title: Preoperative radiotherapy with capecitabine and mitomycin C in locally advanced rectal carcinoma.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of preoperative radiotherapy with capecitabine and mitomycin C in patients with locally advanced rectal cancer.
  
  
  METHODS
  A prospective, open-label, non-randomized, phase II study was performed on 49 patients with locally advanced rectal cancer. Preoperative radiotherapy was conducted on linear accelerators (15 or 18 MV) with a tumor dose of 45 Gy in 25 fractions over 5 weeks, combined with mitomycin C 7 mg/m(2) on days 1 and 29 and oral capecitabine 825 mg/m(2) twice daily on days 1-35. Surgery was performed 5-6 weeks after the end of chemoradiation. The primary study endpoint was histopathological complete regression rate (pCR; Dworak grade 4).
  
  
  RESULTS
  Disease stage at diagnosis was T3 in 34 patients (69%) and T4 in 15 patients (31%). Positive lymph nodes were diagnosed in 28 patients (57%). Toxicity (all grades) was documented in 35 patients (71%). Grade 3 toxicities were radiation dermatitis (25%), diarrhea (2%), neutropenia (2%), and granulocytopenia (2%). No patient experienced grade 4 toxicity. A pCR was seen in 8 (16%, 95% CI 9-29%) patients, a major response was noted in 24 (49%) patients and a minor response in 14 (29%) patients. R0 resection was performed in 46 patients (93.9%) and R1 in 3 patients (6.1%). Histopathological tumor downstaging was documented in 26 patients (53%). One-year disease-free survival was 93.3% and 1-year survival was 97.7%.
  
  
  CONCLUSIONS
  Preoperative chemoradiation with capecitabine and mitomycin C appeared to be effective with low toxicity in patients with locally advanced rectal cancer.
authors.affiliation: Department of Radiotherapy, Institute for Oncology and Radiology of Serbia, Pasterova 14, Belgrade, Serbia. stojanovics@ncrc.ac.rs
authors.forename: Suzana
authors.initials: S
authors.lastname: Stojanovic
authors.forename: Ivan
authors.initials: I
authors.lastname: Popov
authors.forename: Ljiljana
authors.initials: L
authors.lastname: Radosevic-Jelic
authors.forename: Marjan
authors.initials: M
authors.lastname: Micev
authors.forename: Nenad
authors.initials: N
authors.lastname: Borojevic
authors.forename: Vladimir
authors.initials: V
authors.lastname: Nikolic
authors.forename: Zoran
authors.initials: Z
authors.lastname: Krivokapic
authors.forename: Dragutin
authors.initials: D
authors.lastname: Kecmanovic
authors.forename: Dusica
authors.initials: D
authors.lastname: Gavrilovic
authors.forename: Iva
authors.initials: I
authors.lastname: Kezic
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013534:Survival; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D016685:Mitomycin; D000069287:Capecitabine; D005472:Fluorouracil