Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel for early breast cancer

Journal of the National Cancer Institute

Volumn 100, Issue 11, 2008, Pages 805-814

  Martín, Miguel ^a   Rodríguez Lescure, Álvaro ^b   Ruiz, Amparo ^c   Alba, Emilio ^d   Calvo, Lourdes ^e   Ruiz Borrego, Manuel ^ad   Munárriz, Blanca ^g   Rodríguez, César A ^h   Crespo, Carmen ⁱ   De Alava, Enrique ^j   López García Asenjo, José Antonio ^a   Guitián, María Dolores ^e   Almenar, Sergio ^c   González Palacios, Jesús Fernando ⁱ   Vera, Francisco ^g   Palacios, José ^f   Ramos, Manuel ^f,k   Gracia Marco, Jose Manuel ^l   Lluch, Ana ^m   Alvarez, Isabel ⁿ   Seguí, Miguel Angel ^o   Mayordomo, José Ignacio ^p   Antón, Antonio ^q   Baena, José Manuel ^r   Plazaola, Arrate ^s   Modolell, Alfonso ^t   Pelegrí, Amadeu ^u   Mel, Jose Ramón ^v   Aranda, Enrique ^w   Adrover, Encarna ^x   Álvarez, José Valero ^y   García Puche, José Luis ^z   Sánchez Rovira, Pedro ^aa   Gonzalez, Sonia ^ab   López Vega, José Manuel ^ac   more..

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^b HOSPITAL GENERAL UNIVERSITARIO DE ELCHE   (Spain)

^c INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^d HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^e HOSPITAL JUAN CANALEJO   (Spain)

^f HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^g HOSPITAL UNIVERSITARIO LA FE   (Spain)

^h HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

ⁱ HOSPITAL RAMÓN Y CAJAL   (Spain)

^j Centro de Investigacion del Cancer   (Spain)

^k Centro Oncologico de Galicia   (Spain)

^l HOSPITAL DE CABUEÑES   (Spain)

^m HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

ⁿ HOSPITAL DONOSTIA   (Spain)

^o HOSPITAL DE SABADELL   (Spain)

^p HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^q HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^r HOSPITAL UNIVERSITARIO PUERTA DEL MAR   (Spain)

^s Instituto Oncológico Guipúzcoa   (Spain)

^t Institut Clinica Corachan   (Spain)

^u HOSPITAL UNIVERSITARI SANT JOAN DE REUS   (Spain)

^v HOSPITAL XERAL CALDE   (Spain)

^w HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^x HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

^y Hospital General de Zamora   (Spain)

^z HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

^aa Hosp Univ Ciudad de Jaén   (Spain)

^ab HOSPITAL MÚTUA DE TERRASSA   (Spain)

^ac HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^ad Ciudad Universitaria S/n ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID DERIVATIVE; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DIPHENHYDRAMINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; FLUOROURACIL; HORMONE RECEPTOR; PACLITAXEL; RANITIDINE; SEROTONIN ANTAGONIST; TAMOXIFEN;

ADULT; AGE DISTRIBUTION; AGED; ALOPECIA; AMENORRHEA; ARTHRALGIA; ARTICLE; AXILLARY LYMPH NODE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER SIZE; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; COVARIANCE; DRUG EFFICACY; DRUG FATALITY; FEBRILE NEUTROPENIA; FEMALE; HEART INFARCTION; HEART LEFT VENTRICLE FAILURE; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION; KAPLAN MEIER METHOD; LUNG EMBOLISM; LYMPH NODE METASTASIS; MAJOR CLINICAL STUDY; MENOPAUSE; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PREDICTION; PRIORITY JOURNAL; PROGNOSIS; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SENSORY NEUROPATHY; SEPSIS; SIDE EFFECT; STOMATITIS; SUDDEN DEATH; TREATMENT OUTCOME; VOMITING;

EID: 44949228316     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djn151     Document Type: Article

References (28)

1. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomized trials. Lancet. 1998;352(8785):930-942.
2. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet. 2005;365 (9132):1687-1717.
3. Jensen BV. Cardioconsequences of anthracycline-containing therapy in patients with breast cancer. Semin Oncol. 2006;33(suppl 8):S15-S21.
4. Knoop AS, Knudsen H, Baslev B, et al. Retrospective analysis of topoisomerase Iia amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil: Danish Breast cancer Cooperative Group. J Clin Oncol. 2005;23(30):7483-7490.
5. Pritchard KI, Shepherd LE, O Malley FP, et al. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med. 2006;354(20):2103-2111.
6. 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 (6):976-983.
7. Mamounas EP, Bryant J, Lembersky BC, et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP-B 28. J Clin Oncol. 2005;23(16):3686-3696.
8. Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005;352(22):2302-2313.
9. Roche H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubic-inbased and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PASC 01 trial. J Clin Oncol. 2006;24(36):5664-5671.
10. Jones SE, Savin MA, Holmes FA, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24(34):5381-5387.
11. Martin M. Molecular biology of breast cancer. Clin Transl Oncol. 2006;8(6):7-14.
12. Hayes DF, Thor AD, Dressler LG, et al. HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007;357(15):1496-1506.
13. 90C followed by 8 weekly paclitaxel administrations: interim efficacy analysis of GEICAM 9906 trial. Breast Cancer Res Treat. 2005;94(suppl 1):S20.
14. Hudis CA, Barlow WE, Costantino JP, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007;25(15):2127-2132.
15. Allred DC, Harvey JM, Berardo M, Clark GM. Prognostic and predictive factors in breast cancer by immunohistochemical analysis. Mod Pathol. 1998;11(2):155-168.
16. Jacobs TW, Gown AM, Yaziji H, et al. Specificity of HercepTest in determining Her-2/neu status of breast cancer using the United States Food and Drug Administration-approved scoring system. J Clin Oncol. 1999;17(7):1983-1987.
17. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53(5):457-481.
18. Bloom HJG, Richardson WW. Histological grading and prognosis in breast cancer. Br J Cancer. 1957;11(8):359-377.
19. Albain K, Barlow W, O Malley F, et al. Concurrent (CAFT) versus sequential (CAF-T) chemohormonal therapy (cyclophosphamide, doxorubicin, 5-fluorouracil, tamoxifen) versus T alone for postmenopausal, node-positive, oestrogen and/or progesterone receptor-positive breast cancer; mature outcomes an new biological correlates on phase III intergroup trial 0100 (SWOG-8814). Breast Cancer Res Treat. 2004;88(suppl 1):abstract 37.
20. Berry DA, Cirrincione C, Craig Henderson I, et al. Oestrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA. 2006;295(14):1658-1667.
21. Martin M, Mackey J, Vogel C. Benefit from adjuvant taxanes and endocrine responsiveness in breast cancer. Breast. 2007;16 (S2):S127-S131.
22. 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(2):298-305.
23. Trudeau M, Charbonneau F, Gelman K, et al. Selection of adjuvant chemotherapy for treatment of node-positive breast cancer. Lancet Oncol. 2005;6(11):886-898.
24. Levine MN, Eisen A. Anthracycline adjuvant chemotherapy: how much is enough? J Clin Oncol. 2001;19(3):599-601.
25. Fisher B, Brown A, Dimitrov N, et al. Two months of doxorubicincyclophosphamide with and without interval re-induction therapy compared with 6 months of cyclophosphamide, methotrexate and fluorouracil in positive-node breast cancer patients with tamoxifen-non-responsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol. 1990;8(9):1483-1496.
26. Levine MN, Bramwell VH, Pritchard KI, et al. Randomized trial of intensive cyclophosphamide, epirubicin and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate and fluorouracil in premenopausal women with node-positive breast cancer. J Clin Oncol. 1998;16(8):2651-2658.
27. Mouridsen H, Andersen J, Andersson M, et al. Adjuvant anthracycline in breast cancer: improved outcome in premenopausal patients following substitution of methotrexate in the CMF combination with epirubicin. Proc Am Soc Clin Oncol. 1999;18:68.
28. Martin M, Villar A, Solé-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(6):833-842.