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Goserelin 3.6 mg q28d Tamoxifen 20 mg/d

Adjuvant ovarian suppression combined with tamoxifen or anastrozole, alone or in combination with zoledronic acid, in premenopausal women with hormone-responsive, stage I and II breast cancer: First efficacy results from ABCSG-12.

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Goserelin 3.6 mg q28d Tamoxifen 20 mg/d

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  1. Adjuvant ovarian suppression combined with tamoxifen or anastrozole, alone or in combination with zoledronic acid, in premenopausal women with hormone-responsive, stage I and II breast cancer: First efficacy results from ABCSG-12. Authors: M. Gnant, B. Mlineritsch, W. Schippinger, G. Luschin-Ebengreuth, S. Poestlberger, C. Menzel, R. Jakesz, E. Kubista, C. Marth, R. Greil, On behalf of the ABCSG Date posted: June 1, 2008

  2. Goserelin 3.6 mg q28d Tamoxifen 20 mg/d N= 1803 Primary Outcome: DFS Goserelin 3.6 mg q28d Tamoxifen 20 mg/d Zoledronic Acid 4mg q6mos R Goserelin 3.6 mg q28d Anastrozole 1 mg/d Premenopausal ER and/or PR+ Stage I & II <10 nodes No adjuvant chemo Goserelin 3.6 mg q28d Anastrozole 1 mg/d Zoledronic Acid 4mg q6mos 1:1:1:1

  3. RESULTS

  4. TOXICITY

  5. STUDY COMMENTARY • Previous studies have shown ovarian ablation + Tamoxifen is better than non-anthracycline and non-taxane chemotherapy in premenopausal patients • But this is still not broadly accepted • This current study randomized patients in 2x2 factorial design to one of four treatment arms • Was not blinded • ITT analysis was performed but was underpowered to detect difference between Tamoxifen and AI arms. • 41 vs 29 distant recurrences were found in the AI arm vs. Tam arm respectively • Is LHRH agonist able to adequately suppress ovarian funciton in all premenopausal women? • Significant improvement in DFS and RFS with ZA • Bisphosphonates may have a direct anti-tumour effect as demonstrated in previous studies and supported here.

  6. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • This study is quite suggestive that adjuvant zoledronic acid may be beneficial but it is not ready for prime time yet. We need the confirmatory results from ongoing trials (AZURE trial – SABCS 2008). • Premenopausal women with early ER/PR+ breast cancer do well with ovarian ablation + endocrine therapy • It is suggestive that OFS with LHRH analogs may not be effective and as such consider surgical oophorectomy for those patients receiving an AI in the pre-menopausal setting. • Bone health remains an important issue for women rendered menopausal by treatment for breast cancer, justifying use of BP for prevention of osteoporosis regardless of anti-tumour activity.

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