHODS: A cumulative search for anaphylaxis/hypersensitivity (Roche Standard Adverse Event Group Terms) was performed for all pivotal trials cited in the current EMA P IV/PH FDC SC summaries of product characteristics: MBC: NCT00567190, NCT02402712; EBC: NCT01358877, NCT00545688, NCT00976989, NCT02132949, NCT03493854 and NCT03674112. Occurrence, incidence and severity of events were analysed and a time-trend analysis (by cycle) was performed.

RESULTS: This analysis includes 4772 patients who received PH IV and/or PH FDC SC. Incidence of all-grade (grade >=3) anaphylaxis/hypersensitivity events: 3-11% (<=2%) for PH IV MBC trials; 1-13% (0-3%) for PH IV EBC trials; and 2-3% (<1%; not related to PH FDC SC) for PH FDC SC EBC trials. Discontinuations due to anaphylaxis/hypersensitivity were rare for PH IV (generally <1% except two arms of TRYPHAENA: 1% and 3%); no discontinuations of PH FDC SC have been recorded so far. Time-trend analysis showed that most events were reported during the first 6-8 cycles with concurrent chemotherapy, with a decrease in later cycles (except MetaPHER).

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