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Continuous versus intermittent tamoxifen versus intermittent/alternated tamoxifen and medroxyprogesterone acetate as first line endocrine treatment in advanced breast cancer: An EORTC phase III study (10863)

Beex, L. ; Rose, Carsten LU ; Mouridsen, H. ; Jassem, J. ; Nooij, M. ; Estape, J. ; Paridaens, R. ; Piccart, M. ; Gorlia, T. and Lardenoije, S. , et al. (2006) In European Journal of Cancer 42(18). p.3178-3185
Abstract
Background: Continuous ligand depletion of endocrine responsive tumours may enhance resistance to therapy. Intermittent treatment with tamoxifen (T) was considered to mimic (incomplete) ligand depletion and reintroduction. Furthermore it was postulated that alternating tamoxifen with a non-cross resistant endocrine modality could (further) postpone hormone resistance. Patients and methods: Postmenopausal patients with advanced breast cancer who did not progress after 4 months of first line T therapy were randomised to continue T (40 mg daily) or to 2 monthly intermittent T or intermittent/alternated T and medroxyprogesterone acetate (MPA, 300 mg daily). At progression during break or during MPA, T should be reintroduced. Endpoints of the... (More)
Background: Continuous ligand depletion of endocrine responsive tumours may enhance resistance to therapy. Intermittent treatment with tamoxifen (T) was considered to mimic (incomplete) ligand depletion and reintroduction. Furthermore it was postulated that alternating tamoxifen with a non-cross resistant endocrine modality could (further) postpone hormone resistance. Patients and methods: Postmenopausal patients with advanced breast cancer who did not progress after 4 months of first line T therapy were randomised to continue T (40 mg daily) or to 2 monthly intermittent T or intermittent/alternated T and medroxyprogesterone acetate (MPA, 300 mg daily). At progression during break or during MPA, T should be reintroduced. Endpoints of the study were progression free survival (PFS), time to resistance to tamoxifen and overall survival (OS). Results: Of 593 registered patients, 276 were randomised. After 8 years follow-up the median PFS for continuous T, intermittent T and intermittent/alternated T and MPA was 11.0 (8.1-15.2), 8.0 (6.2-12.4) and 10.8 (7.1-16.7) months, respectively (NS). Resistance to tamoxifen was established only in 84%, 70% and 55% of patients in the three treatment arms, respectively The median times from randomisation to resistance to tamoxifen were 12.5 (9.1-21.1), 13.2 (8.8-19.8) and 24.0 (16.9-60.9) months, respectively (p < 0.001), without translation in differences in survival times. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
endocrine therapy, alternated, advanced breast cancer, intermittent endocrine therapy, tamoxifen medroxyprogesterone acetate, randomised, study
in
European Journal of Cancer
volume
42
issue
18
pages
3178 - 3185
publisher
Elsevier
external identifiers
  • wos:000243304900022
  • scopus:33845224929
ISSN
1879-0852
DOI
10.1016/j.ejca.2006.08.020
language
English
LU publication?
yes
id
70c6ffd7-95e0-42df-92a3-276281f72f58 (old id 679462)
date added to LUP
2016-04-01 12:36:43
date last changed
2022-01-27 07:28:23
@article{70c6ffd7-95e0-42df-92a3-276281f72f58,
  abstract     = {{Background: Continuous ligand depletion of endocrine responsive tumours may enhance resistance to therapy. Intermittent treatment with tamoxifen (T) was considered to mimic (incomplete) ligand depletion and reintroduction. Furthermore it was postulated that alternating tamoxifen with a non-cross resistant endocrine modality could (further) postpone hormone resistance. Patients and methods: Postmenopausal patients with advanced breast cancer who did not progress after 4 months of first line T therapy were randomised to continue T (40 mg daily) or to 2 monthly intermittent T or intermittent/alternated T and medroxyprogesterone acetate (MPA, 300 mg daily). At progression during break or during MPA, T should be reintroduced. Endpoints of the study were progression free survival (PFS), time to resistance to tamoxifen and overall survival (OS). Results: Of 593 registered patients, 276 were randomised. After 8 years follow-up the median PFS for continuous T, intermittent T and intermittent/alternated T and MPA was 11.0 (8.1-15.2), 8.0 (6.2-12.4) and 10.8 (7.1-16.7) months, respectively (NS). Resistance to tamoxifen was established only in 84%, 70% and 55% of patients in the three treatment arms, respectively The median times from randomisation to resistance to tamoxifen were 12.5 (9.1-21.1), 13.2 (8.8-19.8) and 24.0 (16.9-60.9) months, respectively (p &lt; 0.001), without translation in differences in survival times.}},
  author       = {{Beex, L. and Rose, Carsten and Mouridsen, H. and Jassem, J. and Nooij, M. and Estape, J. and Paridaens, R. and Piccart, M. and Gorlia, T. and Lardenoije, S. and Baila, L.}},
  issn         = {{1879-0852}},
  keywords     = {{endocrine therapy; alternated; advanced breast cancer; intermittent endocrine therapy; tamoxifen medroxyprogesterone acetate; randomised; study}},
  language     = {{eng}},
  number       = {{18}},
  pages        = {{3178--3185}},
  publisher    = {{Elsevier}},
  series       = {{European Journal of Cancer}},
  title        = {{Continuous versus intermittent tamoxifen versus intermittent/alternated tamoxifen and medroxyprogesterone acetate as first line endocrine treatment in advanced breast cancer: An EORTC phase III study (10863)}},
  url          = {{http://dx.doi.org/10.1016/j.ejca.2006.08.020}},
  doi          = {{10.1016/j.ejca.2006.08.020}},
  volume       = {{42}},
  year         = {{2006}},
}