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Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer

Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer,Henning Mouridsen,Anita Giobbie-Hurder,Aron Goldhirsch,Beat Thürlima

Letrozole Therapy Alone or in Sequence with Tamoxifen in Women with Breast Cancer   (Citations: 39)
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Methods In this randomized, phase 3, double-blind trial of the treatment of hormone-recep- tor-positive breast cancer in postmenopausal women, we randomly assigned wom- en to receive 5 years of tamoxifen monotherapy, 5 years of letrozole monotherapy, or 2 years of treatment with one agent followed by 3 years of treatment with the other. We compared the sequential treatments with letrozole monotherapy among 6182 women and also report a protocol-specified updated analysis of letrozole ver- sus tamoxifen monotherapy in 4922 women. Results At a median follow-up of 71 months after randomization, disease-free survival was not significantly improved with either sequential treatment as compared with letro- zole alone (hazard ratio for tamoxifen followed by letrozole, 1.05; 99% confidence interval (CI), 0.84 to 1.32; hazard ratio for letrozole followed by tamoxifen, 0.96; 99% CI, 0.76 to 1.21). There were more early relapses among women who were as- signed to tamoxifen followed by letrozole than among those who were assigned to letrozole alone. The updated analysis of monotherapy showed that there was a non- significant difference in overall survival between women assigned to treatment with letrozole and those assigned to treatment with tamoxifen (hazard ratio for letro- zole, 0.87; 95% CI, 0.75 to 1.02; P = 0.08). The rate of adverse events was as expected on the basis of previous reports of letrozole and tamoxifen therapy. Conclusions Among postmenopausal women with endocrine-responsive breast cancer, sequen- tial treatment with letrozole and tamoxifen, as compared with letrozole monotherapy, did not improve disease-free survival. The difference in overall survival with letro- zole monotherapy and tamoxifen monotherapy was not statistically significant. (ClinicalTrials.gov number, NCT00004205.)
Published in 2009.
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    • ... Improvements in adjuvant therapy for ER+ breast cancer are, therefore, hard to demonstrate...

    Rodrigo Goncalveset al. Use of neoadjuvant data to design adjuvant endocrine therapy trials fo...

    • ...1–98 Mouridsen et al. [31] Ribi et al. [36] Prospective, randomized, double-blind phase III L vs T vs L? Tv s T?L (5 years) Postmenopausal women with early hormone-sensitive BC 8,028...
    • ...The BIG 1–98 trial did not report BMD for the monotherapy groups; however, the fracture rate at 71 months was 9.8% for the letrozole group [31]...
    • ...The BIG 1–98 trial did not report data on bone health as measured by BMD for the sequential treatment groups, although the fracture rate at 71 months was 9.4% for patients who switched from tamoxifen to letrozole and 7.5% for patients who switched from letrozole to tamoxifen [31]...
    • ...BIG 1–98 reported comparable cardiovascular events in the letrozole groups (2–7%) [31]...
    • ...The gynecologic adverse events reported in the AI trials are shown in Table 5 [11, 18, 19, 21, 31, 32, 37, 78]...
    • ...In the sequential groups of the BIG 1–98 trial, endometrial cancer developed in 4 patients (0.1%) [31]...
    • ...The reported incidence of hot flashes in the AI trials is shown in Table 6 [11, 18, 19, 21, 31, 32, 37, 78]...
    • ...BIG 1–98, 6 yr [31] 3,074 L vs T Vaginal bleeding...

    Susan F. DentRaniaet al. Aromatase inhibitor therapy: toxicities and management strategies in t...

    • ...Third generation aromatase inhibitors (AI) present a valuable alternative to tamoxifen adjuvant therapy in postmenopausal women with ER+ breast cancer [4-6]...

    Marcela D Salazaret al. During hormone depletion or tamoxifen treatment of breast cancer cells...

    • ...The early improvement in DM events with letrozole has resulted in what appears to be an improvement in overall survival in patients taking letrozole compared with those on tamoxifen [11]...

    J. Michael Dixonet al. Anastrozole and letrozole: an investigation and comparison of quality ...

    • ... is based on proliferation-associated genes and proved to be an independent predictor of relapse in participants of the Breast International Group (BIG) 1-98 trial [...

    A. E. Mooret al. PRO_10 – A New Tissue-Based Prognostic Multigene Marker in Patients wi...

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