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Percutaneous hepatic perfusion with melphalan improved hepatic PFS in ocular, cutaneous melanoma
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ASCO 2010 Annual Meeting
CHICAGO — Patients with ocular or cutaneous melanoma with hepatic metastases had significantly improved hepatic PFS when they were treated with percutaneous hepatic perfusion with melphalan vs. best available care, according to phase-3 results presented here.
“Increased drug delivery achieved through novel regional therapeutic approaches may increase efficacy of a given agent by overcoming a low therapeutic index,” said James Pingpank Jr, FACS, associate professor of surgery, University of Pittsburgh. Pinghank presented the late-breaking study results at the 2010 ASCO Annual Meeting.
In the phase-3 trial, 93 patients were randomly assigned to percutaneous hepatic perfusion (PHP) with melphalan 3.0 mg/kg (n=44) or best available care at the treating institution (n=49). Twenty-seven patients assigned best available care were permitted to crossover to PHP at hepatic progression. The primary endpoint was hepatic PFS. The expected hepatic PFS was 7.73 months vs. 4 months with best available care.
All patients underwent scanning at baseline, 6 weeks, 12 weeks and then every 2 months. Although a majority of patients had ocular melanoma, there was no difference in survival in patients with ocular vs. cutaneous melanoma, Pingpank said.
Patients who underwent PHP with melphalan had improved hepatic PFS and overall PFS compared with patients assigned best available care. The median hepatic PFS was 49 days for best care vs. 245 days for PHP (P<.0001). Median overall PFS was 46 days for best care vs. 186 days in the PHP group (P<.001).
Due to a high crossover rate, no difference in OS was obtained, according to Pingpank. When examining outcomes in patients who did crossover (n=27), the researchers found a median survival of 398 days vs. 124 days in patients who did not crossover (n=22).
Overall response rate, a secondary endpoint, was 34.1% in patients who underwent PHP vs. 2% in best care patients.
No patients progressed while on PHP with melphalan, Pingpank said. There was a 7.5% mortality rate among patients in the PHP arm. – by Leah Lawrence
Ninety percent of patients in this study have ocular melanoma. A majority of ocular melanoma patients have hepatic metastases. At the onset of metastases, the standard of care is chemoembolization to control hepatic disease, not systemic therapy as it is with cutaneous melanoma. This local therapy is safe and effective, and has been used for more than two decades. However, a majority of ocular melanoma patients will die of extrahepatic metastases in the brain, lung and bone, because there is no effective systemic therapy. Molecular analysis now shows us that there are different pathway mutations when compared with cutaneous melanoma. The control arm of this study should be local therapy such as chemoembolization instead of systemic therapy, such as DTIC, which does not provide local or systemic disease control. Thus, it is not surprising to have the results showing improved local disease control with hepatic perfusion, but no difference in OS.
This treatment is administered in the operating room for several hours each time, it is very costly and has 10% mortality and mobility. It would be much safer, and less expensive, to use chemoembolization. Most recently, radiofrequency ablation has also been combined with chemoembolization, which increases local disease control.
– Wen Jen Hwu, MD
HemOnc Today Editorial Board member
For more information:
- Pingpank JF. #LBA8512. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.
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