TURKISH JOURNAL OF ONCOLOGY 2011 , Vol 26 , Num 2
An electronic non-interventional pharmacovigilance study of early-stage breast cancer patients on adjuvant treatment with anastrozole (Arimidex®)
Necdet USKENT,1 Atilla ÇÖKMEZ,2 Murat Kemal ATAHAN,2 Erol AKSAZ,3 Nilüfer GÜLER,4 Mahmut MÜSLÜMANOĞLU,5 Vahit ÖZMEN5
1Department of Medical/Hematologic Oncology Anadolu Medical Center, Kocaeli
21st Department of General Surgery, Izmir Ataturk Training and Research Hospital, Izmir
3Department of General Surgery, Ali Osman Sonmez Oncology Hospital, Bursa
4Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara
5Department of General Surgery, Istanbul University, Istanbul Faculty of Medicine, Istanbul, all in Turkey
OBJECTIVES
To identify adverse events profile of patients with breast cancer in Turkey during use of anastrozole.

METHODS
Between 2001-2006, 874 postmenopausal women with earlystage breast-cancer treated with anastrozole (1 mg/day) were included. We used electronic case report forms at 3rd, 6th, 12th, 18th and 24th months after the 1st visit.

RESULTS
Mean age of the patients was 60.2±9.6 years. Mean follow-up period was 11.7±7.5 months. Anastrozole was discontinued in 17 (1.9%) patients due to cancer recurrence during observation period. Thirty-five adverse events (16-mild, 3-moderate, 16-severe) were identified in 18 patients. In 4 patients treatment was discontinued. Of the patients attending followup visits %90 experienced no difficulties in taking treatment as prescribed, and 82% and 88% took treatment exactly as prescribed in 6th and 7th visits, respectively.

CONCLUSION
Compliance and drug tolerability assessments revealed that Anastrozole was well tolerated in 83.2% of the patients, and treatment compliance was high in 81.7% of the patients. Keywords : Anastrozole; early breast cancer; safety