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 Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Jones, S.E. Articles by Ravdin, P.M. Search for Related Content PubMed PubMed Citation Articles by Jones, S.E. Articles by Ravdin, P.M. Related Articles Related Editorial

Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer

From Texas Oncology, Dallas, University of Texas Health Science Center at San Antonio, San Antonio, TX; Tufts-New England Medical Center, Boston, MA; University Hospital of Cleveland, and Cleveland Clinic Foundation, Cleveland, University of Cincinnati, Cincinnati, and Hematology Oncology Consultants Inc, Columbus, OH; University of Arkansas for Medical Sciences, Little Rock, AR; Sharp Rees Steal Medical Group, San Diego, CA; Toronto Sunnybrook Regional Cancer Center, Toronto, Ontario, Canada; Providence Portland Medical Center, Portland, OR; Sanofi-Aventis, Bridgewater, NJ

Address reprint requests to Steve E. Jones, MD, Texas Oncology, 3535 Worth St, Suite 600, Dallas, TX 75246; e-mail: steve.jones{at}usoncology.com

PURPOSE: This randomized, controlled, multicenter, open-label, phase III study compared docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an anthracycline-containing chemotherapy regimen.

PATIENTS AND METHODS: Patients (n = 449) were randomly assigned to receive either docetaxel 100 mg/m² (n = 225) or paclitaxel 175 mg/m² (n = 224) on day 1, every 21 days until tumor progression, unacceptable toxicity, or withdrawal of consent.

RESULTS: In the intent-to-treat population, both the median overall survival (OS, 15.4 v 12.7 months; hazard ratio [HR], 1.41; 95% CI, 1.15 to 1.73; P = .03) and the median time to progression (TTP, 5.7 months v 3.6 months; HR, 1.64; 95% CI, 1.33 to 2.02; P < .0001) for docetaxel were significantly longer than for paclitaxel, and the overall response rate (ORR, 32% v 25%; P = .10) was higher for docetaxel. These results were confirmed by multivariate analyses. The incidence of treatment-related hematologic and nonhematologic toxicities was greater for docetaxel than for paclitaxel; however, quality-of-life scores were not statistically different between treatment groups over time.

CONCLUSION: Docetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time.

Supported by Aventis Pharmaceuticals, Bridgewater, NJ.

Presented at the European Cancer Conference (ECCO12), Copenhagen, Denmark, September 21-25, 2003, and the 26th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 3-6, 2003.

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

Related Editorial

• Testing Chemotherapy for Breast Cancer: Timing Is Everything
  Clifford Hudis
  JCO 2005 23: 5434-5436 [Full Text]

This article has been cited by other articles:

				K. S. Albain, S. M. Nag, G. Calderillo-Ruiz, J. P. Jordaan, A. C. Llombart, A. Pluzanska, J. Rolski, A. S. Melemed, J. M. Reyes-Vidal, J. S. Sekhon, et al. Gemcitabine Plus Paclitaxel Versus Paclitaxel Monotherapy in Patients With Metastatic Breast Cancer and Prior Anthracycline Treatment J. Clin. Oncol., August 20, 2008; 26(24): 3950 - 3957. [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]

				J. A. Sparano, M. Wang, S. Martino, V. Jones, E. A. Perez, T. Saphner, A. C. Wolff, G. W. Sledge Jr., W. C. Wood, and N. E. Davidson Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer N. Engl. J. Med., April 17, 2008; 358(16): 1663 - 1671. [Abstract] [Full Text] [PDF]

				J. R. Murillo Jr, J. E. Cox, and M. S. Oholendt An Overview of Chemotherapy-Induced Peripheral Neuropathy Journal of Pharmacy Practice, April 1, 2008; 21(2): 138 - 145. [Abstract] [PDF]

				T. Vu, S. Ellard, C. H. Speers, S. C. M. Taylor, M. L. de Lemos, F. Hu, K. Kuik, and I. A. Olivotto Survival outcome and cost-effectiveness with docetaxel and paclitaxel in patients with metastatic breast cancer: a population-based evaluation Ann. Onc., March 1, 2008; 19(3): 461 - 464. [Abstract] [Full Text] [PDF]

				P. Marino Measuring the cost of chemotherapy is important, but it is not enough Ann. Onc., March 1, 2008; 19(3): 409 - 410. [Full Text] [PDF]

				L.-P. P. Tran and J. L. Grabinski Chemotherapy for Early-Stage Breast Cancer: A Paradigm in Flux Journal of Pharmacy Practice, February 1, 2008; 21(1): 46 - 56. [Abstract] [PDF]

				A. Morabito, M. C. Piccirillo, K. Monaco, C. Pacilio, F. Nuzzo, P. Chiodini, C. Gallo, A. de Matteis, F. Perrone, and NCI Naples Breast Cancer Group First-Line Chemotherapy for HER-2 Negative Metastatic Breast Cancer Patients Who Received Anthracyclines as Adjuvant Treatment Oncologist, November 1, 2007; 12(11): 1288 - 1298. [Abstract] [Full Text] [PDF]

