The International Oncology Network (ION) Study 04-012 results were presented in a poster presentation at the ASCO 2008 Annual Meeting. This study was an open label Phase II study of Abraxane (nab-paclitaxel) therapy at 125 mg/M2 weekly for three out of four weeks, cycles every 4 weeks for first-line treatment of patients with metastatic breast cancer. Patients with her-2 overexpressing or amplified disease also received Herceptin on a standard weekly schedule.
This is a copy of the poster:
Abraxane is a protein-bound paclitaxel formulation, which can be given over shorter infusion duration than other taxanes, and it has a low rate of allergy or infusion reactions because it is cremaphor solvent-free. Abraxane infusions do not require steroid premedication. In previous studies of Abraxane in metastatic breast cancer, encouraging activity has been noted, even in pre-treated patient groups. The response rate seen with Abraxane in other studies appears to be comparable or superior to responses seen with other taxane drugs.
The ION Study enrolled 72 patients. At the time of the analysis, 47 were evaluable for response. There were 29 her-2 negative patients and 17 her-2 positive evaluable patients. One patient had her-2 unknown status. In the her-2 negative group, there were 9 partial responses (31%) and 18 (62%) patients with stable disease. In the her-2 positive group, there were 2 complete responses (12%), 9 partial responses (53%), and 5 (29%) patients with stable disease. Therefore, the overall response rate in her-2 positive patients was 65%. Overall, for all patients, the response rate was 43%. Median time to progression was 15.9 months, and median overall survival was 25 months.
Treatment was well tolerated and grade >=3 toxicities were mostly limited to neutropenia and/or fatigue. Infections were uncommon.
Dr. Barry Mirtsching of CORT was the Principle Investigator of this study. Special thanks to Abraxis Oncology, the many ION investigator physicians, study coordinators, and participating patients who helped make this research study possible.
ION is continuing to study Abraxane therapy in the setting of metastatic breast cancer. Dr. Mirtsching at CORT is also the Principle Investigator for the study of Abraxane and Sorafenib (Nexavar) for first-line therapy of metastatic breast cancer. Sorafenib is an oral drug with anti-angiogenic activity. It is approved for the treatment of metastatic renal (kidney) cancer. The combination of anti-angiogenic drugs and taxane therapy has shown promise in treatment of metastatic breast cancer. Bevacizumab (Avastin), a monoclonal antibody with anti-VEGF (vascular endothelial growth factor) activity, and paclitaxel has been shown to improve progression-free survival when compared to paclitaxel alone. Sorafenib would be a significant advance for breast cancer patients if it proves to be as active as Avastin, because it is oral and has a generally more favorable toxicity profile than Avastin. Abraxane was chosen in this study for the clinical advantages noted previously.
For more information about the ION 06-025 Study of Abraxane and Sorafenib, please call 972-566-5588 (Dallas), or 972-981-4012 (Plano), or visit the www.CORTPA.com.
Tags: Abraxane, Abraxane + Herceptin, Breast Cancer, ION 04-012 Study, ION 06-025 Study, metastatic breast cancer, nab-paclitaxel, Nexavar, sorafenib, trastuzumab
