Abstract
IntroductionBasic research has indicated that tocotrienols have potent antiproliferative and proapoptotic effects that would be expected to reduce the effect of breast cancer.MethodsWe conducted a double-blinded, placebo-controlled pilot trial to test the effectiveness of adjuvant tocotrienol therapy in combination with tamoxifen for 5 years in women with early breast cancer. Two-hundred-forty women, aged between 40 and 60 years, with either tumor node metastases (TNM) Stage I or II breast cancer and estrogen receptor (ER)-positive tumors were nonrandomly assigned to two groups. The intervention group received tocotrienol-rich fraction (TRF) plus tamoxifen, whereas the control group received placebo plus tamoxifen, for 5 years.ResultsDuring the 5 years of the study, eight patients died of breast cancer, whereas in 36 patients, a local or systemic recurrence developed. Five-year breast cancer-specific survival was 98.3% (95% confidence interval (CI), 95.9% to 100%) in the intervention group and 95% (95% CI, 91.1% to 98.9%) in the control group, whereas the 5-year disease-free survival was 86.7% (95% CI, 80.6% to 92.8%) and 83.3% (95% CI, 76.6% to 90.0%), respectively. Risk of mortality due to breast cancer was 60% (HR, 0.40; 95% CI, 0.08 to 2.05) lower in the intervention group versus the controls after adjustment for age, ethnicity, stage, and lymph node status, but this was not statistically significant. Adjuvant TRF therapy was not associated with breast cancer recurrence (HR, 0.84; 95% CI, 0.43 to 1.65).ConclusionsFrom the current study, no association seems to exist between adjuvant tocotrienol therapy and breast cancer-specific survival in women with early breast cancer.Trial registrationClinicalTrials.gov Identifier: NCT01157026.
Highlights
Basic research has indicated that tocotrienols have potent antiproliferative and proapoptotic effects that would be expected to reduce the effect of breast cancer
We investigated the effectiveness of tocotrienol-rich fraction (TRF) in combination with tamoxifen compared with placebo with tamoxifen as adjuvant therapy in improving breast cancer-specific survival in women with estrogen receptor (ER)-positive tumors who had been treated for tumor node metastases (TNM) stage 1 and stage 2 breast cancer
61% of patients in the TRF-plus-tamoxifen group and 49% of patients in the placebo-plus-tamoxifen group were in TNM stage 1 of breast cancer, whereas 39% of patients in the TRF-plus-tamoxifen group and 51% in the tamoxifen group were in TNM stage 2 (P = 0.07)
Summary
Basic research has indicated that tocotrienols have potent antiproliferative and proapoptotic effects that would be expected to reduce the effect of breast cancer. Previous studies reported that individual tocopherols and tocotrienols exhibit different potencies in suppressing tumor cell growth and inducing apoptosis in neoplastic mammary epithelial cells [3,4]. Administrations of a- and g-tocotrienol, and not a-tocopherol, have shown a life-prolonging effect in Because tocotrienols are more potent than tocopherols [6,7,8,11,12], we hypothesize that tocotrienol intake may be associated with improved survival and lower recurrence in patients with early breast cancer. It should be noted that tocotrienols with tamoxifen have shown a synergistic inhibitory effect on the proliferative rate and growth of breast cancer cells in vitro [11]
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