Evidence-based use of neoadjuvant taxane in operable and inoperable breast cancer

Clinical Cancer Research

Volumn 10, Issue 10, 2004, Pages 3249-3261

  Estévez, Laura G ^a   Gradishar, William J ^b  

^a Hospital UniversitarioFundación Jiménez Díaz   (Spain)

^b NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT; ANTHRACYCLINE DERIVATIVE; CISPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; GEMCITABINE; METHOTREXATE; PACLITAXEL; PLATINUM; PREDNISOLONE; TAMOXIFEN; TAXANE DERIVATIVE; TRASTUZUMAB; VINCRISTINE;

ADVANCED CANCER; ANTINEOPLASTIC ACTIVITY; BLOOD TOXICITY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG POTENTIATION; DRUG TOLERABILITY; EVIDENCE BASED MEDICINE; HUMAN; INFECTION; INOPERABLE CANCER; LEUKOPENIA; LYMPH NODE METASTASIS; NEUROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; REVIEW; THROMBOCYTOPENIA;

ANTHRACYCLINES; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; BRIDGED COMPOUNDS; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS; FEMALE; HUMANS; PACLITAXEL; TAXOIDS; TREATMENT OUTCOME;

EID: 2542472363     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-03-0133     Document Type: Review

References (81)

1. 4) breast cancer. Cancer Chemother Pharmacol 1978;1:53-9.
2. Hunt KK, Ames FC, Singletary SE, Buzdar AU, Hortobagyi GN. Locally advanced noninflammatory breast cancer. Surg Clin North Am 1996;76:393-410.
3. Fisher B, Bryant J, Wolmark N, et al. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol 1998;16:2672-85.
4. Fisher B, Gunduz N, Coyle J, Rudock C, Saffer E. Presence of a growth-stimulating factor in serum following primary tumor removal in mice. Cancer Res 1989;49:1996-2001.
5. Valero V, Buzdar AU, Kau S-W, et al. Pathologically involved axillary nodes following primary chemotherapy in locally advanced breast cancer is an early biological prognostic factor for long-term outcome in patients with LABC [abstract]. Ann Oncol 2002;13 Suppl 5:37.
6. Jakesz R. Comparison of pre- vs postoperative chemotherapy in breast cancer patients: four-year results of Austrian Breast & Colorectal Cancer Study Group (ABCSG) Trial 7 [abstract]. Proc Am Soc Clin Oncol 2001;20:32a.
7. Makris A, Powles TJ, Ashley SE, et al. A reduction in the requirements for mastectomy in a randomised trial of neoadjuvant chemoendocrine therapy in primary breast cancer. Ann Oncol 1998;9:1179-84.
8. Mauriac L, MacGrogan G, Avril A, et al. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonie Bordeaux Groupe Sein (IBBGS). Ann Oncol 1999;10:47-52.
9. Ragaz J, Baird R, Rebbeck PC, Trevisan C, Goldie J, Coldman A. Preoperative (neoadjuvant) versus postoperative adjuvant chemotherapy for stage I-II breast cancer. Long-term analysis of British Columbia randomized trial [abstract]. Proc Am Soc Clin Oncol 1997;16:142a.
10. Scholl SM, Fourquet A, Asselain B, et al. Neoadjuvant versus adjuvant chemotherapy in premenopausal patients with tumours considered too large for breast conserving surgery: preliminary results of a randomised trial: S6. Eur J Cancer 1994;30:645-52.
11. Semiglazov VF, Topuzov EE, Bavli JL, et al. Primary (neoadjuvant) chemotherapy and radiotherapy compared with primary radiotherapy alone in stage IIb-IIIa breast cancer. Ann Oncol 1994;7:591-5.
12. Chollet P, Amat S, Cure H, et al. Prognostic significance of a complete pathological response after induction chemotherapy in operable breast cancer. Br J Cancer 2002;86:1041-6.
13. Chevallier B, Roche H, Olivier JP, Chollet P, Hurteloup P. Pilot study of intensive induction chemotherapy (FEC-HD) results in a high histologic response rate. Am J Clin Oncol 1993;16:223-8.
14. Kuerer HM, Newman LA, Smith TL, et al. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol 1999;17:460-9.
15. Honkoop AH, van Diest PJ, de Jong JS, et al. Prognostic role of clinical, pathological and biological characteristics in patients with locally advanced breast cancer. Br J Cancer 1998;77:621-6.
16. Smith IA, Miller ID. Issues involved in research into the neoadjuvant treatment of breast cancer. Anticancer Drugs 2001;12 Suppl 1: S25-9.
17. Sataloff DM, Mason BA, Prestipino AJ, Seinige UL, Lieber CP, Baloch Z. Pathologic response to induction chemotherapy in locally advanced carcinoma of the breast: a determinant of outcome. J Am Coll Surg 1995;180:297-306.
