title: Preoperative radiotherapy combined with capecitabine chemotherapy in Chinese patients with locally advanced rectal cancer.
abstract: BACKGROUND
  This phase II study is performed to evaluate the efficacy and safety of capecitabine combined with preoperative radiotherapy (RT) in Chinese patients with locally advanced rectal cancer (LARC).
  
  
  METHODS
  Between February 2007 and December 2008, 62 patients with LARC were treated with capecitabine (825 mg/m(2), twice daily) and concurrent RT (50.4 Gy/28 fractions). Patients underwent surgery after 6-8 weeks of combined therapy, followed by 4 cycles of adjuvant capecitabine (1,250 mg/m(2), twice daily on days 1-14, every 3 weeks). The primary endpoint was the rate of pathologic complete response (pCR).
  
  
  RESULTS
  Fifty-eight patients (93.5%) completed the preoperative chemoradiation course as initially planned. The most severe hematologic adverse event was leucopenia, which occurred with grade 2 intensity in 12 (19.7%) patients and grade 3 in 2 (3.3%) patients. Grade 3 diarrhea and hand-foot syndrome (HFS) were observed in one (1.6%) and two (3.3%) patients, respectively. However, no grade 4 toxicity was observed. There were no treatment-related deaths during this study. Of the 59 patients treated with surgery, all had radial margins (R0 resections). Among the 29 patients with the primary tumor ≤5 cm from the anal verge, 18 (62.1%) underwent sphincter-preserving surgical resections. pCR was found in eight patients (13.6%). The pathologic stage was lower than the initial clinical stage in 57.6% (34/59), 63.4% (26/41), and 81.4% (48/59) of the resected tumors for the primary tumor (T), lymph node (N), and combined TN categories, respectively. The estimate of disease-free survival and overall survival at 24 months were 80.6% (95% CI, 70.8-90.4%) and 92.5% (95% CI, 85.9-99.1%), respectively.
  
  
  CONCLUSIONS
  Preoperative chemoradiotherapy with capecitabine and RT appears to be a safe, well-tolerated, and effective neoadjuvant treatment modality for LARC.
authors.affiliation: Department of Medical Oncology, Wujin People's Hospital, Jiangsu University, People's Republic of China. jjh20102010@163.com
authors.forename: Jianhua
authors.initials: J
authors.lastname: Jin
authors.forename: Hua
authors.initials: H
authors.lastname: Meng
authors.forename: Guanghua
authors.initials: G
authors.lastname: Zhou
authors.forename: Xuezhong
authors.initials: X
authors.lastname: Xu
authors.forename: Zhixin
authors.initials: Z
authors.lastname: Xue
authors.forename: Xiyuan
authors.initials: X
authors.lastname: Xu
authors.forename: Fang
authors.initials: F
authors.lastname: Wang
authors.forename: Wenbin
authors.initials: W
authors.lastname: Lu
authors.forename: Xianwen
authors.initials: X
authors.lastname: Li
authors.forename: Hua
authors.initials: H
authors.lastname: Zhang
authors.forename: Jianzhong
authors.initials: J
authors.lastname: Deng
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic; D000069287:Capecitabine; D059186:Chemoradiotherapy, Adjuvant; D002681:China; D015331:Cohort Studies; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil