title: Risk-Adapted Adjuvant Chemotherapy After Concomitant Fluoropyrimidine-Radiotherapy Neoadjuvant Treatment for Patients With Resectable CT3-4 or N+ Rectal Cancer: Five-Year Disease-Free Survival Results of a Single-Center Series.
abstract: Providing adjuvant chemotherapy in locally advanced rectal cancer after neoadjuvant chemoradiation is currently a matter of debate. Recommendations from clinical guidelines range from offering no treatment to oxaliplatin-based combinations. We present a risk-adapted approach based on the response to initial chemoradiation as the strongest prognostic factor for disease-free survival (DFS).
  
  
  
  One hundred one patients were treated at a single institution with preoperative long-course radiotherapy plus concurrent fluoropyrimidines. Patients with disease downstaged to pT0-2N0 received adjuvant fluoropyrimidines alone, while the remaining received an oxaliplatin-based combination. The primary study end point was 5-year DFS.
  
  
  
  Overall, the disease of 54 patients was downstaged to pT0-2N0 (53.5%), while that of 47 patients was staged as pT3-4 or N+ (46.5%) after surgery. In the intention-to-treat analysis, 5-year DFS for patients in the good-prognosis group (downstaging to pT0-2 N0) and for those with poor prognosis (pT3-4 or N+) were 79.4% and 66.3%, respectively (hazard ratio, 0.489; P = .043). Downstaging and pN+ were independent prognostic factors for DFS.
  
  
  
  A risk-adapted adjuvant therapy strategy based on pathologic stage after neoadjuvant chemoradiation is feasible and achieves high rates of 5-year DFS. Patients with good prognostic factors can be treated with adjuvant fluoropyrimidines alone, thus permitting the avoidance of oxaliplatin-derived toxicities.
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain. Electronic address: jsastrev@salud.madrid.org.
authors.forename: Javier
authors.initials: J
authors.lastname: Sastre
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain.
authors.forename: Juan Jose
authors.initials: JJ
authors.lastname: Serrano
authors.affiliation: Biostatistic and Preventive Medicine Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Ramirez
authors.affiliation: Pathology Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Ortega
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: García-Paredes
authors.affiliation: Radiation Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Corona
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain.
authors.forename: Rosario
authors.initials: R
authors.lastname: Alfonso
authors.affiliation: Radiation Oncology Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Sofía
authors.initials: S
authors.lastname: Córdoba
authors.affiliation: Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Center affiliated to Red Temática de Investigación Cooperativa (RD06/0020/0021) Instituto Carlos III, Spanish Ministry of Science and Innovation, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods*; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D016016:Proportional Hazards Models; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D005472:Fluorouracil
keywords: Capecitabine; FOLFOX/XELOX; Neoadjuvant chemoradiation; Rectal cancer; Risk-adapted adjuvant treatment