Weekly docetaxel in the treatment of metastatic breast cancer

Laura Palmeri, Marina Vaglica, Sergio Palmeri, Laura Palmeri, Marina Vaglica, Sergio Palmeri

Abstract

Breast cancer is the most frequent tumor among women worldwide and is the second cause of cancer-related mortality in the US. Metastatic breast cancer (MBC) accounts for less than 10% of newly diagnosed breast cancer patients and about 30% of early breast cancer patients will develop recurrent, advanced, or metastatic disease. It remains an incurable illness and the primary goal of its management is palliative. Several agents are active for the first-line treatment of MBC. The taxanes, paclitaxel and docetaxel, represent the standard of care for the treatment of these patients. Among the various schedules, docetaxel can be administered weekly, achieving similar efficacy results with lower toxicity compared with conventional schedules. Weekly docetaxel (25-40 mg/m(2)) has been widely tested in several phase I and II studies both as a single agent and in multichemotherapy regimens, reaching overall response rates ranging from 26% and 86% or 20% and 73% with docetaxel alone or in combination, respectively, depending on doses, associations, and line of treatment. Overall, published data support the administration of weekly docetaxel for the treatment of MBC patients even if data from phase III randomized trials are still lacking.

Keywords: chemotherapy; docetaxel; metastatic breast cancer; weekly.

