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Ann Oncol. 2016 May;27(5):834-42. doi: 10.1093/annonc/mdw062. Epub 2016 Feb 15.

Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study.

Author information

1
Department of Radiotherapy bujko@coi.waw.pl.
2
Department of Gastroenterological Oncology.
3
Department of Pathology.
4
Department of Radiotherapy.
5
Department of Bioinformatics and Biostatistics Unit, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
6
Department of Colorectal Surgery, Medical University, Warsaw.
7
Department of Gynecology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
8
Department of Rehabilitation, Jozef Piłsudski University of Physical Education, Warsaw Clinical Department of General and Colorectal Surgery, Bielański Hospital, Warsaw.
9
Department of General, Oncologic and Digestive Tract Surgery, Medical Centre of Postgraduate Education, Orłowski Hospital, Warsaw.
10
Department of Surgical Oncology, Medical University of Lublin, Lublin.
11
First Department of General Surgery, Transplantology and Nutritional Therapy, Medical University of Lublin, Lublin.
12
Department of Surgery, MSW Hospital, Lublin.
13
II Chair and Department of General and Gastrointestinal Surgery and Surgical Oncology of the Alimentary Tract, Medical University, Lublin.
14
Department of Surgical Oncology, Medical University of Lublin, Lublin Department of Radiotherapy, St John's Cancer Center, Lublin.
15
Department of Radiotherapy, St John's Cancer Center, Lublin.
16
Department of Surgery.
17
Medical Oncology.
18
Pathology, Silesian Oncological Centre, Wroclaw.
19
Department of Surgery, Beskid Centre of Oncology, Bielsko-Biala.
20
Department of Radiotherapy, Beskid Centre of Oncology, Bielsko-Biala.
21
Department of Oncological Surgery, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz.
22
Department of Radiotherapy, Regional Cancer Centre, Tarnów.
23
Department Radiotherapy, Independent Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn.
24
Department of Surgery, Regional Hospital, Elbląg.
25
Department of Surgery, Medical University, Lódź
26
Department of Surgery, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw.
27
Department of Surgery, Regional Cancer Centre, Białystok.
28
Department of Radiotherapy, Regional Oncological Centre, Kielce.
29
Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Gliwice, Poland.

Abstract

BACKGROUND:

Improvements in local control are required when using preoperative chemoradiation for cT4 or advanced cT3 rectal cancer. There is therefore a need to explore more effective schedules.

PATIENTS AND METHODS:

Patients with fixed cT3 or cT4 cancer were randomized either to 5 × 5 Gy and three cycles of FOLFOX4 (group A) or to 50.4 Gy in 28 fractions combined with two 5-day cycles of bolus 5-Fu 325 mg/m(2)/day and leucovorin 20 mg/m(2)/day during the first and fifth week of irradiation along with five infusions of oxaliplatin 50 mg/m(2) once weekly (group B). The protocol was amended in 2012 to allow oxaliplatin to be then foregone in both groups.

RESULTS:

Of 541 entered patients, 515 were eligible for analysis; 261 in group A and 254 in group B. Preoperative treatment acute toxicity was lower in group A than group B, P = 0.006; any toxicity being, respectively, 75% versus 83%, grade III-IV 23% versus 21% and toxic deaths 1% versus 3%. R0 resection rates (primary end point) and pathological complete response rates in groups A and B were, respectively, 77% versus 71%, P = 0.07, and 16% versus 12%, P = 0.17. The median follow-up was 35 months. At 3 years, the rates of overall survival and disease-free survival in groups A and B were, respectively, 73% versus 65%, P = 0.046, and 53% versus 52%, P = 0.85, together with the cumulative incidence of local failure and distant metastases being, respectively, 22% versus 21%, P = 0.82, and 30% versus 27%, P = 0.26. Postoperative and late complications rates in group A and group B were, respectively, 29% versus 25%, P = 0.18, and 20% versus 22%, P = 0.54.

CONCLUSIONS:

No differences were observed in local efficacy between 5 × 5 Gy with consolidation chemotherapy and long-course chemoradiation. Nevertheless, an improved overall survival and lower acute toxicity favours the 5 × 5 Gy schedule with consolidation chemotherapy.

CLINICAL TRIAL NUMBER:

The trial is registered as ClinicalTrials.gov number NCT00833131.

KEYWORDS:

preoperative chemoradiation; rectal cancer

PMID:
26884592
DOI:
10.1093/annonc/mdw062
[Indexed for MEDLINE]

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