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Ann Oncol. 2019 Jun 13. pii: mdz186. doi: 10.1093/annonc/mdz186. [Epub ahead of print]

Long-course preoperative chemoradiation vs. 5 x 5 Gy and consolidation chemotherapy for clinical T4 and fixed clinical T3 rectal cancer: Long-term results of the randomized Polish II study.

Author information

1
Department of Surgical Oncology, Medical University of Lublin, Poland.
2
II Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
3
Bioinformatics and Biostatistics Unit, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
4
Department of Clinical Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
5
Department of Gastroenterological Oncology, M. Skłodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
6
Department of Radiotherapy, St. John's Cancer Center, Lublin, Poland.
7
1st Department of General Surgery, Transplantology and Nutritional Therapy, Medical University of Lublin, Poland.
8
Department of Surgery, Silesian Oncological Centre, Wrocław, Poland.
9
Department of Radiotherapy, Silesian Oncological Centre, Wrocław, Poland.
10
Department of Radiotherapy, Regional Oncological Centre, Kielce, Poland.
11
Department of Radiotherapy, Beskid Centre of Oncology, Bielsko-Biala, Poland.
12
Department of Oncological Surgery, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz, Poland.
13
Department of Clinical Oncology, Collegium Medicum Nicolaus Copernicus University and Oncology Centre, Bydgoszcz, Poland.
14
Department of Surgery, Regional Hospital, Elbląg, Poland.
15
Department of Radiotherapy, Regional Cancer Centre, Tarnów, Poland.
16
Department of Radiotherapy, Military Institute of Medicine, Warsaw, Poland.
17
Department of Radiotherapy, Regional Oncology Center, Czestochowa, Poland.
18
Radiotherapy Department, Public Health Care Facility of the Ministry of the Interior and Warmian-Masurian Oncology Centre, Olsztyn, Poland.
19
Department of Oncology, University of Warmia and Mazury, Olsztyn, Poland.
20
Department of Surgery, Regional Cancer Centre, Białystok, Poland.
21
Department of General Surgery and Surgical Oncology First Clinical Hospital of Pomeranian Medical University, Szczecin, Poland.
22
Department of Surgery, Regional Hospital, Wałbrzych, Poland.
23
Department of Radiotherapy, Regional Cancer Centre, Copernicus Memorial Hospital of Łódź, Poland.
24
Department of Radiotherapy, M. Skłodowska-Curie Memorial Cancer Centre, Gliwice, Poland.

Abstract

BACKGROUND:

This trial evaluated whether preoperative short-course radiotherapy and consolidation chemotherapy (CCT) were superior to chemoradiation in rectal cancers with clinical (c)T4 or fixed cT3. Previously, we reported early results showing no differences in the radical surgery rate (primary end-point). In the short-course/CCT group, we observed lower acute toxicity of preoperative treatment and better overall survival (OS). We updated results to determine whether the benefit in OS was sustained and to evaluate late complications.

PATIENTS AND METHODS:

Patients with cT4 or fixed cT3 rectal cancer were randomized either to preoperative 5 × 5 Gy and three cycles of FOLFOX4 or to chemoradiation (50.4 Gy with bolus 5-Fu, leucovorin and oxaliplatin).

RESULTS:

515 patients were eligible for analysis, 261 in the short-course/CCT group and 254 in the chemoradiation group. The median follow-up was 7.0 years. The difference in OS was insignificant, HR = 0.90 (95% confidence interval [CI] 0.70-1.15), P = 0.38. However, the difference in early OS favouring short-course/CCT previously reported was observed again, being 9% at 3 years (95% CI 0.5%-17%). This difference disappeared later; at 8 years OS was 49% in both groups. There was no difference in disease-free survival, HR = 0.95 (95% CI 0.75-1.19), P = 0.65, at 8 years 43% vs. 41% in the short-course/CCT group vs. the chemoradiation group, respectively. The corresponding values for cumulative incidences of local failure and distant metastases did not differ and were HR = 1.08, 95% CI 0.70-1.23, P = 0.60, 35% vs. 32% and HR = 1.10, 95% CI 0.68-1.23, P = 0.54, 36% vs. 34%, respectively. The rate of late complications was similar (P = 0.66), grade 3+ being 11% vs. 9% in the short-course/CCT group vs. the chemoradiation group, respectively.

CONCLUSION:

The superiority of preoperative short-course/CCT over chemoradiation was not demonstrated.

CLINICAL TRIAL NUMBER:

The trial is registered as ClinicalTrials.gov number NCT00833131.

KEYWORDS:

preoperative chemoradiation; rectal cancer

PMID:
31192355
DOI:
10.1093/annonc/mdz186

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