Adjuvant chemotherapy in curatively resected rectal cancer: How valid are the data?

Table 2 Summary of the three analyzed studies

	CCCSGJ[10] 1995	Krook et al[11] 1991	Quasar[12] 2007
Included patients	335 vs 323 vs 346 [3 trial arms for rectal carcinoma (IV, V, VI)]	104 vs 100	474 vs 474
Inclusion criteria	(1) Rectal carcinomas intraoperatively assessed as T3 or T4 and/or N1, N2, or N3 (before resection); (2) age ≤ 75 and no serious problems; (3) no cancer therapy in the past; (4) no other primary carcinomas; (5) satisfying laboratory tests at the beginning of treatment; and (6) consent to participation	(1) Potentially curative resection of histologically confirmed rectal adenocarcinoma; (2) T3 or T4; N1 or N2; (3) primary rectal carcinoma if extension of the carcinoma within 12 cm from of anal verge or inferior edge extended the sacral promontory; (4) anterior resection: entering in the study no later than 56 d postoperative; Abdominal perineal resection: 70 d; (5) met laboratory value requirements; (6) no prior radiation to the pelvis or CTx; and (7) no other malignancies within the last 5 years apart from superficial skin cancer and CIS of the cervix	(1) Presumably complete resection of colon or rectal cancer; no evident distant metastases; (2) no contraindications to CTx; (3) no prior CTx apart from one-week portal-vein infusion of fluorouracil after surgery; and (4) written consent before randomisation
Intervention group	(1) Trial arm IV: Intraoperative + postoperative mitomycin C iv; postoperative 5-FU po; and (2) Trial arm V: Postoperative mytomycin C iv + 5-FU po	Postoperative CTx with fluorouracil and semustine + radiation	CTx with fluorouracil and folinic acid after apparently curative (until October 1997 levamisole or placebo was added)
Control group	Trial arm VI: Surgery alone	Postoperative radiation alone	Surgery alone
Outcome (intervention vs Control): HR (95%CI)	HR (IV + V compared to VI) shown in the Cochrane meta-analysis: 0.66 [0.52-0.84]	HR shown in the Cochrane meta-analysis: 0.71 (0.55-0.92)	HR shown in the Cochrane meta-analysis: 0.77 (0.60-0.99)
Weight assigned in the Cochrane review (%)	7.6	6.8	7.0

5-FU: 5-fluorouracil; HR: Hazard Ratio; CI: Confidence interval; CIS: Carcinoma in situ; CTx: Chemotherapy.