Activity and safety of pegylated liposomal doxorubicin, 5-fluorouracil and folinic acid in inoperable hepatocellular carcinoma: A phase II study

Table 1 Main eligibility criteria

Age < 85 yr

WHO performance status 0 or 1

Histologically confirmed HCC

Stage III-IV

No prior systemic chemotherapy

Child-Pugh A or B

Complete history of the patient (including previous treatment)

Informed consent

Normal hematologic, renal and cardiac functions

Table 2 Patient characteristics

No. of patients	31
Male	26
Female	5
Median age (range)	65 (41-82) yr
WHO performance status
0	12
1	19
Positive hepatitis status
Hepatitis B	3
Hepatitis C	28
AFP > ULN
Yes	22
No	9
Child–Pugh status
A	14
B	17
Disease stage at study entry (TNM)
III C	15
IV	16
Grading (AJCC) at initial diagnosis
Well-differentiated	15
Moderately-well-differentiated	10
Poorly differentiated	6
Prior treatment
Chemoembolization	15
Local alcholization	6
Local radiofrequency	5
None	10

Data are expressed as median (range) or n. WHO: World Health Organization. ULN: Upper limit of normal; AJCC: American Joint Committee on Cancer.

Table 3 Responses and survival rates (n = 31)

Response after three cycles	No. of patients (%)
PR	2 (6.5)
SD	16 (51.5)
Progression	13 (42)
Median progression-free survival (95% CI)	4 (1.7-7) mo
Overall survival rate
6 mo	21 (68)
12 mo	9 (29)
24 mo	1 (0.3)
Survival rate in
PR or SD patients (n = 18)
6 mo	15 (83)
12 mo	9 (50)
24 mo	1 (0.56)

Table 4 Reported toxicity by 31 patients n (%)

Toxicity	Grade 1-2	Grade 3-4
Neutropenia	7 (22.5)	3 (10)
Anemia	8 (26)	2 (6.5)
Thrombocytopenia	5 (16)	2 (6.5)
Oral stomatitis	7 (22.5)	1 (3)
Nausea/vomiting	3 (10)	2 (6.5)
Diarrhea	3 (10)	1 (3)
Hand-foot syndrome	5 (16)	0
Hepatic dysfunction	3 (10)	0
Peripheral neuropathy	3 (10)	0