Progress Against Solid Tumors in Danger: The Metastatic Breast Cancer Example
Ces deux articles analysent la controverse relative au retrait récent de l'autorisation de mise sur le marché, par les autorités réglementaires américaines, du bevacizumab dans le traitement d'un cancer métastatique du sein
In 2012, the estimated number of cancer diagnoses in the United States will exceed 1.6 million, with more than a half-million deaths. In broad terms, the goals of treatment for patients with metastatic solid tumors are improving quality of life and overall survival (OS). From a regulatory standpoint, an improvement in OS is the gold standard for approval, but in some diseases and treatment settings, progression-free survival (PFS) is a valid surrogate end point. In fact, PFS has several important advantages: first, it is a timely end point that is reached before OS; second, it is well-known that disease control provides meaningful patient benefit; and third, it is not affected by subsequent therapies. For example, for metastatic breast cancer (MBC), an increasing number of agents are available for use; thus, patients may receive multiple lines of therapy, and it is always possible that better and/or subsequent therapies will be administered to patients preferentially in one study arm, which creates imbalances that can affect OS but not PFS...
Journal of Clinical Oncology , résumé, 2012