18. Smith IC, Heys SD, Hutcheon AW, et al. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol 2002;20:1456-66.
19. Bonadonna G, Valagussa P, Brambilla C, et al. Primary chemotherapy in operable breast cancer: eight-year experience at the Milan Cancer Institute. J Clin Oncol 1998;16:93-100.
20. Chang J, Powles TJ, Allred DC, et al. Biologic markers as predictors of clinical outcome from systemic therapy for primary operable breast cancer. J Clin Oncol 1999;17:3058-63.
21. Gregory RK, Powles TJ, Salter J, Chang JC, Ashley S, Dowsett M. Prognostic relevance of cerbB2 expression following neoadjuvant chemotherapy in patients in a randomised trial of neoadjuvant versus adjuvant chemoendocrine therapy. Breast Cancer Res Treat 2000;59:171-5.
22. Kandioler-Eckersberger D, Ludwig C, Rudas M, et al. TP53 mutation and p53 overexpression for prediction of response to neoadjuvant treatment in breast cancer patients. Clin Cancer Res 2000;6:50-6.
23. Makris A, Powles TJ, Dowsett M, et al. Prediction of response to neoadjuvant chemoendocrine therapy in primary breast carcinomas Clin Cancer Res 1997;3:593-600.
24. Pierga JY, Mouret E, Dieras V, et al. Prognostic value of persistent node involvement after neoadjuvant chemotherapy in patients with operable breast cancer. Br J Cancer 2000;83:1480-7.
25. Remvikos Y, Vielh P, Padoy E, Benyahia B, Voillemot N, Magdelenat H. Breast cancer proliferation measured on cytological samples: a study by flow cytometry of S-phase fractions and BrdU incorporation. Br J Cancer 1991;64:501-7.
26. Willsher PC, Pinder SE, Gee JM, et al. c-erbB2 expression predicts response to preoperative chemotherapy for locally advanced breast cancer. Anticancer Res 1998;18:3695-8.
27. Gianni L, Baselga J, Eiermann W, et al., for the ECTO Study Group. First report of the European Cooperative Trial in Operable Breast Cancer (ECTO): effects of primary systemic therapy on localregional disease [abstract]. Proc Am Soc Clin Oncol 2002;21:34a.
28. Chang JC, Wooten EC, Tsimelzon A, et al. Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer. Lancet 2003;362:362-9.
29. Pusztai L, Ayers M, Simmans FW, et al. Emerging science: prospective validation of gene expression profiling-based prediction of complete pathologic response to neoadjuvant paclitaxel/FAC chemotherapy in breast cancer [abstract]. Proc Am Soc Clin Oncol 2003;22:1a.
30. Nabholtz JM, Tonkin K, Smylie M, Au HJ, Lindsay MA, Mackey J. Chemotherapy of breast cancer: are the taxanes going to change the natural history of breast cancer? Exp Opin Pharmacother 2000;1:187-206.
31. Sjostrom J, Blomqvist C, Mouridsen H, et al. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group. Eur J Cancer 1999;35:1194-201.
32. 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.
33. Ravdin, P., Erban, B., Overmoyer, B., et al. Phase III comparison of docetaxel and paclitaxel in patients with metastatic breast cancer [abstract]. Eur J Cancer 2003;1 Suppl 5: S201.
34. Wang LG, Liu XM, Kreis W, Budman DR. The effect of antimicrotubule agents on signal transduction pathways of apoptosis: a review. Cancer Chemother Pharmacol 1999;44:355-61.
35. Lau DH, Xue L, Young LJ, Burke PA, Cheung AT. Paclitaxel (Taxol): an inhibitor of angiogenesis in a highly vascularized transgenic breast cancer. Cancer Biother Radiopharm 1999;14:31-6.
36. Sweeney CJ, Miller KD, Sissons SE, et al. The antiangiogenic property of docetaxel is synergistic with a recombinant humanized monoclonal antibody against vascular endothelial growth factor or 2-methoxyestradiol but antagonized by endothelial growth factors. Cancer Res 2001;61:3369-72.
37. Moos PJ, Fitzpatrick FA. Taxane-mediated gene induction is independent of microtubule stabilization: induction of transcription regulators and enzymes that modulate inflammation and apoptosis. Proc Natl Acad Sci USA 1998;95:3896-901.
38. Lavelle F, Bissery MC, Combeau C, Riou JF, Vrignaud P, Andre S. Preclinical evaluation of docetaxel (Taxotere). Semin Oncol 1995;22:3-16.
39. Bellot R, Robert J, Dieras V, et al. Taxotere® does not change the pharmacokinetic profile of doxorubicin or doxorubicinol [abstract]. Proc Am Soc Clin Oncol 1998;17:221a.
