Dose-finding study of epidoxorubicin and docetaxel as first-line chemotherapy in patients with advanced breast cancer

Annals of Oncology

Volumn 10, Issue 5, 1999, Pages 539-545

  Pagani, O ^a   Sessa, C ^a   Martinelli, G ^b   Crivellari, D ^c   Buonadonna, A ^c   Thurlimann B ^d   Hess, D ^d   Borner, M ^e   Bauer, J ^f   Zampino, G ^b   Zimatore, M ^b   Graffeo, R ^a   Riva, A ^g   Goldhirsch, A ^a,b  

^a OSPEDALE SAN GIOVANNI   (Switzerland)

^b EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^e UNIVERSITY OF BERN   (Switzerland)

^f LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^g SANOFI   (France)

Author keywords

Advanced breast cancer; Docetaxel; Epidoxorubicin; G CSF

Indexed keywords

DOCETAXEL; EPIRUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE CALCULATION; DRUG EFFICACY; DRUG SAFETY; ECHOCARDIOGRAPHY; FOLLOW UP; HEART FUNCTION; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; NEUTROPENIA; PRIORITY JOURNAL; PROGNOSIS; THROMBOCYTOPENIA;

EID: 0032976893     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1026437731354     Document Type: Article

References (41)

1. Henderson IC. Chemotherapy for metastatic disease. In Harris JR, Hellman S, Henderson IC et al. (eds): Breast Diseases, second edition. Philadelphia, PA: Lippincott 1991; 604-65.
2. Mouridsen HT. Systemic therapy of advanced breast cancer. Drugs 1992; 44 (Suppl 4): 17-28.
3. French Epirubicin Study Group. A prospective randomised phase III trial comparing combination chemotherapy with cyclophosphamide, fluorouracil and either doxorubicin or epirubicin. J Clin Oncol 1988; 4: 679-88.
4. Italian multicentre breast study with epirubicin: Phase III randomised study of fluorouracil, epirubicin and cyclophosphamide vs. fluorouracil, doxorubicin and cyclophosphamide in advanced breast cancer. An Italian multicentre trial. J Clin Oncol 1988; 6: 976-82.
5. Bonadonna G, Gianni L, Santoro A et al. Drugs ten years later: Epirubicin. Ann Oncol 1993; 4: 359-69.
6. van Oosterom AT, Schrijvers D. Docetaxel (Taxotere), a review of preclinical and clinical experience. Part II: Clinical experience. Anticancer Drugs 1995; 6: 356-68.
7. Valero V. Docetaxel as single-agent therapy in metastatic breast cancer: Clinical efficacy. Semin Oncol 1997; 24 (4, Suppl 13): 11-8.
8. Cortes JE, Pazdur R. Docetaxel. J Clin Oncol 1995; 13: 2643-55.
9. Trudeau ME. First-line treatment of metastatic breast cancer. Anticancer Drugs 1996; 7 (Suppl 2): 9-12.
10. Ravdin PM. Docetaxel (Taxotere) for the treatment of anthracycline-resistant breast cancer. Semin Oncol 1997; 24 (4, Suppl 10): 18-21.
11. Nabholtz JM, Crown J. Phase III studies of single-agent docetaxel in patients with metastatic breast cancer who have progressed despite previous chemotherapy regimens: Preliminary results. Semin Oncol 1998; 25 (6, Suppl 13): 4-9.
12. Fisherman JS, Cowan KH et al. Phase I-II study of 72-hour infusional paclitaxel and doxorubicin with granulocyte colony stimulating factor in patients with metastatic breast cancer. J Clin Oncol 1996; 14: 774-82.
13. Holmes FA, Valero V et al. The M.D. Anderson Cancer Center experience with Taxol in metastatic breast cancer. Monogr Natl Cancer Inst 1993; 15: 161-9.
14. Sledge G, Robert N et al. ECOG studies of paclitaxel and doxorubicin in advanced breast cancer. Semin Oncol 1995; 22 (3, Suppl 6): 105-8.
15. Holmes FA, Madden TL, Newman RA et al. Sequence-dependent alteration of doxorubicin pharmacokinetics by paclitaxel in a phase I study of paclitaxel and doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1996; 14: 2713-21.
16. Gianni L, Vigano L, Locatelli A et al. Human pharmacokinetic characterisation and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J Clin Oncol 1997; 15: 1906-15.
17. Gianni L, Vigani L, Locatelli A et al. Different interference of paclitaxel on human pharmacokinetics of doxorubicin and epirubicin. Proc Am Soc Clin Oncol 1997; 14: 457 (Abstr 785).
18. Dombernowsky P, Boesgaard M et al. Doxorubicin plus paclitaxel in advanced breast cancer. Semin Oncol 1997; 24 (5, Suppl 17): 15-8.
