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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin
Journal of Clinical Oncology, Volume 25, No. 21, Year 2007
Notification
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Description
Purpose: The study objective was to compare the overall survival (OS) of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with nolatrexed (NOL) or doxorubicin (DOX). Patients and Methods: Patients from North America, Europe, and South Africa (N = 445) with HCC were randomly assigned to receive NOL or DOX. Eligible patients had Kamofsky performance status (KPS) ≥ 60%, Cancer of the Liver Italian Program (CLIP) score ≤ 3, and adequate organ function. Primary end point was OS. Secondary end points included progression-free survival (PFS), objective response rates, and safety. The treatment groups were well-balanced with regards to age, sex, ethnic origin, and underlying liver disease. Randomization was stratified according to KPS and CLIP score. Results: At the time of the final analysis, 377 patients had died. Median OS was 22.3 weeks for NOL and 32.3 weeks for DOX (P = .0068). The hazard ratio was 0.753 in favor of DOX. Objective response rate (complete response [CR] plus partial response [PR]) was 1.4% for NOL and 4.0% for DOX. Median PFS was 12 weeks for NOL and 10 weeks for DOX (P = .7091). Median time to treatment failure was 8.4 weeks for NOL and 9.1 weeks for DOX (P = .0969). Grade 3 and 4 stomatitis, vomiting, diarrhea, and thrombocytopenia were more common in the NOL arm. Alopecia was more common in the DOX arm. More patients were withdrawn from study for toxicity in the NOL arm than in the DOX arm. Conclusion: NOL showed minimal activity in this phase III trial. Further exploration at this dose and schedule in HCC is not warranted. © 2007 by American Society of Clinical Oncology.
Authors & Co-Authors
Gish, Robert G.
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Porta, Camillo G.
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Ruff, Paul W.
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Croitoru, Adina Emilia
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Feun, Lynn G.
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Statistics
Citations: 248
Authors: 5
Affiliations: 1
Identifiers
Doi:
10.1200/JCO.2006.08.4046
ISSN:
0732183X
Research Areas
Cancer
Environmental
Study Design
Randomised Control Trial
Study Approach
Quantitative
Study Locations
South Africa