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  1. Article ; Online: The MARECA (national study of management of breast cancer locoregional recurrence and oncological outcomes) study: protocol for a prospective, multicentre cohort study.

    Hartup, Sue M / Morgan, Jenna L / Cheng, Vinton Wt / Barry, Peter A / Copson, Ellen / Cutress, Ramsey I / Dave, Rajiv / Elsberger, Beatrix / Fairbrother, Patricia / Hogan, Brian / Horgan, Kieran / Kirwan, Cliona C / McIntosh, Stuart A / O'Connell, Rachel L / Patani, Neill / Potter, Shelley / Rattay, Tim / Sheehan, Lisa / Wyld, Lynda /
    Kim, Baek

    International journal of surgery protocols

    2024  Volume 28, Issue 1, Page(s) 20–26

    Abstract: Background: Despite a UK 5-year breast cancer survival rate of 86.6%, patients may develop breast cancer recurrence within the same breast after breast conserving surgery, as well as in the remaining skin or chest wall after mastectomy or in the ... ...

    Abstract Background: Despite a UK 5-year breast cancer survival rate of 86.6%, patients may develop breast cancer recurrence within the same breast after breast conserving surgery, as well as in the remaining skin or chest wall after mastectomy or in the ipsilateral lymph glands. These recurrences, collectively termed locoregional recurrence (LRR), occur in around 8% of patients within 10 years of their original diagnosis. Currently, there is a lack of robust information on the presentation and prevalence of LRR with no UK-specific clinical guidelines available for the optimal management of this patient group. Additionally, there is a need to identify patterns of LRR presentation and their progression, which will enable prognostic factors to be determined. This will subsequently enable the tailoring of treatment and improve patient outcome.
    Methods: The MARECA study is a prospective, multicentre cohort study recruiting patients diagnosed with breast cancer LRR +/- associated distant metastases. Over 50 UK breast units are participating in the study with the aim of recruiting at least 500 patients over a recruitment period of 24 months. The data collected will detail the tumour pathology, imaging results, surgical treatment, radiotherapy and systemic therapy of the primary and recurrent breast cancer. Study follow-up will be for up to 5 years following LRR diagnosis to determine subsequent oncological outcomes and evaluate potential prognostic factors.
    Discussion: This study will address the current knowledge gap and identify subgroups of patients who have less successful treatment outcomes. The results will determine the current management of LRR and the prognosis of patients diagnosed with breast cancer LRR +/- distant metastases in the UK, with the aim of establishing best practice and informing future national guidelines. The results will direct future research and inform the design of additional interventional trials and translational studies.
    Language English
    Publishing date 2024-01-26
    Publishing country England
    Document type Journal Article
    ISSN 2468-3574
    ISSN (online) 2468-3574
    DOI 10.1097/SP9.0000000000000018
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Combined Perioperative Lapatinib and Trastuzumab in Early HER2-Positive Breast Cancer Identifies Early Responders: Randomized UK EPHOS-B Trial Long-Term Results.

    Bundred, Nigel / Porta, Nuria / Brunt, Adrian Murray / Cramer, Angela / Hanby, Andrew / Shaaban, Abeer M / Rakha, Emad A / Armstrong, Anne / Cutress, Ramsey I / Dodwell, David / Emson, Marie A / Evans, Abigail / Hartup, Sue M / Horgan, Kieran / Miller, Sarah E / McIntosh, Stuart A / Morden, James P / Naik, Jay / Narayanan, Sankaran /
    Ooi, Jane / Skene, Anthony I / Cameron, David A / Bliss, Judith M

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2022  Volume 28, Issue 7, Page(s) 1323–1334

    Abstract: Purpose: EPHOS-B aimed to determine whether perioperative anti-HER2 therapy inhibited proliferation and/or increased apoptosis in HER2-positive breast cancer.: Patients and methods: This randomized phase II, two-part, multicenter trial included newly ...

    Abstract Purpose: EPHOS-B aimed to determine whether perioperative anti-HER2 therapy inhibited proliferation and/or increased apoptosis in HER2-positive breast cancer.
    Patients and methods: This randomized phase II, two-part, multicenter trial included newly diagnosed women with HER2-positive invasive breast cancer due to undergo surgery. Patients were randomized to: part 1 (1:2:2), no treatment (control), trastuzumab or lapatinib; part 2 (1:1:2) control, trastuzumab, or lapatinib and trastuzumab combination. Treatment was given for 11 days presurgery. Coprimary endpoints were change in Ki67 and apoptosis between baseline and surgery tumor samples (biologic response: ≥30% change). Central pathology review scored residual cancer burden (RCB). Relapse-free survival (RFS) explored long-term effects.
    Results: Between November 2010 and September 2015, 257 patients were randomized (part 1: control 22, trastuzumab 57, lapatinib 51; part 2: control 29, trastuzumab 32, combination 66). Ki67 response was evaluable for 223 patients: in part 1 Ki67 response occurred in 29/44 (66%) lapatinib versus 18/49 (37%) trastuzumab (P = 0.007) and 1/22 (5%) control (P < 0.0001); in part 2 in 36/49 (74%) combination versus 14/31 (45%) trastuzumab (P = 0.02) and 2/28 (7%) control (P < 0.0001). No significant increase in apoptosis after 11 days was seen in treatment groups. Six patients achieved complete pathologic response (pCR, RCB0) and 13 RCB1, all but two in the combination group. After 6 years median follow-up, 28 (11%) had recurrence and 19 (7%) died. No recurrences or deaths were observed among patients who achieved a pCR. Ki67% falls ≥50% associated with fewer recurrences (P = 0.002).
    Conclusions: Early response after short duration anti-HER2 dual therapy identifies cancers dependent on the HER2 pathway providing a strategy for exploring risk-adapted individualized treatment de-escalation.
    MeSH term(s) Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Female ; Humans ; Ki-67 Antigen/genetics ; Lapatinib ; Neoadjuvant Therapy ; Neoplasm Recurrence, Local/drug therapy ; Quinazolines ; Receptor, ErbB-2/metabolism ; Trastuzumab ; United Kingdom
    Chemical Substances Ki-67 Antigen ; Quinazolines ; Lapatinib (0VUA21238F) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK)
    Language English
    Publishing date 2022-02-05
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-21-3177
    Database MEDical Literature Analysis and Retrieval System OnLINE

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