title: Phase II trial of concomitant neoadjuvant chemotherapy with oxaliplatin and capecitabine and intensity-modulated radiotherapy (IMRT) in rectal cancer.
abstract: OBJECTIVE
  The purposes of this study are to evaluate the activity and safety of preoperative intensity-modulated radiotherapy and concurrent capecitabine and oxaliplatin (Xelox), the accuracy of preoperative magnetic resonance (MRI) for predicting pathologic results, and the correlation between carcinoembryonic antigen (CEA) and the existence of a pathologic complete response (pCR).
  
  
  METHODS
  Twenty-seven patients (pt) with T3/T4N0/N+ rectal cancer were included. Capecitabine was administered at 825 t.i.d. mg/m2 the days of the radiotherapy (RT), and oxaliplatin was administered weekly at 50 mg/m2. RT was planned to 50.4 Gy. Surgery was scheduled 6 to 8 weeks after completion of Xelox RT. Before the intervention, a pelvic MRI was performed and a CEA level was determined.
  
  
  RESULTS
  After Xelox RT, 7 pt had pCR (26%), 2 pt progression disease, and 18 pt tumor downstaging. Presurgical MRI did not predict the pathological result in 21 pt. Main side effects were diarrhea grade (G) 3 in four pt, hand and foot G1 five Pt and G2 four pt. Paresthesias G1 ten pt, G2 seven pt, and leukopenia six pt G1. Median RT dose was 49.7 Gy (47.5-50.4 Gy). At a mean follow-up of 22.5 months, four pt presented metastatis. Mean pretreatment CEA was 6.8 ng/mL (2.1-17.0). A difference statistically significant when compared pretreatment CEA with presurgical CEA (p < 0.001) was detected. We found a nadir of <5 ng/mL as significantly associated with pCR (p = 0.036).
  
  
  CONCLUSIONS
  Preoperative chemoradiotherapy with oxaliplatin and capecitabine is safe and well tolerated, and offers an interesting ratio of pCR and of tumor downstaging. Presurgical CEA level should be studied as predictors of pCR.
authors.affiliation: Hospital de Dénia, Partida de Beniadlà s/n. Dénia. MarinaSalud, Dénia, Alicante, Spain. joanmagasent@telefonica.net
authors.forename: Joan Manel
authors.initials: JM
authors.lastname: Gasent Blesa
authors.forename: Javier
authors.initials: J
authors.lastname: Garde Noguera
authors.forename: Juan Bautista
authors.initials: JB
authors.lastname: Laforga Canales
authors.forename: Vicent
authors.initials: V
authors.lastname: Giner Bosch
authors.forename: Antonio
authors.initials: A
authors.lastname: Alberola
authors.forename: Miguel
authors.initials: M
authors.lastname: Soler Tortosa
authors.forename: Miguel
authors.initials: M
authors.lastname: Peris Godoy
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Sanchez
authors.forename: Mariano
authors.initials: M
authors.lastname: Provencio Pulla
authors.forename: Vicente
authors.initials: V
authors.lastname: Alberola Candel
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis; D000069287:Capecitabine; D002272:Carcinoembryonic Antigen / Q000032:analysis; D059248:Chemoradiotherapy / Q000379:methods; D003841:Deoxycytidine / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010071:Oxaloacetates; D050397:Radiotherapy, Intensity-Modulated; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D014408:Biomarkers, Tumor; D002272:Carcinoembryonic Antigen; D010071:Oxaloacetates; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil