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Ann Thorac Surg 2004;78:1919-1927
© 2004 The Society of Thoracic Surgeons

Original article: General Thoracic

Isolated Lung Perfusion With Melphalan for Resectable Lung Metastases: A Phase I Clinical Trial

Jeroen M. H. Hendriks, MD, PhDa, Marco J. J. H. Grootenboers, MDf, Franz M. N. H. Schramel, MD, PhDf, Wim J. van Boven, MDg, Bernard Stockman, MDb, Huub T. M. ter Beekg, Cornelis A. Seldenrijk, MD, PhDj, Pieter ten Broecke, MDc, Catherijne A. J. Knibbe, PharmD, PhDi, Peter Slee, MD, PhDi, Ernst De Bruijn, PharmD, PhDd, Renate Vlaeminckc, Jos Heerenh, Jan B. Vermorken, MD, PhDd, Bart van Putte, MD, PhDa, Sander Romijn, MDa, Eric Van Marck, MD, PhDe, Paul E. Y. Van Schil, MD, PhDa,*

a Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Edegem, Belgium
b Department of Cardiac Surgery, University Hospital Antwerp, Edegem, Belgium
c Department of Anesthesiology, University Hospital Antwerp, Edegem, Belgium
d Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium
e Department of Pathology, University Hospital Antwerp, Edegem, Belgium
f Department of Pulmonary Medicine, Antonius Hospital, Nieuwegein, The Netherlands
g Department of Cardiothoracic Surgery, Antonius Hospital, Nieuwegein, The Netherlands
h Department of Anesthesiology, Antonius Hospital, Nieuwegein, The Netherlands
i Department of Clinical Pharmacy, Antonius Hospital, Nieuwegein, The Netherlands
j Department of Pathology, Antonius Hospital, Nieuwegein, The Netherlands

Accepted for publication May 19, 2004.

* Address reprint requests to Dr Van Schil, Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Wilrijkstraat 10, B-2650 Edegem, Belgium
paul.van.schil{at}uza.be

Presented at the Fortieth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 26–28, 2004.

BACKGROUND: Current 5-year survival after complete resection of pulmonary metastases is 20% to 40%, and many patients develop intrathoracic recurrences. Isolated lung perfusion is an experimental technique to deliver high-dose chemotherapy to the lung without systemic exposure. A phase I trial of isolated lung perfusion with melphalan (MN) combined with pulmonary metastasectomy for resectable lung metastases was conducted to define the dose-limiting toxicity and maximum tolerated dose.

METHODS: From May 2001 to August 2003, 16 patients underwent isolated lung perfusion with MN, followed by surgical resection of lung metastases. Patients were treated with increasing MN doses (15, 30, 45, and 60 mg). For each dose level, normothermia (37°C) and hyperthermia (42°C) were evaluated (n = 3 per level). Serum samples were obtained during the procedure. Pulmonary, hematologic, and nonhematologic toxicities were recorded. The primary tumor was colorectal in 7 patients, renal in 5, sarcoma in 3, and salivary gland in 1. Isolated lung perfusion was performed unilaterally in 11 patients, and staged bilaterally in 5.

RESULTS: In total, 21 procedures of isolated lung perfusion with complete metastasectomy were performed without technical difficulties. Operative mortality was 0%, and no systemic toxicity was encountered. Grade 3 pulmonary toxicity developed at a dose of 60 mg of MN at 37°C in 2 of 3 patients at this dose, terminating the trial.

CONCLUSIONS: Isolated lung perfusion with MN combined with pulmonary metastasectomy is feasible. Dose-limiting toxicity occurred at a dose of 60 mg of MN at 37°C, and the maximum tolerated dose was set at 45 mg of MN at 42°C.




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