A phase II study of irinotecan in patients with advanced hepatocellular carcinoma Journal Article
| Authors: | O'Reilly, E. M.; Stuart, K. E.; Sanz-Altamira, P. M.; Schwartz, G. K.; Steger, C. M.; Raeburn, L.; Kemeny, N. E.; Kelsen, D. P.; Saltz, L. B. |
| Article Title: | A phase II study of irinotecan in patients with advanced hepatocellular carcinoma |
| Abstract: | BACKGROUND. Advanced hepatocellular carcinoma has a poor prognosis. In a Phase II clinical trial, two academic centers assessed irinotecan, a topoisomerase-1 inhibitor with broad spectrum clinical activity, in patients who had advanced hepatocellular cancer. METHODS. Patients who had up to one prior chemotherapy regimen were eligible. Bidimensionally measurable disease, a good performance status, and adequate major organ function were required. At a starting dose of 125 mg/m2, irinotecan was administered weekly for 4 weeks followed by a 2 week break, which constituted 1 treatment cycle. Patients were restaged radiologically after two cycles of therapy. Dose attenuations were made as indicated for toxicity. RESULTS. Fourteen patients were enrolled over a 10-week period in 1997. There were ten males and four females. The median age was 58 years (range, 38-74 yrs). The Eastern Cooperative Oncology Group median performance status was 1 (range, 0-1). Two patients had prior chemotherapy (14%), and 1 patient (7%) had had radiation. A total of 30 cycles of therapy were delivered (median, 1; range, 1-6). Considerable toxicity, was observed, mostly neutropenia, diarrhea, nausea, vomiting, and fatigue. All patients required at least one dose attenuation for toxicity. One partial response (7%; confidence interval, 0-20%) was noted to last 7 months. One patient had transient stable disease, and all others (86%) had progression of disease as their best response. CONCLUSIONS. Irinotecan had modest activity in advanced hepatocellular cancer. Toxicity was substantial, presumably reflecting impaired underlying liver function or poor ability to metabolize and eliminate the drug. The current study indicated that continued new therapy assessment is warranted for this disease. © 2001 American Cancer Society. |
| Keywords: | adult; cancer chemotherapy; clinical article; treatment outcome; aged; middle aged; clinical trial; disease course; fatigue; neutropenia; diarrhea; dose response; liver cell carcinoma; liver function; carcinoma, hepatocellular; liver neoplasms; chemotherapy; phase 2 clinical trial; nausea; vomiting; antineoplastic agents, phytogenic; camptothecin; irinotecan; nausea and vomiting; drug metabolism; phase ii clinical trial; cpt-11; hepatocellular cancer; hepatoma; humans; prognosis; human; male; female; priority journal; article |
| Journal Title: | Cancer |
| Volume: | 91 |
| Issue: | 1 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2001-01-01 |
| Start Page: | 101 |
| End Page: | 105 |
| Language: | English |
| DOI: | 10.1002/1097-0142(20010101)91:1<101::aid-cncr13>3.0.co;2-k |
| PUBMED: | 11148565 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 21 May 2015 -- Source: Scopus |
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