Japanese Journal of Clinical Oncology, Vol 29, Issue 1 23-27, Copyright © 1999 by Foundation for Promotion of Cancer Research
T Ikeda, I Adachi, S Takashima, M Ogita, H Aoyama, M Sano, J Ando, T Tabei, T Tominaga, K Enomoto, K Kanda, T Fukutomi and M Shimoyama
BACKGROUND: Liver metastasis from breast cancer has a poor prognosis. While
there are some reports of good response rates of hepatic metastasis from
breast cancer by hepatic intra-arterial infusion chemotherapy, no phase I
study including pharmacokinetic analysis has been reported. We performed a
phase I/II study of intra-arterial infusion chemotherapy using adriamycin
and 5-fluorouracil to find the maximum tolerated dose and response rate in
patients with advanced or recurrent breast cancer. METHODS: A hepatic
arterial catheter with an access port was inserted into the proper hepatic
artery. Patients received 30 mg/m2 adriamycin on days 1 and 8 and 100 mg/m2
5-fluorouracil at level 1, 200 mg/m2 at level 2,300 mg/m2 at level 3 and
400 mg/m2 at level 4 continuously from day 1 through day 14 every 28 days.
At least two cycles were required before evaluation. Twenty-eight patients
were entered into this study and 26 patients were evaluable. Seventeen
patients had hepatic metastasis only, although nine patients had additional
metastasis to other sites. RESULTS: Dose-limiting toxicity of
thrombocytopenia and neurotoxicity occurred at level 4. Leukocytopenia
(ECOG grade 3-4) was observed in five (19%), thrombocytopenia in three
(12%) and anemia in two (8%) patients. There were 11 catheter-related
complications which were not dose dependent. Seven out of 13 evaluable
patients (54%) responded at level 3. The median duration of response was
5.8 months (range, 1-23+) and median survival was 25.3 months (range,
6.2-54.7+). CONCLUSION: Hepatic arterial infusion therapy appears to be
safe and effective but catheter-related complications must be overcome
before starting a phase III trial.
CASE REPORTS
A phase I/II study of continuous intra-arterial chemotherapy using an implantable reservoir for the treatment of liver metastases from breast cancer: a Japan Clinical Oncology Group (JCOG) study 9113. JCOG Breast Cancer Study Group
Department of Surgery, School of Medicine, Keio University, Tokyo, Japan. ikedat@mc.med.keio.ac.jp
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