Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial

Table 5 Grade 3/4 adverse events related to study treatment and special adverse event categories in the safety and KRAS populations n (%)

Adverse event	FOLFOX6 plus cetuximab (arm A)		FOLFIRI plus cetuximab (arm B)
	Grade 3/4a	Grade 4	Grade 3/4a	Grade 4
Safety populationb
Any related AE	48 (62)	12 (16)	37 (50)	6 (8)
Neutropenia	22 (29)	9 (12)	15 (20)	4 (5)
Diarrhea	7 (9)	-	9 (12)	-
Rash	5 (6)	-	3 (4)	-
Dermatitis acneiform	4 (5)	-	2 (3)	-
Special AE categories
Skin reactionsc	11 (14)	-	6 (8)	-
Acne-like rashd	10 (13)	-	6 (8)	-
Infusion-related reactionse	5 (6)	2 (3)	1 (1)	1 (1)
Allergy/anaphylaxis	5 (6)	2 (3)	1 (1)	1 (1)
KRAS wild-type populationf
Any related AE	24 (71)	5 (15)	10 (36)	1 (4)
Neutropenia	12 (35)	3 (9)	3 (11)	1 (4)
Diarrhea	3 (9)	-	2 (7)	-
Dermatitis acneiform	3 (9)	-	-	-
Mucosal inflammation	3 (9)	-	-	-
Rash	2 (6)	-	-	-
Neuropathy peripheral	2 (6)	-	-	-
Hypersensitivity	2 (6)	1 (3)	-	-
Special AE categories
Skin reactionsc	6 (18)	-	1 (4)	-
Acne-like skin rashd	5 (15)	-	1 (4)	-
Infusion-related reactionse	2 (6)	1 (3)	-	-
Allergy/anaphylaxis	2 (6)	1 (3)	-	-
KRAS mutation populationg
Any related AE	14 (61)	4 (17)	18 (56)	4 (13)
Neutropenia	6 (26)	3 (13)	9 (28)	2 (6)
Diarrhea	3 (13)	-	4 (13)	-
Thrombocytopenia	2 (9)	-	-	-
Rash	1 (4)	-	2 (6)	-
Mucosal inflammation	-	-	2 (6)	-
Dehydration	-	-	2 (6)
Special AE categories
Skin reactionsc	2 (9)	-	3 (9)	-
Acne-like rashd	2 (9)	-	3 (9)	-
Infusion-related reactionse	2 (9)	1 (4)	1 (3)	1 (3)
Allergy/anaphylaxis	2 (9)	1 (4)	1 (3)	1 (3)

^aGrade 3/4 adverse events occurring in ≥ 5% of patients in either treatment group in each population are reported;

^bSafety population: 77 patients received FOLFOX6 plus cetuximab in arm A, 74 patients received FOLFIRI plus cetuximab in arm B; ^c-eComposite categories. Skin reactions include the terms: acne*, acne pustular*, cellulitis, dermatitis acneiform*, dry skin*, erysipelas, erythema*, face edema, folliculitis*, hair growth abnormal, hypertrichosis, nail bed infection, nail disorder, nail infection, paronychia, pruritus*, rash*. Of these, all terms marked with an asterisk constituted the acne-like rash subset of the skin reaction category. Infusion-related reactions refer to special adverse-event categories, including the MedDRA preferred terms: acute myocardial infarction, acute respiratory failure, anaphylactic reaction, **anaphylactic shock, **anaphylactoid reaction, **anaphylactoid shock, **angina pectoris, apnea, bronchial obstruction, bronchospasm, cardiac failure, cardiopulmonary failure, chills, clonus, convulsion, cyanosis, drug hypersensitivity, **dyspnea, dyspnea at rest, dyspnea exacerbated, dyspnea exertional, epilepsy, hyperpyrexia, hypersensitivity, **hypotension, **hypoxia, infusion-related reaction, loss of consciousness, myocardial infarction, myocardial ischemia, orthopnea, pyrexia, respiratory distress, respiratory failure, shock, sudden death, syncope. A double asterisk refers to those included regardless of when they occurred, all other terms were included only if the onset of the adverse event occurred on the same day as the first administration of cetuximab;

^gPatients with KRAS wild-type tumors: 34 in arm A, 28 in arm B;

^fPatients whose tumors harbored KRAS mutations: 23 in arm A, 32 in arm B. AE: Adverse event.