| Project Detail |
The standard medical-and-surgical treatment of ovarian carcinoma patients relies on a systemic chemotherapy (carboplatin-paclitaxel), a tumor debulking surgery meant to be complete (no post-operative residual lesion), and a subsequent maintenance treatment with modern targeted agents. Recent studies identified a patient population (~14,000 patients / year in Europe), whose prognostic is poor (5 year-overall survival (OS) <20%) due to a refractory cancer, characterized by a poor chemosensitivity (assessable online with the numeric CA-125 KELIMTM score <1.0) and by a disease found non-resectable disease after 3-4 cycles of chemotherapy. In these patients, there is a high uncertainty about the best treatment adjustments to apply.
SALVOVAR is a European project led by HCL, meant 1) to raise the physician awareness, and propose practical and affordable diagnostic tools for identifying these patients, and 2) to assess the utility (OS benefit), acceptability (quality-of-life; patient perception) and affordability (cost-effectiveness, including country coverage policies) of solutions based on adjustments of their medical-and-surgical treatment. These solutions implementable in routine may improve their prognosis, according to recent literature data. The project will be based on a large pragmatic randomized phase III trial, sponsored by ARCAGY-GINECO group, and activated in 6 countries (ENGOT network; ~100 recruiting centers), with the objective of demonstrating an OS benefit with the chemotherapy densification (weekly carboplatine-paclitaxel dose-dense regimen) compared to the continuation of the standard 3-weekly regimen. Total 685 patients treated with the standard neo-adjuvant chemotherapy will be pre-screened to randomize 240 patients. Dissemination, and communication will be carried-on to ensure the quality of the project, and inform the stakeholders, patients, public, health authorities/ payers of the project outcomes, mean to change the practices.
This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’. |
