A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study

Annals of Oncology

Volumn 23, Issue 5, 2012, Pages 1121-1129

  Vici, P ^a   Brandi, M ^b,c   Giotta, F ^b   Foggi, P ^a   Schittulli, F ^b   Di lauro, L ^a   Gebbia, N ^d   Massidda, B ^e   Filippelli, G ^f   Giannarelli, D ^a   Di benedetto, A ^a   Mottolese, M ^a   Colucci, G ^b   Lopez, M ^a  

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b NATIONAL CANCER INSTITUTE GIOVANNI PAOLO II   (Italy)

^c Hospital Dimiccoli   (Italy)

^d UNIVERSITY OF PALERMO   (Italy)

^e UNIVERSITY OF CAGLIARI   (Italy)

^f S Francesco Hospital   (Italy)

Author keywords

Adjuvant chemotherapy; Docetaxel; Early breast cancer

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN;

ADULT; AGED; ALOPECIA; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER LOCALIZATION; CANCER SURVIVAL; CARDIOTOXICITY; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG EFFECT; DRUG EFFICACY; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; LEUKEMIA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; NONHODGKIN LYMPHOMA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE;

ADULT; ALGORITHMS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; EPIRUBICIN; FEMALE; HUMANS; ITALY; LYMPH NODES; LYMPHATIC METASTASIS; MIDDLE AGED; PROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TAXOIDS;

EID: 84860484222     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr412     Document Type: Article

References (54)

1. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet 1998; 352: 930-942.
2. Fisher B, Brown AM, Dimitrov NV et al. Two months of doxorubicincyclophosphamide 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: 1483-1496.
3. 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 1985; 3: 818-826.
4. French Epirubicin Study Group. A prospective randomized phase III trial comparing combination chemotherapy with cyclophosphamide, fluorouracil, and either doxorubicin or epirubicin. French Epirubicin Study Group. J Clin Oncol 1988; 6: 679-688.
5. Medical Department, Farmitalia Carlo Erba, Milano, Italy. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. Italian Multicentre Breast Study with Epirubicin. J Clin Oncol 1988; 6: 976-982.
6. Lopez M, Vici P, Di Lauro L et al. Randomized prospective clinical trial of highdose epirubicin and dexrazoxane in patients with advanced breast cancer and soft tissue sarcomas. J Clin Oncol 1998; 16: 86-92.
7. Bastholt L, Dalmark M, Gjedde SB et al. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol 1996; 14: 1146-1155.
8. López-Tarruella S, Martìn M. Advances in adjuvant systemic chemotherapy of early breast cancer. Breast Cancer Res 2009; 11: 204.
9. Antón A, Hornedo J, Lluch A et al. A phase II study of sequential docetaxel followed by doxorubicin/cyclophosphamide as first-line chemotherapy for metastatic breast cancer. Clin Breast Cancer 2003; 4: 286-291.
10. Khayat D, Chollet P, Antoine EC et al. Phase II study of sequential administration of docetaxel followed by doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer. J Clin Oncol 2001; 19: 3367-3375.
11. Spielmann M, Tubiana-Hulin M, Namer M et al. Sequential or alternating administration of docetaxel (Taxotere) combined with FEC in metastatic breast cancer: a randomised phase II trial. Br J Cancer 2002; 86: 692-697.
12. Cresta S, Grasselli G, Mansutti M et al. A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first-line chemotherapy for women with metastatic breast cancer. Ann Oncol 2004; 15: 433-439.
13. Paridaens R, Van Aelst F, Georgoulias V et al. A randomized phase II study of alternating and sequential regimens of docetaxel and doxorubicin as first-line chemotherapy for metastatic breast cancer. Ann Oncol 2003; 14: 433-440.
14. Perez EA, Geeraerts L, Suman VJ et al. A randomized phase II study of sequential docetaxel and doxorubicin/cyclophosphamide in patients with metastatic breast cancer. Ann Oncol 2002; 13: 1225-1235.
15. Demetri GD, Berry D, Norton L et al. Clinical outcomes of node-positive breast cancer patients treated with dose-intensified Adriamycin/cyclophosphamide (AC) followed by Taxol (T) as adjuvant systemic chemotherapy (CALGB 9141). Proc Am Soc Clin Oncol 1997;; (Abstr 503).
16. Hudis C, Seidman A, Baselga J et al. Sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide for resectable high-risk breast cancer: feasibility and efficacy. J Clin Oncol 1999; 17: 93-100.
17. Mamounas EP, Bryant J, Lembersky BC et al. Paclitaxel (T) following doxorubicin/cyclophosphamide (AC) as adjuvant chemotherapy for nodepositive breast cancer: results from NSABP B-28. Proc Am Soc Clin Oncol 2003; 22: (Abstr 12).
18. 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 1998;; (Abstr 390).
19. Papaldo P, Lopez M, Cortesi E et al. Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide. J Clin Oncol 2003; 21: 3462-3468.
20. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103-115.
21. 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: 2127-2132.
22. 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 randomised trials. Lancet 2005; 365: 1687-1717.
23. Peto R. The worldwide overview: new result for sistemic adjuvant therapy. Plenary lecture. 30th Annual San Antonio Breast Cancer Symposium, San Antonio; 2007.
24. Bria E, Nistico C, Cuppone F et al. Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients. Cancer 2006; 106: 2337-2344.
25. Ferguson T, Wilcken N, Vagg R et al. Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev 2007; (4): CD004421.
26. De Laurentiis M, Cancello G, D'Agostino D et al. Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 2008; 26: 44-53.
27. Francis P, Crown J, Di Leo A et al. Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial. J Natl Cancer Inst 2008; 100: 121-133.
28. Goldstein LJ, O'Neill A, Sparano JA et al. Concurrent doxorubicin plus docetaxel is not more effective than concurrent doxorubicin plus cyclophosphamide in operable breast cancer with 0 to 3 positive axillary nodes: North American Breast Cancer Intergroup Trial E 2197. J Clin Oncol 2008; 26: 4092-4099.
29. Jones S, Holmes FA, O'Shaughnessy J et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. J Clin Oncol 2009; 27: 1177-1183.
30. Martin M, Pienkowski T, Mackey J et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 2005; 352: 2302-2313.
31. Martìn M, Rodrìguez-Lescure A, Ruiz A et al. Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel fo early breast cancer. J Natl Cancer Inst 2008; 100: 805-814.
32. Martín M, Lluch A, Segui MA et al. TAC versus FAC as adjuvant chemotherapy for high-risk node-negative breast cancer: results of the GEICAM 9805 trial. Ann Oncol 2008; 19 (Suppl 8): viii77-viii88 (Abstr 1830).
33. Burnell M, Levine MN, Chapman JA et al. Cyclophosphamide, epirubicin, and fluorouracil versus dose-dense epirubicin and cyclophosphamide followed by paclitaxel versus doxorubicin and cyclophosphamide followed by paclitaxel in node-positive or high-risk node-negative breast cancer. J Clin Oncol 2010; 8: 77-82.
34. Roche H, Fumoleau P, Spielmann M et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 2006; 24: 5664-5671.
35. Ellis P, Barrett-Lee P, Johnson L et al. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. Lancet 2009; 373: 1681-1692.
36. 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: 976-983.
37. Fountzilas G, Skarlos D, Dafni U et al. Postoperative dose-dense sequential chemotherapy with epirubicin, followed by CMF with or without paclitaxel, in patients with high-risk operable breast cancer: a randomized phase III study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 2005; 16: 1762-1771.
38. Gianni L, Baselga J, Eiermann W et al. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European Cooperative Trial in Operable Breast Cancer. J Clin Oncol 2009; 27: 2474-2481.
39. Cognetti F, De Laurentiis M, De Matteis A et al. Docetaxel added to anthracycline regimens improves outcomes in early breast cancer. Proc Eur Soc Med Oncol 2008;; (Abstr 1820).
40. Bear HD, Anderson S, Smith RE et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2006; 24: 2019-2027.
41. Polyzos A. FEC versus sequential docetaxel followed by epirubicin/ cyclophosphamide as adjuvant chemotherapy in women with axillary nodepositive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG). Breast Cancer Res Treat 2010; 119: 95-104.
42. Boccardo F, Amadori D, Guglielmini P et al. Epirubicin followed by cyclophosphamide, methotrexate and 5-fluorouracil versus paclitaxel followed by epirubicin and vinorelbine in patients with high-risk operable breast cancer. Oncology 2010; 78: 274-281.
43. de Azambuja E, Paesmans M, Beauduin M et al. Long-term benefit of high-dose epirubicin in adjuvant chemotherapy for node-positive breast cancer: 15-year efficacy results of the Belgian multicentre study. J Clin Oncol 2009; 27: 720-725.
44. Bonneterre J, Bercez C, Bonneterre ME et al. Cost-effectiveness analysis of breast cancer adjuvant treatment: FEC 50 versus FEC 100 (FASG05 study). Ann Oncol 2005; 16: 915-922.
45. Chirivella I, Bermejo B, Insa A et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant setting improves outcome of breast cancer patients. Breast Cancer Res Treat 2009; 114: 479-484.
46. Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809-820.
47. Piedbois P, Serin D, Priou F et al. Dose-dense adjuvant chemotherapy in nodepositive reast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weeks. AERO B03 randomized phase II study. Ann Oncol 2007; 18: 52-57.
48. Puhalla S, Mrozek E, Young D et al. Randomized phase II adjuvant trial of dosedense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol 2008; 26: 1691-1697.
49. Wildiers H, Dirix L, Neven P et al. Delivery of adjuvant sequential dose-dense FEC-Doc to patients with breast cancer is feasible, but dose reductions and toxicity are dependent on treatment sequence. Breast Cancer Res Treat 2009; 114: 103-112.
50. Earl HM, Vallier A, Hiller L et al. Neo-tAnGo: a neoadjuvant randomized phase III trial of epirubicin/cyclophosphamide and paclitaxel 6 gemcitabine in the treatment of women with high-risk early breast cancer (EBC): first report of the primary endpoint, pathological complete response (pCR). Proc Am Soc Clin Oncol 2009; 27: 15s. (Abstr 522).
51. Alvarez RH, Bianchini G, Hsu L et al. The effect of different sequencing regimens of taxanes and anthracyclines in the primary systemic treatment (PST) of breast cancer (BC) patients (pts): M. D. Anderson Cancer Center retrospective analysis. J Clin Oncol 2010; 28: 15s. (Abstr 548).
52. Tang SC. Taxanes in the adjuvant treatment of early breast cancer, emerging consensus and unanswered questions. Cancer Invest 2009; 27: 489-495.
53. André F, Broglio K, Roche H et al. Estrogen receptor expression and efficacy of docetaxel-containing adjuvant chemotherapy in patients with node-positive breast cancer: results from a pooled analysis. J Clin Oncol 2008; 26: 2636-2643.
54. Del Mastro L, Costantini M, Durando A et al. Cyclophosphamide, epirubicin and 5-fluorouracile versus epirubicin plus paclitaxel in node-positive early breast cancer patients: A randomized, phase III study of Gruppo Oncologico Nord-Ovest Mammella Intergruppo Group. Proc Am Soc Clin Oncol 2008; 26: 10s. (Abstr 516).