Пегилированный липосомальный доксорубицин и трастузумаб у HER2-позитивных пациенток с метастатическим раком молочной железы: многоцентровое исследование второй фазы

1. Chia SK, Speers C, Kang A et al. The impact of new chemotherapeutic and hormonal agents on the survival of women with metastatic breast cancer (MBC) in a population based cohort. Proc Am Soc Clin Oncol 2003; 22 (6): abstr 22.
2. 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.
3. Buzdar A, Jonat W, Howell A et al. Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: Results of overview analysis of two phase III trials. J Clin Oncol 1996; 14: 2000–11.
4. Kaufmann M, Bajetta E, Dirix LY et al. Exemestane is superior to megestrol acetate following tamoxifen failure in postmenopausal women with advanced breast cancer: Results of a phase III randomized double-blind trial. J Clin Oncol 2000; 18: 1399–411.
5. Jones SE, Erban J, Overmoyer B et al. Randomized phase III study of docetaxel compared to paclitaxel in metastatic breast cancer. J Clin Oncol 2005; 23: 5542–51.
6. O’Shaughnessy J, Miles D, Vukelja S et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 2002; 20: 2812–3.
7. Nabholtz JM, Senn HJ, Bezwoda WR et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol 1999; 17: 1413–24.
8. Seidman A, Hudis C, Pierri MK et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002; 20: 1215–21.
9. O’Brien MER, Wigler N, Inbar M et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCL (caelyx/doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15: 440–9.
10. 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 over-expression. Breast Cancer Res Treat 1999; 57: 467.
11. Sledge GW, Neuberg D, Bernardo P et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as frontline chemotherapy for metastatic breast cancer: An intergroup trial (E1193). J Clin Oncol 2003; 21: 588–92.
12. Paridaens R, Biganzoli L, Bruning P et al. Paclitaxel versus doxorubicin as first-line singleagent chemotherapy for metastatic breast cancer: A European Organization for Research and Treatment of Cancer randomized study with cross-over. J Clin Oncol 2000; 18: 724–33.
13. 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.
14. Von Hoff DD, Layard MW, Basa P et al: Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 1979; 91: 710–7.
15. Swain SM, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: A retrospective analysis of three trials. Cancer 2003; 97: 2869–79.
16. 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.
17. Ravdin PM, Chamness GC. The c-erbB-2 proto-oncogene as a prognostic and predictive marker in breast cancer: A paradigm for the development of other macromolecular markers – A review. Gene 1995; 159: 19–27.
18. Paik S, Bryant J, Park C et al. ErbB-2 and response to doxorubicin in patients with axillary lymph node-positive, hormone receptor-negative breast cancer. J Natl Cancer Inst 1998; 90: 1361–70.
19. Pritchard KI, O’Malley FA, Audrulis I et al. Prognostic and predictive value of HER-2/neu in a randomized trial comparing CMF to CEF in premenopausal women with axillary lymph node positive breast cancer (NCIC CTG MA. 5). Proc Am Soc Clin Oncol 2002; 21 (42a): abstr 165.
20. Kim E, Gaiotti DA, Volm MD et al. Reversible cardiotoxicity from pegylated liposomal doxorubicin plus trastuzumab (herceptin): Results from 2 prospective studies. Breast Cancer Res Treat 2004; 88: S204, abstr 5058.
21. Wolff AC, Wang M, Sparano JA et al. Cardiac safety and clinical activity of pegylated liposomal doxorubicin and docetaxel with and without trastuzumab as 1st line chemotherapy in HER2 positive and HER-2 negative metastatic breast cancer: Eastern Cooperative Oncology Group trial E3198. Breast Cancer Res Treat 2004; 88: S125, abstr 3040.
22. Eidtmann H, Thomseen C, Untch M et al. Herceptin in combination with epirubicin plus cyclophosphamide: Cardiac safety and efficacy in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 2002; 21: 60a, abstr 236.
23. Theodoulou M, Campos SM, Batist G et al. TLC D99 (D, Myocet) and herceptin is safe in advanced breast cancer: Final cardiac and safety analysis. Proc Am Soc Clin Oncol 2002; 21: 55a, abstr 216.
24. 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: 2889–95.
25. Pegram MD, Pienkowski T, Northfelt DW et al. Results of two open-label, multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J Natl Cancer Inst 2004; 96: 759–69.
26. Robert N, Leyland-Jones B, Asmar L et al. Phase III comparative study of trastuzumab and paclita xel with and without carboplatin in patients with HER-2/neu positive advanced breast cancer. Breast Cancer Res Treat 2002; 76: S37, abstr 35.
27. 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.
28. Budzar AU, Ibrahim NK, Francis D et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin: Results of a randomized trial in human epidermal growth factor receptor-2 positive operable breast cancer. J Clin Oncol 2005; 23: 3676–85.

S. Chia, M. Clemons, L.-A. Martin, A. Rogers, K. Gelmon, G. R. Pond, L. Panasci