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Ann Thorac Surg 2007;83:1235-1236
© 2007 The Society of Thoracic Surgeons

Correspondence

Re-Evaluation of Toxicity and Long-Term Follow-Up of Isolated Lung Perfusion With Melphalan in Patients With Resectable Pulmonary Metastases: A Phase I and Extension Trial

Marco J.J.H. Grootenboers, MDa, Franz M.N.H. Schramel, MD, PhDa, Wim J. van Boven, MDb, Bart P. van Putte, MD, PhDb, Jeroen M.H. Hendriks, MD, PhDc, Paul E.Y. Van Schil, MD, PhDc

a Department of Pulmonary Medicine, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, 3430 EM the Netherlands
b Department of Cardiothoracic Surgery, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, 3430 EM the Netherlands
c Department of Thoracic and Vascular Surgery, University Hospital Antwerp, Wilrijkstraat 10, Edegem (Antwerp), B-2650 Belgium

(Email: m.grootenboers{at}antonius.net; paul.van.schil{at}uza.Be).

To the Editor:

Isolated lung perfusion (ILuP) is an experimental surgical technique to deliver high-dose chemotherapy without systemic exposure. Previously, we reported ILuP with melphalan combined with pulmonary metastasectomy for patients with resectable pulmonary metastases to be a feasible procedure with a maximum tolerated dose (MTD) of 45 mg at 42°C [1]. In this letter, we would like to describe toxicity and clinical follow-up of the patients of this previously described phase I trial with the addition of patients included in an extension trial.

In the initial phase I trial with ILuP with escalating doses of melphalan under normothermic and hyperthermic conditions followed by surgical resection of pulmonary metastases, 21 procedures were performed in 16 patients until dose-limiting toxicity was met without technical difficulties or operative mortality. We reported only minor clinical toxicity in the procedures of the phase I trial besides the 2 patients with chemical pneumonitis occurring after perfusion with 60 mg of melphalan at 37°C. An extension trial was conducted to expand the data on toxicity and clinical follow-up. Eight additional ILuP procedures were performed in 7 patients with either 15 or 45 mg of melphalan at 42°C, followed by pulmonary metastasectomy. In contrast to the findings of the phase I trial, 3 of 8 procedures under hyperthermic conditions in the extension trial were complicated by empyema, rhabdomyolysis, and postoperative bleeding, respectively. These patients recovered from their complications, but hospitalization periods were prolonged. In total, 29 procedures in 23 patients included in the clinical trials were performed without technical difficulties. With a mean follow-up of 25 months, 8 out of 23 patients are alive and disease-free and 14 patients developed recurrent disease, of which 3 patients died. One disease-free patient died of a nonmalignancy-related disease.

We conclude that significant pulmonary and systemic morbidity was encountered in the extension trial under hyperthermic conditions. In contrast with our previous report, MTD of melphalan in isolated lung perfusion should be 45 mg under normothermic and not hyperthermic conditions. Further studies in ILuP with melphalan are needed to evaluate pulmonary toxicity and long-term efficacy.


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  1. Hendriks JM, Grootenboers MJ, Schramel FM, et al. Isolated lung perfusion with melphalan for resectable lung metastases: a phase I clinical trial Ann Thorac Surg 2004;78:1919-1927.[Abstract/Free Full Text]



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 Eur. J. Cardiothorac. Surg.Home page
P. E. Van Schil, J. M. Hendriks, B. P. van Putte, B. A. Stockman, P. R. Lauwers, P. W. ten Broecke, M. J. Grootenboers, and F. M. Schramel
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[Abstract] [Full Text] [PDF]

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