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Adjuvant trastuzumab duration trials in HER2 positive breast cancer : what results would be practice-changing? Persephone investigator questionnaire prior to primary endpoint results

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Hiller, Louise, Dunn, Janet A., Loi, Shrushma, Vallier, Anne-Laure, Howe, Donna L., Cameron, David A., Miles, David, Wardley, Andrew M. and Earl, Helena M. (2018) Adjuvant trastuzumab duration trials in HER2 positive breast cancer : what results would be practice-changing? Persephone investigator questionnaire prior to primary endpoint results. BMC Cancer, 18 . 391. doi:10.1186/s12885-018-4307-8

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Official URL: https://doi.org/10.1186/s12885-018-4307-8

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Abstract

Background: Twelve months treatment is the current standard of care for adjuvant trastuzumab in patients with HER2 positive early breast cancer however the optimal duration is not known. Persephone is a non-inferiority randomised controlled trial comparing 6- to 12-months of trastuzumab. In this trial there will be a trade-off between a possible small decrease in disease-free survival (DFS) with 6-months and reduced cardiotoxicity and cost.

Methods: A structured questionnaire asked clinicians who had recruited patients into the Persephone trial about their
prior beliefs with regards to the clinical effectiveness of trastuzumab and cardiotoxicity profile, in the comparison of 6- and 12-month durations.

Results: Fifty-one clinicians from 40 of the 152 Persephone sites completed the questionnaire. 30/50 responders (60%)
believed that 6-months trastuzumab would give the same 4-year DFS rate as 12-months trastuzumab, with 21/50 (42%) holding this belief across all breast cancer subsets. In addition, 46/49 responders (94%) reported expecting to change their clinical practice to 6-months, with their prior beliefs (most commonly 85% 4-year DFS rate with 6-months) being greater than their lowest acceptable rate (most commonly 83% 4-year DFS rate with 6-months). Low levels of cardiotoxicity were expected with both 6 and 12-months trastuzumab, with the majority expecting lower levels with 6-months. With increasing hypothesised differences of cardiotoxicity rates between the two durations, significantly lower levels of 4-year DFS with 6-months trastuzumab were deemed acceptable (p < 0.0001).

Conclusion: Most responders believe that 6-months trastuzumab is adequate, both overall and within each subset of breast cancer, and plan to change their clinical practice if the Persephone results support their prior belief. An individual patient meta-analysis of the duration trials would give greater precision to estimates of the differences
in efficacy and toxicity, and adequate statistical power to establish a 2% level of non-inferiority for 6-months adjuvant trastuzumab.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Trastuzumab, Breast -- Cancer -- Chemotherapy, Cancer -- Gene therapy, Cardiovascular toxicology
Journal or Publication Title: BMC Cancer
Publisher: BioMed Central Ltd.
ISSN: 1471-2407
Official Date: 5 April 2018
Dates:
DateEvent
5 April 2018Published
26 March 2018Accepted
Volume: 18
Article Number: 391
DOI: 10.1186/s12885-018-4307-8
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
06/303/98[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
UNSPECIFIEDUniversity Hospitals Coventry and Warwickshire NHS Trust‏http://viaf.org/viaf/152707181

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