TY - JOUR
T1 - Phase III randomized multicenter study on the effects of adjuvant CMF in patients with node-negative, rapidly proliferating breast cancer
T2 - Twelve-year results and retrospective subgroup analysis
AU - Amadori, Dino
AU - Nanni, Oriana
AU - Volpi, Annalisa
AU - Casadei Giunchi, Donata
AU - Marangolo, Maurizio
AU - Livi, Lorenzo
AU - Ravaioli, Alberto
AU - Rossi, Andrea Paolo
AU - Gambi, Angelo
AU - Luzi Fedeli, Stefano
AU - Perroni, Davide
AU - Scarpi, Emanuela
AU - Becciolini, Aldo
AU - Silvestrini, Rosella
PY - 2008/3
Y1 - 2008/3
N2 - The randomized multicenter study on rapidly proliferating breast cancer, assessed according to thymidine labelling index (TLI), was activated at the end of the 1980s. The present work investigated whether and to what degree the short-term advantages observed from adjuvant CMF (cyclophosphamide, methotrexate, 5-fluorouracil) were maintained at a longer follow-up. Two hundred and eighty-one patients with node-negative and high TLI tumors were randomized to receive six cycles of CMF or no further treatment. At a median follow-up of 12 years, CMF produced a 25% and 20% relative reduction in relapse and death cumulative incidence, respectively. A breakdown analysis identified a subgroup of patients with intermediate proliferating tumors for whom a 70% and 73% reduction in relapse and death was observed in the intention-to-treat population. An even higher reduction of 80% and 84% in relapse and death was seen for the patients who had received the full CMF dose. We identified a subgroup of patients with intermediate proliferating tumors in whom the high benefit obtained from adjuvant CMF was maintained at a long-term follow up.
AB - The randomized multicenter study on rapidly proliferating breast cancer, assessed according to thymidine labelling index (TLI), was activated at the end of the 1980s. The present work investigated whether and to what degree the short-term advantages observed from adjuvant CMF (cyclophosphamide, methotrexate, 5-fluorouracil) were maintained at a longer follow-up. Two hundred and eighty-one patients with node-negative and high TLI tumors were randomized to receive six cycles of CMF or no further treatment. At a median follow-up of 12 years, CMF produced a 25% and 20% relative reduction in relapse and death cumulative incidence, respectively. A breakdown analysis identified a subgroup of patients with intermediate proliferating tumors for whom a 70% and 73% reduction in relapse and death was observed in the intention-to-treat population. An even higher reduction of 80% and 84% in relapse and death was seen for the patients who had received the full CMF dose. We identified a subgroup of patients with intermediate proliferating tumors in whom the high benefit obtained from adjuvant CMF was maintained at a long-term follow up.
KW - Adjuvant CMF
KW - High-risk node-negative breast cancer
KW - Randomized study
KW - Tumor Proliferative activity
UR - http://www.scopus.com/inward/record.url?scp=39749110535&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=39749110535&partnerID=8YFLogxK
U2 - 10.1007/s10549-007-9593-9
DO - 10.1007/s10549-007-9593-9
M3 - Article
C2 - 17530429
AN - SCOPUS:39749110535
VL - 108
SP - 259
EP - 264
JO - Breast Cancer Research and Treatment
JF - Breast Cancer Research and Treatment
SN - 0167-6806
IS - 2
ER -