Percutaneous infusion (local chemo washings) with melphalan gives significantly better at melanoompatienten with liver tumors on survival time thus phase III study results. Article update 18 april 2012
June 6, 2010: Source ASCO 2010
Percutaneous infusion (local chemo rinses, such as e.g. also TACE is) with melphalan with liver metastases melanoompatienten gives significantly better results on the median survival time in vergeljiking with standard care. The time until a new relapse went from 45 days in the standard care group to 245 days in the group that got through the local chemo rinses melphalan. Also the response to treatment was many times greater in the group that got the local chemo washings: 34.1% t.o. 2% in the control group. This is evidenced by a randomized phase III study of 93 patients divided into two groups with half of the patients from the control group still in progression of their illness switched to the study group with percutaneous perfusion.
Interestingly, also mentions that patients also use additional resources such as Meds cape bv. shall indicate in their report about this study that some patients were using hyperthermia . See also the two of erevaringsverhalen and Eric mevr. of Deelen who both in a 3.5-year total remission already came by dendritic cell therapy plus hyperthermia and the wood smuller diet. See under experience stories in melanomas in alphabetical list
Here the abstract was presented at ASCO 2010:
A phase III trial comparing percutaneous hepatic perfusion with melphalan random assignment (PHP-mel) to standard of care for patients with hepatic metastases from melanoma metastatic ocular or cutaneous.Sub-category: Melanoma Category: Melanoma/Skin Cancers Meeting: 2010 ASCO Annual Meeting Citation: J Clin Oncol 28: 7s, 2010 (Suppl. abstract expressionism; LBA8512) Abstract No: LBA8512 |
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Author (s): J. F. Pingpank, M. S. Hughes, M. B. Faries, J. S. Zager, H. R. Alexander, R. Royal, E. D. Whitman, C. W. Nutting, G. P. Siskin, S. S. Agarwala; University of Pittsburgh, Hillman Cancer Center, Pittsburgh, PA; Surgery Branch, National Cancer Institute, Bethesda, MD; John Wayne Cancer Institute, Santa Monica, CA; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; University of Maryland School of Medicine, Baltimore, MD; University of Texas m. d. Anderson Cancer Center, Houston, TX; Atlantic Melanoma Center, Morristown, NJ; Radiology Imaging Associates, Englewood, CO; Albany Medical Center Hospital, Albany, NY; St. Luke's Hospital and Health Network, Bethlehem, PA
Background:Patients with hepatic metastases from primary melanoma have a median survival between 6 and 9 months. Few treatment strategies provide a meaningful impact on outcome. This report examines the efficacy of a minimally invasive regional therapy with melphalan in patients with hepatic metastases (MEL) from malignant melanoma.
Methods: Between February 2006 and October 2009, 93 patients (M:F; 45: 48) were accrued to a phase III trial comparing percutaneous hepatic perfusion, random-assignment (PHP-mel) (n = 44) to standard of care (BAC) (n = 49). This represents 100% of a planned 92 patient accrual. The primary endpoint was hepatic progression-free survival (H-PFS). Crossover to PHP-mel therapy was permitted at hepatic progression. Secondary endpoints included assessment of response rate (RR), duration of response (RES), and overall survival (OS) after PHP. A planned PHP treatment regimen included 4 to 6 at 28 to 35 day intervals procedures PHP. MEL (3.0 mg/kg) was delivered via the hepatic artery hepatic artery in a 30-minute infusion via a catheter placed percutaneously with hepatic venous hemofiltration using a double balloon catheter retrohepatic, (Delcath Systems, Inc.) and paired hemofiltration cartridges. Patients randomized to BAC were offered treatment considered to be the best alternative regimen by the treating physician. Staging evaluations were performed at baseline and then at 6 to 8 week intervals post baseline. All responses represent investigator-based results and were evaluated via standard RECIST criteria. Intent to treat analysis was via the Kaplan-Meier survival based method, with a 2-sided p < 0.05 defining significance.
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.
