Chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma.


Journal

Melanoma research
ISSN: 1473-5636
Titre abrégé: Melanoma Res
Pays: England
ID NLM: 9109623

Informations de publication

Date de publication:
01 04 2022
Historique:
entrez: 7 3 2022
pubmed: 8 3 2022
medline: 22 4 2022
Statut: ppublish

Résumé

Uveal melanoma, the most common primary ocular malignancy in adults, carries a poor prognosis: 50% of patients develop the metastatic disease with a 10-25% 1-year survival and no established standard of care treatment. Prior studies of melphalan percutaneous hepatic perfusion (M-PHP) have shown promise in metastatic uveal melanoma (mUM) patients with liver predominant disease but are limited by small sample sizes. We contribute our findings on the safety and efficacy of the procedure in the largest sample population to date. A retrospective analysis of outcome and safety data for all mUM patients receiving M-PHP was performed. Tumour response and treatment toxicity were evaluated using RECIST 1.1 and Common Terminology Criteria for Adverse Events v5.03, respectively. 250 M-PHP procedures were performed in 81 patients (median of three per patient). The analysis demonstrated a hepatic disease control rate of 88.9% (72/81), a hepatic response rate of 66.7% (54/81), and an overall response rate of 60.5% (49/81). After a median follow-up of 12.9 months, median overall progression-free (PFS) and median overall survival (OS) were 8.4 and 14.9 months, respectively. There were no fatal treatment-related adverse events (TRAE). Forty-three grade 3 (29) or 4 (14) TRAE occurred in 23 (27.7%) patients with a significant reduction in such events between procedures performed in 2016-2020 vs. 2012-2016 (0.17 vs. 0.90 per patient, P < 0.001). M-PHP provides excellent response rates and PFS compared with other available treatments, with decreasing side effect profile with experience. Combination therapy with systemic agents may be viable to further advance OS.

Identifiants

pubmed: 35254333
doi: 10.1097/CMR.0000000000000806
pii: 00008390-202204000-00005
pmc: PMC8893121
doi:

