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Clinical Trial
. 2012 May;23(5):1121-1129.
doi: 10.1093/annonc/mdr412. Epub 2011 Sep 28.

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

P Vici  1 , M Brandi  2 , F Giotta  3 , P Foggi  4 , F Schittulli  5 , L Di Lauro  4 , N Gebbia  6 , B Massidda  7 , G Filippelli  8 , D Giannarelli  9 , A Di Benedetto  10 , M Mottolese  10 , G Colucci  3 , M Lopez  4
Affiliations
Clinical Trial

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

P Vici et al. Ann Oncol. 2012 May.

Abstract

Background: The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer.

Patients and methods: Patients were randomly assigned to EC (E 120 mg/m(2), C 600 mg/m(2), arm A) for four cycles or four cycles of D (100 mg/m(2)) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety.

Results: There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B.

Conclusions: This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.

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Figures

Figure 1.
Figure 1.
CONSORT diagram. D, docetaxel; EC, epirubicin plus cyclophosphamide; ITT, intention to treat.
Figure 2.
Figure 2.
Disease-free survival (A) and overall survival (B) by treatment. D, docetaxel; EC, epirubicin plus cyclophosphamide.
Figure 3.
Figure 3.
Hazard ratios for disease-free survival by patient and tumor characteristics.
Figure 4.
Figure 4.
Meta-analysis on disease-free survival of main taxane first-generation adjuvant/neoadjuvant trials.
See this image and copyright information in PMC

References

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