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)

Aldo Sainato, Valentina Cernusco Luna Nunzia, Vincenzo Valentini, Antonino De Paoli, Enrici Riccardo Maurizi, Marco Lupattelli, Cynthia Aristei, Cristiana Vidali, Monica Conti, Alessandra Galardi, Pietro Ponticelli, Maria Luisa Friso, Tiziana Iannone, Falchetto Mattia Osti, Bruno Manfredi, Marianna Coppola, Cinzia Orlandini, Luca Cionini

Research output: Contribution to journalArticlepeer-review

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 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.

Original languageEnglish
Pages (from-to)223-229
Number of pages7
JournalRadiotherapy and Oncology
Volume113
Issue number2
DOIs
Publication statusPublished - Nov 1 2014

Keywords

  • Adjuvant chemotherapy
  • Preoperative radiochemotherapy
  • Rectal cancer

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Hematology
  • Medicine(all)

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