Miller, R and Dewar, EP and Kapadia, CR and Nejim, A and Hutchinson, IF and McAdam, WA and Morris, IR and Deasy, JM and Irwin, ST and Oates, GD and O'Dwyer, STP and Dorricott, NJ and Stock, SE and Wilkinson, MJS and Ostick, DG and Hobbiss, JH and Farrands, PA and Ross, AHM and Sauven, P and Sandilands, DGD and De Castella, HC and McCarthy, D and Lee, P and Allen-Mersh, TG and Haynes, S and Bristol, JB and Donovan, IA and Neoptolemos, JP and Wolverson, RL and Silverman, SH and Lee, M and Backhouse, C and Millar, DM and Kirwan, WO and Edwards, P and Morran, CG and Maddox, C and Palmer, JG and Nicoll, J and Jacob, GH and Archbold, JAA and Bell, JC and Rennie, JA and Turner, AR and Turner, J and Maddox, C and Fearon, KCH and Vaar, A and Ratsep, V and Nasmyth, DG and McCarthy, D and McKee, RF and Cooke, TG and McArdle, C and Stephenson, RF and Baxter, JN and Rew, DA and Thomson, WHF and Gear, MW and Allan, A and Pearson, HJ and Goldberg, PA and Kmiot, WAW and Irving, MH and Bancewicz, J and Mughal, M and Jones, DJ and Kipping, RA and Dudley, NE and Mortensen, NJ and Parker, M and Armistead, PR and Gillison, EW and Rennie, JA and Loughlin, V and Turner, J and Kelly, MJ and Mosley, J and Cade, D and Guy, A and Moorehead, J and Harvey, CF and Parisi, VP and Delrio, P and Jones, DRB and Bozzino, JM and Griffin, SM and Griffith, CDM and Bulman, A and Stebbings, WSL and Deakin, M and Adab, F and Goulbourne, IA and Berry, AR and Cunningham, FO and Ingoldby, CJH and Talbot, R and Burgess, P and Stamatakis, J and Offori, T and Cullen, PT and Oates, GD and Neoptolemos, JP and Turner, AR and Logie, JRC and Thomson, A and Maybury, NK and Fozard, BJ and Cooper, MJ and Vellacott, KD and Shorthouse, AJ and Jacob, GH and Poston, GJ and Neoptolemos, JP and Simkin, EP and McIntosh, HR and Karran, DR and Royle, GT and Karanjia, N and Marks, CG and Maxwell, RJ and Varma, JS and Simson, JNL and Burkitt, D and Johnson, CD and Steer, HW and Primrose, JN and McGinn, FP and Taylor, I and Zeiderman, MR and Edwards, P and Sagor, GR and Hawley, P and Northover, JMA and Donaldson, DR and Scott, HJ and Gallagher, P and Crossling, FT and McKelvey, STD and Rickett, JW and Kingston, RD and Taylor, I and Davidson, T and Boulos, PB and Smith, DC and Smith, IS and Gillespie, G and Kashi, SH and Grieve, RJ and Fraser, IA and Roberts, PN and Lam, FT and Parker, RW and Stockdale, A and Jurewicz, A and Woodward, DAK and Taylor, BA and Thomas, JM and Sarin, S and Reilly, DT and Stebbings, W and Hamer-Hodges, DW and Nixon, SJ and Saunders, JH and Macintyre, IMC and Yosef, H and Smith, AN and Varma, JS and Lock, MR and Lake, SP and Smart, PJG and Grimley, R and Silverman, SH and Hall, R and Jamison, MH and Jenkinson, LR and James, RD and Donaldson, D and Gray, R and Northover, JMA and Stenning, SP and Taylor, I and Garten, L and McQueen, A and Simnett, S and Johnstone, C and Cain, D and Lallemand, E and Peto, R and Finan, P and Slevin, M and Altman, D and AXIS Collaborators, (2003) Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS). BRIT J SURG , 90 (10) 1200 - 1212. 10.1002/bjs.4266.
Full text not available from this repository.
Background: Postoperative portal vein infusion (PVI) of 5-fluorouracil (5-FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X-ray and 5-FU Infusion Study (AXIS) is the largest such trial yet reported.Methods: Consenting patients with presumed colorectal. cancer were randomized to surgery with or without 7 days of PVI (1 g 5-FU plus 5000 units heparin in I litre 5 per cent dextrose infused over each 24-h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery.Results: Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71.2 per cent of patients) were 1.00 (0.92 to 1.11) and 0.94 (0.83 to 1.06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease-free survival (hazard ratio 0.79 versus 1.03; P = 0.07), and there was a non-significant trend with respect to overall survival (hazard ratio 0.87 versus 1.03; P = 0.17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature.Conclusion: No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta-analysis incorporating the previous trials. Combining the data gave hazard ratios of 0.82 and 1.00 for colonic and rectal tumours respectively (test for interaction, P = 0.024), equating to an absolute survival benefit for patients with colonic cancer of 5.8 (95 per cent c.i. 2.8 to 8.5) per cent, a level close to that seen for prolonged systemic therapy.
|Title:||Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)|
|Keywords:||PORTAL-VEIN INFUSION, COLON-CANCER, FOLINIC ACID, FLUOROURACIL, ADENOCARCINOMA, CHEMOTHERAPY, THERAPY, CARCINOMA, PERFUSION, EFFICACY|
|UCL classification:||UCL > School of Life and Medical Sciences > Faculty of Medical Sciences > UCL Medical School|
UCL > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health Care > CHIME
Archive Staff Only: edit this record