Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: A European Organization for Research and Treatment of Cancer Randomized Study with cross-over

Journal of Clinical Oncology

Volumn 18, Issue 4, 2000, Pages 724-733

  Paridaens, R ^a   Biganzoli, L ^a   Bruning, P ^a   Klijn, J G M ^a   Gamucci, T ^a   Houston, S ^a   Coleman, R ^a   Schachter, J ^a   Van Vreckem, A ^a   Sylvester, R ^a   Awada, A ^a   Wildiers, J ^a   Piccart, M ^a  

^a EORTC DATA CENTER   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BREAST CANCER; CANCER RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; METASTASIS; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0033956932     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.2000.18.4.724     Document Type: Article

References (48)

1. Fisher B, Osborne CK, Margolese RG, et al: Neoplasms of the breast, in Holland JF, Bast RC Jr, Morton DL, et al (eds): Cancer Medicine. Williams and Wilkins, Baltimore, MD; 1977, pp 2349-2429
2. De Lena M, Brambilla C, Morabito A, et al: Adriamycin plus vincristine compared to and combined with cyclophosphamide, methotrexate and fluorouracil for advanced breast cancer. Cancer 35:1108-1115, 1975
3. Steiner R, Stewart JF, Cantwell BMJ, et al: Adriamycin alone or combined with vincristine in the treatment of advanced breast cancer. Eur J Cancer Clin Oncol 19:1553-1557, 1983
4. Rubens RD, Begent RHJ, Knight RK, et al: Combined cytotoxic and progestogen therapy for advanced breast cancer. Cancer 42:1680-1686, 1978
5. Richards MA, Hopwood P, Ramirez AJ, et al: doxorubicin in advanced breast cancer: Influence of the schedule on response, survival and quality of life. Eur J Cancer 28A:1023-1028, 1992
6. Wani MC, Taylor HL, Wall ME, et al: Plant antitumor agents: VI. The isolation and structure of Taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc 93:2325-2327, 1971
7. Schiff PB, Fant J, Horwitz SB: Promotion of microtubule assembly in vitro by Taxol. Nature 77:665-667, 1979
8. Wall ME, Wani MC: Antineoplastic agents from plants. Ann Rev Pharmacol Toxicol 17:117-132, 1977
9. Holmes FA, Walters RS, Theriault RL: Phase II trial of Taxol, an active drug in the treatment of metastatic breast cancer. J Natl Cancer Inst 83:1797-1805, 1991
10. Hainsworth JD, Greco FA: Paclitaxel administered by 1-hour infusion. Cancer 74:1377-1382, 1994
11. Seidman AD, Hudis CA, Norton L: Memorial Sloan-Kettering Cancer experience with paclitaxel in the treatment of breast cancer: From advanced disease to adjuvant therapy. Semin Oncol 22:3-8, 1995 (suppl 8)
12. Seidman AD, Tiersten A, Hudis C, et al: Phase II trial of paclitaxel by 3-hour infusion as initial salvage chemotherapy for metastatic breast cancer. J Clin Oncol 13:2575-2581, 1995
13. Nabholtz JM, Gelmon K, Bontenbal M, et al: Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. J Clin Oncol 14:1858-1867, 1996
14. Gianni L, Munzone E, Capri G, et al: Paclitaxel in metastatic breast cancer: A trial of two doses by a 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines. J Natl Cancer Inst 87:1169-1175, 1995
15. Vermorken JB, ten Bokkel Huinink WW, Mandjes IAM, et al: High dose paclitaxel with granulocyte colony-stimulating factor in patients with advanced breast cancer refractory to anthracycline therapy: A European Cancer Center trial. Semin Oncol 22:16-22, 1995 (suppl 8)
16. Holmes FA: Update: The M.D. Anderson Cancer Center experience with paclitaxel in the management of breast carcinoma. Semin Oncol 22:9-15, 1995 (suppl 8)
17. Seidman AD, Reichman BS, Crown JPA, et al: Paclitaxel as second and subsequent therapy for metastatic breast cancer: Activity independent of prior anthracycline response. J Clin Oncol 13:1152-1159, 1995
18. Abrams JS, Vena DA, Baltz J, et al: Paclitaxel activity in heavily pretreated breast cancer: A National Cancer Institute treatment referral center trial. J Clin Oncol 13:2056-2065, 1995
19. Wilson WH, Berg SL, Bryant G, et al: Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: A phase I/II trial of 96-hour infusion. J Clin Oncol 12:1621-1629, 1994
20. Seidman AD, Hochhauser D, Yao TJ, 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)
21. MacDonald J, Haller D, Mayer R: Grading of toxicity, in MacDonald J, Haller D, Mayer R (eds): Manual of Oncologic Therapeutics. Philadelphia, PA, Lippincott, 1995, pp 519-523
22. De Haes JCJM, van Knippenberg FCE, Neijt JP: Measuring physiological and physical distress in cancer patients: Structure and application of the Rotterdam Symptom Checklist. Br J Cancer 62:1034-1038, 1990
23. Hayward JL, Carbone PP, Heuson JC: Assessment of response to therapy in advanced breast cancer. Eur J Cancer 13:89-94, 1977
24. Kaplan EL, Meier P: Non parametric estimation from incomplete observations. J Am Statist Assoc 53:457-481, 1958
25. Parmar MKB, Machin D. Survival analysis: A practical approach. Chichester, England, John Wiley and Sons, 1995
26. Cox DR: Regression models and life-tables. JR Stat Soc 34:187-202, 1972
27. Sledge GW, Neuberg D, Ingle J, et al: Phase III trial of doxorubicin vs paclitaxel vs doxorubicin plus paclitaxel as first line therapy for metastatic breast cancer: An Intergroup trial. Proc Am Soc Clin Oncol 16:1a, 1997 (abstr 2)
28. Winer E, Berry D, Duggan D, et al: Failure of higher dose paclitaxel to improve outcome in patients with metastatic breast cancer: Results from CALGB 9342. Proc Am Soc Clin Oncol 17:101a, 1998 (abstr 388)
29. Mamounas E, Brown A, Smith R, et al: Effect of Taxol duration of infusion in advanced breast cancer (ABC): Results from NSABP B-26 trial comparing 3-to 24-hour infusion of high-dose Taxol. Proc Am Soc Clin Oncol 17:101a, 1998 (abstr 389)
30. Holmes FA, Valero V, Buzdsar AU, et al: Final results: Randomized phase III trial of paclitaxel by 3-hour versus 96-hour infusion in patients (pt) with metastatic breast cancer (MBC) - The long & short of it. Proc Am Soc Clin Oncol 17:110a, 1998 (abstr 426)
31. Seidman AD, Hochhauser D, Gollub M: Ninety-six-hour paclitaxel infusion after progression during short taxane exposure: A phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. J Clin Oncol 14:1877-1882, 1996
32. Seidman AD, Hudis CA, Albanel J, et al: Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol 16:3353-3361, 1998
33. Hoogstraten B, George SL, Samal B, et al: Combination chemotherapy and Adriamycin in patients with advanced breast cancer. Cancer 38:13-20, 1976
34. Brambilla C, Rossi A, Bofante V, et al: Phase II study of doxorubicin versus epirubicin an advanced breast cancer. Cancer Treat Rep 70:261-266, 1986
35. Carmo-Pereira J, Costa FQ, Heriques E, et al: A comparison of two doses of Adriamycin in the primary chemotherapy of disseminated breast carcinoma. Br J Cancer 56:471-473, 1987
36. Ingle JN, Mailliard JA, Schaid DJ, et al: Randomized trial of doxorubicin alone or combined with vincristine and mitomycin C in women with metastatic breast cancer. Am J Clin Oncol 12:474-480, 1989
37. 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
38. Gottlieb JA, Rivkin SE, Spigel SC, et al: Superiority of Adriamycin over oral nitrosoureas in patients with advanced breast carcinoma: A Southwestern Cancer Chemotherapy Group Study. Cancer 33:519-526, 1974
39. Fredriksen PL, Joergensen ST, Roesdahl K, et al: Activity of Adriamycin in metastatic breast cancer resistant to combination regimen with cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone. Cancer Treat Rep 62:449-450, 1978
40. Chan S, Friedrichs K, Noël D, et al: A randomized phase III study of Taxotere (T) versus doxorubicin (D) in patients (pts) with metastatic breast cancer (MBC) who have failed an alkylating containing regimen: Preliminary results. Proc Am Soc Clin Oncol 16:154a, 1997 (abstr 540)
41. Gianni L, Munzone E, Capri G, et al: 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 study. J Clin Oncol 13:2688-2699, 1995
42. Gehl K, Boesgaard M, Paaske T, et al: Combined doxorubicin and paclitaxel in advanced breast cancer: Effective and cardiotoxic. Ann Oncol 7:687-693, 1996
43. Rowinski EK, Mc Guire WP, Guarnieri T, et al: Cardiac disturbances during the administration of Taxol. J Clin Oncol 9:1704-1712, 1991
44. Holmes FA, Madden T, Newman R, 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 14:2713-2721, 1996
45. Gianni L, Vigano L, Locatelli A, et al: Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J Clin Oncol 15:1906-1915, 1997
46. Gianni L, Dombernowsky P, Sledge G, et al: Cardiac function following combination therapy with Taxol® (T) and doxorubicin (A) for advanced breast cancer (ABC). Proc Am Soc Clin Oncol 17:115a, 1998 (abstr 444)
47. Gianni L, Capri G: Experience at the Istituto Nazionale Turmori with paclitaxel in combination with doxorubicin in women with untreated breast cancer. Semin Oncol 24:S3-1-S3-3, 1997 (suppl 3)
48. Henderson IC, Berry D, Demetri G, et al: Improved disease-free (DFS) and overall survival (OS) from the addition of sequential paclitaxel (T) but not from the escalation of doxorubicin (A) dose level in the adjuvant chemotherapy of patients (pts) with node-positive primary breast cancer (BC). Proc Am Soc Clin Oncol 17:101a, 1998 (abstr 390A)