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 Burris, H. Articles by Hainsworth, J. Search for Related Content PubMed PubMed Citation Articles by Burris, H., III Articles by Hainsworth, J. Social Bookmarking                            What's this?

Phase II Trial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin As First-Line Treatment for Patients With Metastatic Breast Cancer

From The Sarah Cannon Cancer Center/Tennessee Oncology, Nashville, TN; Jackson Oncology Associates, Jackson, MS; and Northern Virginia Oncology Group, Fairfax, VA

Address reprint requests to Howard A. Burris III, MD, The Sarah Cannon Cancer Center, 250 25th Avenue N, Suite 110, Nashville, TN 37203; e-mail: hburris{at}tnonc.com

PURPOSE: To determine the response rate of trastuzumab as first-line therapy in patients with HER-2 overexpressing metastatic breast cancer. To assess the feasibility and toxicity of weekly paclitaxel/carboplatin with or without trastuzumab following initial treatment with trastuzumab.

PATIENTS AND METHODS: Sixty-one patients received trastuzumab (8 mg/kg followed by 4 mg/kg/wk) for 8 weeks. Responding patients received 8 additional weeks of trastuzumab (4 mg/kg/wk), and then proceeded to receive trastuzumab (2 mg/kg) in combination with paclitaxel 70 mg/m² and carboplatin (area under the curve, 2) weekly for 6 weeks followed by 2 weeks rest. Stable patients after the initial 8 weeks of trastuzumab proceeded to treatment with trastuzumab, paclitaxel, and carboplatin. Patients with disease progression during the initial 8 weeks had the trastuzumab discontinued and were treated with weekly paclitaxel/carboplatin.

RESULTS: Weekly paclitaxel/carboplatin with or without trastuzumab was well tolerated. Fifty-two patients were assessable for response and all 61 patients were assessable for survival. Seventeen (33%) of 52 patients experienced a minor/partial response to single-agent trastuzumab and received 8 additional weeks of single-agent trastuzumab. Fifteen (29%) of 52 patients had stable disease and proceeded to receive paclitaxel/carboplatin/trastuzumab. Thirty-one patients with measurable disease were assessable for response after initial single-agent trastuzumab followed by paclitaxel/carboplatin/trastuzumab. An overall response rate of 84% (eight complete responses/18 partial responses), median time to progression of 14.2 months, and median overall survival of 32.2 months was reported with the triplet combination. In the patients treated with paclitaxel/carboplatin alone after disease progression on initial single-agent trastuzumab, an overall response rate of 69% (one complete response/10 partial responses), median time to progression of 8.3 months, and median overall survival of 22.2 months was reported. Median time to progression for all 61 patients is 10 months and the median overall survival is 26.7 months.

CONCLUSION: This trial confirms the activity and tolerability of weekly paclitaxel/carboplatin alone or in combination with trastuzumab in women with HER-2 overexpressing metastatic breast cancer.

Supported by a grant from Bristol-Myers Squibb and Genentech.

Presented in part at the 24th and 25th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 10-13, 2001 and December 11-14, 2002; and the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002.

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

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				S. Beslija, J. Bonneterre, H. J. Burstein, V. Cocquyt, M. Gnant, V. Heinemann, J. Jassem, W. J. Kostler, M. Krainer, S. Menard, et al. Third consensus on medical treatment of metastatic breast cancer Ann. Onc., November 1, 2009; 20(11): 1771 - 1785. [Abstract] [Full Text] [PDF]

				N. Normanno, A. Morabito, A. De Luca, M. C. Piccirillo, M. Gallo, M. R Maiello, and F. Perrone Target-based therapies in breast cancer: current status and future perspectives Endocr. Relat. Cancer, September 1, 2009; 16(3): 675 - 702. [Abstract] [Full Text] [PDF]

				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]

				F. Revillion, V. Lhotellier, L. Hornez, J. Bonneterre, and J.-P. Peyrat ErbB/HER ligands in human breast cancer, and relationships with their receptors, the bio-pathological features and prognosis Ann. Onc., January 1, 2008; 19(1): 73 - 80. [Abstract] [Full Text] [PDF]

				A. Chan and R. de Boer Use of Trastuzumab for Metastatic Breast Cancer in Australia: Inaccurate Results and Alternative Interpretation of Findings J. Clin. Oncol., December 10, 2007; 25(35): 5662 - 5663. [Full Text] [PDF]

				S Beslija, J Bonneterre, H Burstein, V Cocquyt, M Gnant, P Goodwin, V Heinemann, J Jassem, W. Kostler, M Krainer, et al. Second consensus on medical treatment of metastatic breast cancer Ann. Onc., February 1, 2007; 18(2): 215 - 225. [Abstract] [Full Text] [PDF]

				M. S. Ewer, M. T. Vooletich, J.-B. Durand, M. L. Woods, J. R. Davis, V. Valero, and D. J. Lenihan Reversibility of Trastuzumab-Related Cardiotoxicity: New Insights Based on Clinical Course and Response to Medical Treatment J. Clin. Oncol., November 1, 2005; 23(31): 7820 - 7826. [Abstract] [Full Text] [PDF]

				J. D. Floyd, D. T. Nguyen, R. L. Lobins, Q. Bashir, D. C. Doll, and M. C. Perry Cardiotoxicity of Cancer Therapy J. Clin. Oncol., October 20, 2005; 23(30): 7685 - 7696. [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]

				S Leibl and F Moinfar Metaplastic breast carcinomas are negative for Her-2 but frequently express EGFR (Her-1): potential relevance to adjuvant treatment with EGFR tyrosine kinase inhibitors? J. Clin. Pathol., July 1, 2005; 58(7): 700 - 704. [Abstract] [Full Text] [PDF]

				P. Nagy, E. Friedlander, M. Tanner, A. I. Kapanen, K. L. Carraway, J. Isola, and T. M. Jovin Decreased Accessibility and Lack of Activation of ErbB2 in JIMT-1, a Herceptin-Resistant, MUC4-Expressing Breast Cancer Cell Line Cancer Res., January 15, 2005; 65(2): 473 - 482. [Abstract] [Full Text] [PDF]

				C. Bernard-Marty, F. Cardoso, and M. J. Piccart Facts and Controversies in Systemic Treatment of Metastatic Breast Cancer Oncologist, November 1, 2004; 9(6): 617 - 632. [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]