Primary systemic therapy in operable breast cancer: Clinical data and biological fall-out

Annals of Oncology

Volumn 17, Issue SUPPL. 5, 2006, Pages

  Maur, M ^a   Guarneri, V ^a   Frassoldati, A ^a   Conte, Pier Franco ^a  

^a UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

Author keywords

Biomarkers; Breast conserving surgery; Pathological complete response; Primary systemic therapy

Indexed keywords

ANASTROZOLE; ANTHRACYCLINE; BIOLOGICAL MARKER; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; GEMCITABINE; LETROZOLE; METHOTREXATE; MITOMYCIN; MITOMYCIN C; MITOXANTRONE; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TAMOXIFEN; TAXANE DERIVATIVE; THIOTEPA; TRASTUZUMAB; VINCRISTINE; VINDESINE;

ADVANCED CANCER; ARTICLE; BIOLOGICAL MODEL; BLOOD TOXICITY; BREAST CANCER; BREAST SURGERY; CANCER ADJUVANT THERAPY; CANCER GRADING; CANCER LOCALIZATION; CANCER SURVIVAL; CLINICAL PROTOCOL; CLINICAL TRIAL; CONSERVATIVE TREATMENT; DIARRHEA; FEBRILE NEUTROPENIA; GENE EXPRESSION; HUMAN; IN VIVO STUDY; MASTECTOMY; MEDICAL DECISION MAKING; META ANALYSIS; NEUTROPENIA; POSTOPERATIVE CARE; PREDICTION; PRIORITY JOURNAL; PROGNOSIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME;

ANTHRACYCLINES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOLOGICAL MARKERS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; DECISION MAKING; HUMANS; MASTECTOMY, SEGMENTAL; NEOADJUVANT THERAPY; POSTOPERATIVE PERIOD; SURVIVAL ANALYSIS; TAXOIDS;

EID: 33745609547     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdj973     Document Type: Article

References (74)

