title: Analysis of bevacizumab-based preoperative radiochemotherapy in patients with locally advanced rectal cancer on surgery-associated spectrum of complications.
abstract: BACKGROUND
  Preoperative radiochemotherapy (RCT) is a standard of care for patients with locally advanced rectal cancer (LARC; stages II and III). Results of our phase II study (BevXelOx-RT) have shown that this regimen is feasible but without a significant improvement of pathological complete response. Whether preoperatively administered bevacizumab, due to its specific toxicity profile, leads to increased rates of surgical complications is currently a subject for debate. This analysis focusses on the surgery-associated spectrum of complications.
  
  
  METHODS
  Data from 62 patients with rectal cancer (uT3-4; N0/1, M0) of the phase II trial were analyzed. Patients received radiotherapy (50.4/1.8 Gy fractions), simultaneous bevacizumab 5 mg/kg (d1, d15, d29), and capecitabine 825 mg/m(2) twice daily (d1-14, d22-35), oxaliplatin 50 mg/m(2) (d1, d8, d22, d29). Four to six weeks after RCT, surgical resection was performed.
  
  
  RESULTS
  Overall, 69/69 patients underwent surgery, and 66 (95.7 %) patients had R0 resection. Surgery was mainly conducted (in 66 %) by highly experienced surgeons (>20 resections of rectal cancer/year) with differences between the institutions due to the operative procedures but without effects on the rate of R0 resection or complications. The average duration of surgery was 239 min (±10). Frequency of multivisceral resections (11 %), intraoperative (8 %) and postoperative (43 %) complications were all in the expected range. In particular, we did not observe an increased rate of postoperative bleedings (3 %). The postoperative mortality rate was 0 %.
  
  
  CONCLUSIONS
  Quantity and the kind of surgery-associated spectrum of complications followed by a preoperative bevacizumab-containing RCT regimen in patients with LARC were in line with comparable trials of bevacizumab-based approaches.
authors.affiliation: Department of Radiooncology Kiel/Luebeck, University of Kiel, Kiel, Germany, Kathrin.Dellas@uksh.de.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Dellas
authors.forename: Johannes
authors.initials: J
authors.lastname: Buller
authors.forename: Gregor Jürgen
authors.initials: GJ
authors.lastname: Görtz
authors.forename: Michael
authors.initials: M
authors.lastname: Richter
authors.forename: Thomas
authors.initials: T
authors.lastname: Höhler
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
authors.forename: Tobias
authors.initials: T
authors.lastname: Keck
authors.forename: Jürgen
authors.initials: J
authors.lastname: Dunst
authors.forename: Helmut
authors.initials: H
authors.lastname: Zühlke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011183:Postoperative Complications / Q000175:diagnosis*; D011300:Preoperative Care; D011379:Prognosis; D011878:Radiotherapy; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D012189:Retrospective Studies; D015996:Survival Rate
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil