Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: High antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study

Journal of Clinical Oncology

Volumn 13, Issue 11, 1995, Pages 2688-2699

  Gianni, Luca ^a   Munzone, Elisabetta ^a   Capri, Giuseppe ^a   Fulfaro, Fabio ^a   Tarenzi, Emiliana ^a   Villani, Fabrizio ^a   Spreafico, Carlo ^a   Laffranchi, Alberto ^a   Caraceni, Augusto ^a   Martini, Cinzia ^a   Stefanelli, Marco ^a   Valagussa, Pinuccia ^a   Bonadonna, Gianni ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; PACLITAXEL;

ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BREAST CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DOSE CALCULATION; DOSE RESPONSE; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; INTRAVENOUS DRUG ADMINISTRATION; MAXIMUM PERMISSIBLE DOSE; MUCOSA INFLAMMATION; NEUTROPENIA; PRIORITY JOURNAL; TREATMENT OUTCOME;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHI-SQUARE DISTRIBUTION; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEART; HEART FAILURE, CONGESTIVE; HUMAN; INFUSIONS, INTRAVENOUS; MIDDLE AGE; NEOPLASM METASTASIS; NEUTROPENIA; PACLITAXEL; PERIPHERAL NERVOUS SYSTEM DISEASES; REMISSION INDUCTION; SUPPORT, NON-U.S. GOV'T;

EID: 0028877036     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1995.13.11.2688     Document Type: Article

References (49)

