Results of a Randomized Controlled Multicenter Phase III Trial of Percutaneous Hepatic Perfusion Compared with Best Available Care for Patients with Melanoma Liver Metastases

Hughes, Marybeth S.; Zager, Jonathan S.; Faries, Mark B.; Alexander, H. Richard; Royal, Richard E.; Wood, Bradford J.; Choi, Junsung; McCluskey, Kevin; Whitman, Eric D.; Agarwala, Sanjiv S.; Siskin, Gary P.; Nutting, Charles; Toomey, Mary Ann; Webb, Carole C.; Beresnev, Tatiana; Pingpank, James F.

doi:10.1245/s10434-015-4968-3

Cited by 127 publications

(161 citation statements)

References 24 publications

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“…During recent years, different treatment approaches have been tested in patients with metastatic UM. Responses have been reported mainly with localized treatment in patients with a limited number of metastases in the liver [2][3][4][5][6]. When diffuse liver involvement and/or extrahepatic disease have developed, systemic therapies are warranted.…”

mentioning

confidence: 99%

Anti-PD1 treatment in metastatic uveal melanoma in the Netherlands

et al. 2016

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mentioning

confidence: 99%

Anti-PD1 treatment in metastatic uveal melanoma in the Netherlands

et al. 2016

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“…Some fatalities were observed on this trial and each death lead to further safety maneuvers in the development of improved filters. [15,16] The authors concluded that the results of their phase III study demonstrate the efficacy of PHP-Mel. They report that the toxicity is significant but manageable in order to provide effective therapy for this select cohort of patients.…”

Section: Phase III Multicenter Trialmentioning

confidence: 99%

“…Hughes et al [16] published results of the phase III, multicenter randomized trial comparing PHP with melphalan (PHP-Mel) to best alternative care (BAC) for patients with cutaneous or ocular melanoma metastatic to the liver. The trial accrued 93 patients between February 2006 and July 2009.…”

Section: Phase III Multicenter Trialmentioning

confidence: 99%

“…Patients were eligible to receive up to 6 PHP procedures in the absence of progressive disease. [9] The primary endpoint reported by Hughes et al [16] includes hPFS, with secondary endpoints including xPFS (date of randomization to the first observation of extrahepatic disease progression or death due to any cause), hepatic objective response (hOR), objective response rate (ORR), overall progression-free survival (oPFS), overall survival (OS), and safety. The results of the trial include a median hPFS in PHP-Mel of 7 months compared to 1.6 months in BAC.…”

Section: Phase III Multicenter Trialmentioning

confidence: 99%

“…There was no significant difference in OS observed between the 2 groups -the median OS of 10.6 months observed in PHP-Mel vs. 10.0 months in BAC was due to the built in crossover design. [16] Hughes et al [16] described immediate peri-procedural events (within 72 h) observed in 90% of PHP-Mel treated patients to include mostly self-limited thrombocytopenia and anemia. These events were attributed to platelet sequestration in the filters and/or hemodilution.…”

Section: Phase III Multicenter Trialmentioning

confidence: 99%

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Percutaneous hepatic perfusion with melphalan for unresectable liver metastasis

Quadri¹,

Payabyab²,

Chen³

et al. 2016

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Percutaneous hepatic perfusion (PHP) is an investigative technique for treating patients with diffuse unresectable metastatic liver disease. The technique has been clinically evaluated and shows great treatment potential for regional therapy to the liver. The advantage of PHP lies in its minimally invasive approach and ability to be repeated when compared to isolated hepatic perfusion. In a literature search, 135 publications were screened and 16 of these publications, including clinical trials and reviews, contributed to this review of PHP with melphalan. Melphalan is an alkylating agent that, when used as the chemotherapeutic agent in PHP, has shown potential for significant control of tumor burden in the liver, especially in metastatic ocular melanoma. In the current landscape of liver directed therapy, PHP is a viable option for those with unresectable metastatic disease to the liver. This article will focus on the technical aspects of PHP and describe the current data available from clinical trials, including outcomes of patients treated with this minimally invasive approach.

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Cryotherapy for liver metastases

Bała

Riemsma

Wolff

et al. 2019

Cochrane Database of Systematic Reviews

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Background The liver is a ected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma. Liver metastases are significantly more common than primary liver cancer and long-term survival rates reported for patients a er radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of patients. Cryotherapy is performed with the use of an image-guided cryoprobe which delivers liquid nitrogen or argon gas to the tumour tissue. The subsequent process of freezing is associated with formation of ice crystals, which directly damage exposed tissue, including cancer cells. Objectives To assess the beneficial and harmful e ects of cryotherapy compared with no intervention, other ablation methods, or systemic treatments in people with liver metastases. Search methods We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, and six other databases up to June 2018. Selection criteria Randomised clinical trials assessing beneficial and harmful e ects of cryotherapy and its comparators for liver metastases, irrespective of the location of the primary tumour. Data collection and analysis We used standard methodological procedures expected by Cochrane. We extracted information on participant characteristics, interventions, study outcomes, and data on the outcomes important for our review, as well as information on the design and methodology of the trials. Two review authors independently assessed risk of bias in each study. One review author performed data extraction and a second review author checked entries.

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Results of a Randomized Controlled Multicenter Phase III Trial of Percutaneous Hepatic Perfusion Compared with Best Available Care for Patients with Melanoma Liver Metastases

Abstract: This randomized, phase III study demonstrated the efficacy of the PHP-Mel procedure. hPFS, oPFS, and hOR were significantly improved with PHP-Mel. PHP with melphalan should provide a new treatment option for unresectable metastatic melanoma in the liver.

Cited by 127 publications

References 24 publications

Anti-PD1 treatment in metastatic uveal melanoma in the Netherlands

Anti-PD1 treatment in metastatic uveal melanoma in the Netherlands

Percutaneous hepatic perfusion with melphalan for unresectable liver metastasis

Cryotherapy for liver metastases

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