Adjuvant docetaxel for node-positive breast cancer

New England Journal of Medicine

Volumn 352, Issue 22, 2005, Pages 2302-2313

  Martin, Miguel ^a   Pienkowski, Tadeusz ^b   Mackey, John ^c   Pawlicki, Marek ^d   Guastalla, Jean Paul ^e   Weaver, Charles ^f   Tomiak, Eva ^g   Al Tweigeri, Taher ^h   Chap, Linnea ⁱ   Juhos, Eva ^j   Guevin, Raymond ^k   Howell, Anthony ^l   Fornander, Tommy ^m   Hainsworth, John ⁿ   Coleman, Robert ^o   Vinholes, Jeferson ^p   Modiano, Manuel ^q   Pinter, Tamas ^r   Tang, Shou C ^s   Colwell, Bruce ^t   Prady, Catherine ^u   Provencher, Louise ^v   Walde, David ^w   Rodriguez Lescure, Alvaro ^x   Hugh, Judith ^c   Loret, Camille ^y   Rupin, Matthieu ^y   Blitz, Sandra ^y   Jacobs, Philip ^z   Murawsky, Michael ^aa   Riva, Alessandro ^y   Vogel, Charles ^ab   more..

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^b INSTITUTE OF ONCOLOGY   (Poland)

^c CROSS CANCER INSTITUTE   (Canada)

^d INSTITUTE OF ONCOLOGY   (Poland)

^e CENTRE LÉON BÉRARD   (France)

^f Response Oncology   (United States)

^g OTTAWA REGIONAL CANCER CENTRE   (Canada)

^h Saskatoon Cancer Center   (Canada)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j NATIONAL INSTITUTE OF ONCOLOGY   (Hungary)

^k Hôpital Saint Luc   (Canada)

^l CHRISTIE HOSPITAL   (United Kingdom)

^m STOCKHOLM SÖDER HOSPITAL   (Sweden)

ⁿ Cannon Cancer Center   (United States)

^o WESTON PARK HOSPITAL   (United Kingdom)

^p Hospital Santa Casa de Misericordia   (Brazil)

^q Arizona Clinical Research Center   (United States)

^r Petz Aladar County Teaching Hospital   (Hungary)

^s Murphy Cancer Centre   (Canada)

^t Nova Scotia Cancer Center   (Canada)

^u Dumont Hospital   (Canada)

^v LAVAL UNIVERSITY   (Canada)

^w Plummer Memorial Hospital   (Canada)

^x Hospital General   (Spain)

^y Paris   (France)

^z INSTITUTE OF HEALTH ECONOMICS   (Canada)

^aa SANOFI   (France)

^ab Cancer Research Network   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CIPROFLOXACIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; ANTINEOPLASTIC AGENT; CAF PROTOCOL; TAXOID;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; ADJUVANT CHEMOTHERAPY; ADULT; AGED; ALLERGY; ALOPECIA; AMENORRHEA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASTHENIA; AXILLARY LYMPH NODE; BREAST CANCER; CANCER MORTALITY; CANCER SURVIVAL; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE CLASSIFICATION; DISEASE SEVERITY; DRUG EFFICACY; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MYALGIA; NAIL DISEASE; NAUSEA; NEUTROPENIA; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RISK REDUCTION; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING; BREAST TUMOR; DISEASE FREE SURVIVAL; LYMPH NODE METASTASIS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; SURVIVAL;

ADULT; AGED; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; LYMPHATIC METASTASIS; MIDDLE AGED; QUALITY OF LIFE; SURVIVAL ANALYSIS; TAXOIDS;

EID: 21144435932     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa043681     Document Type: Article

References (35)

1. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomized trials. Lancet 1998;352:930-42.
2. Fisher B, Brown AM, Dimitrov NV, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol 1990;8:1483-96.
3. Hutchins L, Green S, Ravdin P, et al. CMF versus CAF with and without tamoxifen in high-risk node-negative breast cancer patients and a natural history follow-up study in low-risk node-negative patients: first results of Intergroup Trial INT 0102. Proc Am Soc Clin Oncol 1998;17:1a. abstract.
4. Martin M, Villar A, Sole-Calvo A, et al. Doxorubicin in combination with fluorouracil and cyclophosphamide (i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group. Ann Oncol 2003;14:833-42.
5. Fumoleau P, Kerbrat P, Romestaing P, et al. Randomized trial comparing six versus three cycles of epirubicin-based adjuvant chemotherapy in premenopausal, node-positive breast cancer patients: 10-year follow-up results of the French Adjuvant Study Group 01 trial. J Clin Oncol 2003;21:298-305.
6. Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thurlimann B, Senn HJ. Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003;21:3357-65.
7. Parnes HL, Cirrincione C, Aisner J, et al. Phase in study of cyclophosphamide, doxorubicin, and fluorouracil (CAF) plus leucovorin versus CAF for metastatic breast cancer: Cancer and Leukemia Group B 9140. J Clin Oncol 2003;21:1819-24.
8. Aisner J, Weinberg V, Perloff M, et al. Chemotherapy versus chemoimmunotherapy (CAF v CAFVP v CMF each +/- MER for metastatic carcinoma of the breast: a CALGB study: Cancer and Leukemia Group B. J Clin Oncol 1987;5:1523-33.
9. Smalley RV, Carpenter J, Bartolucci A, Vogel C, Krauss S. A comparison of cyclophosphamide, adriamycin, 5-fluorouracil (CAF) and cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, prednisone (CMFVP) in patients with metastatic breast cancer: a Southeastern Cancer Study Group project. Cancer 1977;40:625-32.
10. Buzdar AU, Singletary SE, Valero V, et al. Evaluation of paclitaxel in adjuvant chemotherapy for patients with operable breast cancer: preliminary data of a prospective randomized trial. Clin Cancer Res 2002;8:1073-9.
11. Nabholtz JM, Riva A, Lindsay MA, Reese DM, Tonkin K. The taxanes: paclitaxel and docetaxel. In: Nabholtz J-M, Tonkin K, Reese DM, Aapro M, Buzdar AU, eds. Breast cancer management: application of clinical and translational evidence to patient care. Philadelphia: Lippincott Williams & Wilkins, 2003:147-68.
12. Valero V, Holmes F, Walters RS, et al. Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracyclineresistant metastatic breast cancer. J Clin Oncol 1995;13:2886-94.
13. Ravdin PM, Burris HA III, Cook G, et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedioneresistant breast cancer. J Clin Oncol 1995;13:2879-85.
14. 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.
15. Schüller J, Czejka M, Kletzl H, et al. Doxorubicin (DOX) and Taxotere (TXT) - a pharmacokinetic (PK) study of the combination in advanced breast cancer. Proc Am Soc Clin Oncol 1998;17:205a. abstract.
16. Bellot R, Robert J, Dieras V, et al. Taxotere (T) does not change the pharmacokinetic (PK) profile of doxorubicin (dox) and doxorubicinol (Dx-ol). Proc Am Soc Clin Oncol 1998;17:221a. abstract.
17. Gianni L, Munzone E, Capri G, et al. Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastaric breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 1995;13:2688-99.
18. Gehl J, Boesgaard M, Paaske T, et al. Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic. Ann Oncol 1996;7:687-93.
19. 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 1997;15:1906-15.
20. Nabholtz JM, Mackey JR, Smylie M, et al. Phase II study of docetaxel, doxorubicin, and cyclophosphamide as first-line chemotherapy for metastatic breast cancer. J Clin Oncol 2001;19:314-21.
21. Nabholtz JM, Falkson C, Campos D, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 2003;21:968-75. [Erratum, J Clin Oncol 2003;21:2048.]
22. Mackey JR, Paterson A, Dirix LY, et al. Final results of the phase III randomized trial comparing docetaxel (T), doxorubicin (A) and cyclophosphamide (C) to FAC as first line chemotherapy (CT) for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2002;21:35a. abstract.
23. Bontenbal M, Braun JJ, Creemers GJ, et al. Phase III study comparing AT (adriamycin, docetaxel) to FAC (fluorouracil, adriamycin, cyclophosphamide) as first-line chemotherapy (CT) in patients with metastatic breast cancer (MBC). Eur J Cancer Suppl 2003;1:S201.
24. Nabholtz JM, Pienkowski T, Mackey J, et al. Phase III trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer (BC) patients: interim analysis of the BCIRG 001 study. Proc Am Soc Clin Oncol 2002;21:36a. abstract.
25. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Br J Cancer 1976;34:585-612.
26. Elledge RM, Green S, Pugh R, et al. Estrogen receptor (ER) and progesterone receptor (PgR), by ligand binding assay compared with ER, PgR, and pS2, by immunohistochemistry in predicting response to tamoxifen in breast cancer: a Southwest Oncology Group Study. Int J Cancer 2000;89:111-7.
27. Jacobs TW, Gown AM, Yaziji H, Barnes MJ, Schnitt SJ. HER-2/neu protein expression in breast cancer evaluated by immunohistochemisoy: a study of interlaboratory agreement Am J Clin Pathol 2000;113:251-8.
28. Mass RD, Sanders C, Kasian C, Johnson L, Everett T, Anderson S. The concordance between the clinical trials assay (CTA) and fluorescence in situ hybridization in the Herceptin pivotal trials. Proc Am Soc Clin Oncol 2000;19:75a. abstract.
29. Pauletti G, Godolphin W, Press MF, Slamon DJ. Detection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridization. Oncogene 1996;13:63-72.
30. Persons DL, Borelli KA, Hsu PH. Quantitation of HER-2/neu and c-myc gene amplification in breast carcinoma using fluorescence in situ hybridization. Mod Pathol 1997;10:720-7.
31. Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med 1995;333:1456-61.
32. Bear HD, Anderson S, Brown A, et al. The effect on rumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cydophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003;21:4165-74.
33. Henderson IC, Berry DA, Demetri GD, et al. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 2003;21:976-83.
34. Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 2003;21:1431-9. [Erratum, J Clin Oncol 2003;21:2226.]
35. Ozer H, Armitage JO, Bennett CL, et al. 2000 Update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. J Clin Oncol 2000;18:3558-85.