A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: Changing the natural history of HER2-positive disease

Annals of Oncology

Volumn 17, Issue 4, 2006, Pages 630-636

  Papaldo, P ^a   Fabi, A ^a   Ferretti, Gia ^a   Mottolese, M ^a   Cianciulli, A M ^a   Di Cocco, B ^a   Pino, M S ^a   Carlini, P ^a   Di Cosimo, S ^a   Sacchi, I ^a   Sperduti, I ^a   Nardoni, C ^a   Cognetti, F ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

HER2; Metastatic breast cancer; Trastuzumab; Weekly vinorelbine

Indexed keywords

ANTHRACYCLINE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; NAVELBINE; RECOMBINANT ERYTHROPOIETIN; TAXANE DERIVATIVE; TRASTUZUMAB;

ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL PROTOCOL; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; HEADACHE; HEART LEFT VENTRICLE FAILURE; HUMAN; HYPERTENSION; IMMUNOHISTOCHEMISTRY; LIVER DYSFUNCTION; LIVER TOXICITY; MAJOR CLINICAL STUDY; METASTASIS; MONOTHERAPY; NEUROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROTEIN EXPRESSION; SCORING SYSTEM; TACHYCARDIA; THROMBOCYTOPENIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENES, ERBB-2; HUMANS; IMMUNOHISTOCHEMISTRY; MIDDLE AGED; VINBLASTINE;

EID: 33645284988     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdj110     Document Type: Article

References (56)

