Table 1.
Studies in which previous experiences are presented and summarized
| Authors | Okishiro et al. [11] | Nowell et al. [33] | Wegmann et al. [18] | Goetz et al. [38] | Newmann et al. [8] | Schroth et al. [7] | Ramón y Cajal et al. [9] | Bijl et al. [10] | Xu et al. [12] | Kyotani et al. [19] |
|---|---|---|---|---|---|---|---|---|---|---|
| Patients, n | 173 | 337 | 677 | 190 | 115 | 1325 | 91 | 85 | 293 | 282 |
| Tamoxifen dose | 20 mg/day, median 52 months | not reported | 40 mg/day for 2 or 5 years; 20 mg/day for 5 years | 20 mg/day for 5 years | 20 mg/day, median duration > 4 years | not reported | not reported | average 33.7 mg/day | 20 mg/day for 5 years | 20 mg/day for 5 years |
| Age group | 78% postmeno-pausal | 60% > 50 years | postmeno-pausal | postmeno-pausal | 27-68 years | 96% post-menopausal | 40% postmeno-pausal | 55 years | 75% > 50 years | median 50 years |
| Adjustments treatment | adjuvant therapy | none | none | no chemo-therapy | none | no chemo-therapy | none | none | no chemo-therapy | no chemo-therapy |
| Adjustments CYP2D6 inhibitors | excluding paroxetine | none | none | exposure definition | exposure definition | none | none | exposure definition | none | restricted to SSRI |
| Adjustments tamoxifen adherence | none | none | tamoxifen duration | none | none | tamoxifen duration | none | tamoxifen duration | none | 5 years completed |
| Adjustments prognostic markers | tumor size, node status, histologic grade, ER, PR, HER2 | age, stage, race, ER, PR | age, tumor size, node status | age, tumor size, node status | node status | tumor size, grade, ER, PR, node status, retrospective versus prospective | none | age, calendar time | age, tumor size, node status, adjuvant therapy, ER, PR, c-erb2 | age, tumor size, node status, menopausal status, nuclear grade, ER, PR, HER2 |
| Impact | no clinically significant impact on prognosis | no significant impact on survival | clinically significant impact of CYP3A5 | clinically significant impact on prognosis | significant impact on survival | significant impact on event-free and disease-free survival | significant impact on disease-free survival | increased risk of breast cancer mortality | significant impact on disease-free survival | significant impact on recurrence-free survival |
All studies (except for [7]) were retrospectively evaluated. Sample size varied widely between 91 and 1325. Data were derived from clinical series and trials [18, 38 during the years 1975-2006 ([8], data collection not indicated). Follow-up duration was heterogeneous and varied between 4.7 [11] and 11.4 years [38]. ER testing was either performed by pathology laboratory protocol or trial protocol [18, 38. Tamoxifen dose was not reported in 3 studies. Postmenopausal status was indicated in 4 studies, 2 studies reported 40-78% postmenopausal status, while 4 studies did not clearly indicate the menopause status. Selection of study subjects was performed either by frozen tumor tissue (4 studies), successful genotyping (3 studies) or patient survival follow-up (4 studies). 5 studies performed no adjustments to treatment; 4 studies allowed no chemotherapy. Scattered adjustments were performed with respect to CYP2D6 inhibitors, tamoxifen adherence and prognostic markers.