References

    1. Aihara T, Kim Y, Takatsuka Y. Phase II study of weekly docetaxel in patients with metastatic breast cancer. Ann Oncol. 2002;13:286–92.
    1. Brenner H, Gondos A, Arndt V. Recent major progress in long-term cancer patient survival disclosed by modeled period analysis. J Clin Oncol. 2007;25:3274–80.
    1. Briasoulis E, Karavasilis V, Anastasopoulos D, et al. Weekly docetaxel in minimally pretreated cancer patients: a dose-escalation study focused on feasibility and cumulative toxicity of long-term administration. Ann Oncol. 1999;10:701–6.
    1. Brugnatelli S, Danova M, De Bella MT, et al. Weekly administration of gemcitabine plus docetaxel in patients with advanced breast cancer: a phase 1 study. Oncology. 2002;62:33–8.
    1. Burstein HJ, Harris LN, Marcom PK, et al. Trastuzumab and vinorel-bine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol. 2003;21:2889–95.
    1. Burstein HJ, Keshaviah A, Baron AD, et al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing meta-static breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer. 2007;110:965–72.
    1. Burstein HJ, Manola J, Younger J, et al. Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol. 2000;18:1212–9.
    1. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17:2341–54.
    1. Colozza M, de Azambuja E, Personeni N, et al. Achievements in systemic therapies in the pregenomic era in metastatic breast cancer. Oncologist. 2007;12:253–70.
    1. Cortes JE, Pazdur R. Docetaxel. J Clin Oncol. 1995;13:2643–55.
    1. D’Andrea GM, Seidman AD. Docetaxel and paclitaxel in breast cancer therapy: present status and future prospects. Semin Oncol. 1997;24(Suppl 13):S13-27–S13-44.
    1. D’Hondt R, Paridaens R, Wildiers H, et al. Safety and efficacy of weekly docetaxel in frail and/or elderly patients with metastatic breast cancer: a phase II study. Anticancer Drugs. 2004;15:341–6.
    1. Esteva FJ, Valero V, Booser D, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2002;20:1800–8.
    1. Findlay BP, Walker-Dilks C. Epirubicin, alone or in combination chemotherapy, for metastatic breast cancer. Provincial Breast Cancer Disease Site Group and the Provincial Systemic Treatment Disease Site Group. Cancer Prev Control. 1998;2:140–6.
    1. Ford HE, Yap YS, Miles DW, et al. A phase II study of weekly docetaxel in patients with anthracycline pretreated metastatic breast cancer. Cancer Chemother Pharmacol. 2006;58:809–15.
    1. Frasci G, Comella P, D’Aiuto G, et al. Weekly docetaxel plus gem-citabine or vinorelbine in refractory advanced breast cancer patients: a parallel dose-finding study. Southern Italy Cooperative Oncology Group (SICOG) Ann Oncol. 2000;11:367–71.
    1. Ghersi D, Wilcken N, Simes J, et al. Taxane containing regimens for metastatic breast cancer. Cochrane Database Syst Rev. 2005;2:CD003366.
    1. Ghosn M, Farhat FS, Kattan JG, et al. Navcap (vinorelbine and capecitabine) versus navcap followed by weekly docetaxel as first-line treatment in metastatic breast cancer patients: A randomized multicenter phase II trial. Proc Am Soc Clin Oncol. 2008a;26:1119a.
    1. Ghosn M, Kattan J, Farhat F, et al. Sequential vinorelbine-capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial. Cancer Chemother Pharmacol. 2008b;62:11–8.
    1. Hainsworth JD, Burris HA, 3rd, Erland JB, et al. Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol. 1998;16:2164–8.
    1. Hainsworth JD, Burris HA, 3rd, Yardley DA, et al. Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial. J Clin Oncol. 2001;19:3500–5.
    1. Hayat MJ, Howlader N, Reichman ME, et al. Cancer statistics, trends, and multiple primary cancer analyses from the Surveillance, Epidemiology, and End Results (SEER) Program. Oncologist. 2007;12:20–37.
    1. Holmes FA, Walters RS, Theriault RL, et al. Phase II trial of taxol, an active drug in the treatment of metastatic breast cancer. J Natl Cancer Inst. 1991;83:1797–805.
    1. Hotchkiss KA, Ashton AW, Mahmood R, et al. Inhibition of endothelial cell function in vitro and angiogenesis in vivo by docetaxel (Taxotere): association with impaired repositioning of the microtubule organizing center. Mol Cancer Ther. 2002;1:1191–200.
    1. Ibrahim T, Serra P, Vertogen B, et al. Doxorubicin (Dox), cyclophosphamide (Cyc) and weekly docetaxel (Doc) as first-line treatment of advanced breast cancer (ABC) Proc Am Soc Clin Oncol. 2007;25(18S):11516a.
    1. Ito Y, Aiba K, Horikoshi N, et al. Dose-finding phase I study of simultaneous weekly infusion with doxorubicin and docetaxel in patients with advanced breast cancer. Int J Clin Oncol. 2001;6:242–7.
    1. Jackisch C, Eibach H, Knuth A, et al. Phase-II trial of docetaxel weekly as dose dense treatment in metastatic breast cancer (MBC) Proc Am Soc Clin Oncol. 2000;19:417a.
    1. Kornek GV, Ulrich-Pur H, Penz M, et al. Treatment of advanced breast cancer with vinorelbine and docetaxel with or without human granulocyte colony-stimulating factor. J Clin Oncol. 2001;19:621–7.
    1. Kouroussis C, Agelaki S, Mavroudis D, et al. A dose escalation study of weekly docetaxel in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2000;46:488–92.
    1. Loeffler TM, Freund W, Droge C, et al. Activity of weekly Taxotere in patients with metastatic breast cancer [abstract] J Clin Oncol. 1998;17 abstr 113.
    1. Luck HJ, Donnè S, Glaubitz M, et al. Phase I study of weekly docetaxel (Taxotere) in heavily pretreated breast cancer patients. Eur J Cancer. 1997;33(s8):s158. (abstract 703).
    1. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005;23:4265–74.
    1. Meier CR, Illiger HJ, Steder M, et al. Weekly vinorelbine (VIN) vs weekly docetaxel (DOC) for metastatic breast cancer failing anthracyclines. Planned interim analysis of a randomized trial. Proc Am Soc Clin Oncol. 2004;22(14s):774a.
    1. Miles D, Chan A, Romieu G, et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol. 2008;26:1011a.
