Annals of Oncology Advance Access originally published online on June 14, 2005
Annals of Oncology 2005 16(9):1469-1476; doi:10.1093/annonc/mdi278
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© 2005 European Society for Medical Oncology
Primary chemotherapy in operable breast carcinoma comparing CMF (cyclophosphamide, methotrexate, 5-fluorouracil) with an anthracycline-containing regimen: short-term responses translated into long-term outcomes
1 Medical Oncology Division, Azienda Ospedaliera Universitaria of Parma 2 Medical Oncology Service, Azienda Ospedaliera, Reggio Emilia 3 Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi 10, Genova, Italy
* Correspondence to: Dr G. Cocconi, Medical Oncology Division, Azienda Ospedaliera Universitaria, Via Gramsci 14, 43100 Parma, Italy. Tel: +39-0521-460474; Fax: +39-0521-467829; Email: giorgio.cocconi{at}tin.it
Background: The role of anthracyclines has been extensively studied in adjuvant chemotherapy, but much less in the primary chemotherapy of early breast carcinoma. This study, comparing CMF (cyclophosphamide, methotrexate, 5-fluorouracil) with the rotational anthracycline-containing regimen CMFEV (CMF plus epirubicin and vincristine) administered as primary chemotherapy, demonstrated a significant increase in clinical complete response in premenopausal women. We report the long-term results.
Patients and methods: Two hundred and eleven patients with stage I or II palpable breast carcinoma and a tumour diameter of >2.5 cm were randomised to receive CMF or CMFEV for four cycles before surgery. After surgery, the patients in both arms received adjuvant CMF for three cycles.
Results: In the study population as a whole, there was a non-significant 20% reduction in mortality and relapse rates in the CMFEV arm. However, the effect of the experimental regimen was only found in premenopausal patients, especially in terms of relapse-free survival (P=0.07) and locoregional relapse-free survival (P=0.0009), thus mirroring the effect on response rates. After 10 years, the proportions of premenopausal patients free from locoregional relapse as a first event in the CMF and CMFEV groups were 68% and 97%, respectively. No relevant differences were found in postmenopausal patients.
Conclusion: The overall results of this study showed that the greater activity of the experimental anthracycline-containing combination over CMF as primary chemotherapy in premenopausal patients translated into long-term effects in the same subgroup.
Key words: anthracycline, breast carcinoma, CMF, complete response, outcome, primary chemotherapy