Background: The aims of the study were: (1) to determine toxicity, response rate, local-regional control, and survival in the entire population of the perfused patients; (2) to compare toxicity, response, and survival among patients who underwent melphalan-based perfusion with or without low-dose tumor necrosis factor (TNF); and (3) to identify factors that predict a complete response and survival. Materials and Methods: A total of 53 patients with extensive in-transit metastases (47%) underwent perfusion with melphalan, and 59 (53%) also received low-dose TNF. Results: No difference was observed between the 2 drug regimens for what concerns local toxicity (P = 1.0). The tumor complete response rate was higher in patients treated with TNF (60.3% versus 41.5%, P = .036), in particular in the case of locally advanced tumors (66.7% versus 30%, P = .049). The presence of lymph node metastases had a negative influence on the tumor response rate (P = .003). Median time to local progression and survival were 19.6 and 34.5 months, respectively. Long-term complete response was achieved in 68% of the patients with initial CR (39 of 57 patients). The tumor response after perfusion was the only prognostic factor for local control and survival (P <.0001 and P = .002, respectively). Conclusions: In the case of locally advanced disease, the addition of low-dose TNF to melphalan-based isolated limb perfusion appears safe and particularly useful. The presence of lymph node metastases is associated with decreased response rates. A sustained complete response was obtained in about one-third of the patients.
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