First-Line Nab-Paclitaxel Is Superior To Docetaxel For Metastatic Breast Cancer

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Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 27 May 2009 - 4:00 PDT

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CHICAGO, May 26, 2009 - New data show that nab-paclitaxel (Abraxane^R for Injectable Suspension) prolongs investigator-assessed, median progression-free survival (PFS) by almost seven months versus the highest standard dose of docetaxel in women with metastatic breast cancer.

Nab-paclitaxel is a novel albumin-bound paclitaxel, an established chemotherapy agent, combined with albumin, a very small naturally-occurring protein.

The findings, from a phase 2 trial that enrolled 302 women with previously untreated metastatic breast cancer, were published online today in the Journal of Clinical Oncology (JCO).

"We believe that the results suggest that weekly nab-paclitaxel may be a suitable alternative to the taxane docetaxel given every three weeks for the first-line treatment of metastastic breast cancer," principal investigator William J. Gradishar, MD, Director of Breast Medical Oncology at Northwestern University's Robert H. Lurie Comprehensive Cancer Center, said.

In prior research involving metastatic breast cancer patients, nab-paclitaxel had produced significantly higher anti-tumor activity than solvent-based paclitaxel.

The present study was undertaken to evaluate the efficacy and safety of three nab-paclitaxel dosing regimens (weekly versus every three weeks) and to examine differences in safety and efficacy between these dosing regimens of nab-paclitaxel and docetaxel administered at the highest standard dose.

Patients were randomized to receive nab-paclitaxel 300 mg/m² every three weeks (q3w), 100 mg/m² weekly, 150 mg/m² weekly, or docetaxel 100 mg/m² q3w.

Results showed that patients treated with nab-paclitaxel 150 mg/m² weekly had a significantly longer median PFS than docetaxel-treated patients when assessed by both the independent radiologists (12.9 versus 7.5 months, respectively, p=0.0065) and the investigator (14.6 months versus 7.8 months, respectively, p=0.012) using RECIST guidelines.

The overall response rate (ORR) tended to be higher with both weekly nab-paclitaxel regimens than docetaxel by independent radiology review. The investigator assessment found that the difference in ORR between both weekly nab- paclitaxel doses and docetaxel was statistically significant.

Review by both the investigator and the independent radiologist found a significantly higher disease control rate (DCR) in patients receiving either dose of weekly nab-paclitaxel compared to docetaxel.

All nab-paclitaxel doses showed an overall superior safety and toxicity profile over docetaxel.

Dr. Gradishar said that the results of this study bolster earlier data identifying a role for nab-paclitaxel as a suitable option to docetaxel for first-line treatment of metastatic breast cancer.

The study was sponsored by Abraxis BioScience, Inc. in Los Angeles, California.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail.com
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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