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Применение трастузумаба (герцептин®) после проведения адъювантной химиотерапии у пациентов с HER2-положительным раком молочной железы
Применение трастузумаба (герцептин®) после проведения адъювантной химиотерапии у пациентов с HER2-положительным раком молочной железы
Martine J. Piccart-Gebhart et al. Применение трастузумаба (герцептин®) после проведения адъювантной химиотерапии у пациентов с HER2-положительным раком молочной железы. Онкология. 2006; 2: 40-49.
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Список литературы
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2. Gschwind A, Fischer OM, Ullrich A. The discovery of receptor tyrosine kinases: targets for cancer therapy. Nat Rev Cancer 2004; 4: 361–70.
3. 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: 177–82.
4. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244: 707–12.
5. Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 719–26.
6. Baselga J, Carbonell X, CastaЦeda-Soto NJ et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005; 23: 2162–71.
7. Slamon DJ, Leyland-Jones B, Shak S et al. Concurrent administration of anti-HER2 monoclonal antibody and first-line chemotherapy for HER2-overexpressing metastatic breast cancer. A phase III, multinational, randomized controlled trial. N Engl J Med 2001; 344: 783–92.
8. 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.
9. Bell R. What can we learn from Herceptin trials in metastatic breast cancer? Oncology 2002; 63 (Suppl. 1): 39–46.
10. Goldhirsch A, Wood WC, Gelber RD et al. Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003; 21: 3357–65.
11. Menard S, Calini P, Tomasic G et al. Pathologic identification of two distinct breast carcinoma subsets with diverging clinical behaviours. Breast Cancer Res Treat 1999; 55: 169–77.
12. Pietras RJ, Pegram MD, Finn RS et al. Remission of human breast cancer xenografts on therapy with humanized monoclonal antibody to HER2 receptor and DNA-reactive drugs. Oncogene 1998; 17: 2235–49.
13. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–717.
14. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-15.
15. Schiller NB, Shah PM, Crawford M et al. Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. J Am Soc Echocardiogr 1989; 2: 358–65.
16. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659–63.
17. Coussens L, Yang-Feng TL, Liao YC et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science 1985; 230: 1132–9.
18. King CR, Kraus MH, Aaronson SA. Amplification of a novel v-erbB-related gene in a human mammary carcinoma. Science 1985; 229: 974–6.
19. Akiyama T, Sudo C, Ogawara H et al. The product of the human c-erbB-2 gene: a 185-kilodalton glycoprotein with tyrosine kinase activity. Science 1986; 232: 1644–6.
20. Hudziak RM, Schlessinger J, Ulrich A. Increased expression of the putative growth factor receptor p185HER2 causes transformation and tumorigenesis of NIH 3T3 cells.Proc Natl Acad Sci U S A 1987; 84: 7159–63.
21. Di Fiore PP, Pierce JH, Kraus MH et al. ErbB-2 is a potent oncogene when overexpressed in NIH/3T3 cells. Science 1987; 237: 178–82.
22. Lacroix H, Iglehart JD, Skinner MA et al. Overexpression of erbB-2 or EGF receptor proteins present in early stage mammary carcinoma is detected simultaneously in matched primary tumors and regional metastases. Oncogene 1989; 4: 145–51.
23. Hudziak RM, Lewis GD, Winget M et al. p185HER2 monoclonal antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor necrosis factor. Mol Cell Biol 1989; 9: 1165–72.
24. Shepard HM, Lewis GD, Sarup JC et al. Monoclonal antibody therapy of human cancer: taking the HER2 protooncogene to the clinic. J Clin Immunol 1991; 11: 117–27.
25. Guy CT, Webster MA, Schaller M et al. Expression of the neu protooncogene in the mammary epithelium of transgenic mice induces metastatic disease. Proc Natl Acad Sci USA 1992; 89: 10578–82.
26. Pietras RJ, Arboleda J, Reese DM et al. HER-2 tyrosine kinase pathway targets estrogen receptor and promotes hormoneindependent growth in human breast cancer cells. Oncogene 1992; 7: 1859–66.
27. Carter P, Presta L, Gorman CM et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci USA 1992; 89: 4285–9.
28. Sliwkowski MX, Schaefer G, Akita RW et al. Coexpression of erbB2 and erbB3 proteins reconstitutes a high affinity receptor for heregulin. J Biol Chem 1994; 269: 14661–5.
29. Baselga J, Tripaty D, Mendelsohn J et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996; 14: 737–44.
30. Baselga J, Norton L, Albanell J et al. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res 1998; 58: 2825–31.
31. Pegram MD, Lipton A, Hayes DF et al. Phase II study of receptor enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER-2/neuoverexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 1998; 16: 2659–71.
32. Pegram M, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999; 18: 2241–51.
33. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER-2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17: 2639–48.
34. Bendell JC, Domchek SM, Burstein HJ et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer 2003; 97: 2972–7.
35. Paik S, Bryant J, Tan-Chi E et al. Real world performance of HER2 testing: National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 2002; 94: 852–4.
36. Tan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology 2002; 63 (Suppl. 1): 57–63.
37. 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.
2. Gschwind A, Fischer OM, Ullrich A. The discovery of receptor tyrosine kinases: targets for cancer therapy. Nat Rev Cancer 2004; 4: 361–70.
3. 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: 177–82.
4. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244: 707–12.
