Lorenzo GD, Rea A, Carlomagno C, Pepe S, Palmieri G, Labianca R, Chirianni A, Stefano AD, Esposito V, Placido SD, Montesarchio V. Activity and safety of pegylated liposomal doxorubicin, 5-fluorouracil and folinic acid in inoperable hepatocellular carcinoma: A phase II study. World J Gastroenterol 2007; 13(48): 6553-6557 [PMID: 18161926 DOI: 10.3748/wjg.v13.i48.6553]
Corresponding Author of This Article
Giuseppe Di Lorenzo, MD, PhD, Cattedra di Oncologia Medica, Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Università degli Studi Federico II, Naples, Italy. giuseppedilorenzoncol@hotmail.com
Article-Type of This Article
Rapid Communication
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Dec 28, 2007; 13(48): 6553-6557 Published online Dec 28, 2007. doi: 10.3748/wjg.v13.i48.6553
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
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
Citation: Lorenzo GD, Rea A, Carlomagno C, Pepe S, Palmieri G, Labianca R, Chirianni A, Stefano AD, Esposito V, Placido SD, Montesarchio V. Activity and safety of pegylated liposomal doxorubicin, 5-fluorouracil and folinic acid in inoperable hepatocellular carcinoma: A phase II study. World J Gastroenterol 2007; 13(48): 6553-6557