Abstract
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
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Sainato, Aldo;
[1]
Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it;
[1]
Valentini, Vincenzo;
[2]
De Paoli, Antonino, E-mail: adepaoli@cro.it;
[3]
Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it;
[4]
Lupattelli, Marco;
[5]
Aristei, Cynthia;
[5]
Vidali, Cristiana;
[6]
Conti, Monica;
[7]
Galardi, Alessandra;
[8]
Ponticelli, Pietro;
[9]
Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it;
[10]
Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it;
[11]
Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com;
[4]
Manfredi, Bruno;
[1]
others, and
- Department of Radiotherapy, Pisa University (Italy)
- Cattedra di radioterapia, Università Cattolica S. Cuore, Rome (Italy)
- Oncology Referral Center, National Cancer Institute, Aviano (Italy)
- Department of Radiotherapy, “La Sapienza University”, Rome (Italy)
- Department of Radiotherapy, Perugia University (Italy)
- Department of Radiotherapy, Trieste University (Italy)
- Department of Radiotherapy, Hospital of Venice (Italy)
- Department of Radiotherapy, Florence University (Italy)
- Department of Radiotherapy, Hospital of Arezzo (Italy)
- Oncological Institute of Veneto, Padova (Italy)
- Department of Radiotherapy, Hospital of Belluno (Italy)
Citation Formats
Sainato, Aldo, Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it, Valentini, Vincenzo, De Paoli, Antonino, E-mail: adepaoli@cro.it, Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it, Lupattelli, Marco, Aristei, Cynthia, Vidali, Cristiana, Conti, Monica, Galardi, Alessandra, Ponticelli, Pietro, Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it, Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it, Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com, Manfredi, Bruno, and others, and.
No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT).
Ireland: N. p.,
2014.
Web.
doi:10.1016/J.RADONC.2014.10.006.
Sainato, Aldo, Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it, Valentini, Vincenzo, De Paoli, Antonino, E-mail: adepaoli@cro.it, Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it, Lupattelli, Marco, Aristei, Cynthia, Vidali, Cristiana, Conti, Monica, Galardi, Alessandra, Ponticelli, Pietro, Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it, Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it, Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com, Manfredi, Bruno, & others, and.
No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT).
Ireland.
https://doi.org/10.1016/J.RADONC.2014.10.006
Sainato, Aldo, Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it, Valentini, Vincenzo, De Paoli, Antonino, E-mail: adepaoli@cro.it, Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it, Lupattelli, Marco, Aristei, Cynthia, Vidali, Cristiana, Conti, Monica, Galardi, Alessandra, Ponticelli, Pietro, Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it, Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it, Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com, Manfredi, Bruno, and others, and.
2014.
"No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT)."
Ireland.
https://doi.org/10.1016/J.RADONC.2014.10.006.
@misc{etde_22438469,
title = {No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT)}
author = {Sainato, Aldo, Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it, Valentini, Vincenzo, De Paoli, Antonino, E-mail: adepaoli@cro.it, Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it, Lupattelli, Marco, Aristei, Cynthia, Vidali, Cristiana, Conti, Monica, Galardi, Alessandra, Ponticelli, Pietro, Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it, Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it, Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com, Manfredi, Bruno, and others, and}
abstractNote = {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.}
doi = {10.1016/J.RADONC.2014.10.006}
journal = []
issue = {2}
volume = {113}
journal type = {AC}
place = {Ireland}
year = {2014}
month = {Nov}
}
title = {No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT)}
author = {Sainato, Aldo, Cernusco Luna Nunzia, Valentina, E-mail: magnolia720@hotmail.it, Valentini, Vincenzo, De Paoli, Antonino, E-mail: adepaoli@cro.it, Maurizi, Enrici Riccardo, E-mail: Riccardo.Maurizienrici@uniroma1.it, Lupattelli, Marco, Aristei, Cynthia, Vidali, Cristiana, Conti, Monica, Galardi, Alessandra, Ponticelli, Pietro, Friso, Maria Luisa, E-mail: marialuisa.friso@ioveneto.it, Iannone, Tiziana, E-mail: tiziana.iannone@ulss.belluno.it, Osti, Falchetto Mattia, E-mail: mattiafosti@gmail.com, Manfredi, Bruno, and others, and}
abstractNote = {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.}
doi = {10.1016/J.RADONC.2014.10.006}
journal = []
issue = {2}
volume = {113}
journal type = {AC}
place = {Ireland}
year = {2014}
month = {Nov}
}