Today, standard treatment for early Breast carcinoma starts with a surgical step consisting of the tumor resection and sentinel lymph-node (SLN) detection, in order to select patients to be proposed for complementary axillary lymphadenectomy. This requested information may be obtained during the same operation time by intra operative examination, or after surgery with the consequence of a second surgical procedure when lymphadenectomy appears to be indicated. In France, three strategies are currently used for the management of sentinel lymph nodes:
* intra operative pathological frozen section examination followed by final pathological diagnosis,
* intra operative molecular biology using the OSNA technique (One Step Nuclear Acid analysis)
* no intra operative examination, but the final pathological examination. Each of these 3 strategies has advantage and drawbacks and their own cost. With more than 50000 new cases per year in France, Breast carcinoma, thanks to population screening, more and more small tumors are detected where such information about sentinel LN invasion is needed.
Our proposed study is a prospective, cost-effectiveness and comparative non randomised study where three strategies are evaluated in the current practice of the participating teams.
Main Objective :
• to evaluate in each of these 3 strategies for sentinel LN diagnosis, cost-effectiveness and cost-utility (QALY), Quality of Life,…
Secondary Objectives :
* rate of second surgery needed
* rate of mico-metastases or macro-metastases detected to build a decision score,
* follow-up of non re-operated patient despite positive sentinel LN,
* RNA collection from the crushed and blended sentinel LN
* Quality of Life evaluation through the surgical times using QLQ C30 and Br 23 scales.
Medical section :
At pre-operative consultation, patients will be informed to consent participating in our observational study, without any change in their treatment strategy. Inclusion parameters are strictly the same in the three groups.
At the time of surgery, if intra operative examination is planned, patient will be informed that a complete axillary dissection could be indicated.
Included patients will be followed 15 days after surgery and at 3 and 9 months. Then every 6 months during 2 years, then yearly.
Economical section :
Main objective of " SAGE " study is to light up decision maker in striking the balance of each strategy (induced costs and prevented costs) and results in terms of health as expressed by individuals preference depending on different health status, treatment strategies and clinical practice in French centers.
In our study, the medico-economical evaluation on such a quite National scale (17 different centers) takes place in a practice standardization prospect.
General methodology :
In each participating center, one of the 3 strategies for the sentinel LN analysis is currently used (with or without extemporaneous procedure).
Cost-effect evaluation will inventory all undertaken costs in each strategy and all induced positive or negative consequences, both at a qualitative and quantitative level using micro costing and macro costing evaluations. Evaluation of Quality of Life adjusted to health will be included to the cost effect analysis.
In our study, population studied with a localized breast carcinoma, are women aged between 18 and 65 years old and likely to be active : inclusion criteria are strictly the same in the 3 strategies studied.
In our study, we will consider Hospital and Health Insurance point of view. Hospital prospect will identify and value the cost paid by health institution due to the use of any of these 3 techniques.
Insurance Health prospect will value the costs of each treatment strategy including direct costs related to private medical care and not only those to be reimbursed to the hospital.
The study starts at the time of the sentinel LN excision and ends 9 months later, including the post-operative complications and the possible second surgery for axillary LN excision.
At all 920 patients will be included in the 20 participating team.
