Lokale chemo spoelingen, (TACE) met melphalan bij levertumoren vanuit een melanoom geeft significant betere kwaliteit van leven en betere 1-jaars overleving. Door scross-over tijdens studie was mediane overall overleving slechts iets beter maar niet significant. Artikel update 18 april 2012
26 september 2011: Bron: Medscape
Lokale chemo spoelingen, chemo embolisatie, van de lever om tumoren ontstaan vanuit een melanoom te bestrijden geeft een significant betere kwaliteit van leven, een significant langere ziektevrije tijd (1,6 maanden versus 6,1 maanden) en een significant betere 1-jaars overleving. Omdat veel patienten overstapten vanuit de controlegroep naar de studiegroep tijdens de studie was de mediane overall overleving wel iets beter maar statistisch niet significant 29% in de studiegroep tegenover 26% in de controlegroep. Echter de onderzoekers stellen nadrukkelijk dat deze vorm van behandelen van in de lever uitgezaaide melanoom een levensverlengende behandeling is in vergelijking met beste zorg. De resultaten van deze studie waren vorig jaar al aangekondigd en nu werden de definitieve resultaten gepubliceerd van deze gerandomiseerde studie.
Results: Median H-PFS was 245 days (CI:136, 267) for PHP-mel vs. 49 days (CI:43, 68) for BAC (p<0.001). Overall response rate was 34.1 % (15/44) (CI: 20.5, 49.9) for PHP (15/44) vs. 2.0 % (1/49) (CI: 0.1, 10.9) for BAC (p<0.001). Upon hepatic progression, crossover to PHP occurred in 27 patients (55%) randomized to BAC. Conclusions: For patients with metastatic melanoma to the liver, H-PFS is significantly improved with PHP-mel versus best available care
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Percutaneous hepatic perfusion appears to extend progression-free survival in melanoma patients with liver metastases
Percutaneous hepatic infusion is designed to saturate the liver with high doses of chemotherapy using a minimally invasive procedure.
In their study, Dr. Pingpank and colleagues randomized 93 patients with uveal melanoma from 10 clinics in the United States to either percutaneous hepatic infusion or best alternative care. Patients received melphalan 3 mg/kg of ideal body weight infused through the hepatic artery over 30 minutes.
The type of alternative treatment was determined by the patient's clinician, and consisted of interleukin 2, ipilimumab, transcatheter arterial chemoembolization, systemic chemotherapy, or inclusion in a clinical trial.
The primary end point of the study was hepatic progression-free survival. Secondary end points included overall response rate, progression-free survival, and overall survival.
Investigator-assessed hepatic progression-free survival was significantly better in the experimental group than in the control group (8.1 vs 1.6 months; hazard ratio, 0.34; P < .0001), with a 6.5-month difference at the median.
Overall survival was 11.4 months in the percutaneous infusion group, and 9.9 months in the control group. The authors note that the patients who crossed over appeared to do well, despite being among the sickest in the cohort, and survived for an average of 9.2 months without liver metastasis and 6.5 months without any overall progression of the disease.
Adverse effects were more severe in patients who received percutaneous hepatic perfusion than among those who received best alternative care. However, noted Dr. Pingpank, they generally resolved within a short period of time.
The majority of toxicities were based on systemic delivery, he explained. "The filtering system was quite efficient, but we did see some drugs get into the system," he said. "The majority of patients had treatable thrombocytopenia or neutropenia."
The device that delivers and filters the melphalan has already been approved in Europe for use in all malignant liver tumors. Approval is currently pending melanoma only in the United States.
"Patients with uveal melanoma and liver metastasis do extremely poorly, so this study is very important," said Jean-Charles Soria, MD, who comoderated the session.
"This is something that oncologists need to think about it," added Dr. Soria, who is a medical oncologist at Institut Gustave Roussy, Paris, France, and professor of medicine and medical oncology at Paris University XI. Dr. Soria pointed out that when he has a patient with lung cancer with massive liver involvement, he is using this approach.
"This is a novel regional strategy of high value, and a nice demonstration of a multidisciplinary approach," he added.
2011 European Multidisciplinary Cancer Congress: Abstract 9304. Presented September 24, 2011.