5. Vogel CL, Cobleigh MA, Tripathy D et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 719–26.
6. Baselga J, Carbonell X, CastaЦeda-Soto NJ et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005; 23: 2162–71.
7. Slamon DJ, Leyland-Jones B, Shak S et al. Concurrent administration of anti-HER2 monoclonal antibody and first-line chemotherapy for HER2-overexpressing metastatic breast cancer. A phase III, multinational, randomized controlled trial. N Engl J Med 2001; 344: 783–92.
8. 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.
9. Bell R. What can we learn from Herceptin trials in metastatic breast cancer? Oncology 2002; 63 (Suppl. 1): 39–46.
10. Goldhirsch A, Wood WC, Gelber RD et al. Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003; 21: 3357–65.
11. Menard S, Calini P, Tomasic G et al. Pathologic identification of two distinct breast carcinoma subsets with diverging clinical behaviours. Breast Cancer Res Treat 1999; 55: 169–77.
12. Pietras RJ, Pegram MD, Finn RS et al. Remission of human breast cancer xenografts on therapy with humanized monoclonal antibody to HER2 receptor and DNA-reactive drugs. Oncogene 1998; 17: 2235–49.
13. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–717.
14. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-15.
15. Schiller NB, Shah PM, Crawford M et al. Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. J Am Soc Echocardiogr 1989; 2: 358–65.
16. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659–63.
17. Coussens L, Yang-Feng TL, Liao YC et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science 1985; 230: 1132–9.
18. King CR, Kraus MH, Aaronson SA. Amplification of a novel v-erbB-related gene in a human mammary carcinoma. Science 1985; 229: 974–6.
19. Akiyama T, Sudo C, Ogawara H et al. The product of the human c-erbB-2 gene: a 185-kilodalton glycoprotein with tyrosine kinase activity. Science 1986; 232: 1644–6.
20. Hudziak RM, Schlessinger J, Ulrich A. Increased expression of the putative growth factor receptor p185HER2 causes transformation and tumorigenesis of NIH 3T3 cells.Proc Natl Acad Sci U S A 1987; 84: 7159–63.
21. Di Fiore PP, Pierce JH, Kraus MH et al. ErbB-2 is a potent oncogene when overexpressed in NIH/3T3 cells. Science 1987; 237: 178–82.
22. Lacroix H, Iglehart JD, Skinner MA et al. Overexpression of erbB-2 or EGF receptor proteins present in early stage mammary carcinoma is detected simultaneously in matched primary tumors and regional metastases. Oncogene 1989; 4: 145–51.
23. Hudziak RM, Lewis GD, Winget M et al. p185HER2 monoclonal antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor necrosis factor. Mol Cell Biol 1989; 9: 1165–72.
24. Shepard HM, Lewis GD, Sarup JC et al. Monoclonal antibody therapy of human cancer: taking the HER2 protooncogene to the clinic. J Clin Immunol 1991; 11: 117–27.
25. Guy CT, Webster MA, Schaller M et al. Expression of the neu protooncogene in the mammary epithelium of transgenic mice induces metastatic disease. Proc Natl Acad Sci USA 1992; 89: 10578–82.
26. Pietras RJ, Arboleda J, Reese DM et al. HER-2 tyrosine kinase pathway targets estrogen receptor and promotes hormoneindependent growth in human breast cancer cells. Oncogene 1992; 7: 1859–66.
27. Carter P, Presta L, Gorman CM et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci USA 1992; 89: 4285–9.
28. Sliwkowski MX, Schaefer G, Akita RW et al. Coexpression of erbB2 and erbB3 proteins reconstitutes a high affinity receptor for heregulin. J Biol Chem 1994; 269: 14661–5.
29. Baselga J, Tripaty D, Mendelsohn J et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996; 14: 737–44.
30. Baselga J, Norton L, Albanell J et al. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu overexpressing human breast cancer xenografts. Cancer Res 1998; 58: 2825–31.
31. Pegram MD, Lipton A, Hayes DF et al. Phase II study of receptor enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER-2/neuoverexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 1998; 16: 2659–71.
32. Pegram M, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999; 18: 2241–51.
33. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER-2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17: 2639–48.
34. Bendell JC, Domchek SM, Burstein HJ et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer 2003; 97: 2972–7.
35. Paik S, Bryant J, Tan-Chi E et al. Real world performance of HER2 testing: National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 2002; 94: 852–4.
36. Tan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology 2002; 63 (Suppl. 1): 57–63.
37. 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.
Авторы
Martine J. Piccart-Gebhart, M.D., Ph.D., Marion Procter, M.Sci., Brian Leyland-Jones, M.D., Ph.D., Aron Goldhirsch, M.D., Michael Untch, M.D., Ian Smith, M.D., Luca Gianni, M.D., Jose Baselga, M.D., Richard Bell, M.D., Christian Jackisch, M.D., David Cameron, M.D., Mitch Dowsett, Ph.D., Carlos H. Barrios, M.D., Günther Steger, M.D., Chiun-Shen Huang, M.D., Ph.D., M.P.H., Michael Andersson, M.D., Dr.Med.Sci., Moshe Inbar, M.D., Mikhail Lichinitser, M.D., Dr.Med.Sci., István Láng, M.D., Ulrike Nitz, M.D., Hiroji Iwata, M.D., Christoph Thomssen, M.D., Caroline Lohrisch, M.D., Thomas M. Suter, M.D., Josef Rüschoff, M.D., Tamás Süto, M.D., Ph.D., Victoria Greatorex, M.Sc., Carol Ward, M.Sc., Carolyn Straehle, Ph.D., Eleanor McFadden, M.A., M. Stella Dolci, Richard D. Gelber, Ph.D., for the Herceptin Adjuvant (HERA) Trial Study Team
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