Substances chimiques

Antineoplastic Agents, Alkylating 0
Melphalan Q41OR9510P

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103-111

Informations de copyright

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Références

Vidwans SJ, Flaherty KT, Fisher DE, Tenenbaum JM, Travers MD, Shrager J. A melanoma molecular disease model. PLoS One 2011; 6:e18257.
Amaro A, Gangemi R, Piaggio F, Angelini G, Barisione G, Ferrini S, Pfeffer U. The biology of uveal melanoma. Cancer Metastasis Rev 2017; 36:109–140.
Karlsson J, Nilsson LM, Mitra S, Alsén S, Shelke GV, Sah VR, et al. Molecular profiling of driver events in metastatic uveal melanoma. Nat Commun 2020; 11:1894.
Field MG, Durante MA, Anbunathan H, Cai LZ, Decatur CL, Bowcock AM, et al. Punctuated evolution of canonical genomic aberrations in uveal melanoma. Nat Commun 2018; 9:116.
Singh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology 2011; 118:1881–1885.
Diener-West M, Reynolds SM, Agugliaro DJ, Caldwell R, Cumming K, Earle JD, et al. Collaborative Ocular Melanoma Study Group, development of metastatic disease after enrollment in the COMS trials for treatment of choroidal melanoma: Collaborative Ocular Melanoma Study Group Report No. 26. Arch Ophthalmol 2005; 123:1639–1643.
Kujala E, Mäkitie T, Kivelä T. Very long-term prognosis of patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci 2003; 44:4651–4659.
Gragoudas ES, Egan KM, Seddon JM, Glynn RJ, Walsh SM, Finn SM, et al. Survival of patients with metastases from uveal melanoma. Ophthalmology 1991; 98:383–389.
Karydis I, Chan PY, Wheater M, Arriola E, Szlosarek PW, Ottensmeier CH. Clinical activity and safety of pembrolizumab in ipilimumab pre-treated patients with uveal melanoma. Oncoimmunology 2016; 5:e1143997.
Sacco JJ, Carvajal R, Butler MO, Shoushtari AN, Hassel JC, Ikeguchi A, et al. A phase II, multi-center study of the safety and efficacy of tebentafusp (IMCgp100) in patients with metastatic uveal melanoma. Ann Oncol 2020; 31(Suppl 7):S1442–S1443.
Pingpank JF, Libutti SK, Chang R, Wood BJ, Neeman Z, Kam AW, et al. Phase I study of hepatic arterial melphalan infusion and hepatic venous hemofiltration using percutaneously placed catheters in patients with unresectable hepatic malignancies. J Clin Oncol 2005; 23:3465–3474.
Hughes MS, Zager J, Faries M, Alexander HR, Royal RE, Wood B, et al. Results of a randomized controlled multicenter phase III trial of percutaneous hepatic perfusion compared with best available care for patients with melanoma liver metastases. Ann Surg Oncol 2016; 23:1309–1319.
Meijer TS, Burgmans MC, Fiocco M, de Geus-Oei LF, Kapiteijn E, de Leede EM, et al. Safety of percutaneous hepatic perfusion with melphalan in patients with unresectable liver metastases from ocular melanoma using the Delcath systems’ second-generation hemofiltration system: a prospective non-randomized phase II trial. Cardiovasc Intervent Radiol 2019; 42:841–852.
Rantala ES, Hernberg MK, Tero T. Overall survival after treatment for metastatic uveal melanoma: a systematic review and meta-analysis. Melanoma Res 2019; 29:561–568.
Khoja L, Atenafu EG, Suciu S, Leyvraz S, Sato T, Marshall E, et al. Meta-analysis in metastatic uveal melanoma to determine progression-free and overall survival benchmarks: an International Rare Cancers Initiative (IRCI) ocular melanoma study. Ann Oncol 2019; 30:1370–1380.
Rodriguez-Vidal C, Fernandez-Diaz D, Fernandez-Marta B, Lago-Baameiro N, Pardo M, Silva P, et al. Treatment of metastatic uveal melanoma: systematic review. Cancers (Basel) 2020; 12:2557.
Rowcroft A, Loveday BPT, Thomson BNJ, Banting S, Knowles B. Systematic review of liver directed therapy for uveal melanoma hepatic metastases. HPB (Oxford) 2020; 22:497–505.
Artzner C, Mossakowski O, Hefferman G, Grosse U, Hoffmann R, Forschner A, et al. Chemosaturation with percutaneous hepatic perfusion of melphalan for liver-dominant metastatic uveal melanoma: a single center experience. Cancer Imaging 2019; 19:31.
Vogl TJ, Koch SA, Lotz G, Gebauer B, Willinek W, Engelke C, et al. Percutaneous isolated hepatic perfusion as a treatment for isolated hepatic metastases of uveal melanoma: patient outcome and safety in a multi-centre study. Cardiovasc Intervent Radiol 2017; 31:31.
Schönfeld L, Hinrichs JB, Marquardt S, Voigtländer T, Dewald C, Koppert W, et al. Chemosaturation with percutaneous hepatic perfusion is effective in patients with ocular melanoma and cholangiocarcinoma. J Cancer Res Clin Oncol 2020; 146:3003–3012.
Meijer TS, Burgmans MC, de Leede EM, de Geus-Oei LF, Boekestijn B, Handgraaf HJM, et al. Percutaneous hepatic perfusion with melphalan in patients with unresectable ocular melanoma metastases confined to the liver: a prospective phase II study. Ann Surg Oncol 2021; 28:1130–1141.
Karydis I, Gangi A, Wheater MJ, Choi J, Wilson I, Thomas K, et al. Percutaneous hepatic perfusion with melphalan in uveal melanoma: a safe and effective treatment modality in an orphan disease. J Surg Oncol 2018; 117:1170–1178.
Daud A, Kluger HM, Kurzrock R, Schimmoller F, Weitzman AL, Samuel TA, et al. Phase II randomised discontinuation trial of the MET/VEGF receptor inhibitor cabozantinib in metastatic melanoma. Br J Cancer 2017; 116:432–440.
Maio M, Danielli R, Chiarion-Sileni V, Pigozzo J, Parmiani G, Ridolfi R, et al. Efficacy and safety of ipilimumab in patients with pre-treated, uveal melanoma. Ann Oncol 2013; 24:2911–2915.
Piulats JM, Espinosa E, de la Cruz Merino L, Varela M, Alonso Carrión L, Martín-Algarra S, et al. Nivolumab plus ipilimumab for treatment-naïve metastatic uveal melanoma: an open-label, multicenter, phase II trial by the Spanish multidisciplinary melanoma group (GEM-1402). J Clin Oncol 2021; 39:586–598.
Carvajal RD, Sosman JA, Quevedo JF, Milhem MM, Joshua AM, Kudchadkar RR, et al. Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma: a randomized clinical trial. JAMA 2014; 311:2397–2405.
Shoushtari AN, Kudchadkar RR, Panageas K, Murthy RK, Jung M, Shah R, et al. A randomized phase 2 study of trametinib with or without GSK2141795 in patients with advanced uveal melanoma. J Clin Oncol 2016; 34(Suppl 15):9511.
Robertson AG, Shih J, Yau C, Gibb EA, Oba J, Mungall KL, et al.; TCGA Research Network. Integrative analysis identifies four molecular and clinical subsets in uveal melanoma. Cancer Cell 2017; 32:204–220.e15.
Olofsson R, Ny L, Eilard MS, Rizell M, Cahlin C, Stierner U, et al. Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial. Trials 2014; 15:317.
Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (FOCUS); NCT02678572; Multi-centre, single-arm, open-label study; US and Europe. https://clinicaltrials.gov/ct2/show/NCT02678572
Gajek A, Poczta A, Łukawska M, Cecuda-Adamczewska V, Tobiasz J, Marczak A. Chemical modification of melphalan as a key to improving treatment of haematological malignancies. Sci Rep 2020; 10:4479.

Auteurs

Sachin Modi (S)

Department of Interventional Radiology, University Hospital Southampton NHS Foundation Trust.

Tom Gibson (T)

Department of Interventional Radiology, University Hospital Southampton NHS Foundation Trust.

Ganesh Vigneswaran (G)

Department of Interventional Radiology, University Hospital Southampton NHS Foundation Trust.
University of Southampton.

Shian Patel (S)

Department of Interventional Radiology, University Hospital Southampton NHS Foundation Trust.

Matthew Wheater (M)

Department of Medical Oncology, University Hospital Southampton NHS Foundation Trust.

Ioannis Karydis (I)

University of Southampton.
Department of Medical Oncology, University Hospital Southampton NHS Foundation Trust.

Sanjay Gupta (S)

Department of Anaesthesia, University Hospital Southampton NHS Foundation Trust.

Arjun Takhar (A)

Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton.

Neil Pearce (N)

Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton.

Christian Ottensmeier (C)

Institute of Systems, Molecular and Integrative Biology (ISMIB), University of Liverpool, Liverpool, UK.

Brian Stedman (B)

Department of Interventional Radiology, University Hospital Southampton NHS Foundation Trust.

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