19. Gianni L, Munzone E et al. Paclitaxel by three-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: High antitumour efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 1995; 13: 2688-99.
20. Frassineti GL, Zoli W et al. Paclitaxel plus doxorubicin in breast cancer: An Italian experience. Semin Oncol 1997; 24 (5, Suppl 17): 19-25.
21. Gehl J, Ejlersen B, Boesgaard M et al. Doxorubicin and paclitaxel, a highly active combination in the treatment of metastatic breast cancer. Semin Oncol 196; 23: 23-7.
22. Misset JL, Dieras V, Bozec L et al. Long-term follow-up of the phase I-II study of docetaxel (D) and doxorubicin (Dx) as firstline CT of metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 1998; 17: 160a (Abstr 613).
23. Blackstein M et al. Epirubicin in extensive small-cell lung cancer: A phase II study in previously untreated patients: A National Cancer Institute of Canada Clinical Trials Group study. J Clin Oncol 1990; 8: 385-9.
24. Feld R, Wierbick R, Walde PLD et al. Phase I-II study of high-dose epirubicin in advanced non-small-cell lung cancer. J Clin Oncol 1992; 10: 297-303.
25. Neri B et al. Epirubicin high-dose therapy in advanced breast cancer. Int J Clin Pharmacol TherTox 1989; 27: 388-91.
26. Focan C et al. Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: A prospective randomised trial. J Clin Oncol 1993; 11: 1253-63.
27. Habeshaw Tet al. Epirubicin at two dose levels with prednisolone as treatment for advanced breast cancer: The results of a randomised trial. J Clin Oncol 1991; 9: 295-304.
28. Marschner N et al. Evaluation of the importance and relevance of dose intensity using epirubicin and cyclophosphamide in metastatic breast cancer. Interim analysis of a prospective randomised trial. Semin Oncol 1994; 21 (Suppl 1): 10-6.
29. Conte PF, Baldini E, Gennari A et al. Dose-finding study and pharmacokinetics of epirubicin and paclitaxel over three hours: A regimen with high activity and low cardiotoxicity in advanced breast cancer. J Clin Oncol 1997; 15: 2510-7.
30. Luck HJ, Thomssen C, Du Bois A et al. Metastatic breast cancer: Experience with the combination paclitaxel plus epirubicin. Oncology 1998; 12 (1, Suppl 1): 36-9.
31. Catimel G, Spielmann M, Dieras V et al. Phase I studies of combined paclitaxel-epirubicin and paclitaxel-epirubicin-cyclophosphamide in patients with metastatic breast cancer: The French experience. Semin Oncol 1997; 24 (1, Suppl 3): 8-12.
32. Bruno R, Hille D, Thomas L et al. Population pharmacokinetics/pharmacodynamics (PK/PD) of docetaxel (Taxotere®) in phase II studies. Proc Am Soc Clin Oncol 1995; 14: 457 (Abstr 1471).
33. Miller AB, Hoogstraten B, Staquet M et al. Reporting results of cancer treatment. Cancer 1981; 47: 207-14.
34. Pizzo P. Management of fever in patients with cancer and treatment-induced neutropenia. N Engl J Med 1993; 328: 1323-32.
35. Kerbrat P, Viens P, Rochè H et al. Docetaxel (D) in combination with epirubicin (E) as first-line chemotherapy (CT) of metastatic breast cancer (MBC): Final results. Proc Am Soc Clin Oncol 1998; 17: 151a (Abstr 579).
36. Venturini M, Michelotti P, Papaldo L et al. First-line epirubicin (epi) and taxotere (TXT) in advanced breast cancer: A phase I study. Proc Am Soc Clin Oncol 1998; 17: 179a (Abstr 690).
37. Trudeau ME, Crump M, Latreille J et al. escalating doses of docetaxel and epirubicin as first-line therapy for metastatic breast cancer. A phase I study of the National Cancer Institute of Canada-Clinical Trials Group. Proc Am Soc Clin Oncol 1998; 17: 178a (Abstr 687).
38. Panagos G, Mavroudis D, Potamianou A et al. Phase I study of docetaxel and epirubicin in advanced breast cancer. Ann Oncol 1998; 9 (Suppl 4): 21 (Abstr 97P).
39. Colombo T, Gonzales Paz O, Zucchetti M et al. Paclitaxel induces significant changes in epidoxorubicin distribution in mice. Ann Oncol 1996; 7 (8): 801-5.
40. Colombo T, Parisi I, Zucchetti M et al. Pharmacokinetic interactions of paclitaxel, docetaxel and their vehicles with doxorubicin. Ann Oncol 1999; 10 (4): 391-5.
41. Bastholt L, Dalmark M, Gjedde SB et al. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: A randomised study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol 1996; 14 (4): 1146-55.