1. Seidman AD: The emerging role of paclitaxel in breast cancer therapy. Clin Cancer Res 1:247-256, 1995
2. Abrams JS, Vena DA, Baltz J, et al: Paclitaxel (Taxol) activity in heavily treated metastatic breast cancer. Ann Oncol 5:199, 1994 (suppl 5, abstr 494)
3. Podda S, Ward M, Himelstein A, et al: Transfer and expression of the human multiple drug resistance gene into live mice. Proc Natl Acad Sci USA 89:9676-9680, 1992
4. Seidman AD, Crown JPA, Reichman B, et al: Lack of clinical cross resistance of Taxol with anthracycline in the treatment of metastatic breast cancer. Proc Am Soc Clin Oncol 12:63, 1993 (abstr 53)
5. Gelmon K, Nabholtz JM, Bontenbal M, et al: Randomized trial of two doses of paclitaxel in metastatic breast cancer after failure of standard therapy. Ann Oncol 5:198, 1994 (suppl 5, abstr 493)
6. Bonadonna G, Gianni L, Santoro A, et al: Drugs ten years later: Epirubicin. Ann Oncol 4:359-369, 1993
7. Henderson IC: Chemotherapy for metastatic disease, in Harris JR, Hellman S, Henderson IC, et al (eds): Breast Diseases (ed 2). Philadelphia, PA, Lippincott, 1991, pp 604-665
8. Rowinsky EK, Gilbert MR, McGuire WP, et al: Sequence of Taxol and cisplatin: A phase I and pharmacologic study. J Clin Oncol 9:1692-1703, 1991
9. Holmes FA, Valero V, Walters RS, et al: The M.D. Anderson Cancer Center experience wint Taxol in metastatic breast cancer. Monogr Natl Cancer Inst 15:161-169, 1993
10. Sledge GW Jr, Robert N, Sparano JA, et al: Paclitaxel (Taxol)/ doxorubicin combinations in advanced breast cancer: The Eastern Cooperative Oncology Group experience. Semin Oncol 21:15-18, 1994 (suppl 8)
11. Fisherman JS, McCabe M, Noone M, et al: Phase I study of Taxol, doxorubicin, plus granulocyte colony stimulating factor (G-CSF) in patients with metastatic breast cancer. Monogr Natl Cancer Inst 15:189-194, 1993
12. Eisenhauer EA, ten Bokkel Huinink W, Swenerton KD, et al: European-Canadian randomized trial of Taxol in relapsed ovarian cancer: High versus low dose and long versus short infusion. J Clin Oncol 12:2654-2666, 1994
13. Gianni L, Munzone E, Capri G, et al: Paclitaxel in metastatic breast cancer: A trial of two doses by 3-hour infusion in patients who failed prior therapy with anthracyclines. J Natl Cancer Inst 87:1169-1175, 1995
14. Wilson WH, Berg SL, Bryant G, et al. Paclitaxel in doxorubicin-refraclory or mitoxantrone-refractory breast cancer: A phase I/ II trial of 96-hour infusion. J Clin Oncol 12:621-629, 1994
15. Seidman AD, Hochhauser D, Yao T-J, et al: 96 Hour paclitaxel after prior short taxane infusion: Phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. Proc Am Soc Clin Oncol 14:113, 1995 (abstr 151)
16. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
17. Teichholz LE, Kreulen T, Herman MV, et al: Problems in echocardiographic volume determinations: Echocardiographic-angiographic correlations in the presence or absence of asynergy. Am J Card 37:7-12, 1976
18. Villani F, Misrachi D, Galimberti M: Cardiac arrhythmia and ischaemic events after combination chemotherapy for testicular cancer. Eur Heart J 15:1533-1536, 1994
19. Capri G, Munzone E, Tarenzi E, et al: Optic nerve disturbances: A new form of paclitaxel neurotoxicity. J Natl Cancer Inst 86:1099-1101, 1994
20. Koch GG, Landis JR, Freeman GL, et al: A general method for the analysis of experiments with repeated measurement of categorical data. Biometrics 33:133-158, 1977
21. Robert J, Gianni L: Pharmacokinetics and metabolism of anthracyclines. Cancer Surv 17:219-251, 1993
22. 2. J Clin Oncol 12:1741-1742, 1994 (letter)
23. Holmes FA, Newman EA, Madden T, et al: Schedule dependent pharmacokinetics in a phase I trial of Taxol and doxorubicin as initial chemotherapy for metastatic breast cancer. Ann Oncol 5:197, 1994 (suppl 5, abstr 489)
24. Myers CE, Chabner BA: Anthracyclines, in Chabner BA, Collins JM (eds): Cancer Chemotherapy: Principles and Practice (ed 2). Philadelphia, PA, Lippincott, 1990, pp 356-381
25. Bristow MR, Thomson PD, Martin RP, et al: Early anthracycline cardiotoxicity. Am J Med 65:823-820, 1978
26. Rowinsky EK, McGuire WP, Guarnieri T, et al: Cardiac disturbances during the administration of Taxol. J Clin Oncol 9:1704-1712, 1991
27. Bristow MR, Ginsburg R, Harrison DC: Histamine and the human heart: The other receptor system. Am J Cardiol 49:249-251, 1982
28. Bristow MR, Sageman WS, Scott RH, et al: Acute and chronic cardiovascular effects of doxorubicin in the dog: The cardiovascular pharmacology of drug-induced histamine release. J Cardiovasc Pharmacol 2:487-515, 1980
29. Munzone E, Gianni L, Capri G, et al: Cardiac function in breast cancer patients given paclitaxel by 3-h infusion and previous or concomitant doxorubicin. Proc Am Soc Clin Oncol 14:128, 1995 (abstr 211)
30. Jain KK, Casper ES, Geller NL, et al: A prospective randomized comparison of epirubicin and doxorubicin in patients with advanced breast cancer. J Clin Oncol 3:818-826, 1985
31. Palmeri ST, Bonow RO, Myers CE, et al: Prospective evaluation of doxorubicin cardiotoxicity by rest and exercise radionuclide angiography. Am J Cardiol 58:600-607, 1986
32. Minow RA, Benjamin RS, Gottlieb JA: Adriamycin (NSC 123127) cardiomyopathy. An overview with determination of risk factors. Cancer Chemother Rep 6:195-190, 1975
33. Alexander J, Dainiak N, Thorning D, et al: Serial assessment of doxorubicin cadiotoxicity with quantitative radionuclide angiocardiography. N Engl J Med 300:278-283, 1979
34. Fisherman J, McCabe M, Hillig M, et al: Phase I of Taxol and doxorubicin with G-CSF in previously untreated metastatic breast cancer. Proc Am Soc Clin Oncol 11:57, 1992 (abstr 54)
35. Bristow MR, Lopez MB, Mason JW, et al: Efficacy and cost of cardiac monitoring in patients receiving doxorubicin. Cancer 50:32-41, 1982
36. Schwartz RG, McKenzie WB, Alexander J, et al: Congestive heart failure and left ventricular dysfunction complicating doxorubicin therapy: A seven year experience using radionuclide angiocardiography. Am J Med 82:1109-1118, 1987
37. Choy H, Rodriguez FF, Koester S, et al: Investigation of Taxol as a potential radiation sensitizer. Cancer 71:3774-3778, 1993
38. Raghavan VT, Bloomer WD, Merkel DE: Taxol and radiation recall dermatitis. Lancet 341:1354, 1993 (letter)
39. Torti FM, Bristow MR, Howes AE, et al: Reduced cardiotoxicity of doxorubicin delivered on a weekly schedule assessed by endomyocardial biopsy. Ann Intern Med 99:745-740, 1983
40. Dresdale AR, Bonow RO, Wesley R, et al: Prospective evaluation of doxorubicin-induced cardiomyopathy resulting from post-surgical adjuvant treatment of patients with soft tissue sarcomas. Cancer 52:51-60, 1983
41. Ahmann DL, Schaid DJ, Bisel HF, et al: The effect on survival of initial chemotherapy in advanced breast cancer: Polychemotherapy versus single drug. J Clin Oncol 5:1928-1932, 1987
42. Eddy DM: High-dose chemotherapy with autologous bone marrow transplantation for the treatment of metastatic breast cancer. J Clin Oncol 10:657-670, 1992
43. Jones RB, Holland JF, Bhardwaj S, et al: A phase I-II study of intensive-dose Adriamycin for advanced breast cancer. J Clin Oncol 5:172-177, 1987
44. Hahn SM, Liebmann JE, Cook J, et al: Taxol in combination with doxorubicin or etoposide. Possible antagonism in vitro. Cancer 72:2705-2711, 1993
45. Berg SL, Cowan KH, Baus FM, et al: Pharmacokinetics of Taxol and doxorubicin administered alone and in combination by continuous 72-hour infusion. J Natl Cancer Inst 86:143-145, 1994
46. Millward LK, Cosson EJ, Stokes KH, et al: Cremophor EL changes the pharmacokinetics of doxorubicin. Proc Am Assoc Cancer Res 36:373, 1995 (abstr 2221)
47. Webster L, Linsenmeyer M, Millward M, et al: Measurement of Cremophor EL Following taxol: Plasma levels sufficient to reverse drug exclusion mediated by the multidrug-resistant phenotype. J Natl Cancer Inst 85:1685-1690, 1993
48. Rothenberg M, Ling V: Multidrug resistance: Molecular biology and clinical relevance. J Natl Cancer Inst 81:907-910, 1989
49. Gianni L, Kearns CM, Giani A, et al: Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180-190, 1995