title: Short-course preoperative radiotherapy combined with chemotherapy, delayed surgery and local hyperthermia for rectal cancer: a phase II study.
abstract: OBJECTIVE
  The aim of this study was to investigate the feasibility of short-course radiotherapy with oral capecitabine, hyperthermia and delayed surgery for neoadjuvant treatment of rectal cancer.
  
  
  METHODS
  Patients with clinically staged T2-3N0-2M0 primary rectal cancer were included. All patients received short-course 25 Gy in 5 Gy fractions radiotherapy with capecitabine, local hyperthermia and metronidazole. Capecitabine 1000 mg/m2twice a day was given on days 1-14. Local hyperthermia, 41-45 °C for 60 min, was performed on days 3-5. Metronidazole 10 g/m2was administered per rectum on days 3 and 5. The time interval to surgery was not less than four weeks after neoadjuvant treatment. The primary end-point was pathological complete response (pCR). Secondary end-points included neoadjuvant treatment toxicity, tumour regression, surgical and oncological outcomes.
  
  
  RESULTS
  A total of 81 patients were included in the analysis. Ten (12.3%) patients had grade 3 toxicity and one (1.2%) patient had grade 4 toxicity. Sphincter-sparing surgery was performed for 78 (96.3%) patients. There was no postoperative mortality. Postoperative complications occurred in 11 (13.8%) patients. Sixteen (20%) patients had a pCR. The median follow-up was 40.9 months. There were no local recurrences. Nine (11.1%) patients developed distant metastases. Three-year overall survival was 97% and the three-year disease-free survival was 85%.
  
  
  CONCLUSIONS
  Short-course radiotherapy with chemotherapy, radiosensitizers and delayed surgery is a feasible treatment for rectal cancer and may lead to tumour regression rate comparable with long-course chemoradiation.
authors.affiliation: a Department of Oncoproctology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: A O
authors.initials: AO
authors.lastname: Rasulov
authors.affiliation: a Department of Oncoproctology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: S S
authors.initials: SS
authors.lastname: Gordeyev
authors.affiliation: a Department of Oncoproctology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: Yu A
authors.initials: YA
authors.lastname: Barsukov
authors.affiliation: b Department of Radiational Oncology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: S I
authors.initials: SI
authors.lastname: Tkachev
authors.affiliation: a Department of Oncoproctology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: A G
authors.initials: AG
authors.lastname: Malikhov
authors.affiliation: c Department of Radiology , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.|d Department of Radiology , The Royal Marsden NHS Foundation Trust, Imperial College London , London , UK.
authors.forename: S S
authors.initials: SS
authors.lastname: Balyasnikova
authors.affiliation: e Department of Clinical Pharmacology and Chemotherapy , N.N. Blokhin Russian Cancer Research Center , Moscow , Russia.
authors.forename: M Yu
authors.initials: MY
authors.lastname: Fedyanin
keywords: Rectal cancer; chemoradiosensitizer; chemoradiotherapy; short-course radiotherapy with delayed surgery; tumour regression