1. Sledge GW. Preoperative chemotherapy for breast cancer: Lessons learned and future prospects. J Clin Oncol 2003; 21: 4481-4482.
2. Baldini E, Gardin G, Giannessi PG et al. Accelerated versus standard cyclophosphamide, epirubicin and 5-fluorouracil or cyclophosphamide, methotrexate and 5-fluorouracil: A randomized phase III trial in locally advanced breast cancer. Ann Oncol 2003; 14: 227-232.
3. Collecchi P, Baldini E, Giannessi P et al. Primary chemotherapy in locally advanced breast cancer (LABC): Effects on tumour proliferative activity, bcl-2 expression and the relationship between tumour regression and biological markers. Eur J Cancer. 1998 Oct; 34(11): 1701-1704.
4. Kaufmann M, von Minckwitz G, Smith R et al. International expert panel on the use of primary (preoperative) systemic treatment of operable breast cancer: Review and recommendations. J Clin Oncol 2003; 21: 2600-2608.
5. van der Hage JA, van de Velde CJ, Julien JP et al. Preoperative chemotherapy in primary operable breast cancer: Results from the European Organization for Research and Treatment of Cancer trial 10902. J Clin Oncol 2001; 19: 4224-4237.
6. 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: 2672-2685.
7. Gianni L, Baselga J, Eiermann W et al. European Cooperative Trial in operable breast cancer (ECTO): Improved freedom from proression (FFP) from adding paclitaxel(T) to doxorubicin (A) followed by cyclophosphamide methetrexate and fluorouracil (CMF). Proc Am Soc Clin Oncol 2005; 23: N16S, (Abstr 513).
8. Jakesz R. for the ABCSG. Comparison of pre- vs. postoperative chemotherapy in breast cancer patients: Four-year results of Austrian Breast, Colorectal Cancer Study Group (ABCSG) trial 7. Proc Am Soc Clin Oncol 2001; 20: 125.
9. 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. Eur J Cancer 30A. 1994; 645-652.
10. Smith IC, Heys SD, Hutcheon AW et al. Neoadjuvant chemotherapy in breast cancer: Significantly enhanced response with docetaxel. J Clin Oncol 2002; 20: 1456-1466.
11. Lipton L. Preoperative/neoadjuvant medical therapy for early breast cancer. The Lancet Oncology 2001; Vol2: 561-570.
12. Makris A, Powles TJ, Ashley SE et al. A reduction in the requirements for mastectomy in a randomized trial of neoadjuvant chemoendocrine therapy in primary breast cancer. Ann Oncol 1998; 9: 1179-1184.
13. Luporsi E, Vanlemmens L, Coudert B et al. 6 cycles of FEC 100 vs. 6 cycles of epirubicin-docetaxel (ED) as neoadjuvant chemotherapy in operable breast cancer patients (pts): Preliminary results of a randomized phase II trial of Girec S01. Proc Am Soc Clin Oncol 2000; 19: 355.
14. 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.
15. Bonadonna G, Zambetti M, Bumma C et al. Multimodal treatment with primary single-agent epirubicin in operable breast cancer: 5-year experience of the Michelangelo Cooperative Group. Ann Oncol 2002; 13: 1049-1058.
16. Fisher B, Brown A, Mamounas E et al. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: Findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol 1997; 15: 2483-2493.
17. Von Minckwitz G, Raab G, Schutte M et al. Dose-dense versus sequential Adriamycin/docetaxel combination as preoperative chemotherapy (pCHT) in operable breast cancer (T2-3, NO-2,MO): Primary end-point analysis of the GEPARDUO study. Proc Am Soc Clin Oncol 2003; 21: 43a (abstr 168).
18. Untch M, Konency G, Ditsch N et al. Dose-dense sequential epirubicin-paclitaxel as preoperative treatment of breast cancer: results of a randomised AGO study. Proc Am Soc Clin Oncol 2002; 21: 34a (Abstr 133).
19. 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: 3506-3515.
20. Dieras V, Fumoleau P, Romieu G et al. Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breastcancer. J Clin Oncol. 2004 22: 4958-65.
21. 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: 3412-341.
22. Mauri D, Pavlidis N, Ioannidis JPA. Neoadjuvant versus adjuvant systemic treatment in breast cancer: A meta-analysis. J Natl Cancer Inst 2005; 97(3): 188-194.
23. 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.
24. Evans TRJ, Gould A, Foster E et al. Phase III randomised trial of adriamycin (A) and docetaxel (D) versus A and cyclophosphamide (C) as primary medical therapy (PMT) in women with breast cancer: An ACCOG study. Proc Am Soc Clin Oncol 2002; 20: 35a (Abstr 136).
25. Chen AM, Meric F, Hunt KK et al. Breast-conserving therapy after neoadjuvant chemotherapy: The M.D. Anderson Cancer Center experience. Breast Cancer Res Treat 2003; 82(Suppl. 1): (Abstr 6).
26. Eiermann W, Paepke S, Appfelstaedt J et al. Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicentre study. Ann Oncol 2001; 12: 1527-1532.