40. 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.
41. Nabholtz JM, Falkson C, Campos D, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 2003;21;968-75.
42. Climent MA, Tabernero J, Albanell J, et al. Preliminary results of a phase II randomized trial of docetaxel (Taxotere®) as a single agent chemotherapy administered weekly or 3-weekly in patients with metastatic breast cancer[abstract]. Proc Am Soc Clin Oncol 2002;21:52a.
43. Cook DJ, Mulrow CD, Haynes RB. Systematic reviews: synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376-80.
44. Amat S, Bougnoux P, Penault-Llorca F, et al. Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate. Br J Cancer 2003;88:1339-45.
45. Gradishar, W. J. Docetaxel as neoadjuvant chemotherapy in patients with stage III breast cancer. Oncology 1997;11 Suppl 8:5-18.
46. Estévez LG, Cuevas JM, Anton A, et al. Weekly docetaxel is effective as neoadjuvant chemotherapy for stage II and III breast cancer. Efficacy and correlation with biological markers in a Phase II, multicenter study. Clin Cancer Res 2003;9:686-92.
47. Baltali E, Altundag MK, Onat DA, et al. Neoadjuvant chemotherapy with Taxotere-epirubicin-5-fluorouracil (TEF) in local-regionally advanced breast cancer: a preliminary report. Tumori 2002;88:474-7.
48. de Matteis A, Nuzzo F, D'Aiuto G, et al. Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast. A single-center, phase II study. Cancer (Phila) 2002;94:895-901.
49. Tubiana-Hulin M, Dieras V, Fumoleau P, et al. Phase II trial combining docetaxel and doxorubicin in the neoadjuvant setting in patients with operable breast carcinoma: final results [abstract]. Breast Cancer Res Treat 2000;64:250.
50. Valero V, Esteva FJ, Sahin AA, et al. Phase II trial of neoadjuvant chemotherapy with docetaxel and doxorubicin, surgery, adjuvant CMF, and radiotherapy +/- tamoxifen in locally advanced breast cancer. [abstract] Breast Cancer Res Treat 2000;64:9.
51. von Minckwitz G, Costa SD, Eiermann W, et al. Maximized reduction of primary breast tumor size using preoperative chemotherapy with doxorubicin and docetaxel. J Clin Oncol 1999;17:1999-2005.
52. Wenzel C, Locker GJ, Schmidinger M, et al. Combined analysis of two phase II trials in patients with primary and advanced breast cancer with epidoxorubicin and docetaxel + granulocyte colony-stimulating factor. Anticancer Drugs 2002;13:67-74.
53. Evans TRJ, Gould A, Foster E, Crown JP, Leonard RCF, Mansi JL. Phase III randomized trial of adriamycin and docetaxel versus adriamycin and cyclophosphamide as primary medical therapy in women with breast cancer: an ACCOG study [abstract]. Proc Am Soc Clin Oncol 2002;21:35a.
54. Vinholes J, Bouzid K, Salas F, et al. Preliminary results of a multicentre phase III trial of Taxotere and doxorubicin versus 5-fluorouracil, doxorubicin and cyclophosphamide in patients with unresectable locally advanced breast cancer [abstract]. Proc Am Soc Oncol 2001;20:26a.
55. Luporsi L, Vanlemmens L, Coudert B, et al. 6 cycles of FEC 100 vs 6 cycles of epirubicin-docetaxel as neoadjuvant chemotherapy in operable breast cancer patients: preliminary results of a randomized phase II trial of Girec S01 [abstract]. Proc Am Soc Clin Oncol 2000;19:92a.
56. von Minckwitz G, Costa SD, Raab G, et al. Dose-dense doxorubicin, docetaxel, and granulocyte colony-stimulating factor support with or without tamoxifen as preoperative therapy in patients with operable carcinoma of the breast: a randomized, controlled open phase IIb study. J Clin Oncol 2001;19:3506-15.
57. Ferlini C, Scambia G, Distefano M, et al. Synergistic antiproliferative activity of tamoxifen and docetaxel on three estrogen receptor-negative cancer cell lines is mediated by the induction of apoptosis. Br J Cancer 1997;75:884-91.
58. Albain KS, Green SJ, Ravdin PM, et al. Adjuvant chemohormonal therapy for primary breast cancer should be sequential instead of concurrent: initial results from intergroup trial 0100 (SWOG-8814) [abstract]. Proc Am Soc Clin Oncol 2002;21:37a.
