Table 4. Published papers and abstracts documenting toxicity and surgical morbidity in preoperative chemoradiation studies using cetuximab.
No of pts* | Cetuximab | Oxali | irinotecan | RT dose | G3/G4 diarrhoea | SEPSIS | Anastom leak | Reoperation | |
---|---|---|---|---|---|---|---|---|---|
Chung 2006 (45) | 20 | Yes | No | No | 50.4 Gy/28#/38 | 2/20 (10%) | NS | NS | NS |
Machiels 2007 (46) | 40 | Yes | No | No | 45 Gy/25#/33 | 6/40 (15%) | 5/40 (12.5%) | NS | 5/40 (12.5%) |
Rodel 2008 (47) | 48 | Yes | Yes | No | 50.4 Gy/28#/38 | 9/48 (19%) | 2/48 (4%) | 5/48 (11%) | 5/48 (11%) |
Hofheinz 2006 (48) | 20 | Yes | No | Yes | 50.4 Gy/28#/38 | 2/10 (20%) | 2/20 (10%) | 3/20 (15%) | NS |
Horisberger 2009 (49) | 50 | Yes | No | Yes | 50.4 Gy/28#/38 | 15/50 (30%) | NS | 8/50 (16%) | NS |
Bertolini 2007 (50) | 40 | Yes | No | No | 50 Gy/25#/33-50.4 Gy/28#/38 | 3/40 (7.5%) | 1/40 (5%) | 1/40 (5%) | 1/40 (5%) |
Hong 2007 (51) | 10 | Yes | No | Yes | 50.4 Gy/28#/38 | 1/40 (5%) | NS | NS | NS |
Cabebe 2008 (52) | 23 | Yes | First 10 pts | No | 50.4 Gy/28#/38 | 4/23 (17%) | NS | NS | NS |
Eisterer 2009 (53) | 28 | Yes | No | No | 45 Gy/25#/33 | 4/28 (15%) | NS | NS | NS |
Velenik 2009 (54) | 37 | Yes | No | No | 45 Gy/25#/33 | 4/37 (11%) | NS | NS | NS |
Kim 2011 (55) | 40 | Yes | No | Yes | 50.4 Gy/28#/38 | 2/40 (5%) | NS | 1/40 | NS |
Dewdney 2012 (58) | 78 | Yes | No | No | 50.4 Gy/28#/38 | 10/78 (16%) | NS | NS | NS |
Sun 2012 (57) | 63 | yes | No | No | 50.4 Gy/28#/38 | 23/63 (38.5%) | |||
Total | 497 | 45-50.4 Gy | 82/494 (16.6%) |
*number entering study; **number having had surgery; ***using tumour regression grading not yp; NS, not specified in paper; RT, radiotherapy; G3/G4, grade 3 and grade 4 toxicity