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. 

 -  2022 
<br/><br/> 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). 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>0959-8049 
<br/><br/><label>Standard No.: </label>10.1016/j.ejca.2022.09.024 [doi] S0959-8049(22)00764-X [pii] 
<br/><br/><label>Subjects--Topical Terms: </label><br/>IN PROCESS -- NOT YET INDEXED
<br/><br/><label>Index Terms--Occupation: </label><br/>MedStar Health
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article