59. Estévez L, Sanchez Rovira P, Domine M, et al. Biweekly docetaxel and gemcitabine as neoadjuvant chemotherapy in stage II and III breast cancer: a phase II clinical trial with pharmacogenomic study [abstract]. Proc Am Soc Clin Oncol 2003;22:61.
60. Hurley J, Doliny P, Silva O, et al. Is there an alternative to anthracycline-based chemotherapy: an evaluation of a non-anthracycline containing regimen as neoadjuvant therapy in locally advanced and inflammatory breast cancer [abstract]. Breast Cancer Res Treat 2002;76:S51.
61. Hurley J, Doliny P, Silva O, et al. Neoadjuvant herceptin/taxotere/cisplatin in the treatment of locally advanced and inflammatory breast cancer[abstract]. Proc Am Soc Clin Oncol 2002;21:50a.
62. Pegram MD, Lopez A, Konecny G, and Slamon, D. J. Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 2000;27(6 Suppl 11):21-5.
63. 0) [abstract]. Breast Cancer Res Treat 2002;76:S50.
64. Miller KD, McCaskill-Stevens W, Sisk J, et al. Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer: a randomized pilot trial of the Hoosier Oncology group. J Clin Oncol 1999;17:3033-7.
65. Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003;21:4165-74.
66. Heys, SD, Hutcheon AW, Sarkar TK, et al. Neoadjuvant docetaxel in breast cancer: 3-year survival results from the Aberdeen trial. Clin Breast Cancer 2002;3 Suppl 2 S69-74.
67. Buzdar AU, Singletary SE, Theriault RL, et al. Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer. J Clin Oncol 1999;17:3412-7.
68. Green MC, Buzdar AU, Smith T, et al. Weekly paclitaxel followed by FAC as primary systemic chemotherapy of operable breast cancer improves pathologic complete remission rates when compared to every 3-week paclitaxel therapy followed by FAC-final results of a prospective phase III randomized trial [abstract]. Proc Am Soc Clin Oncol 2002;21:35a.
69. Bellino R, Cortese P, Danese S, et al. Epidoxorubicin and paclitaxel as primary chemotherapy for T >3 cm and T4 breast cancer patients. Anticancer Res 2000;20:4825-8.
70. Gogas H, Papadimitriou C, Kalofonos HP, et al. Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group. Ann Oncol 2002;13:1737-42.
71. Fumoleau P, Tubiana-Hulin M, Romieu G, et al. A randomized phase II study of 4 or 6 cycles of adriamycin/Taxol® (paclitaxel) as neoadjuvant treatment of breast cancer [abstract]. Breast Cancer Res Treat 2001;69:298.
72. Moliterni A, Tarenzi E, Capri G, et al. Pilot study of primary chemotherapy with doxorubicin plus paclitaxel in women with locally advanced or operable breast cancer. Semin Oncol 1997;24 Suppl 17:10-4.
73. Pouillart P, Fumoleau P, Romieu G, et al. Final results of a phase II randomized, parallel study of doxorubicin/cyclophosphamide and doxorubicin/Taxol® (paclitaxel) as neoadjuvant treatment of local-regional breast cancer [abstract]. Proc Am Soc Clin Oncol 1999;18:73a.
74. Sanchez-Rovira P, Jaén A, Dueñas R, et al. Primary chemotherapy in locally advanced breast cancer with gemcitabine, adriamycin and paclitaxel. A phase II trial and predictive value of Erb2 [abstract]. Proc Am Soc Clin Oncol 2001;29:31b.
75. Sanchez-Rovira P, Jaen A, Duenas R, et al. Neoadjuvant gemcitabine therapy for breast cancer. Clin Breast Cancer 2002;3 Suppl 1:S39-44.
76. Semiglazov VF, Bojok AA, Arsumanov AS, et al. Breast conserving surgery after neoadjuvant chemotherapy paclitaxel + doxorubicin vs fluorouracil + doxorubicin + cyclophosphamide [abstract]. Breast Cancer Res Treat 2002;76 Suppl 1:S52.
77. Sousa GC. Neoadjuvant chemotherapy of locally advanced breast cancer: a phase II trial of epirubicin, cyclophosphamide and paclitaxel [abstract]. Acta Oncol 2002;13 Suppl 5:54.
78. Formenti SC, Volm M, Skinner KA, et al. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol 2003;21:864-70.
79. Ezzat AA, Ibrahim EM, Ajarim DS, et al. High complete pathological response in locally advanced breast cancer using paclitaxel and cisplatin. Breast Cancer Res Treat 2000;62:237-44.
80. Burstein HJ, Harris LN, Gelman R, et al. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study. J Clin Oncol 2003;21:46-53.
81. Untch M, Konecny M, Ditsch N, et al. Dose-dense sequential epirubicin-paclitaxel as preoperative treatment of breast cancer: results of a randomised AGO study [abstract]. Proc Am Soc Clin Oncol 2002;21:34a.