Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study

Table 4 Grade 3 and 4 adverse events. Reported is the highest grade observed

Events^a	Grade 3 - 4^b GEM (n = 9)	Grade 3 - 4^b CIS/GEM (n = 21)	Total
	No. (%)
Hematologic toxic effects
Leukopenia	0	8 (38)	8 (27)
Neutropenia	3 (33)	12 (57)	15 (50)
Thrombocytopenia	1 (11)	4 (19)	5 (17)
Anaemia	0	3 (14)	3 (10)
Non-hematologic toxic effects
Alopecia	0	2 (10)	2 (7)
Anorexia	0	2 (10)	2 (7)
Fatigue	3 (33)	4 (19)	6 (20)
Nausea	0	1 (5)	1 (3)
Vomiting	0	1 (5)	1 (3)
Impaired renal function	0	2 (5)	2 (7)
Infection	0 (0)	3 (14)	3 (10)
Without neutropenia	0	0	0 (0)
With neutropenia	0	3	3 (10)
Biliary sepsis	0	2	2 (7)
Deep-vein thrombosis	0	1 (5)	1 (3)
Other	1 (11)	5 (24)	6 (20)
Liver function
Increased ALAT level	0	1 (5)	1 (3)
Other abnormal liver function^c	0	2 (10)	2 (7)
Any abnormal liver function^d	0	0 (0)	0 (0)

Abbreviations: GEM gemcitabine, CIS cisplatin, ALAT alanine aminotransferase
^aMultiple adverse events per patient possible
^bPre-existing conditions are reported only in case of worsening during study treatment
^cElevated gamma-GT
^dHypoalbumia, decreased Vitamin K level

ISSN: 1471-2407