More than a thousand patients and 50 hospitals participated in the study, which represents an important step toward better Spanish breast cancer research
Spanish Oncology has established a new standard treatment for Breast Cancer at early stages thanks to the results of the study 9805/Target 0 funded by Spanish Breast Cancer Research Group (GEICAM) and sponsored by Sanofi Aventis.
More than thousand patients and 50 hospitals participated in the study, whose findings are reported in the latest issue of The New England Journal of Medicine. Results indicate that docentaxel during quimotherapy reduces the risk of recurrence by 32% in women with high-risk but node-negative, early stage breast cancer when cancer has not spread to lymph nodes.
The aim of the research was to test the efficiency between a drug combination of docetaxel and cyclophosphamide (TAC) in comparision with the traditional treatment of fluorouracil, doxorubicin and cyclophosphamide (FAC). The research has scientifically supported the Food and Drug Administration (FDA) approval of a new use of docetaxel for Breast Cancer.
"This study represents a hit within Spanish Breast Cancer researches and demonstrates the high-level of Spanish Oncology. For the first time, a National research, developed by an independent research group and with Spanish patients, has established a new Standard treatment for this tumour at early-stages", points out doctor Miguel Martin of Gregorio Mara-on Hospital, Madrid. "Apart from this important acknowledge to our scientific labour, it is also important that our research has been published by a prestigious publication such as The New England Journal of Medicine, that only reports those researches which modify standards of treatments".
Improvements on screening campaigns have risen the number of diagnosed women at early stages, just before the tumour has spread to the lymph nodes. However, until now there were no studies with those drug combinations aimed at this profile: women with high-risk but node-negative, early-stage breast cancer. Up to date, we had no approved treatment with taxanos", explains doctor Ana Lluch of Clinico Hospital, Valencia.
"The research launches real figures concerning Breast cancer patients. Treatment benefits were seen in around 70% of patients at early stage and additionally almost 6% patients improved disease-free survival, which means 800 women disease-free per year thanks to this treatment", states doctor Marin. "Up to now, those women were considered low-risk patients and they were not subject of any scientific researches. This concept has been mistaken and caused suboptimal treatments. Thanks to this study we have achieved a new therapeutic tool for a bigger group".
A high-risk of recurrence is considered in the case of women following at least one of the following criteria set by St. Gallen in 1998: patient age of 35 years or older, tumour size greater than 2 cm, negative estrogen-receptor or progesterone-receptor status, tumour histologic grade of 2 or 3.
1060 women participating in the study were randomly assigned to receive TAC or FAC after surgery treated. They received treatment one day every three weeks during six cycles. Scientifics evaluated those criteria: disease-free survival, global survival, treatment security levels and life quality. Results after six years show that adjuvant therapy based on TAC reduce risk of recurrence by 32% and improves disease-free survival. Almost 90% remained disease-free after this period.
For both experts, since now those women will have new alternative therapy. "It is a step towards personalized treatments of this tumour, since the goal is to administrate just those therapies aimed at caused a benefit, avoiding secondary effects. We would thank both women and Spanish Breast Cancer women Federation (FECMA) for all the support. Knowing that one out of eight women will suffer Breast cancer, it is key that all of them are aware of the importance of clinic essays and new researches", explains doctor Miguel Martin.
Eva Carrasco, scientific director of Geicam Fundation, remarks the engagement of this group with scientific investigation, as well as the quality of formation and information. "target 0 started in June 1999, meaning more than 10 years of hard work behind. The study has been created with the collaboration of an independent research group and Sanofi-Aventis, whish demonstrate that those synergies are essential for the development of further effective therapies facing this disease. On behalf of Geicam, we will continue working to guarantee our patients the best treatments in the future".
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