Abstract | BACKGROUND: PATIENTS AND METHODS: Dose escalation was tested over four dose levels in each 21-day cycle: level 1 (Gem 1000 mg/m(2) on days 1 and 8, Dox 30 mg/m(2) on day 1), level 2 (Gem/Dox 1250/30), level 3 (Gem/Dox 1250/45) and level 4 (Gem/Dox 1250/60). The MTD was further evaluated in phase II. RESULTS: Patients' characteristics were: 47 men, three women; median age 53 years (range 28-70); Zubrod performance status (PS) scores 0-1 (74%), PS 2 (26%); Okuda stage I (24%) and stage II (76%). Fifteen patients were enrolled in phase I: level 1 (n = 3), level 2 (n = 6), level 3 (n = 6), level 4 (n = 0). Level 2 was identified as the MTD. Dose-limiting toxicities included esophageal bleeding, grade 4 neutropenia and neutropenic fever. Of the 34 patients evaluable for response in phase II (of 35 total), there were four (11.8%) partial responses (95% CI, 0.8% to 22.8%) and six (17.6%) minor responses; nine (26.5%) had stable disease and 15 (44.1%) progressed. Sixteen per cent of patients had a decline of >or=50% in alpha-fetoprotein levels after treatment. Median survival and progression-free survival were 4.6 months (range 0.3-19.2) and 2.5 months (range 0.2-7.8), respectively, for 35 patients. Grade 3/4 hematological toxicities included anemia (45.7%), neutropenia (51.4%), thrombocytopenia (25.7%); febrile neutropenia (11.8%) and non-hematological toxicities were mild to moderate. CONCLUSIONS:
Gemcitabine plus doxorubicin produces modest activity and moderate toxicity in this cohort of Chinese patients with advanced HCC.
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Authors | T S Yang, C H Wang, R K Hsieh, J S Chen, M C Fung |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 13
Issue 11
Pg. 1771-8
(Nov 2002)
ISSN: 0923-7534 [Print] England |
PMID | 12419750
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Deoxycytidine
- Doxorubicin
- Gemcitabine
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Biopsy, Needle
- Carcinoma, Hepatocellular
(drug therapy, mortality, pathology)
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives)
- Dose-Response Relationship, Drug
- Doxorubicin
(administration & dosage, adverse effects)
- Drug Administration Schedule
- Female
- Humans
- Infusions, Intravenous
- Liver Neoplasms
(drug therapy, mortality, pathology)
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasm Invasiveness
(pathology)
- Neoplasm Staging
- Prognosis
- Survival Analysis
- Taiwan
- Treatment Outcome
- Gemcitabine
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