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Extended Adjuvant Therapy With Anastrozole Safe, Effective for Up to 5 Years After Initial Treatment: Presented at SGBCC

By Mary Wessling

ST. GALLEN, Switzerland -- March 14, 2009 -- Extended adjuvant therapy with anastrozole offers a safe and efficacious treatment for as long as 3 years in cancer patients who have already undergone 5 years of treatment, said researchers here at the St. Gallen Oncology Conferences: Primary Therapy of Early Breast Cancer International Conference (SGBCC).

Results of the ongoing study by the Austrian Breast Cancer Study Group 16 (ABCSG-16) were presented on March 13 by lead investigator Michael Gnant, MD, Medical University of Vienna, Vienna, Austria.

Studies on aromatase inhibitors (AIs) have reported significant improvements in disease-free survival. However, until now, no optimal duration of adjuvant AI therapy has been established.

Anastrozole has been shown to have no additional safety concerns, and offers the possibility of extending adjuvant therapy for up to 2 to 5 years after the initial treatment.

Therefore, researchers conducted a prospective, open-label, randomised, multicentre, phase 3 study in 2,887 postmenopausal women with early breast cancer (median age, 63.9 years) to investigate the tolerability of long-term aromatase inhibition after initial modern endocrine therapy. Recruitment continues until 2010, with final data available in 2012.

The primary endpoint is disease-free survival and secondary endpoints are overall survival, fracture rate, contralateral breast cancer, and secondary primary cancers between groups.

The women in the study had been recurrence-free for 5 years after surgery, and had completed a primary 5-year adjuvant treatment with either a selective oestrogen receptor modulator (SERM) or with 2 years of SERMs and 3 years of AIs, and in some cases chemotherapy and/or radiotherapy.

Participants were randomised to receive an additional 2 years of treatment with anastrozole (arm A, n = 1,441) or an additional 5 years of treatment (arm B, n = 1,446).

Both groups had similar baseline characteristics including tumour size, lymph-node status, receptor status, cancer grade, and type of previous surgery.

As of June 2008, after a median follow-up of 29.2 months, 2 myocardial infarctions, 3 anginas, 1 myocardial ischaemia, and 6 cases of coronary artery disease had been reported.

As of February 16, 2009, a few reports of ischaemic cardiac events and 87 fractures were documented, for a total of 969 serious adverse events, including instances of endometrial cancer, some secondary cancers and endometrial hyperplasia, vaginal bleeding, polyps, and fibroids.

The safety profile of anastrozole with respect to serious adverse events seems to be consistent with the known safety profile. Many of the problems reported are typical of older, postmenopausal women, and may not be aggravated by the continuation of endocrine treatment, the researchers concluded.

[Presentation title: ABCSG-16/SALSA: Prospective, Open, Randomised, Multicentre Phase III Study to Assess Extended Adjuvant Treatment With 2 or 5 Years' Anastrozole in Postmenopausal Women With Endocrine-Responsive Early Breast Cancer After 5 Years of Initial Adjuvant Endocrine Therapy. Abstract 0138]

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