PMID- 36005450 OWN - NLM STAT- MEDLINE DCOM- 20221122 LR - 20221203 IS - 1097-0215 (Electronic) IS - 0020-7136 (Linking) VI - 152 IP - 2 DP - 2023 Jan 15 TI - Pertuzumab study in the neoadjuvant setting for HER2-positive nonmetastatic breast cancer in Australia (PeRSIA). PG - 267-275 LID - 10.1002/ijc.34245 [doi] AB - The pertuzumab study in the neoadjuvant setting for HER2+ nonmetastatic breast cancer in Australia (PeRSIA-ML39622) is an analysis of safety and effectiveness data from the pertuzumab patient registry. Although the prognosis of patients with early stage HER2+ breast cancer has been greatly improved by advances in chemotherapy approximately 25% to 30% of patients develop recurrent disease. Our study aimed to examine the effectiveness of neoadjuvant pertuzumab on surgical outcomes, describe the medium-term effectiveness outcomes of patients treated with pertuzumab, and describe the planned and actual anticancer treatment regimens that patients received. Deidentified data were collected from the patients' medical records and entered into REDCap, between March 2018 and July 2019 (n = 95). The adverse events (AEs) reported most frequently were diarrhea (20; 21.1%), rash (4; 4.2%), and LVSD (4; 4.2%; two patients during neoadjuvant treatment and two patients during adjuvant treatment). AEs, >/=Grade 3 were diarrhea (2; 2.1%) and LVSD (1; 1.1%). Following surgery, a breast pathological complete response (bpCR) was achieved in 65 patients (70.7%; 95% CI: 60.2%-79.7%) and total pathological complete response (tpCR) in 59 patients (64.1%; 95% CI: 53.4%-73.9%). All patients who did not achieve a tpCR obtained a partial response (33/92, 35.9%). Our study is the first to capture real-world data on the use of pertuzumab in the neoadjuvant setting in Australia. The effectiveness and safety data are consistent with those reported in clinical trials of pertuzumab in patients with HER2+ breast cancer, with no new safety concerns. CI - (c) 2022 UICC. FAU - Lok, Sheau Wen AU - Lok SW AUID- ORCID: 0000-0002-9919-1665 AD - The Walter and Eliza Hall Institute of Medical Research and Peter MacCallum Cancer Centre, Parkville, Victoria, Australia. FAU - De Boer, Richard AU - De Boer R AD - Peter MacCallum Cancer Centre and St Vincent's Private Hospital, Melbourne, Victoria, Australia. FAU - Baron-Hay, Sally AU - Baron-Hay S AUID- ORCID: 0000-0002-9748-1458 AD - Royal North Shore Hospital, St Leonards, New South Wales, Australia. FAU - Button, Peter AU - Button P AD - OzBiostats Pty. Ltd, Sydney, New South Wales, Australia. FAU - Devitt, Bianca AU - Devitt B AUID- ORCID: 0000-0002-7854-4302 AD - Eastern Health Clinical School, Box Hill, Victoria, Australia. FAU - Forster, Benjamin C AU - Forster BC AUID- ORCID: 0000-0001-9356-8639 AD - The Poche Centre, North Sydney, New South Wales, Australia. AD - Northern Clinical School, The University of Sydney, St Leonards, New South Wales, Australia. FAU - Fox, Peter AU - Fox P AUID- ORCID: 0000-0002-7646-9003 AD - Orange Health Service, New South Wales, Australia. FAU - Harold, Michael AU - Harold M AD - The Walter and Eliza Hall Institute of Medical Research and Peter MacCallum Cancer Centre, Parkville, Victoria, Australia. FAU - Ketheeswaran, Sahisha AU - Ketheeswaran S AD - Roche Products, Pty. Limited, Sydney, New South Wales, Australia. FAU - Kichenadasse, Ganessan AU - Kichenadasse G AUID- ORCID: 0000-0001-9923-5149 AD - Flinders Centre for Innovation in Cancer, Flinders Medical Centre, Bedford Park, South Australia, Australia. FAU - Kiely, Belinda E AU - Kiely BE AUID- ORCID: 0000-0002-1662-3523 AD - Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown, New South Wales, Australia. FAU - Marx, Gavin AU - Marx G AD - Sydney Adventist Hospital, New South Wales, Australia. AD - ANU College of Health and Medicine, The Australian National University, Canberra, Australian Capital Territory, Australia. FAU - Nott, Louise AU - Nott L AUID- ORCID: 0000-0001-8646-1585 AD - Royal Hobart Hospital, Hobart, Tasmania, Australia. FAU - Pellegrini, Laura AU - Pellegrini L AD - Eastern Health Clinical School, Box Hill, Victoria, Australia. FAU - Tafreshi, Ali AU - Tafreshi A AD - Wollongong Private Hospital, Wollongong, New South Wales, Australia. FAU - Gibbs, Peter AU - Gibbs P AUID- ORCID: 0000-0003-1423-4484 AD - The Walter and Eliza Hall Institute of Medical Research and Peter MacCallum Cancer Centre, Parkville, Victoria, Australia. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220825 PL - United States TA - Int J Cancer JT - International journal of cancer JID - 0042124 RN - K16AIQ8CTM (pertuzumab) SB - IM MH - Humans MH - Female MH - *Neoadjuvant Therapy MH - *Breast Neoplasms/drug therapy MH - Persia MH - Australia MH - Diarrhea/chemically induced OTO - NOTNLM OT - HER2-positive breast cancer OT - anti-HER2 drugs OT - pertuzumab OT - trastuzumab EDAT- 2022/08/26 06:00 MHDA- 2022/11/23 06:00 CRDT- 2022/08/25 08:12 PHST- 2022/06/26 00:00 [received] PHST- 2022/07/19 00:00 [accepted] PHST- 2022/08/26 06:00 [pubmed] PHST- 2022/11/23 06:00 [medline] PHST- 2022/08/25 08:12 [entrez] AID - 10.1002/ijc.34245 [doi] PST - ppublish SO - Int J Cancer. 2023 Jan 15;152(2):267-275. doi: 10.1002/ijc.34245. Epub 2022 Aug 25.