    1. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357:2666–76.
    1. Mrozek E, Ramaswamy B, Young D, et al. Phase II study of weekly docetaxel and capecitabine in patients with metastatic breast cancer. Clin Breast Cancer. 2006;7:141–5.
    1. Nabholtz JM, Gelmon K, Bontenbal M, et al. Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 1996;14:1858–67.
    1. Nabholtz JM, Thuerlimann B, Bezwoda WR, et al. Docetaxel vs mitomycin plus vinblastine in anthracycline-resistant metastatic breast cancer. Oncology (Williston Park) 1997;11(8 Suppl 8):25–30.
    1. Nistico C, Cognetti F, Frontini L, et al. Weekly docetaxel in pre-treated metastatic breast cancer patients: a phase I–II study. Oncology. 2005;68:356–63.
    1. O’Brien ME, Leonard RC, Barrett-Lee PJ, et al. Docetaxel in the community setting: an analysis of 377 breast cancer patients treated with docetaxel (Taxotere) in the UK. UK Study Group. Ann Oncol. 1999;10:205–10.
    1. Palmeri S, Vaglica M, Spada S, et al. Weekly docetaxel and gem-citabine as first-line treatment for metastatic breast cancer: results of a multicenter phase II study. Oncology. 2005;68:438–45.
    1. Paridaens R, Biganzoli L, Bruning P, et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer Randomized Study with cross-over. J Clin Oncol. 2000;18(4):724–33.
    1. Peacock NW, Infante JR, Yardley DA, et al. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients (pts) with HER2-positive metastatic breast cancer (MBC) Proc Am Soc Clin Oncol. 2008;26:1032a.
    1. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659–72.
    1. Raab G, Brugger W, Harbeck N, et al. Multi-center randomized phase II study of docetaxel (Doc) given q3w vs. q1wk plus trastuzumab (Tra) as first line therapy for HER2 overexpressing adjuvant anthracycline pretreated metastatic breast cancer (MBC) Breast Cancer Res Treat. 2002;76(Suppl 1):S114 a.
    1. Raff JP, Rajdev L, Malik U, et al. Phase II study of weekly docetaxel alone or in combination with trastuzumab in patients with metastatic breast cancer. Clin Breast Cancer. 2004;4:420–7.
    1. Ramaswamy B, Elias AD, Kelbick NT, et al. Phase II trial of beva-cizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res. 2006;12:3124–9.
    1. Ramos M, Gonzalez-Ageitos A, Amenedo M, et al. Weekly docetaxel as second-line therapy for patients with advanced breast cancer resistant to previous anthracycline treatment. J Chemother. 2003;15:192–7.
    1. Ravdin PM, Burris HA, 3rd, Cook G, et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol. 1995;13:2879–85.
    1. Ringel I, Horwitz SB. Studies with RP 56976 (taxotere): a semi-synthetic analogue of taxol. J Natl Cancer Inst. 1991;83:288–91.
    1. Rivera E, Mejia JA, Arun BK, et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008;112:1455–61.
    1. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673–84.
    1. Rosati MS, Raimondi C, Quadrini S, et al. WALT trial (Phase I–II): Weekly non-pegylated liposomal anthracycline and taxane combination in first-line breast cancer chemotherapy. J Clin Oncol. 2008;26:1097a.
    1. Salminen E, Bergman M, Huhtala S, et al. Docetaxel: standard recommended dose of 100 mg/m(2) is effective but not feasible for some metastatic breast cancer patients heavily pretreated with chemotherapy-A phase II single-center study. J Clin Oncol. 1999;17:1127.
    1. Sedky L, Saad I, Hashem B, et al. Weekly docetaxel vs. every 3-week in advanced breast cancer: results of a pilot comparative study. Proc Am Soc Clin Oncol. 2002;20:2013a.
    1. SEER 2008. Accessed 04 February 2008. URL: .
    1. Seidman AD, Reichman BS, Crown JP, et al. Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol. 1995a;13:1152–9.
    1. Seidman AD, Tiersten A, Hudis C, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995b;13:2575–81.
    1. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783–92.
    1. Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193) J Clin Oncol. 2003;21:588–92.
    1. Stemmler HJ, Gutschow K, Sommer H, et al. Weekly docetaxel (Taxotere) in patients with metastatic breast cancer. Ann Oncol. 2001;12:1393–8.
    1. Stemmler J, Mair W, Stauch M, et al. High efficacy and low toxicity of weekly docetaxel given as first-line treatment for metastatic breast cancer. Oncology. 2005;68:71–8.
    1. Stockler M, Wilcken NR, Ghersi D, et al. Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer. Cancer Treat Rev. 2000;26:151–68.
    1. Tabernero J, Climent MA, Lluch A, et al. A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer. Ann Oncol. 2004;15:1358–65.
    1. Tedesco KL, Thor AD, Johnson DH, et al. Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: a multi-institutional phase II trial. J Clin Oncol. 2004;22:1071–7.
    1. Tomiak E, Piccart MJ, Kerger J, et al. Phase I study of docetaxel administered as a 1-hour intravenous infusion on a weekly basis. J Clin Oncol. 1994;12:1458–67.
    1. Valero V. Docetaxel as single-agent therapy in metastatic breast cancer: clinical efficacy. Semin Oncol. 1997;24(Suppl 13):S13-1–S-8.
    1. Valero V, Holmes FA, Walters RS, et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol. 1995;13:2886–94.
    1. Waterhouse DM, Mainwaring M, Barton J, et al. Phase II pilot results of imatinib mesylate with weekly docetaxel in metastatic breast cancer. Proc Am Soc Clin Oncol. 2008;26:1090a.
    1. Wenzel C, Hussian D, Bartsch R, et al. Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study. J Cancer Res Clin Oncol. 2004;130:400–4.
    1. Wenzel C, Locker GJ, Pluschnig U, et al. Phase I/II trial of weekly epidoxorubicin and docetaxel (wED) in the neoadjuvant and palliative treatment of patients with breast cancer. Cancer Chemother Pharmacol. 2002;50:155–9.
    1. Zimatore M, Danova M, Vassallo E, et al. Weekly taxanes in meta-static breast cancer (review) Oncol Rep. 2002;9:1047–52.

Source: PubMed

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