Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program

Table 2 Frequency of adverse events grade ≥ 3, reported in ≥ 2 (4 %) of patients of either group regardless of causality

Adverse events	Sunitinib plus FOLFIRI^a		Placebo plus FOLFIRI^a
Adverse events	N = 45	100 %	N = 45	100 %
Neutropenia	25	56	9	20
Leucopenia	12	27	7	16
Diarrhea	1	2	6	13
Nausea	3	7	3	7
Vomiting	3	7	3	7
Fatigue	-	-	4	9
Pain	-	-	4	9
Pulmonary embolism	2	4	2	4
General physical health deterioration	2	4	2	4
Mucosal inflammation	2	4	2	4
Gamma-glutamyltransferase increased	3	7	1	2
Pneumonia	-	-	3	7
Subileus	-	-	3	7
Blood acid phosphatase increased	2	4	-	-
Blood bilirubin increased	2	4	-	-

FOLFIRI 5-fluorouracil, leucovorin and irinotecan
^aSchedule: 4/2, 4 weeks on treatment, followed by 2 weeks off; dosage: starting dose 25 mg/day
Neutropenia: p < 0.001, leucopenia p = 0.20, all other items statistically not significant (Fisher’s exact test)

ISSN: 1471-2407