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Abraxane and gemcitbine for pancreatic cancer

Posted Mar 04 2011 2:17pm


Abraxane and paclitaxel may be very effective for metastatic pancreatic cancer but no full scale studies have yet been published in peer-reviewed venues.

Abraxane (nab-paclitaxel) is an albumin-bound, 130-nm particle form of paclitaxel that was developed to avoid cremophor/ethanol-associated toxicities associated with the parent compound. Abraxane is FDA-approved for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months Clinical data in the prevailing peer-reviewed published medical literature is not adequate to conclude that paclitaxel (abraxane) is effective for the treatment of metastatic pancreatic cancer.

There was a study of 44 patients presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago in 2010. These findings were discussed during a keynote address by Daniel Von Hoff, M.D., "Epithelium and Stroma: Double Trouble," during the "Progress in Pancreatic Cancer" session on April 18 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C. the median overall survival (OS) time was 12.2 months, a doubling of survival compared to historical control of gemcitabine administered alone. This combination of nab-paclitaxel and gemcitabine also resulted in a confirmed overall response rate in 50 percent of patients treated, and a disease control rate (CR, PR and stable disease for 16 weeks or longer according to RECIST criteria) of 68 percent. In the overall study (n=67), three patients achieved a complete response.

There was as well a small phase II trial presented at ASCO 2010. One of 19 patients (5.3%) achieved partial response.

In 2009, Abraxane for Injectable Suspension (paclitaxel albumin [human]-bound particles for injectable suspension) was granted orphan status for the treatment of pancreatic cancer and Stage IIB-IV melanoma. A Phase III study hads been opened that will evaluate ABRAXANE plus gemcitabine versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer.

On 3/2/11 NCCN updated its principles of chemotherapy guideline(PANC-6) to include gemcitabine + nab-paclitaxel (Abraxane) as a category 2B recommendation for the management of locally advanced unresectable and metastatic disease in patients with good performance status.

Von Hoff DD, et al. Promising clinical activity of a NAB paclitaxel plus gemcitabine combination in a disease-specific Phase I trial in patients with advanced pancreatic cancer. 2008 annual meeting of the American Association for Cancer Research. Abstract 4179.

Hosein PJ, Pastorini VH, Gomez CM, Macintyre J, Merchan JR, Ferrell A, et al.A phase II trial of nab-paclitaxel (NP) in patients with advanced pancreatic cancer (PC) who have progressed on gemcitabine-based therapy. 2010 ASCO Gastrointestinal Cancers Symposium. Abstract No. 214.

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