10.10.10

The final results of a phase II study of the PARP inhibitor iniparib in combination with gemcitabine/carboplatin are presented by Dr. Joyce O'Shaughnessy and colleagues. The results of this study, which enrolled 123 patients with triple-negative breast cancer, confirm that iniparib improves the outcome of this particularly aggressive subtype of breast cancer, without important associated toxicity. This improved outcome includes an increase in median survival, a rare finding in advanced disease. "While results from this relatively small phase II study add to currently available data on this new therapeutic option, any enthusiasm must be balanced with some degree of caution until data are confirmed by large randomized phase III studies" comments Dr. Fatima Cardoso, Chair. Such studies are currently ongoing in the metastatic setting, evaluating combinations with taxanes and platinums. Additionally, studies in the neoadjuvant setting are in an advanced stage of planning and will include treatment combinations with anthracyclines. Together these studies will provide the evidence needed to confirm if PARP inhibitors are indeed the much needed breakthrough in the treatment of triple-negative breast cancer. Until then, these promising drugs can only be used within the context of a clinical trial.