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Resource Sparing Curative Treatment in Breast Cancer
Closed for proposals
Project Type
Project Code
E33025CRP
1288Approved Date
Status
Start Date
Expected End Date
Completed Date
30 January 2013Description
Breast cancer is rapidly increasing in developing countries. Due to the lack of public education and scarcity of health care facilities, most patients in developing countries present with advanced disease. Radiotherapy is a very important component of the treatment of breast cancer and is usually given after surgery. The main objective of the clinical research project "Resource-sparing curative treatment in breast cancer" is to develop ‘resource-sparing’ radiotherapy treatment protocols that will allow more patients to be effectively treated with the available radiotherapy resources in developing countries. An additional objective is to improve the outcome of those patients whose cancer is too advanced for surgery. Therefore two patient groups will be studied , one whose cancer has been removed by surgery, and the other where surgery is not feasible. The excepted outcomes are a good quality, resource-sparing radiotherapy protocol for patients with operable breast cancer and an improved outcome for patients with inoperable breast cancer.
Objectives
The overall objective of this study is to improve the outcomes of treatment for patients with advanced breast cancer in developing countries. This objective will be achieved by exploring the optimization of treatment techniques which are effective, safe, and resource-sparing.
Specific objectives
2. To evaluate and compare the acute and late adverse events associated with radiotherapy in each of the treatment arms.
Primary Objectives
1. To compare the local control, regional control, overall and disease-free survival of stage IIA – IIIA breast cancer patients randomly assigned to one of two post-mastectomy radiotherapy treatment arms. The treatment arms differ only in one factor, the irradiation or no irradiation of the supraclavicular fossa. the study thus attempts to determine the real benefit of irradiating the supraclavicular fossa which contains the supraclavicular and upper-axilla groups of lymph nodes.
Secondary Objective
1. To assess the demographics, reproductive history and family history in this patient population.
Secondary Objective
2. To characterize the molecular profile of breast cancer in these patient populations.
Impact
The objectives of the clinical trial were met, and there are publications in preparation. However, we think is too early to assess the overall impact of this CRP in the radiation oncology community practice.
It can be anticipated that, in view of the results of this clinical trial, we will be in a position to recommend to radiotherapy departments in Member States to omit the irradiation of the supra-clavicular field when giving post-mastectomy radiotherapy using an hypofractionated regimen (40 Gy in 15 fractions).
Relevance
The research question continues to be very relevant.
We have been able to demonstrate that, although not very toxic, the irradiation of the supra-clavicular field does not add significant benefit in terms of overall survival or loco-regional control of disease. Therefore, we can recommend sparing the irradiation of the S/C field in patients with advanced breast cancer who underwent a mastectomy, thus reducing radiation exposure and improving convenience for the patients and saving resources for the healthcare system.
In a recent ECCO meeting in Amsterdam in September 2013, a recent study of the EORTC was reported. This study - which was conducted over >10 years - showed that the irradiation of the internal mammary chain of lymph nodes in breast cancer patients following mastectomy, results in a small (5%) but measurable benefit in terms of patient survival.
In our study, the internal mammary chain of nodes was not irradiated, but the irradiation of the supra-clavicular and apex-axilla groups of nodes was not beneficial. The omission of irradiation of this field will represent resource sparing, reduction of treatment times and more convenience to patients.
Lymphedema of the arm was not significantly different in both study arms.