27. Smith IE, Dowsett M, Ebbs SR et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrazole, tamoxifen, or both in combination: The Immediate Preoperative Anastrazole Tamoxifen or Combined with Tamxifen (IMPACT) multicenter double-blind randomized trial. J Clin Oncol 2005; vol 23: 5108-5116.
28. Broet P, Scholl SM, de la Rochefordiere A et al. Short and long-term effects on survival in breast cancer patients treated by primary chemotherapy: An updated analysis of a randomized trial. Breast Cancer Res Treat 1999; 58: 151-156.
29. Cleator S, Lal K, Ashley S et al. Good clinical response of breast cancers to neoadjuvant chemoendocrine therapy is associated with superior overall survival. Ann Oncol 2005; 16: 267-272.
30. Kuerer HM, Newman LA, Smith T et al. Clinical course of cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol 1999; 17: 460-469.
31. Machiavelli MR, Romero AO, Perez JE et al. Prognostic significance of pathological response of primary tumor and metastatic axillary lymph nodes after neoadjuvant chemotherapy for locally advanced breast carcinoma. Cancer J Sci Am 1998; 4: 125-131.
32. Cameron DA, Anderson ED, Levack P et al. Primary systemic therapy for operable breast cancer-10-year survival data after chemotherapy and hormone therapy. Br J Cancer 1997; 76: 1099-1105
33. Macchiavelli MR, Ellis P, Smith I, Ashley G et al. Clinical prognostic and predictive factors for primary chemotherpy in operable breast cancer. J Clin Oncol 1998; 16: 107-114.
34. 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: 1480-1487.
35. Pierga JY, Mouret E, Laurence V et al. Prognostic factors for survival after neoadjuvant chemotherapy in operable breast cancer. the role of clinical response. Eur J Cancer 2003; 39: 1089-1096.
36. Rouzier R, Extra JM, Klijanienko J et al. Incidence and prognostic significance of complete axillary downstaging after primary chemotherapy in breast cancer patients with T1 to T3 tumors and cytologically proven axillary metastatic lymph nodes. J Clin Oncol 2002; 20: 1304-1310.
37. Ferriere JP, Assier I, Cure H et al. Correlation between tumor response and patient outcome. Am J Clin Oncol 1998; 21: 117-120.
38. Gogas H, Fountzilas G. The role of taxanes as a component of neoadjuvant chemotherapy for breast cancer Annal Oncol 2003; (14): 667-74.
39. Smith IC, Heys SD, Hutcheon AW et al. Neoadjuvant chemotherapy in breast cancer: Significantly enhanced response with docetaxel J Clin Oncol 2002; 20: 1456-1466.
40. Reitsamer R, Peintinger F, Prokop E et al. Pathological complete response rates comparing 3 versus 6 cycles of epidoxorubicin and docetaxel in the neoadjuvant setting of patients with stage II and III breast cancer. Anticancer Drugs 2005; 16(8): 867-870.
41. Roumieu G, Tubiana-Hulin M, Fumoleau P et al. A multicenter randomized phase II study of 4 or 6 cycles of adriamycin/taxol (paclitaxel) (AT) as neoadjuvant treatment of breast cancer(BC). Ann Oncol 2002; 13(Suppl 5): 33.
42. Luporsi E, Vanlemmens L, Coudert B et al. 6 cycles of FEC 100 vs 6 cycles of epirubicin-docetaxel (ED) as neoadjuvant chemotherapy in operable breast cancer patients (pts): Preliminary results of a randomized phase II trial of Girec S01. Proc Am Soc Clin Oncol 2000; 19: 355.
43. Miller K, McCaskill-Stevens W 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: 3033-3037.
44. 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-S74.
45. von Minckwitz G, Blohmer JU, Raab G et al. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer: The GEPARTRIO pilot study. Ann Oncol 2005; 16: 56-63.
46. Jackisch C, von Minckwitz G, Eidtmann H et al. Dose-dense biweekly doxorubicin/docetaxel versus sequential neoadjuvant chemotherapy with doxorubicin/cyclophosphamide/docetaxel in operable breast cancer: Second interim analysis. Clin Breast Cancer 2002; 3: 276-280.
47. von Minckwitz G, Raab G, Caputo A et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: The GEPARDUO study of the German BreastGroup. J Clin Oncol 2005 Apr 20; 23(12): 2676-85.
48. Gomez H, Kahatt C, Falcon S et al. A phase II study of neoadjuvant gemcitabine plus doxorubicin in stage IIIB breast cancer: A preliminary report. Semin Oncol 2001; 28(Suppl 10): 57-61.
49. Conte PF, Gennari A, Donati S et al. Gemcitabine plus epirubicin plus taxol (GET in advanced breast cancer: A phase II study. Breast Cancer Res Treat 2001; 68: 171-179.
50. Cappuzzo F, Mazzoni F Gennari A et al. Multicentric phase II trial of gemcitabine plus epirubicin plus paclitaxel as first-line chemotherapy in metastatic breast cancer Br J Cancer 2004; 90: 31-35.
51. Conte PF, Donati S, Gennari A et al. Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: A phase II study. Br J Cancer 2005; 93: 406-411.
52. Schmid P, Krocher C, Jehn C et al. Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: Final results of a phase II trail Ann Oncol 2005 [Epub ahead of print].
