Prof Andrea De Censi speaks to ecancer at SABCS 2018 about the results of the phase III TAM-01 clinical trial, where low-dose tamoxifen was found to be safe and effective in reducing recurrence and new breast disease for patients with DCIS, LCIS and ADH.
So we did a phase three trial of low-dose tamoxifen which is an anti entered estrogen to prevent recurrence in women who had a non invasive breast cancer which can be either an atypical ductal hyperplasia or a nobler or ductal carcinoma site these forms are very common today with the introduction of screening mammography at least 20% of all breast neoplasms are
Intrepid illionaire pleasure we found a 50% reduction in the recurrence in the low-dose tamoxifen arm compared with placebo which is same effect that we can we found in the past with 20 milligram which is the standard dose we used a weber 5 milligram per day which is a lower dose which is associated with fewer side-effects our side effects with tamoxifen typical are
In the metro cancer deep vein thrombosis menopausal symptoms such as hot flashes vaginal dryness pain during intercourse and others in this trial we showed a lowering of this serious adverse events we just noted one case of stage 1 endometrial cancer we would predict nearly 3 with a full dose and we saw one case each of venous thromboembolism both in the tamoxifen
Arm and the placebo arm whereas we would predict 2.5 with the full dose perhaps more importantly we saw no difference in menopausal symptoms there was in fact a slight borderline significant increase in the of hot flashes per day which resulted in one less than one extra hot flash per day compared with the sibo no increase in the intensity of the hot flashes and
Perhaps more importantly no increase in pain during intercourse or vaginal dryness finally we noted no increase in our trousers or moscow skeletal pain which are frequently associated with aromatase inhibitors treatment we saw a very intriguing 75% reduction of contralateral breast cancer which of course opens the doors for a primary prevention trial in healthy
At-risk women with because you know the side effects of tamoxifen have prevented its broad use in prevention despite the strong evidence of efficacy by the side effects preclude its use so with we think we hope that with the lower those more women will take this drug for primary prevention especially those who are at higher risk including perhaps the women with
Brock mutation that the study was supported by the government italian government and two charities the italian association for cancer research and the italian league against cancer we are indebted to these associations institutions for supporting study aim at maintaining fair equitable and affordable medicine
Transcribed from video
Low-dose tamoxifen as effective as higher doses for breast cancer patients By ecancer