1. Hynes NE, Stern DF. The biology of erbB-2/neu/HER-2 and its role in cancer. Biochim Biophys Acta 1994; 1198: 165-184.
2. Révillon F, Bonneterre J, Peyrat JP. ERBB2 oncogene in human breast cancer and its clinical significance. Eur J Cancer 1998; 34: 791-808.
3. Di Fiore PP, Pierce JH, Fleming TP et al. Overexpression of the human EGF receptor confers an EGF-dependent transformed phenotype to HIH 3T3 cells. Cell 1987; 51: 1063-1070.
4. Di Fiore PP, Pierce JH, Kraus MH et al. erbB-2 is a potent oncogene when overexpressed in NIH/3T3 cells. Science 1987; 237: 178-182.
5. Hudziak RM, Schlessinger J, Ullrich A. Incerased expression of the putative growth factor receptor p185 HER2 causes trasformation and tumorigenesis of HIH 3T3 cells. Proc Natl Acad Sci USA 1987; 84: 7159-7163.
6. Menard S, Pupa S, Campiglio M, Tagliabue E. Biologic and therapeutic role of HER2 in cancer. Oncogene 2003; 22: 6570-6578.
7. Zhou B, Hung M. Dysregulation of cellular signaling by HER2/neu in breast cancer. Semin Oncol 2003; 30: 38-48.
8. Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987; 235: 177-182.
9. Ross JS, Flether JA. The Her-2/neu oncogene in breast cancer: Prognostic factor, predictive factor, and target for therapy. Stem Cells 1998; 16: 413-428.
10. Slamon DJ, Godolphin W, Jones LA et al. Studies of HER2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244: 707-712.
11. Slamon DJ, Clark GM, Wong SG et al. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987; 235: 177-182.
12. Pegram MD, Lopez A, Konecny G, Slamon DJ. Trastuzumab and chemotherapeutics: Drug interactions and synergies. Semin Oncol 2000; 27 (6 Suppl 11): 21-25. (discussion 92-100)
13. McKeage K, Perry CM. Trastuzumab. a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs 2002; 62(1): 209-243.
14. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17: 2639-2648.
15. Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 719-726.
16. Baselga J, Norton L, Albanell J et al. Recombinant humanized anti-HER2 antibody (Herceptin TM) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overxpressing human breast cancer xenografts: Cancer Res 1998; 58: 2825-2831.
17. Konecny G, Pegram MD, Beryt M et al. Therapeutic advantage of chemotherapy drugs in combination with Herceptin against human breast cancer cells with HER-2/neu overexpression (Abstr 467). Breast Cancer Res Treat 1999; 57: 114.
18. Pegram M, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER2/neu antibody and chemotherapeutic agents used for treatment of human breast cancer. Oncogene 1999; 18: 2241-2251.
19. 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: 783-792.
20. Gasparini G, Morabito A, De Sio L et al. Preliminary clinical results of a randomized phase IIb study of weekly paclitaxel (PCT) + trastuzumab (T) as first-line therapy of patients (pts) with HER -2/neu positive metastatic breast cancer (MBC). Breast Cancer Res Treat 2003; 82: S51 (Abstr 227).
21. 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(19): 4265-4274.
22. Seidman A, Hudis C, Pierri MK et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002; 20(5): 1215-1221.
23. Romero A, Rabinovich MG, Vallejo CT et al. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336-341.
24. Nisticò C, Garufi C, Milella M et al. Weekly schedule of vinorelbine in pretreated breast cancer patients. Breast Cancer Res Treat 2000; 59: 223-229.
25. Pegram MD, Finn RS, Arzoo K et al. The effect of HER-2/neu overexpression on chemotherapeutic drug sensitivity in human breast and ovarian cancers cells. Oncogene 1997; 15: 537-547.
26. Pegram MD, Konecny GE, O'Callaghan C et al. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004; 19; 96(10): 739-749.
27. Burstein HJ Kuter I, Campos SM et al. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer, J Clin Oncol 2001; 19: 2722-2730.
28. Jahanzeb M, Mortimer JE, Yunus F et al. Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2+ metastatic breast cancer. Oncologist. 2002; 7(5): 410-417.
29. Bunnell CA, Burstein HJ, Kelly-Marcom P et al. Multicenter phase II study of trastuzumab (T) and vinorelbine (V) as first-line therapy for HER2 overexpressing metastatic breast cancer. Ann Oncol 2002; 13: 50 (Abstr. 180P).
30. Bernardo G, Palombo R, Bernardo A et al. Weekly trastuzumab (Herceptin) and vinorelbine (Navelbine) in chemonaive patients with HER2-overexpressing metastatic breast cancer: A phase II trial. Ann Oncol 2002; 13: 51 (Abstr. 181P).
31. Chan A, Untch M, Petruzelka L et al. Multinational phase II study of navelbine (N) and herceptin (H) as first-line therapy for HER2-overexpressing metastatic breast cancer (HER2+ MBC). Breast Cancer Res Treat 2002; 76: S112 (Abstr. 434).
32. Bayo J, Mayordomo JI, Sanchez-Rovira P et al. Trastuzumab and vinorelbine combination in the treatment of HER2-positive metastatic breast cancer. ASCO Annual Meeting Proceedings (Post-Meeting Edition) 2004; Vol, 22, No 14S (July 15 Supplement): 763.
33. Bernardo G, Palumbo R, Bernardo A et al. Final results of a phase II study of weekly trastuzumab and vinorelbine in chemonaive patients with HER2-overexpressing metastatic breast cancer. ASCO Annual Meeting Proceedings (Post-Meeting Edition), 2004, 22 (14S): 731.
34. De Wit M, Harbeck N, Thomssen C et al. Interim results of a prospective, open-label, multicentre phase II trial of the efficacy and safety of vinorelbine (N) and trastuzumab (H) in patients with HER2-positive metastatic breast cancer (MBC). ASCO Annual Meeting Proceedings (Post-Meeting Edition), 2004, 22 (14S): 831.
35. Burstein HJ, Harris LN, Marcom PK et al. Trastuzumab and vinorelbine 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(15): 2889-2895.
36. Hryniuk WM, Goodyear M. The calculation of received dose intensity. J Clin Oncol 1990; 8(12): 1935-1937.
37. Pietras RJ, Fendly B, Chazin VR et al. Antibody to HER-2/neu receptor blocks DNA repair after cisplatin in human breast and ovarian carcinoma cells. Oncogene 1994; 9: 1829-1838.
38. Pietras RJ, Pegram MD, Finn RS et al. Remission of human breast cancer xenografts on therapy with humanized monoclonal antibody to HER-2 receptor and DNA-reactive drugs. Oncogene 1998; 17: 2235-2249.
39. Konecny GE, Thomssen C, Luck HJ, Untch M, Wang HJ et al. Her-2/neu gene amplification and response to paclitaxel in patients with metastatic breast cancer. J Natl Cancer Inst 2004; 96(15): 1141-1151.
40. Papaldo P, Fabi A, Nardoni C et al. Trastuzumab improves the prognosis in HER2 positive when compared to HER2 negative patients. Trastuzumab plus vinorelbine in HER2-positive versus vinorelbine alone in HER2-negative metastatic breast cancer patients. Breast Cancer Res Treat 2003; 82 (Suppl 1): S72 (Abstr 311).
41. Jukkola A, Bloigu R, Soini Y et al. c-erbB-2 positivity is a factor for poor prognosis in breast cancer and poor response to hormonal or chemotherapy treatment in advanced disease. Eur J Cancer 2001; 37(3): 347-354.
42. Waintraub SE. Phase II trial to study the efficacy and toxicity of combined docetaxel (D), carboplatin (C), +/- trastuzumab (T) administered weekly (W) in patients (pts) with HER2/neu +/- metastatic breast cancer (MBC). ASCO Annual Meeting, 2005, #832.
43. Kirsch DG, Ledezma CJ, Mathews CS et al. Brain metastases from breast cancer: Survival by HER2 status in the trastuzumab era. J Clin Oncol 2004; ASCO Annual Meeting Proceedings, 22, 14S: 779.
44. Seidman AD, Fornier MN, Esteva FJ et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001; 19 (10): 2587-2595.
45. Kuzur ME, Albain KS, Huntington MO et al. A phase II trial of docetaxel and herceptin in metastatic breast cancer patients overexpressing HER-2. Proc Am Soc Clin Oncol 2000; 19: 131a.
46. Seidman AD, Berry D, Cirrincione L et al. CALGB 9840: Phase III study of weekly paclitaxel via 1-hour infusion versus standard 3-hour infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol; Vol, 22, 148, 2004, (Abstr. 512).
47. Toussaint C, Izzo J, Spielmann M et al. Phase I/II trial of continuous infusion vinorelbine for advanced breast cancer. J Clin Oncol 1994; 12: 2102-2112.
48. Gasparini G, Caffo O, Barni S et al. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: A phase II study. J Clin Oncol 12: 2094-2101.
49. Extra J-M, Leandri S, Dieras V et al. Phase II study of vinorelbine in first and second-line treatment of advanced breast cancer, Navelbine update and new trends. P. Solal Celigny (ed), John Libby Eurotext 1991; 213-220.
50. Livingston RB, Ellis GK, Gralow JR et al. Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1997; 15: 1395-1400.
51. Degardin M, Bonneterre J, Hecquet B et al. Vinorelbine (Navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 1994; 5: 423-426.
52. Jones S, Winer E, Vogel C et al. Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. J Clin Oncol 1995; 13: 2567-2574.
53. Suzuki Y, Tokuda Y, Saito Y et al. Combination of trastuzumab and vinorelbine in metastatic breast cancer. Jap J Clin Oncol 2003; 33(10): 514-517.
54. Seidman AD. Monotherapy options in the management of metastatic breast cancer. Semin Oncol 2003; 30 (2 Suppl 3): 6-10.
55. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005; 353(16): 1673-1684.
56. 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 (16): 1659-1672.