This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Loesch, D. Articles by Cox, E. Search for Related Content PubMed PubMed Citation Articles by Loesch, D. Articles by Cox, E.

Phase II Multicenter Trial of a Weekly Paclitaxel and Carboplatin Regimen in Patients With Advanced Breast Cancer

From U.S. Oncology, Inc, Houston, TX.

Address reprint requests to David Loesch, MD, 1347 East County Line Rd South, Indianapolis, IN 46227; email: david.loesch{at}usoncology.com

PURPOSE: To determine the activity of weekly paclitaxel plus carboplatin as first-line therapy in patients with advanced breast cancer (ABC) by assessing response rate, survival, and safety.

PATIENTS AND METHODS: One hundred patients with ABC received paclitaxel 135 mg/m² (group 1, n = 20) and carboplatin area under the concentration-time curve (AUC) of 2. Paclitaxel was subsequently reduced to 100 mg/m² (group 2, n = 80) because of toxicity. The median age was 58.5 years, and most patients had an Eastern Cooperative Oncology Group performance status of 2. Estrogen and progesterone receptor status were evenly distributed among both groups. Sixty-one patients received prior chemotherapy, 37 (61%) of whom received prior doxorubicin. Among 47 patients who received prior hormonal therapy, 43 received tamoxifen.

RESULTS: The overall response rate (ORR) among 95 assessable patients was 62%, including 8% complete responses and 54% partial responses. The median time to response was 1.8 months, and the median duration of response was 13.3 months. The median time to progression was 4.8 months. The median survival was 16 months. Neutropenia and leukopenia were the most common grade 3 and 4 toxicities. In group 1, neutropenia (50%) and leukopenia (35%) necessitated dose reductions for 50% of patients during the first three cycles, prompting the reduction in paclitaxel dose to 100 mg/m². Grade 3 and 4 nonhematologic toxicities for all patients included peripheral neuropathy (11%), infection (6%), anemia (5%), weakness (6%), and paresthesia (3%).

CONCLUSION: The 62% ORR achieved with weekly paclitaxel plus carboplatin is among the highest achieved with chemotherapy for ABC. This high response rate and the lack of cardiotoxicity suggest that the regimen should be considered as a nonanthracycline regimen for future adjuvant therapy.

This article has been cited by other articles:

				K. Bullock and K. Blackwell Clinical Efficacy of Taxane-Trastuzumab Combination Regimens for HER-2-Positive Metastatic Breast Cancer Oncologist, May 1, 2008; 13(5): 515 - 525. [Abstract] [Full Text] [PDF]

				N. Robert, B. Leyland-Jones, L. Asmar, R. Belt, D. Ilegbodu, D. Loesch, R. Raju, E. Valentine, R. Sayre, M. Cobleigh, et al. Randomized Phase III Study of Trastuzumab, Paclitaxel, and Carboplatin Compared With Trastuzumab and Paclitaxel in Women With HER-2-Overexpressing Metastatic Breast Cancer J. Clin. Oncol., June 20, 2006; 24(18): 2786 - 2792. [Abstract] [Full Text] [PDF]

				A. Eniu, F. M. Palmieri, and E. A. Perez Weekly Administration of Docetaxel and Paclitaxel in Metastatic or Advanced Breast Cancer Oncologist, October 1, 2005; 10(9): 665 - 685. [Abstract] [Full Text] [PDF]

				N. U. Lin, J. R. Bellon, and E. P. Winer CNS Metastases in Breast Cancer J. Clin. Oncol., September 1, 2004; 22(17): 3608 - 3617. [Abstract] [Full Text] [PDF]

				E. A. Perez Carboplatin in Combination Therapy for Metastatic Breast Cancer Oncologist, September 1, 2004; 9(5): 518 - 527. [Abstract] [Full Text] [PDF]

				M. D. Pegram, T. Pienkowski, D. W. Northfelt, W. Eiermann, R. Patel, P. Fumoleau, E. Quan, J. Crown, D. Toppmeyer, M. Smylie, et al. Results of Two Open-Label, Multicenter Phase II Studies of Docetaxel, Platinum Salts, and Trastuzumab in HER2-Positive Advanced Breast Cancer J Natl Cancer Inst, May 19, 2004; 96(10): 759 - 769. [Abstract] [Full Text] [PDF]

				H. Burris III, D. Yardley, S. Jones, G. Houston, C. Broome, D. Thompson, F. A. Greco, M. White, and J. Hainsworth Phase II Trial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin As First-Line Treatment for Patients With Metastatic Breast Cancer J. Clin. Oncol., May 1, 2004; 22(9): 1621 - 1629. [Abstract] [Full Text] [PDF]

				M. Markman, K. Zanotti, G. Peterson, B. Kulp, K. Webster, and J. Belinson Expanded Experience With an Intradermal Skin Test to Predict for the Presence or Absence of Carboplatin Hypersensitivity J. Clin. Oncol., December 15, 2003; 21(24): 4611 - 4614. [Abstract] [Full Text] [PDF]