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Recruitment, clinical equipoise, patient acceptance and compliance in the UK-ANZ POSNOC trial
Cancer Research Conference ; 83(5 Supplement), 2022.
Article in English | EMBASE | ID: covidwho-2261127
ABSTRACT

Background:

POSNOC is a UK-ANZ multicentre, non-inferiority, randomised trial comparing systemic therapy alone with systemic therapy plus Axillary Treatment (Axillary radiotherapy or ALND) for women with <=2 macrometastases at SNB. The primary outcome is axillary recurrence within 5 years. This paper describes screening, recruitment and compliance data. Method(s) Sites were requested on a monthly basis to upload screening data and provide reasons for nonrecruitment of eligible patients into the trial. Sites entered in the online database whether the patients were compliant with their randomisation allocation. Result(s) The study opened in July 2014 and completed target recruitment of 1900 women (24% of those screened) in July 2021, at 95 sites in the UK and 20 sites in Australia and New Zealand. The reason for non-enrolment was unknown in 1300 women. Of the remaining 4774 women with known reasons, who were screened but not randomised, the most common reasons for non-recruitment were due to either patients (n=2219, 46.5%) or their clinicians (n=782, 16.4%) favouring axillary treatment, or patients (n=490, 10.3%) or their clinicians (n=170, 3.6%) not wishing to have axillary treatment. Over the course of the study, there was an increase in the proportion of patients wanting axillary treatment and declining the trial (Mean % patients declined 2015 - 17.9%, 2021 - 39.1%). Mean number of participants recruited per site per month was 0.24 (SD 0.18) overall, 0.25 (SD 0.19) in the UK, and 0.19(SD 0.15) in ANZ. The mean was < 0.3 in 79 sites and >0.9 in only one site. Recruitment rate remained consistent throughout the study (mean 25.3 per month) except for during the first 6 months of recruitment (5.7) and during the COVID pandemic Apr-Sep 2020 (7.5). Of 89 (4.8%) participants non-compliant with allocation, n=45 (50.6%) received systemic therapy alone and n=44 (49.4%) received systemic therapy plus axillary treatment. There was no fluctuation in the direction of non-compliance during the study duration. There was increasing uptake of axillary radiotherapy to treat the axilla instead of ALND over the course of the study in patients receiving axillary treatment (Number who had ART of all who had axilla treatment2014-2017 - 248/454 (54.6 %);2018-2021 - 315/449 (70.2%)). Conclusion(s) Recruitment and compliance with randomised allocation remained consistent over a seven-year period. POSNOC with in-built radiotherapy QA will provide definitive data on axillary management in patients undergoing mastectomy or BCS with <=2 macrometastases on SNB.
Keywords

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Cancer Research Conference Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Cancer Research Conference Year: 2022 Document Type: Article