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Am J Clin Oncol. 2010 Feb;33(1):43-6. doi: 10.1097/COC.0b013e31819d8668.

Phase I study of hepatic arterial infusion of oxaliplatin in advanced hepatocellular cancer: a brown university oncology group study.

Author information

1
Division of Hematology/Oncology, Roger Williams Hospital, Providence, Rhode Island 02908, USA. rrathore@rwmc.org

Abstract

PURPOSE:

We performed a phase I study to evaluate the feasibility and determine the maximally tolerated dose of hepatic arterial infusion (HAI) of oxaliplatin in advanced hepatocellular carcinoma (HCC).

PATIENTS AND METHODS:

Patients with unresectable or recurrent HCC received HAI-oxaliplatin over 2 hours at dose escalation levels of 90, 110, 130, and 150 mg/m given every 3 weeks. The therapy was continued until disease progression or excessive toxicity not amenable to appropriate modifications. Restaging was performed after every 2 cycles.

RESULTS:

A total of 23 patients were enrolled, with 17 patients evaluable for toxicity assessment. The median age was 63 years (range: 47-84 years), with 22 men and 1 woman. Stage distribution was as follows: stage II, 3 patients; stage III, 12 patients; and stage IV, 8 patients. A total of 53 cycles (range: 1-3) of HAI-oxaliplatin were delivered. The conventional grade 3/4 hematologic and gastrointestinal toxicities were infrequent. Among 17 evaluable patients receiving >2 cycles, 3 patients had partial responses and 8 had stable disease. A greater than 50% reduction in alphafetoprotein was seen in the 3 patients with partial responses and 3 patients with stable disease.

CONCLUSIONS:

HAI-oxaliplatin is a feasible, well tolerated, and demonstrated activity in this advanced HCC cohort. HAI-oxaliplatin 150 mg/m every 3 weeks was determined as the dose for further evaluation in phase II trials.

PMID:
19687731
DOI:
10.1097/COC.0b013e31819d8668
[Indexed for MEDLINE]
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