Feasibility of two dose-dense FEC regimens with growth factor support for adjuvant therapy in patients with early breast cancer: Results from a randomised study of the Central European Cooperative Oncology Group (CECOG)

Breast Cancer Research and Treatment

Volumn 112, Issue 3, 2008, Pages 557-563

  Kahán, Zsuzsanna ^a   Spanik, Stanislav ^b   Wagnerova, Maria ^c   Skacel, Tomas ^d   Planko, Barbara ^e   Fitzthum, Elisabeth ^f   Lindner, Elisabeth ^f   Soldatenkova, Victoria ^g   Zielinski, Christoph C ^h   Brodowicz, Thomas ⁱ  

^a UNIVERSITY OF SZEGED   (Hungary)

^b Oddelenie Klinickej Farmakologie   (Slovakia)

^c Vychodoslovensky Onkologicky Ustav Kosice   (Slovakia)

^d AMGEN INC   (United States)

^e Central European Cooperative Oncology Group Austria   (Austria)

^f Pharmaceutical Monitoring Agency   (Austria)

^g InnoPharm ^*  (Russian Federation)

^h MEDICAL UNIVERSITY OF VIENNA   (Austria)

ⁱ UNIVERSITY OF VIENNA   (Austria)

Author keywords

Breast cancer; Chemotherapy; Cyclophosphamide; Dose densification; Epirubicin; Fluorouracil; Granulocyte colony stimulating factor; Pegfilgrastim

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CYCLOPHOSPHAMIDE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; HEMOGLOBIN; LIVER ENZYME; PROGESTERONE RECEPTOR; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADJUVANT THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE MARROW TOXICITY; BONE PAIN; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONJUNCTIVITIS; DIARRHEA; DOSE DENSIFICATION; DRUG DOSE COMPARISON; DRUG DOSE DENSE REGIMEN; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG TOLERABILITY; DYSPEPSIA; EDEMA; ERYTHROCYTE CONCENTRATE; EUROPE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL TOXICITY; HEMOGLOBIN BLOOD LEVEL; HERPES SIMPLEX; HUMAN; INFECTION; INJECTION SITE REACTION; LEUKOPENIA; LIVER FUNCTION TEST; LIVER TOXICITY; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OPEN STUDY; PERICARDIAL EFFUSION; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; POLYURIA; PRIORITY JOURNAL; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; TASTE DISORDER; THROAT DISEASE; THROMBOEMBOLISM; TREATMENT RESPONSE; VOMITING;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; CYCLOPHOSPHAMIDE; DOSE-RESPONSE RELATIONSHIP, DRUG; EPIRUBICIN; FEMALE; FILGRASTIM; FLUOROURACIL; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; MEDICAL ONCOLOGY; MIDDLE AGED; TREATMENT OUTCOME;

EID: 56549121684     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-008-9894-7     Document Type: Article

References (18)

1. US Cancer Statistics Working Group (2006) United States cancer statistics. 2003 incidence and mortality. US Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute, Atlanta
2. J Ferlay P Autier M Boniol M Heanue M Colombet P Boyle 2007 Estimates of the cancer incidence and mortality in Europe in 2006 Ann Oncol 18 581 592
3. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) 2005 Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials Lancet 365 1687 1717
4. MN Levine VH Bramwell KI Pritchard BD Norris LE Shepherd H Abu-Zahra B Findlay D Warr D Bowman J Myles A Arnold T Vandenberg R MacKenzie J Robert J Ottaway M Burnell CK Williams D Tu 1998 Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group J Clin Oncol 16 2651 2658
5. French Adjuvant Study Group 2001 Benefit of a high-dose epirubicin regimen in adjuvant chemotherapy for node-positive breast cancer patients with poor prognostic factors: 5-year follow-up results of French Adjuvant Study Group 05 randomized trial J Clin Oncol 19 602 611
6. J Bonneterre H Roché P Kerbrat A Brémond P Fumoleau M Namer MJ Goudier S Schraub P Fargeot I Chapelle-Marcillac 2005 Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial J Clin Oncol 23 2686 2693
7. L Norton R Simon 1977 Tumor size, sensitivity to therapy, and design of treatment schedules Cancer Treat Rep 61 1307 1317
8. L Norton 1997 Evolving concepts in the systemic drug therapy of breast cancer Semin Oncol 24 S10
9. Z Kahan G Uhercsak R Hajnal-Papp K Boda L Thurzo 2005 Dose-dense sequential adriamycin-Paclitaxel-cyclophosphamide chemotherapy is well tolerated and safe in high-risk early breast cancer Oncology 68 446 453
10. ML Citron DA Berry C Cirrincione C Hudis EP Winer WJ Gradishar NE Davidson S Martino R Livingston JN Ingle EA Perez J Carpenter D Hurd JF Holland BL Smith CI Sartor EH Leung J Abrams RL Schilsky HB Muss L Norton 2003 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 21 1431 1439
11. M Venturini L Del Mastro E Aitini E Baldini C Caroti A Contu F Testore F Brema P Pronzato G Cavazzini MR Sertoli G Canavese R Rosso P Bruzzi 2005 Dose-dense adjuvant chemotherapy in early breast cancer patients: results from a randomized trial J Natl Cancer Inst 97 1724 1733
12. E Baldini G Gardin PG Giannessi G Evangelista M Roncella T Prochilo P Collecchi R Rosso R Lionetto P Bruzzi F Mosca PF Conte 2003 Accelerated versus standard cyclophosphamide, epirubicin and 5-fluorouracil or cyclophosphamide, methotrexate and 5-fluorouracil: a randomized phase III trial in locally advanced breast cancer Ann Oncol 14 227 232
13. CT Dang GM D'Andrea ME Moynahan MN Dickler AD Seidman M Fornier ME Robson M Theodoulou D Lake VE Currie A Hurria KS Panageas L Norton CA Hudis 2004 Phase II study of feasibility of dose-dense FEC followed by alternating weekly taxanes in high-risk, four or more node-positive breast cancer Clin Cancer Res 10 5754 5761
14. MM Oken RH Creech DC Tormey J Horton TE Davis ET McFadden PP Carbone 1982 Toxicity and response criteria of the Eastern Cooperative Oncology Group Am J Clin Oncol 5 649 655
15. Cancer Therapy Evaluation Program (1999) Common terminology criteria for adverse events index. Version 2.0. National Cancer Institute, Bethesda, MD
16. Fumoleau P, Brain E, Delozier T, Asselain B, Serin D, Roche H, Spielmann M, Geneve J, Jimenez M, Bonnetain F (2005) Adjuvant dose-dense (3 FEC 100 followed by 3 docetaxel every 2 weeks) regimen is not feasible. Results of FNCLCC-PACS 06 study. Poster presented at the 28th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, 8-11 December 2005
17. J Schwartz SM Domchek WT Hwang K Fox 2005 Evaluation of anemia, neutropenia and skin toxicities in standard or dose-dense doxorubicin/ cyclophosphamide (AC)-paclitaxel or docetaxel adjuvant chemotherapy in breast cancer Ann Oncol 16 247 252
18. Burnell M, Levine M, Chapman JA, Bramwell V, Gelmon K, Walley B, Whelan T, Albain K, Perez E, Rugo H, Ding Z, O'Brien P, Shepherd L, Pritchard K (2006) A randomized trial of CEF versus dose dense EC followed by paclitaxel versus AC followed by paclitaxel in women with node positive or high risk node negative breast cancer, NCIC CTG MA.21: Results of an interim analysis. Poster presented at the 29th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, 14-17 December 2006