Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

Robert G Gish; Camillo Porta; Lucian Lazar; Paul Ruff; Ronald Feld; Adina Croitoru; Lynn Feun; Krzysztof Jeziorski; John Leighton; Jennifer Knox; José Gallo; Gerard T Kennealey

doi:10.1200/JCO.2006.08.4046

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Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

Journal article

Peer reviewed

Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin

Robert G Gish, Camillo Porta, Lucian Lazar, Paul Ruff, Ronald Feld, Adina Croitoru, Lynn Feun, Krzysztof Jeziorski, John Leighton, Jennifer Knox, …

Journal of clinical oncology, Vol.25(21), pp.3069-3075

2007-07-20

DOI: https://doi.org/10.1200/JCO.2006.08.4046

PMID: 17634485

Abstract

PurposeThe 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 MethodsPatients from North America, Europe, and South Africa (N = 445) with HCC were randomly assigned to receive NOL or DOX. Eligible patients had Karnofsky 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.ResultsAt 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 More patients were withdrawn from study for toxicity in the NOL arm than in the DOX arm.ConclusionNOL showed minimal activity in this phase III trial. Further exploration at this dose and schedule in HCC is not warranted.

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.111 Liver & Colon Cancer; 1.111.162 Hepatocellular Carcinoma
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Phase III Randomized Controlled Trial Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma Treated With Nolatrexed or Doxorubicin
Creators: Robert G Gish - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Camillo Porta - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Lucian Lazar - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Paul Ruff - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Ronald Feld - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Adina Croitoru - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Lynn Feun - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Krzysztof Jeziorski - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
John Leighton - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Jennifer Knox - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
José Gallo - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Gerard T Kennealey - From the California Pacific Medical Center, San Francisco, CA; University of Miami, FL; Albert Einstein Medical Center, Philadelphia, PA; GPC Biotech Inc, Princeton, NJ; MGI Pharma, Bloomington, MN; IRCCS San Matteo University Hospital, Pavia, Italy; Oncology Institute Ion Chiricuta, Cluj-Napoca; Fundeni Clinical Institute, Bucharest, Romania; The University of Witwatersrand, Johannesburg, South Africa; Princess Margaret Hospital, Toronto, Canada; the Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw
Publication Details: Journal of clinical oncology, Vol.25(21), pp.3069-3075
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Hematology/Oncology
Language: English
Resource Type: Journal article
PMID: 17634485
Record Identifier: 991031576077402976