Jun 06, 2010 - 1:40 pm
CHICAGO (TheStreet) -- Results from a pivotal study of the Delcath Systems(DCTH) drug/device to clear tumors from the liver have gotten better with time as reported from the American Society of Clinical Oncology (ASCO)
Treatment with Delcath's Percutaneous Hepatic Perfusion (PHP) system delayed the time before liver tumors started to grow or death by 6.5 months compared to patients treated with best alternative care, according to updated results from a phase III study released Saturday at the American Society of Clinical Oncology (ASCO) annual meeting.
The improved results from phase III study reflects a later analysis of the data in which patients treated with the PHP system continue to benefit over patients treated with best alternative care, according to a Delcath spokeswoman.
A detailed presentation of the Delcath study with more data on the PHP system takes place Saturday afternoon at the ASCO meeting.
PHP is a system that lets doctors isolate the liver from the rest of the blood supply, allowing tumors in the liver to be treated with very high doses of chemotherapy without causing significant toxicity in the rest of the body.
The PHP "system" isolates the liver using a series of catheters, balloon-like clamps and filters that are inserted via small incisions in the neck and legs. Doctors then infuse the liver with the chemotherapy drug melphalan at 10 times the dose they could use if the drug were injected normally. The PHP system filters out the melphalan as it exits the liver, which keeps the toxic drug out of the patient's blood supply and reduces side effects.
Delcath chose metastatic melanoma patients for its first phase III study since this type of cancer often spreads first and foremost to the liver. Ninety-two patients were enrolled, randomized to treatment with either the PHP system or "best alternative care." The primary endpoint was hepatic progression-free survival (hPFS), defined as the length of time before a patient's liver tumor grows, or death. In the results released Saturday morning by ASCO, patients treated with PHP reported a median hPFS of 245 days compared to 49 days in the control arm, or a benefit of 6.5 months in favor of the PHP system. Just over 34% of patients treated with the PHP system reported significant tumor shrinkage compared to just 2% of patients with best alternative care.
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