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Cardiology monitoring substudy in the PERSEPHONE trial : 6 versus 12 months of trastuzumab
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Hiller, Louise, Vallier, A. L., Ogburn, E., Wardley, A. M., Cameron, D. A., Miles, D., Dunn, Janet A. and Earl, H. M. (2014) Cardiology monitoring substudy in the PERSEPHONE trial : 6 versus 12 months of trastuzumab. Journal of Clinical Oncology, 32 (15). p. 1. doi:10.1200/jco.2014.32.15_suppl.552
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Official URL: https://doi.org/10.1200/jco.2014.32.15\_suppl.552
Abstract
Background: PERSEPHONE is a randomised trial comparing 6month (6m) to 12month (12m) of trastuzumab in patients (pts) with HER2-positive early breast cancer. The trial has recruited 3,166 of 4,000 pts. We report the results of the cardiology monitoring substudy, which the iDSMC reviewed in June 2013 and recommended we release. Methods: Left ventricular ejection fraction (LVEF) was measured prior to trastuzumab, and then 3-monthly for 12 months (x5). LowLVEFwas defined as either <50%, or reported as ‘low’. Results: 11,413 LVEF tests have been reported in 2,484 pts (see Table). Only 10% pts reported low LVEFs, similar across arms (p=0.19). In total, only 483 low LVEFs were reported. There was no difference in time to first low LVEF between treatment arms (log-rank p=0.49). On each treatment arm, there were statistically significant reductions in LVEF % at 6 and 12 months (all p<0.0001). Significantly more 12m pts reported delays (p=0.007) and discontinuations (p<0.0001) due to low LVEFs. Conclusions: Both PERSEPHONE arms are considered safe, with only small relative reductions in LVEF. Duration of treatment has no effect on numbers of pts reporting low LVEFs or time to first low LVEF. However the longer treatment suffers from more delays and discontinuation due to low LVEFs. Low LVEF may relate more to pt factors (e.g.pharmacogenetics), than length of treatment. The data support, and the iDSMC now recommend, less intensive cardiology monitoring during treatment. Clinical trial information: 52968807.
Item Type: | Journal Item | ||||
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Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Journal of Clinical Oncology | ||||
Publisher: | American Society of Clinical Oncology | ||||
ISSN: | 0732-183X | ||||
Official Date: | 20 May 2014 | ||||
Dates: |
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Volume: | 32 | ||||
Number: | 15 | ||||
Page Range: | p. 1 | ||||
DOI: | 10.1200/jco.2014.32.15_suppl.552 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Access rights to Published version: | Restricted or Subscription Access |
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