Evolving treatment strategies for colorectal cancer: A critical review of current therapeutic options

Table 3 Major neoadjuvant therapy trials

Ref.	n	Treatment arms	Local recurrence rate	Overall survival rate
Upsala Trial[23]	471	Arm 1 (236): preoperative RT (25.5 Gy delivered in 5-7 d) Arm 2 (235): postoperative RT (60 Gy delivered in 8 wk)	5 yr of follow-up Arm 1: 12% Arm 2: 21% P = 0.02	5-yr survival rate Arm 1: 42% Arm 2: 38% P = 0.42
Stockholm I Trial[24]	849	Arm 1 (423 patients): 25 Gy during 5-7 d followed by surgery Arm 2 (421 patients): surgery alone	Median follow-up time of 107 mo Arm 1: 14% Arm 2: 28% P < 0.01	Median follow-up time of 107 mo No significant difference between groups
Swedish Rectal Cancer Trial[25]	1168	Arm 1 (553 patients): preoperative RT - 25 Gy delivered in five fractions in 1 wk, followed by surgery Arm 2 (557 patients): Surgery alone	5 yr of follow-up Arm 1: 11% Arm 2: 27% P < 0.001	5-yr survival rate Arm 1: 58.0% Arm 2: 48.0% P = 0.004
Dutch TME Trial[26]	1861	Arm 1 (924 patients): preoperative RT (5 Gy × 5 d) followed by TME Arm 2 (937): TME alone	2 yr of follow-up Arm 1: 2.4% Arm 2: 8.2% P < 0.001	2-yr survival rate Arm 1: 82.0% Arm 2: 81.8% P = 0.84
Stockholm II Trial[27]	557	Arm 1 (272): preoperative radiotherapy (25 Gy in one week) followed by surgery within a week Arm 2 (285): surgery alone	Median follow-up was 8.8 yr Arm 1: 12% Arm 2: 25% P < 0.001	Median follow-up 8.8 yr Arm 1: 39% Arm 2: 36% P = 0.2
German Rectal Cancer Study Group[28]	823	Arm 1 (421 patients): preoperative CHRT: 50.4 Gy/28 fractions/5 fractions weekly and fluorouracil (continuous infusion) in first and fifth week of RT. TME after 6 wk Additional 4 cycles of FU every 4 wk Arm 2 (402 patients): postoperative CHRT (same as in Arm 1 except a 5.4 Gy boost in RT)	5 yr of follow-up Arm 1: 6.0% Arm 2: 13% P = 0.006	5-yr survival rate Arm 1: 76.0% Arm 2: 74.0% P = 0.80
Polish Rectal Cancer Trial[29]	312	Arm 1 (155 patients): preoperative RT (5 Gy × 5 d) followed by TME at 7 d after RT Arm 2 (157 patients): preoperative RT (45 Gy/25 fractions/5 wk) + 2 cycles of chemotherapy on weeks 1 and 5 of RT followed by TME 4-6 wk later. The cycle consisted of leucovorin + fluorouracil both administered as rapid infusion on 5 consecutive days	4 yr of follow-up Arm 1: 9% Arm 2: 14.2% P = 0.170	4-yr survival rate Arm 1: 67.2% Arm 2: 66.2% P = 0.960
MRC CR07 and NCIC CTG C016[30]	1350	Arm 1 (674 patients): short-course radiotherapy (25 Gy/5 fractions) followed by surgery. Arm 2 (676 patients): initial surgery with selective postoperative chemoradiotherapy (45 Gy in 25 fractions plus 5-fluorouracil) restricted to patients with involvement of the circumferential resection margin.	3 yr of follow-up Arm 1: 4.0% Arm 2: 10.6% P < 0. 01	Estimated 5-yr survival rate Arm 1: 70.3% Arm 2: 67.9% P = 0.40

RT: Radiotherapy; TME: Total mesorectal excision; CHRT: Chemoradiotherapy; FU: Fluorouracil.