title: Does the addition of oxaliplatin to preoperative chemoradiation benefit cT4 or fixed cT3 rectal cancer treatment? A subgroup analysis from a prospective study.
abstract: BACKGROUND
  Whether there is any benefit derived from adding oxaliplatin to fluoropyrimidine-based preoperative chemoradiation is currently unknown in cases of advanced cT3 or cT4 tumours. Our aim was to evaluate this issue by analysing a randomized trial, which compared two schedules of preoperative treatment (chemoradiation vs. 5 × 5 Gy with 3 cycles of consolidation chemotherapy) for cT4 or fixed cT3 rectal cancer.
  
  
  METHODS
  Delivery of oxaliplatin was mandatory to the first part of the study. For the second part, its delivery in both treatment-assigned groups was left to the discretion of the local investigator. We analysed a subgroup of 272 patients (136 in the oxaliplatin group and 136 in the fluorouracil-only group) from institutions that had omitted oxaliplatin in the second part of the study.
  
  
  RESULTS
  Circumferential resection margin negative (CRM-) status rate was 68% in the oxaliplatin group and 70% in the fluorouracil-only group, p = 0.72. The pathological complete response rate (pCR) was correspondingly 14% vs. 7%, p = 0.10. Following multivariable analysis, when comparing the CRM- status in the oxaliplatin group to the fluorouracil-only group, the odds ratio was 0.79 (95 CI 0.35-1.74), p = 0.54; there being no interaction between concomitant chemoradiation and 5 × 5 Gy with consolidation chemotherapy; pinteraction= 0.073. For pCR, the corresponding results were 0.47 (95 CI 0.19-1.16), p = 0.10, pinteraction= 0.84.
  
  
  CONCLUSIONS
  No benefit was found of adding oxaliplatin in terms of CRM nor pCR rates for either concomitant or sequential settings in preoperative radiochemotherapy for very advanced rectal cancer.
authors.affiliation: I Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Wiśniowska
authors.affiliation: Department of Pathology, Clinical Hospital of Ministry of Internal Affairs and Administration, Warsaw, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Nasierowska-Guttmejer
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Polkowski
authors.affiliation: Bioinformatics and Biostatistics Unit, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Michalski
authors.affiliation: Bioinformatics and Biostatistics Unit, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland; Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: L
authors.initials: L
authors.lastname: Wyrwicz
authors.affiliation: I Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: L
authors.initials: L
authors.lastname: Pietrzak
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Rutkowski
authors.affiliation: Department of Pathology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Malinowska
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Kryński
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: E
authors.initials: E
authors.lastname: Kosakowska
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Zwoliński
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Winiarek
authors.affiliation: Department of Colorectal Surgery, Medical University, Warsaw, Poland; Medical Faculty, University of Rzeszów, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Olędzki
authors.affiliation: Department of Gynaecology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Kuśnierz
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: L
authors.initials: L
authors.lastname: Zając
authors.affiliation: Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Bednarczyk
authors.affiliation: Department of Rehabilitation, Józef Piłsudski University of Physical Education and Clinical Department of General and Colorectal Surgery, Bielański Hospital, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Szczepkowski
authors.affiliation: Department of General, Oncologic and Digestive Tract Surgery, Medical Centre of Postgraduate Education, Orłowski Hospital Warsaw, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Tarnowski
authors.affiliation: Department of General, Oncological, Metabolic and Thoracic Surgery, Military Institute of Medicine, Warsaw, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Paśnik
authors.affiliation: Department of General and Vascular Surgery, Multidisciplinary Hospital, Warsaw-Międzylesie, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Radziszewski
authors.affiliation: I Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Partycki
authors.affiliation: I Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Bęczkowska
authors.affiliation: 1st Department of General Surgery, Transplantology and Nutritional Therapy, Medical University of Lublin, Poland.
authors.forename: R
authors.initials: R
authors.lastname: Styliński
authors.affiliation: Department of Surgery, MSW Hospital, Lublin, Poland.
authors.forename: R
authors.initials: R
authors.lastname: Wierzbicki
authors.affiliation: Department of General and Gastrointestinal Surgery and Surgical Oncology of the Alimentary Tract, Medical University, Lublin, Poland.
authors.forename: P
authors.initials: P
authors.lastname: Bury
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland; Department of Radiotherapy, St. John's Cancer Centre, Lublin, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Jankiewicz
authors.affiliation: Department of Radiotherapy, St. John's Cancer Centre, Lublin, Poland.
authors.forename: K
authors.initials: K
authors.lastname: Paprota
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Lewicka
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland.
authors.forename: B
authors.initials: B
authors.lastname: Ciseł
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Skórzewska
authors.affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Mielko
authors.affiliation: II Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Danek
authors.affiliation: Department of Surgery, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: G
authors.initials: G
authors.lastname: Nawrocki
authors.affiliation: Department of Surgery, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
authors.forename: R
authors.initials: R
authors.lastname: Sopyło
authors.affiliation: Department Radiotherapy, Independent Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn, Poland.
authors.forename: L
authors.initials: L
authors.lastname: Kępka
authors.affiliation: I Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland. Electronic address: bujko@coi.waw.pl.
authors.forename: K
authors.initials: K
authors.lastname: Bujko
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D013505:Digestive System Surgical Procedures; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D000077150:Oxaliplatin; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: Oxaliplatin; Preoperative chemoradiation; Rectal cancer