title: Sandwich-like neoadjuvant therapy with bevacizumab for locally advanced rectal cancer: a phase II trial.
abstract: OBJECTIVE
  Current neoadjuvant chemoradiotherapy had limited impact on distal metastasis and survival in locally advanced rectal cancer. Here, we investigated a new sandwich-like neoadjuvant regimen with bevacizumab.
  
  
  METHODS
  This was a single-arm, open-labeled, phase II trial. Patients with locally advanced rectal cancer received sandwich-like neoadjuvant therapy with bevacizumab (induction therapy with bevacizumab and FOLFOX, concurrent chemoradiotherapy with bevacizumab and consolidation chemotherapy with FOLFOX). Surgery was performed 4-6 weeks later. The primary endpoint of this study was pathologic complete response.
  
  
  RESULTS
  Twenty-five eligible patients were included. All completed the neoadjuvant therapy protocol. During the course of neoadjuvant therapy, 3 patients (12 %) had grade 4 hematological toxicity events and 12 (48 %) had grade 3 non-hematological toxicity events. According to RECIST criteria, 18 patients (72 %) achieved partial response and the rest seven patients (28 %) remained stable disease. Two patients (8 %) refused the subsequent surgical therapy for personal reasons, and 23 patients (92 %) underwent operations finally. Nine (39.1 %, 95 % CI 18.0-57.5 %) of them achieved pathologic complete response. Five of them (21.7 %) had postoperative complications. After a median follow-up period of 25.3 (14.4-40.9) months, four patients developed disease progression and two died of cancer. The 3-year overall survival rate was 95 % (95 % CI 69.5-99.3 %), and the 3-year disease-free survival rate was 72.5 % (95 % CI 33.7-90.9 %).
  
  
  CONCLUSIONS
  Sandwich-like neoadjuvant therapy with bevacizumab is safe and effective for locally advanced rectal cancer.
authors.affiliation: Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, 26 Yuancun Erheng Rd, Guangzhou, 510655, People's Republic of China.
authors.forename: Jian
authors.initials: J
authors.lastname: Xiao
authors.forename: Zexian
authors.initials: Z
authors.lastname: Chen
authors.forename: Wenyun
authors.initials: W
authors.lastname: Li
authors.forename: Zuli
authors.initials: Z
authors.lastname: Yang
authors.forename: Yan
authors.initials: Y
authors.lastname: Huang
authors.forename: Jian
authors.initials: J
authors.lastname: Zheng
authors.forename: Yanhong
authors.initials: Y
authors.lastname: Deng
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Donglin
authors.initials: D
authors.lastname: Ren
authors.forename: Junsheng
authors.initials: J
authors.lastname: Peng
authors.forename: Ping
authors.initials: P
authors.lastname: Lan
authors.forename: Jianping
authors.initials: J
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D000068258:Bevacizumab; D059248:Chemoradiotherapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil