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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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WRAP-adjuvant-trastuzumab-duration-trials-HER2-positive-breast-cancer-Hiller-2018.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1219Kb) | Preview |
Official URL: https://doi.org/10.1186/s12885-018-4307-8
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 | |||||||||
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| 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 |
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| 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: |
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| Date of first compliant deposit: | 13 July 2018 | |||||||||
| 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: |
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