MARC details
| 000 -LEADER |
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| fixed length control field |
03108nam a22003617a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
221213s20222022 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
0959-8049 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.ejca.2022.09.024 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S0959-8049(22)00764-X [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
36410207 |
| 245 ## - TITLE STATEMENT |
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| Title |
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. |
| 251 ## - Source |
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| Source |
European Journal of Cancer. 178:70-81, 2022 Oct 07. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Eur J Cancer. 178:70-81, 2022 Oct 07. |
| 253 ## - Journal Name |
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| Journal name |
European journal of cancer (Oxford, England : 1990) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2022 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2023 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Publication date |
2022 Oct 07 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2022-12-13 |
| 520 ## - SUMMARY, ETC. |
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| 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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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). |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
IN PROCESS -- NOT YET INDEXED |
| 656 ## - INDEX TERM--OCCUPATION |
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| Department |
MedStar Health |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Swain, Sandra M |
| Institution Code |
MSH |
| 790 ## - Authors |
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| 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 K |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.ejca.2022.09.024">https://dx.doi.org/10.1016/j.ejca.2022.09.024</a> |
| Public note |
https://dx.doi.org/10.1016/j.ejca.2022.09.024 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
