Randomised comparison of 5 years of adjuvant tamoxifen with continuous therapy for operable breast cancer

Stewart, H.J.; Forrest, A. P. M.; Everington, Dawn; McDonald, CC; Dewar, John; Hawkins, R. A.; Prescott, R. J.; George, W.D.

doi:10.1038/bjc.1996.356

Cited by 160 publications

(45 citation statements)

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“…This issue is important, since a history of breast cancer, alone, denotes a 1.6-fold risk of endometrial cancer (Adami et al, 1997). The risk of endometrial carcinoma in tamoxifen users has been shown to be increased in some (Fisher et al, 1994;Rutqvist et al, 1995;Fisher et al, 1998) although not all studies (Ribeiro and Swindell, 1988;Stewart et al, 1996), and close endometrial surveillance has been recommended to these patients (Fornander et al, 1993;van Leeuwen et al, 1994;Tesoro et al, 1999). We followed prospectively a rather large number of postmenopausal patients, whose endometrial status was carefully examined before and during the trial.…”

Section: Discussionmentioning

confidence: 99%

Prospective study on gynaecological effects of two antioestrogens tamoxifen and toremifene in postmenopausal women

et al. 2001

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To assess and compare the gynaecological consequences of the use of 2 antioestrogens we examined 167 postmenopausal breast cancer patients before and during the use of either tamoxifen (20 mg/day, n = 84) or toremifene (40 mg/day, n = 83) as an adjuvant treatment of stage II–III breast cancer. Detailed interview concerning menopausal symptoms, pelvic examination including transvaginal sonography (TVS) and collection of endometrial sample were performed at baseline and at 6, 12, 24 and 36 months of treatment. In a subgroup of 30 women (15 using tamoxifen and 15 toremifene) pulsatility index (PI) in an uterine artery was measured before and at 6 and 12 months of treatment. The mean (±SD) follow-up time was 2.3 ± 0.8 years. 35% of the patients complained of vasomotor symptoms before the start of the trial. This rate increased to 60.0% during the first year of the trial, being similar among patients using tamoxifen (57.1%) and toremifene (62.7%). Vaginal dryness, which was present in 6.0% at baseline, increased during the use of tamoxifen (26.2%) and toremifene (24.1%). Endometrial thickness increased from baseline (3.9 ± 2.7 mm) to 6.8 ± 4.2 mm at 6 months ( P < 0.001), and no difference emerged between the 2 regimens in this regard. Before the start of the antioestrogen regimen, the endometrium was atrophic in 71 (75.5%) and proliferative in 19 of 94 (20.2%) samples; 4 patients had benign endometrial polyps. During the use of antioestrogen altogether 339 endometrial samples were taken (159 in tamoxifen group, 180 in toremifene group). The endometrium was proliferative more often in the tamoxifen group (47.8%) than in the toremifene group (32.2%) ( P < 0.0001). 20 patients had a total of 24 polyps (17 in tamoxifen and 9 in toremifene group, P < 0.05) during the use of antioestrogens. One patient in the toremifene group developed endometrial adenocarcinoma at 12 months, and one patient had breast cancer metastasis on the endometrium. Tamoxifen failed to affect the PI in the uterine artery, but toremifene reduced it by 15.0% ( P < 0.05) by 12 months. In conclusion, tamoxifen and toremifene cause similarly vasomotor and vaginal symptoms. Neither regimen led to the development of premalignant endometrial changes. Our data suggest that so close endometrial surveillance as used in our study may not be mandatory during the first 3 years of use of antioestrogen treatment. © 2001 Cancer Research Campaign http://www.bjcancer.com

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Section: Discussionmentioning

confidence: 99%

Prospective study on gynaecological effects of two antioestrogens tamoxifen and toremifene in postmenopausal women

et al. 2001

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“…In the adjuvant setting, TAM is administered at a daily oral dose of 20 mg, and several studies have now shown that the optimal duration of treatment is 5 years. While shorter (2 years) and longer (10 years) treatment durations produce notable responses, the risk : benefit ratios are strongly in favor of 5 years of treatment (Stewart et al, 1996;EBCTCG, 1998).…”

Section: Antiestrogens and Breast Cancer Treatmentmentioning

confidence: 99%

Antiestrogen resistance in breast cancer and the role of estrogen receptor signaling

et al. 2003

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“…(Early Breast Cancer Trialists' Collaborative, 2005) Tamoxifen (20 mg once daily) is recommended for patients for 5 years adjuvant therapy (Early Breast Cancer Trialists' Collaborative Group, 2004) to provide maximum benefit (Fisher et al, 1996;Stewart et al, 1996;Burstein and Winer, 2000).…”

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confidence: 99%

Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer

et al. 2008

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Increasing duration of tamoxifen therapy improves survival in women with breast cancer but the impact of adherence to tamoxifen on mortality is unclear. This study investigated whether women prescribed tamoxifen after surgery for breast cancer adhered to their prescription and whether adherence influenced survival. A retrospective cohort study of all women with incident breast cancer in the Tayside region of Scotland between 1993 and 2002 was linked to encashed prescription records to calculate adherence to tamoxifen. Survival analysis was used to determine the effect of adherence on all-cause mortality. In all 2080 patients formed the study cohort with 1633 (79%) prescribed tamoxifen. The median duration of use was 2.42 years (IQR ¼ 1.04 -4.89 years). Longer duration was associated with better survival but this varied over time. The hazard ratio for mortality in relation to duration at 2.4 years was 0.85, 95% CI ¼ 0.83 -0.87. Median adherence to tamoxifen was 93% (interquartile range ¼ 84 -100%). Adherence o80% was associated with poorer survival, hazard ratio 1.10, 95% CI ¼ 1.001 -1.21. Persistence with tamoxifen was modest with only 49% continuing therapy for 5 years of those followed up for 5 years or more. Increased duration of tamoxifen reduces the risk of death, although one in two women do not complete the recommended 5-year course of treatment. A significant proportion of women have low adherence to tamoxifen and are at increased risk of death.

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Randomised comparison of 5 years of adjuvant tamoxifen with continuous therapy for operable breast cancer

Cited by 160 publications

References 1 publication

Prospective study on gynaecological effects of two antioestrogens tamoxifen and toremifene in postmenopausal women

Prospective study on gynaecological effects of two antioestrogens tamoxifen and toremifene in postmenopausal women

Antiestrogen resistance in breast cancer and the role of estrogen receptor signaling

Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer

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