Aldo Sainato1, Valentina Cernusco Luna Nunzia2, Vincenzo Valentini3, Antonino De Paoli4, Enrici Riccardo Maurizi5, Marco Lupattelli6, Cynthia Aristei7, Cristiana Vidali8, Monica Conti9, Alessandra Galardi10, Pietro Ponticelli11, Maria Luisa Friso12, Tiziana Iannone13, Falchetto Mattia Osti14, Bruno Manfredi15, Marianna Coppola16, Cinzia Orlandini17, Luca Cionini18. 1. Department of Radiotherapy, Pisa University, Italy. Electronic address: a.sainato@ao-pisa.toscana.it. 2. Department of Radiotherapy, Pisa University, Italy. Electronic address: magnolia720@hotmail.it. 3. Cattedra di radioterapia, Università Cattolica S. Cuore, Rome, Italy. Electronic address: vvalentini@rm.unicatt.it. 4. Oncology Referral Center, National Cancer Institute, Aviano, Italy. Electronic address: adepaoli@cro.it. 5. Department of Radiotherapy, "La Sapienza University", Rome, Italy. Electronic address: Riccardo.Maurizienrici@uniroma1.it. 6. Department of Radiotherapy, Perugia University, Italy. Electronic address: kiralupis@libero.it. 7. Department of Radiotherapy, Perugia University, Italy. Electronic address: cynthia.aristei@unipg.it. 8. Department of Radiotherapy, Trieste University, Italy. Electronic address: cristiana.vidali@libero.it. 9. Department of Radiotherapy, Hospital of Venice, Italy. Electronic address: monica.conti@ulss12.ve.it. 10. Department of Radiotherapy, Florence University, Italy. Electronic address: alessandragalardi@hotmail.com. 11. Department of Radiotherapy, Hospital of Arezzo, Italy. Electronic address: p.ponticelli@usl8.toscana.it. 12. Oncological Institute of Veneto, Padova, Italy. Electronic address: marialuisa.friso@ioveneto.it. 13. Department of Radiotherapy, Hospital of Belluno, Italy. Electronic address: tiziana.iannone@ulss.belluno.it. 14. Department of Radiotherapy, "La Sapienza University", Rome, Italy. Electronic address: mattiafosti@gmail.com. 15. Department of Radiotherapy, Pisa University, Italy. Electronic address: b.manfredi@ao-pisa.toscana.it. 16. Department of Radiotherapy, "Centro Oncologico Fiorentino", Sesto Fiorentino, Italy. Electronic address: marianna-c@hotmail.it. 17. Department of Medical Oncology, Pisa University, Italy. Electronic address: c.orlandini@med.unipi.it. 18. Department of Radiotherapy, "Centro Oncologico Fiorentino", Sesto Fiorentino, Italy. Electronic address: lcionini@tin.it.
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 45Gy/28/ff concurrent with 5FU (350mg/sqm) and Folinic Acid (20mg/sqm) on days 1-5 and 29-33; surgery was performed after 4-6weeks. Median follow up was 63·7months. 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 5year OS and DFS and had no impact on the distant metastasis rate.
RCT Entities:
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 45Gy/28/ff concurrent with 5FU (350mg/sqm) and Folinic Acid (20mg/sqm) on days 1-5 and 29-33; surgery was performed after 4-6weeks. Median follow up was 63·7months. 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 5year OS and DFS and had no impact on the distant metastasis rate.
Authors: Sven Lichthardt; Lisa Zenorini; Johanna Wagner; Johannes Baur; Alexander Kerscher; Niels Matthes; Caroline Kastner; Jörg Pelz; Volker Kunzmann; Christoph-Thomas Germer; Armin Wiegering Journal: J Cancer Res Clin Oncol Date: 2017-07-29 Impact factor: 4.553