53. Estevez LG, Sanchez-Rovira P, Domine M et al. Biweekly docetaxel and gemcitabine as neoadjuvant chemotherapy in stage II and III breast cancer patients: Prelimary results of a phase II and pharmacogenomic study. Semin Oncol 2004; 31(Suppl 5): 31-36.
54. Schneeweiss A. Huober J, Sinn HP et al. Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: Results of a multicentre phase I/II study. Eur J Cancer 2004; 40(16): 2432-2438
55. Hurley J, Franco S, Velez P et al. Primary therapy with Herceptin, Taxotere, and cisplatin in locally advanced and inflammatory breast cancer. Proc Am Soc Clin Oncol 2001; 20: 31b (Abstr 1871).
56. Burstein HJ, Harris LN, Kaelin CM et al. Preoperative herceptin and paclitaxel (taxol) for HER2 overexpressing stage II/III breast cancer; Proc Am Soc Clin Oncol 2001; 20: 26a (Abstr 100).
57. Hurley J, Doliny P, Silva O et al. Neoadjuvant Herceptin/Taxotere/ cisplatin in the treatment of locally advanced and inflammatory breast cancer. Proc Am Soc Clin Oncol 2001; 21: 50a (Abstr 196).
58. Limentani SA, Brufsky AM, Erban JK et al. Dose dense neoadjuvant treatment of women with breast cancer utilizing docetaxel, vinorelbine and trastuzumab with growth factor support. Breast Cancer Res Trea 2003; 82:S55 (Suppl 1).
59. Burstein HJ, Harris LN, Gelman R et al. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/ cyclophosphamide for HER2 overexpressingstage II or III breast cancer: A pilot study. J Clin Oncol 2003; 21: 46-53.
60. Bunnell CA, Younger J, Smith B, Winer EP. preoperative therapy with trastuzumab and paclitaxel follone by sequential adjuvant doxorubicin/ cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study. J Clin Oncol 2003; 21; 46-53.
61. Buzdar AU, Ibrahim NK, Francis D et al. Significantly higher pathological complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: Results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer J Clin Onco 2005; 23(16): 3676-3685.
62. Semiglazov VF, Bojok AA, Arsumanov AS et al. Breast conserving surgery after neoadjuvant chemotherapy with paclitaxel+doxorubicin vs fluorouracil + doxorubicin + cyclophosphamide in locally advanced breast cancer. Br Cancer Res Treat 2002; 76(Suppl 1): (Abstr 159).
63. Ellis MJ, Coop A, Singh B et al. Letrozole is more effective neoadjuvant andocrine therapy than tamoxifen for ErbB1 and/or Erb-B2 positive, estrogen receptor-positive primary breast cance: Evidence from a phase III randomized trial. J Clin Oncol 2001; 19: 3808-3816.
64. Mano MS, Awada A. Primary chemotherapy for breast cancer: The evidence and the future. Ann Oncol 2004; 15: 1161-1171.
65. Mathieu MC, Rouzier R, Llombart-Cussac A et al. The poor responsiveness of infiltrating lobular breast carcinomas to neoadjuvant chemotherapy can be explained by their biological profile. Eur J Cancer. 2004 Feb; 40(3): 342-51.
66. Bear H, Anderson S, Brown A et al. The effecton tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: Preliminary results from National Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003; 21: 4165-4174.
67. Bonnefoi H, Diebold-Berger S, Therasse P et al. Locally advanced/ inflammatory breast cancer treated with intensive epirubicin-based neoadjuvant chemotherapy: Are there molecular markers in the primary tumor that predict for 5-year clinical outcome? Ann Oncol 2003; 14: 406-413
68. Billgren A, Rutqvist L, Tani E et al. Proliferating fraction during neoadjuvant chemotherapy of primary breast cancer in relation to objective local response and relapse free survival. Acta Onco 1991; 38: 597-601.
69. Faneyete IF et al. Breast cancer response to neoadjuvant chemotherapy: predictive markers and relation with outcome. Br J Cancer 2003; 88: 406-412.
70. Burcombe RJ, Makris A, Richman PI et al. Evaluation of ER, PgR, HER-2 and Ki-67 as predictors of response to neoadjuvant anthracycline chemotherapy for operable breast cancer. Br J Cancer 2005; 92: 147-155.
71. Petit T, Wilt M, Velten M et al. Comparative value of tumor grade, hormonal receptors (HR), Ki-67, HER-2 and topoisomerase II alpha status as predictive markers in breast cancer patients treated with neoadjuvant antharcycline-base chemotherapy. Europ J Cancer 2004; 40: 205-211.
72. Hannemann J, Oosterkamp HM, Bosch CAJ, Velds A et al. Changes in gene expression associated with response to neoadjuvant chemotherapy in breast cancer. J Clin Oncoll 2005, 23: 3331-3342.
73. Gianni L, Zambetti M, Clark K et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol 2005; 23: 7265-77.
74. Ayers M, Symmans WF, Stec J et al. Gene expression profiles predict complete pathologic response to neoadjuvant paclitaxel and fluorouracil, doxorubicin and cyclophosphamide chemotherapy in breast cancer. J Clin Oncol 2004; 22: 2284-93.