Current debate in the oncologic management of rectal cancer

Table 1 Landmark radiation trials in rectal cancer

Ref.	Study type	Treatment	Outcomes disease control	Overall survival	Comments
Dutch TME Trial van Gijn et al[1]	Phase III n = 1805	RT + TME vs TME alone	5-yr LR 4.6% vs 11% (P < 0.0001) 10-yr DR 25% vs 28% (P = 0.21)	48% vs 49% (P = 0.86) (10-yr)
German CAO/ARO/AIO-94 Sauer et al[3]	Phase III n = 823	Preoperative vs Postoperative CRT	5-yr LR 6% vs 13% (P = 0.006) 10-yr LR 7.1% vs 10.1% (P = 0.048) 10-yr DR 29.8% vs 29.6% (P = 0.9)	59.6% vs 59.9% (P = 0.85) (10-yr)
TTROG Trial 01.04 Ngan et al[5]	Phase III n = 326	Preoperative RT vs CRT	3-yr LR 7.5% vs 4.4% (P = 0.24) 5-yr DR 27% vs 30% (P = 0.92)	74% vs 70% (0.62) (5-yr)	Short course RT with more pathologic downstaging (28% vs 45%b). No difference in organ sparing surgeries or late toxicities
Polish Colorectal Study Group Bujko et al[6]	Phase III n = 316	Preoperative RT vs CRT	4-yr LR 10.6% vs 15.6% (P = 0.21) 4-yr DR 31.4% vs 34.6% (P = 0.54)	67.2% vs 66.2% (P = 0.960) (4-yr)	CRT with improved pCR is attributed to longer interval before surgery. No difference in rate of sphincter preservation or late toxicities
Polish II Multicentre Bujko et al[8]	Phase III n = 515	Preoperative RT with adjuvant FOLFOX4 vs CRT	R0 77% vs 71% (P = 0.081) pCR 16% vs 11.5% (P = 0.19)	73% vs 64.5% (P = 0.055) (3-yr)	Published at GI ASCO 2016 with median follow up of 35 mo

LR: Local recurrence; DR: Distant recurrence; RT: Radiation therapy; TME: Total mesorectal excision; CRT: Chemotherapy radiation therapy.