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A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma.

Publication ,  Journal Article
Mok, TS; Leung, TW; Lee, SD; Chao, Y; Chan, AT; Huang, A; Lui, MC; Yeo, W; Chak, K; Johnston, A; Johnson, P
Published in: Cancer Chemother Pharmacol
1999

PURPOSE: A multi-centre randomized phase II study of single agent nolatrexed dihydrochloride versus doxorubicin was undertaken in Chinese patients with advanced hepatocellular carcinoma (HCC) to study and compare the clinical efficacy of the two drugs. METHODS: Fifty-four patients with clinical or histological diagnosis of HCC were randomized in a 2:1 ratio to receive nolatrexed or doxorubicin. Nolatrexed 725 mg/m(2)/day was given by continuous infusion via a central venous device for 5 days and doxorubicin 60 mg/m(2) was given as a rapid intravenous infusion every 3 weeks. RESULTS: No objective responses were observed in either treatment arm. Two patients in the nolatrexed arm and none in the doxorubicin arm had >50% decline in serum alpha-fetoprotein. The median survival for the patients in the nolatrexed and doxorubicin arms was 139 days and 104 days, respectively. Moderate toxicities including leukopenia, thrombocytopenia, mucositis and skin rash were observed in both treatment arms. CONCLUSION: Nolatrexed and doxorubicin are minimally active in the treatment of advanced HCC. Given the small sample size, no difference is observed between the two drugs.

Duke Scholars

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Published In

Cancer Chemother Pharmacol

DOI

ISSN

0344-5704

Publication Date

1999

Volume

44

Issue

4

Start / End Page

307 / 311

Location

Germany

Related Subject Headings

  • Survival Analysis
  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Infusions, Intravenous
  • Humans
  • Female
  • Doxorubicin
 

Citation

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Mok, T. S., Leung, T. W., Lee, S. D., Chao, Y., Chan, A. T., Huang, A., … Johnson, P. (1999). A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol, 44(4), 307–311. https://doi.org/10.1007/s002800050982
Mok, T. S., T. W. Leung, S. D. Lee, Y. Chao, A. T. Chan, A. Huang, M. C. Lui, et al. “A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma.Cancer Chemother Pharmacol 44, no. 4 (1999): 307–11. https://doi.org/10.1007/s002800050982.
Mok TS, Leung TW, Lee SD, Chao Y, Chan AT, Huang A, et al. A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 1999;44(4):307–11.
Mok, T. S., et al. “A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma.Cancer Chemother Pharmacol, vol. 44, no. 4, 1999, pp. 307–11. Pubmed, doi:10.1007/s002800050982.
Mok TS, Leung TW, Lee SD, Chao Y, Chan AT, Huang A, Lui MC, Yeo W, Chak K, Johnston A, Johnson P. A multi-centre randomized phase II study of nolatrexed versus doxorubicin in treatment of Chinese patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 1999;44(4):307–311.
Journal cover image

Published In

Cancer Chemother Pharmacol

DOI

ISSN

0344-5704

Publication Date

1999

Volume

44

Issue

4

Start / End Page

307 / 311

Location

Germany

Related Subject Headings

  • Survival Analysis
  • Quinazolines
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Infusions, Intravenous
  • Humans
  • Female
  • Doxorubicin