Bone effects of anastrozole in japanese postmenopausal patients with breast cancer? results of one year follow up by multicenter prospective study, (sbccsg 06：umin 514)
Bone Effects of Anastrozole in Japanese Postmenopausal Breast Cancer Patients: Results of a Two Year Follow-up by Multicenter Prospective Study (SBCCSG-06) Saitama Breast Cancer Clinical Study Group
Hideki Takeuchi, Kazushige Futsuhara, Takashi Yoshida, Hiroyuki Takei, Makoto Kojima, Shigeto Ueda, Tsuyoshi Saito, Satoko Nakano, Sumio Yamashita, Toru Kuroda, Satoshi Hata, Kenichi Inoue, Hiroshi Miyake, Yasuhiko Hakamada, Masafumi Kurosumi, Toshihiro Kai, Toshio Tabei
Background
Anastrozole is superior to tamoxifen in terms of efficacy
• Overall fracture rate was 1.8% (6/330) during the
Figure 1. Trial profile
and safety for adjuvant treatment in postmenopausal
median follow-up period of 33.0 months [Table 3, 4].
patients with hormone-responsive early breast cancer.
• BMD was decreased significantly in any method of
Based on therapeutic guidelines, anastrozole is widely
330 eligible analysed for primary endpoint (ITT)
used for adjuvant treatment in Japan. However, there
• The changes in BMI and weight were not significant.
are only a few reports on the safety of anastrozole in
• In the subset analyses, in only the DXA and 65>
Japanese patients, especially the long-term effects on
group, the height was decreased significantly
despite the fact that the change in BMD was not
• Anastrozole treatment was well tolerated, that was
Objective
indicated by 5.5% of lower occurrence rate for
The aim of this study is to evaluate the frequency of
259 continued(includes 4 fracture continued ANZ)
bone fracture and impact on BMD during the course of
Table 1. Patients profile Table 2. Baseline characteristics
adjuvant treatment with anastrozole in Japanese patients. This is a report on the updated two year
No. of patients (%)
follow-up data after the first year of analysis. Tumor stage Materials and Methods Hormone receptor Patients
• From December 2005 to November 2007, 350
operable breast cancer patients were enrolled in
this clinical trial from 12 centers in Saitama,
Table 3. The BMD (YAM) and details of fracture cases Inclusion criteria
• Operable breast cancer, proven ER and/or PgR
• Completed primary surgery: partial resection or
modified radical mastectomy and sentinel lymphnode
biopsy or axillary dissection, and chemotherapy
• Postmenopausal women: intact uterus and
Table 4. Comparisons between ATAC trial and SBCCSG-06
postmenopausal range of serum FSH and E2 level;
Exclusion criteria
• Severe concomitant disease: hepatic dysfunction;
* ATAC Trialists’ Group. Lancet. 2002; 359: 2131-39. Table 5. Changes in BMD between measuring Table 6. Changes in Height between measuring methods and age (<65, ≥65) methods and age (<65, ≥65)
The eligible patients received adjuvant anastrozoletreatment (1mg/day) for up to 5 years. During the
course of treatment, they were scheduled to undergo
clinical examination for bone fracture and annual
check of BMD (YAM: young-adult-mean). The oral
bisphosphonate could be used concomitantly with
anastrozole for patients diagnosed with osteoporosis
(YAM < 70%). Trial protocol was stopped if any bone
fracture was occurred, the patient refused to continue,
recurrence and secondary cancer were confirmed, or
on the recommendation of the investigator. The data
were mainly analysed for changes in parameters with
Table 7. Adverse events
repeated ANOVA and two-sided p values were used.
Measuring method of BMD
• DXA : dual-energy X-ray absorptiometry for
• MD：microdensitometry for metacarpal bone
Primary endpoint Secondary endpoints
• Bone fracture rate on concomitant oral
Conclusions
In this multicenter prospective study, the fracture rate on anastrozole treatment in Japanese patients was lower than that of
Western population despite the fact that there was a significant reduction of BMD after 2 years of treatment with anastrozole. Annual monitoring of BMD is mandatory in treated patients. Moreover, further long-term follow-up data is necessary to elucidate the racial disparities of the safety profile of anastrozole.
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