Table 2.
Characteristics of randomized trials and observational studies addressing the association of gastric cancer with tamoxifen therapy.
| Authors, year (reference) |
Country where conducted |
Study name or target population |
Study Type |
Median follow-up time in years |
Age range or menopausal status |
Treatment regimen (daily dose and duration) | Treatment regimen | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment regimen | Gastric cancer cases |
n/women-years at risk |
Treatment regimen (daily dose and duration) |
Gastric cancer cases |
n/women-years at risk |
||||||
| Ribeiro et al., 1992 (48) | UK | The Christie Hospital Adjuvant Tamoxifen trial |
RCT | 10 | Postmenopausal | TAM (20 mg/1 yr) | 2 | 282/2,820 | no treatment | 0 | 306/3,060 |
| Ryden et al., 1992 (55) | Sweden | The Southern Sweden Breast Cancer Trial |
RCT | 9 | Postmenopausal | RT + TAM (30 mg/1 yr) |
2 | 239/1,847 a | RT | 0 | 236/1,812 a |
| Cummings et al., 1993 (56) |
US | Eastern Cooperative Oncology Group |
RCT | TAM: 7.4 placebo: 4.4 |
65–84 | TAM (20 mg/1 yr) | 1 | 85/629 | placebo | 1 | 83/365 |
| Rivkin et al., 1994 (57) | US | The Southern Oncology Group Study |
RCT | 6.5 | Postmenopausal | CHEMO + TAM (20 mg/1 yr) |
1 | 303/1,970 | CHEMO | 0 | 300/1,950 |
| Rutquvist et al., 1995 (52) |
Sweden | The Stockholm Breast Cancer Study Group |
RCT | 9 | Postmenopausal | TAM (40 mg /2 or 5 yrs) |
5 | 1372/9,610 | no treatment | 2 | 1357/9,378 |
| Fisher et al.,1996 (50) | US and Canada |
(NSABP) B-14 | RCT | 10.4 (mean) | Mean age: 55 yrs | TAM (20 mg/5 or 10 yrs) |
4 | 1404/14,602 | placebo | 2 | 1414/14,706 |
| Cuzick et al., 2002 (58) | UK | The International Breast Cancer Intervention Study (IBIS-I) |
RCT | 4.2 | 35 – 70 | TAM (20 mg /5 yrs) |
1 | 3578/15,028 | placebo | 3 | 3574/15,011 |
| Fisher et al., 2005 (59) | US | The National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention trial (P-1) |
RCT | 6.2 (mean) | ≥35 | TAM (20 mg /5 yrs) |
2 | 6,681/40,844 | placebo (including crossovers after unblinding) |
2 | 6,707/40,648 |
| Veronesi et al., 2007 (60) |
Italy | Italian Randomized Tamoxifen Prevention Trial |
RCT | 9.1 (mean) | 35 – 70 | TAM (20 mg /5 yrs) |
1 | 2700/30,303 | placebo | 4 | 2708/30,310 |
| Curtis et al., 1996 (53) | US | Cancer registration data from 1980 to 1992 |
Cohort | 12 (maximum) |
≥50 yrs | hormone therapy for their first course of therapy |
15 | 14,358 /39,736 | no hormonal therapy/unknown |
118 | 72,965/348,393 |
| Matsuyama et al., 2000 (61) |
Japan | 9 medical institutions | Cohort | TAM: 7.64 Non-TAM: 8.1 |
Adult women | TAM (20 mg /≤2 yrs mainly) |
32 | 3,497/26717 | CHEMO or no further treatment |
19 | 2,529/20,485 |
| Ursic-Vrscaj et al., 2001 (62) |
Slovenia | Population-based registry from 1987 to 1994 |
Cohort | 8.5(mean); 5–12 (range) |
≥55 yrs | TAM (20 mg /3.33 yrs, median) |
2 | 440/3,740 | no TAM | 0 | 190/1,615 |
| Fowble et al., 2001 (63) | US | University of Pennsylvania or Fox Chase Cancer Center |
Cohort | TAM: 7.4 Non-TAM: 9.6 |
Pre and postmenopausal b |
TAM (−/1 yr) | 0 | 234/1,732 | no TAM | 1 | 681/6,538 |
| Andersson et al., 2008 (46) |
Denmark | Patients registered by the population based Danish Breast Cancer Cooperative Group (DBCG) |
Cohort | 7.8 | 19 – 89 | TAM (−/1 yr) | 19 | 7,204/47,465 | other treatment | 38 | 24,614/209,098 |
Abbreviations: RCT, randomized clinical trial; RT, radiotherapy; TAM, tamoxifen; CHEMO, chemotherapy.
a
Person-time estimates taken from Rutquvist et al., 1995 (52).
b
All women received radiotherapy.
Italicized numbers were approximated based on reported data.