Originally published as JCO Early Release 10.1200/JCO.2008.18.5397 on May 26 2009

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Significantly Longer Progression-Free Survival With nab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic Breast Cancer

From the Northwestern University Feinberg School of Medicine, Chicago, IL; Abraxis BioScience, Los Angeles, CA; Leningrad Regional Oncology Center; St Petersburg Oncology Center, St Petersburg; Yaroslavl Regional Oncology Center, Yaroslavl; and City Oncology Hospital, Moscow, Russian Federation.

Corresponding author: William J. Gradishar, MD, Northwestern University, Breast Oncology, Division of Hematology/Oncology, Department of Medicine, Chicago, IL 60611; e-mail: w-gradishar{at}northwestern.edu.

Purpose In patients with metastatic breast cancer (MBC), nab-paclitaxel produced significantly higher antitumor activity compared with patients who received solvent-based paclitaxel. This phase II study examined the antitumor activity and safety of weekly and every 3 week (q3w) nab-paclitaxel compared with docetaxel as first-line treatment in patients with MBC.

Patients and Methods In this randomized, multicenter study, patients (N = 302) with previously untreated MBC received nab-paclitaxel 300 mg/m² q3w, 100 mg/m² weekly, or 150 mg/m² weekly or docetaxel 100 mg/m² q3w.

Results nab-Paclitaxel 150 mg/m² weekly demonstrated significantly longer progression-free survival (PFS) than docetaxel by both independent radiologist assessment (12.9 v 7.5 months, respectively; P = .0065) and investigator assessment (14.6 v 7.8 months, respectively; P = .012). On the basis of independent radiologist review, both 150 mg/m² (49%) and 100 mg/m² (45%) weekly of nab-paclitaxel demonstrated a higher overall response rate (ORR) than docetaxel (35%), but this did not reach statistical significance. This trend was supported by statistically significant investigator ORR for both weekly nab-paclitaxel doses versus docetaxel. nab-Paclitaxel q3w versus docetaxel was not different for PFS or ORR. On the basis of both the independent radiologist and investigator review, disease control rate was significantly higher for patients receiving either dose of weekly nab-paclitaxel compared with docetaxel. Grade 3 or 4 fatigue, neutropenia, and febrile neutropenia were less frequent in all nab-paclitaxel arms. The frequency and grade of peripheral neuropathy were similar in all arms.

Conclusion This randomized study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel, with a statistically and clinically significant prolongation of PFS (> 5 months) in patients receiving nab-paclitaxel 150 mg/m² weekly compared with docetaxel 100 mg/m² q3w.

Supported by Abraxis BioScience. Financial support for medical editorial assistance was also provided by Abraxis BioScience.

Presented in part at the 29th Annual San Antonio Breast Cancer Symposium, December 14-17, 2006, San Antonio, TX; the 43rd Annual Meeting of the American Society for Clinical Oncology, June 1-5, 2007, Chicago, IL; the 14th European Cancer Conference, September 23-27, 2007, Barcelona, Spain; and the 6th European Breast Cancer Conference, April 15-19, 2008, Berlin, Germany.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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