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Hepatic Transcatheter Arterial Chemoembolization Alternating with Systemic Protracted Continuous Infusion 5-Fluorouracil for Gastrointestinal Malignancies Metastatic to Liver: A Phase II Trial of the Puget Sound Oncology Consortium (PSOC 1104)
We assessed a regimen of alternating regional and systemic therapy in patients with gastrointestinal malignancies with liver-dominant metastases for feasibility, toxicity, response rate, response duration, patterns of progression, and progression-free and overall survival. Regional therapy comprised...
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| Published in: | Clinical cancer research 1999-01, Vol.5 (1), p.95-109 |
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| Main Authors: | , , , , , , , |
| Format: | Article |
| Language: | English |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | We assessed a regimen of alternating regional and systemic therapy in patients with gastrointestinal malignancies with liver-dominant
metastases for feasibility, toxicity, response rate, response duration, patterns of progression, and progression-free and
overall survival. Regional therapy comprised selective hepatic transcatheter arterial chemoembolization (TACE) using a suspension
of cisplatin and particulate polyvinyl alcohol. This procedure was delivered between cycles of protracted continuous infusion
5-fluorouracil (PCI-5FU) as systemic chemotherapy. Patient eligibility criteria included: ( a ) having histologically documented adenocarcinoma arising from a gastrointestinal primary site with unresectable liver metastases
bidimensionally measurable on computerized tomography scan; ( b ) age greater than 18 years; and ( c ) performance status 0â2 (Zubrod). PCI-5FU (250 mg/m 2 /day) was administered i.v. for 28 days, followed by the first TACE (TACE 1) delivered to the hepatic artery supplying the
lobe with the greatest tumor burden. Restaging was performed before TACE 2 and TACE 3, which followed at monthly intervals.
PCI-5FU for 21 days was sandwiched between each of the TACE treatments. After the final TACE, maintenance PCI-5FU was given
for 28 days of each 35-day cycle until toxicity or progression. Between December 23, 1991, and January 19, 1995, 32 patients
were registered in this trial, of whom 27 were eligible; 20 completed one or more treatment cycles and were evaluable for
radiographic response. Patients with colorectal liver metastases predominated (74%). Twelve (44%) of 27 patients had failed
one or more prior treatment regimens. There were no treatment-related deaths, and hematological and hepatic toxicities were
generally manageable and reversible. Two patients, however, developed hepatic abscesses requiring drainage, and one patient
developed an infarcted gallbladder, which necessitated cholecystectomy. There were no patients with complete responses; there
were 8 (40%) with partial responses, 4 (20%) with minor responses, 2 (10%) with stable disease, and 6 (30%) who progressed
on the treatment. The median duration of response for partial responders was 4.2 months (127 days; range, 56â245 days). The
median reduction in carcinoembryonic antigen for responders was 87.5%. Two patients underwent subsequent resection of residual
metastases; one of them is still alive at 58.4 months follow-up. The predominant site of disease progression was t |
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| ISSN: | 1078-0432 1557-3265 |