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
B Ciseł  L Pietrzak  W Michalski  L Wyrwicz  A Rutkowski E Kosakowska  A Cencelewicz  M Spałek  W Polkowski  M Jankiewicz ... Show more
Annals of Oncology, mdz186, https://doi.org/10.1093/annonc/mdz186
Published: 13 June 2019
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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.

rectal cancer, preoperative chemoradiation
Topic: chemotherapy regimen preoperative care rectal carcinoma radiochemotherapy polish
Issue Section: Gastrointestinal tumors