				E. Thomas, J. Tabernero, M. Fornier, P. Conte, P. Fumoleau, A. Lluch, L. T. Vahdat, C. A. Bunnell, H. A. Burris, P. Viens, et al. Phase II Clinical Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Patients With Taxane-Resistant Metastatic Breast Cancer J. Clin. Oncol., August 10, 2007; 25(23): 3399 - 3406. [Abstract] [Full Text] [PDF]

				H. Roche, L. Yelle, F. Cognetti, L. Mauriac, C. Bunnell, J. Sparano, P. Kerbrat, J.-P. Delord, L. Vahdat, R. Peck, et al. Phase II Clinical Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, As First-Line Therapy in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline Chemotherapy J. Clin. Oncol., August 10, 2007; 25(23): 3415 - 3420. [Abstract] [Full Text] [PDF]

				N. Denduluri, J. A. Low, J. J. Lee, A. W. Berman, J. M. Walshe, U. Vatas, C. K. Chow, S. M. Steinberg, S. X. Yang, and S. M. Swain Phase II Trial of Ixabepilone, an Epothilone B Analog, in Patients With Metastatic Breast Cancer Previously Untreated With Taxanes J. Clin. Oncol., August 10, 2007; 25(23): 3421 - 3427. [Abstract] [Full Text] [PDF]

				S. Verma and M. Clemons First-Line Treatment Options for Patients with HER-2 Negative Metastatic Breast Cancer: The Impact of Modern Adjuvant Chemotherapy Oncologist, July 1, 2007; 12(7): 785 - 797. [Abstract] [Full Text] [PDF]

				M. Colozza, E. de Azambuja, N. Personeni, F. Lebrun, M. J. Piccart, and F. Cardoso Achievements in Systemic Therapies in the Pregenomic Era in Metastatic Breast Cancer Oncologist, March 1, 2007; 12(3): 253 - 270. [Abstract] [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]

				H. Roche, P. Fumoleau, M. Spielmann, J.-L. Canon, T. Delozier, D. Serin, M. Symann, P. Kerbrat, P. Soulie, F. Eichler, et al. Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for Node-Positive Breast Cancer Patients: The FNCLCC PACS 01 Trial J. Clin. Oncol., December 20, 2006; 24(36): 5664 - 5671. [Abstract] [Full Text] [PDF]

				V. Harvey, H. Mouridsen, V. Semiglazov, E. Jakobsen, E. Voznyi, B. A. Robinson, V. Groult, M. Murawsky, and S. Cold Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer J. Clin. Oncol., November 1, 2006; 24(31): 4963 - 4970. [Abstract] [Full Text] [PDF]

				E Bria, M Di Maio, C Nistico, F Cuppone, E Terzoli, F Cognetti, and D Giannarelli Factorial design for randomized clinical trials Ann. Onc., October 1, 2006; 17(10): 1607 - 1608. [Full Text] [PDF]

				K. Gelmon, A. Chan, and N. Harbeck The Role of Capecitabine in First-Line Treatment for Patients with Metastatic Breast Cancer Oncologist, September 1, 2006; 11(suppl_1): 42 - 51. [Abstract] [Full Text] [PDF]

				S. Chia, M. Clemons, L.-A. Martin, A. Rodgers, K. Gelmon, G. R. Pond, and L. Panasci Pegylated Liposomal Doxorubicin and Trastuzumab in HER-2 Overexpressing Metastatic Breast Cancer: A Multicenter Phase II Trial J. Clin. Oncol., June 20, 2006; 24(18): 2773 - 2778. [Abstract] [Full Text] [PDF]

				A. D. Colevas Chemotherapy Options for Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck J. Clin. Oncol., June 10, 2006; 24(17): 2644 - 2652. [Abstract] [Full Text] [PDF]

				J. J. Lee and S. M. Swain Peripheral Neuropathy Induced by Microtubule-Stabilizing Agents J. Clin. Oncol., April 1, 2006; 24(10): 1633 - 1642. [Abstract] [Full Text] [PDF]

				M. Harries, P. Ellis, and P. Harper Nanoparticle Albumin-Bound Paclitaxel for Metastatic Breast Cancer J. Clin. Oncol., November 1, 2005; 23(31): 7768 - 7771. [Full Text] [PDF]

				J. O'Shaughnessy Extending Survival with Chemotherapy in Metastatic Breast Cancer Oncologist, October 1, 2005; 10(suppl_3): 20 - 29. [Abstract] [Full Text] [PDF]

				C. Hudis Testing Chemotherapy for Breast Cancer: Timing Is Everything J. Clin. Oncol., August 20, 2005; 23(24): 5434 - 5436. [Full Text] [PDF]