TY - JOUR
T1 - No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC)
T2 - Long term results of a randomized trial (I-CNR-RT)
AU - Sainato, Aldo
AU - Cernusco Luna Nunzia, Valentina
AU - Valentini, Vincenzo
AU - De Paoli, Antonino
AU - Maurizi, Enrici Riccardo
AU - Lupattelli, Marco
AU - Aristei, Cynthia
AU - Vidali, Cristiana
AU - Conti, Monica
AU - Galardi, Alessandra
AU - Ponticelli, Pietro
AU - Friso, Maria Luisa
AU - Iannone, Tiziana
AU - Osti, Falchetto Mattia
AU - Manfredi, Bruno
AU - Coppola, Marianna
AU - Orlandini, Cinzia
AU - Cionini, Luca
PY - 2014/11/1
Y1 - 2014/11/1
N2 - Background and purpose To evaluate the effect of adjuvant chemotherapy (ACT) in locally advanced rectal cancer (LARC) after neoadjuvant chemoradiation (NACT-RT). The study was funded by the Italian National Research Council (CNR). Methods From September 1992 to January 2001, 655 patients with LARC (clinically T3-4, any N) treated with NACT-RT and surgery, were randomized in two arms: follow-up (Arm A) or 6 cycles of ACT with 5 fluorouracil (5FU)-Folinic Acid (Arm B). NACT-RT consisted of 45 Gy/28/ff concurrent with 5FU (350 mg/sqm) and Folinic Acid (20 mg/sqm) on days 1-5 and 29-33; surgery was performed after 4-6 weeks. Median follow up was 63·7 months. Primary end point was overall survival (OS). Results 634/655 patients were evaluable (Arm A 310, Arm B 324); 92·5% of Arm A and 91% of Arm B patients received the preoperative treatment as in the protocol; 294 patients of Arm A (94·8%) and 296 of Arm B (91·3%) underwent a radical resection; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms. 83/297 (28%) patients in Arm B, never started ACT. Five year OS and DFS did not show any significant difference in the two treatment arms. Distant metastases occurred in 62 patients (21%) in Arm A and in 58 (19·6%) in Arm B. Conclusions In patients with LARC treated with NACT-RT, the addition of ACT did not improve 5 year OS and DFS and had no impact on the distant metastasis rate.
AB - Background and purpose To evaluate the effect of adjuvant chemotherapy (ACT) in locally advanced rectal cancer (LARC) after neoadjuvant chemoradiation (NACT-RT). The study was funded by the Italian National Research Council (CNR). Methods From September 1992 to January 2001, 655 patients with LARC (clinically T3-4, any N) treated with NACT-RT and surgery, were randomized in two arms: follow-up (Arm A) or 6 cycles of ACT with 5 fluorouracil (5FU)-Folinic Acid (Arm B). NACT-RT consisted of 45 Gy/28/ff concurrent with 5FU (350 mg/sqm) and Folinic Acid (20 mg/sqm) on days 1-5 and 29-33; surgery was performed after 4-6 weeks. Median follow up was 63·7 months. Primary end point was overall survival (OS). Results 634/655 patients were evaluable (Arm A 310, Arm B 324); 92·5% of Arm A and 91% of Arm B patients received the preoperative treatment as in the protocol; 294 patients of Arm A (94·8%) and 296 of Arm B (91·3%) underwent a radical resection; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms. 83/297 (28%) patients in Arm B, never started ACT. Five year OS and DFS did not show any significant difference in the two treatment arms. Distant metastases occurred in 62 patients (21%) in Arm A and in 58 (19·6%) in Arm B. Conclusions In patients with LARC treated with NACT-RT, the addition of ACT did not improve 5 year OS and DFS and had no impact on the distant metastasis rate.
KW - Adjuvant chemotherapy
KW - Preoperative radiochemotherapy
KW - Rectal cancer
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U2 - 10.1016/j.radonc.2014.10.006
DO - 10.1016/j.radonc.2014.10.006
M3 - Article
C2 - 25454175
AN - SCOPUS:84915768105
VL - 113
SP - 223
EP - 229
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
SN - 0167-8140
IS - 2
ER -