A Phase I-II Study of Isolated Hepatic Perfusion Using Melphalan with or without Tumor Necrosis Factor for Patients with Ocular Melanoma Metastatic to Liver
There are no satisfactory treatment options for patients with ocular melanoma metastatic to liver, and after liver metastases are identified, median survival is only between 2 and 7 months. Because liver metastases are the sole or life-limiting component of disease in the vast majority of patients w...
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Veröffentlicht in: | Clinical cancer research 2000-08, Vol.6 (8), p.3062-3070 |
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Zusammenfassung: | There are no satisfactory treatment options for patients with ocular
melanoma metastatic to liver, and after liver metastases are
identified, median survival is only between 2 and 7 months. Because
liver metastases are the sole or life-limiting component of disease in
the vast majority of patients who recur, we reasoned that complete
vascular isolation and perfusion of the liver might result in
clinically meaningful regression of disease. Between September 1994 and
July 1999, 22 patients (13 women and 9 men; mean age, 49 years)
with ocular melanoma metastatic to liver were treated with a 60-min
hyperthermic isolated hepatic perfusion (IHP) using melphalan alone
(1.5–2.5 mg/kg, n = 11) or with tumor necrosis
factor (TNF, 1.0 mg, n = 11). Via a laparotomy, IHP
inflow was via the hepatic artery alone ( n = 17) or
hepatic artery and portal vein ( n = 5) and outflow
from an isolated segment of inferior vena cava. Most patients had
advanced tumor burden with a mean percentage of hepatic replacement of
25% (range, 10–75%) and a median number of metastatic nodules of 25
(range, 5 to >50). Complete vascular isolation was confirmed in all
patients using a continuous intraoperative leak monitoring technique
with 131 I radiolabeled albumin. There was one treatment
mortality (5%). The overall response rate in 21 patients was 62%
including 2 radiographic complete responses (9.5%) and 11 partial
responses (52%). The overall median duration of response was 9 months
(range, 5–50) and was significantly longer in those treated with TNF
than without (14 versus 6 months, respectively;
P = 0.04). Overall median survival in 22 patients
was 11 months. These data indicate that a single 60-min IHP can result
in significant regression of advanced hepatic metastases from ocular
melanoma. TNF appears to significantly prolong the duration of
response. |
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ISSN: | 1078-0432 1557-3265 |