Phase II trial of oral doxifluridine plus oral levo-leucovorin in unresectable hepatocellular carcinoma

M. Colleoni, M. Di Bartolomeo, E. Bajetta, F. Nole, P. Nelli, C. Carnaghi, G. Vicario, M. Del Vecchio, A. Bono

Research output: Contribution to journalArticle

Abstract

Systemic chemotherapy with currently available agents in unresectable HCC has a minimal impact on disease progression and a predictable response rate of 2, day 1 through 5, cycles being repeated every 10 days. Thirty-seven patients with unresectable HCC entered the study and are evaluable for response and toxicity. Three partial responses have been observed, to a global response rate of 8% (95% confidence interval 2-22%). After a median observation time of 12 months, the median survival was 7 months, with a median time to progression of 4 months. Main toxicity was diarrhea; severe in 30% of the patients. One patient died as a result of uncontrollable diarrhea. In view of the limited activity observed, further trials with this schedule are not warranted.

Original languageEnglish
Pages (from-to)603-606
Number of pages4
JournalOncology Reports
Volume2
Issue number4
Publication statusPublished - 1995

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Levoleucovorin
Hepatocellular Carcinoma
Diarrhea
Disease Progression
Appointments and Schedules
Observation
Confidence Intervals
Drug Therapy
Survival
doxifluridine

Keywords

  • Doxifluridine
  • Hepatocellular carcinoma
  • Leucovorin
  • Oral chemotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Phase II trial of oral doxifluridine plus oral levo-leucovorin in unresectable hepatocellular carcinoma",
abstract = "Systemic chemotherapy with currently available agents in unresectable HCC has a minimal impact on disease progression and a predictable response rate of 2, day 1 through 5, cycles being repeated every 10 days. Thirty-seven patients with unresectable HCC entered the study and are evaluable for response and toxicity. Three partial responses have been observed, to a global response rate of 8{\%} (95{\%} confidence interval 2-22{\%}). After a median observation time of 12 months, the median survival was 7 months, with a median time to progression of 4 months. Main toxicity was diarrhea; severe in 30{\%} of the patients. One patient died as a result of uncontrollable diarrhea. In view of the limited activity observed, further trials with this schedule are not warranted.",
keywords = "Doxifluridine, Hepatocellular carcinoma, Leucovorin, Oral chemotherapy",
author = "M. Colleoni and {Di Bartolomeo}, M. and E. Bajetta and F. Nole and P. Nelli and C. Carnaghi and G. Vicario and {Del Vecchio}, M. and A. Bono",
year = "1995",
language = "English",
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journal = "Oncology Reports",
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TY - JOUR

T1 - Phase II trial of oral doxifluridine plus oral levo-leucovorin in unresectable hepatocellular carcinoma

AU - Colleoni, M.

AU - Di Bartolomeo, M.

AU - Bajetta, E.

AU - Nole, F.

AU - Nelli, P.

AU - Carnaghi, C.

AU - Vicario, G.

AU - Del Vecchio, M.

AU - Bono, A.

PY - 1995

Y1 - 1995

N2 - Systemic chemotherapy with currently available agents in unresectable HCC has a minimal impact on disease progression and a predictable response rate of 2, day 1 through 5, cycles being repeated every 10 days. Thirty-seven patients with unresectable HCC entered the study and are evaluable for response and toxicity. Three partial responses have been observed, to a global response rate of 8% (95% confidence interval 2-22%). After a median observation time of 12 months, the median survival was 7 months, with a median time to progression of 4 months. Main toxicity was diarrhea; severe in 30% of the patients. One patient died as a result of uncontrollable diarrhea. In view of the limited activity observed, further trials with this schedule are not warranted.

AB - Systemic chemotherapy with currently available agents in unresectable HCC has a minimal impact on disease progression and a predictable response rate of 2, day 1 through 5, cycles being repeated every 10 days. Thirty-seven patients with unresectable HCC entered the study and are evaluable for response and toxicity. Three partial responses have been observed, to a global response rate of 8% (95% confidence interval 2-22%). After a median observation time of 12 months, the median survival was 7 months, with a median time to progression of 4 months. Main toxicity was diarrhea; severe in 30% of the patients. One patient died as a result of uncontrollable diarrhea. In view of the limited activity observed, further trials with this schedule are not warranted.

KW - Doxifluridine

KW - Hepatocellular carcinoma

KW - Leucovorin

KW - Oral chemotherapy

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