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Phase I Trial of an Infrared Pulsed Laser Device in Patients with Advanced Neoplasias¹

Fundalas, Foundation for Interdisciplinary Research and Development, Caracas, 1020, Venezuela

Purpose: The objective of this study was to evaluate the toxicity/radiant exposure/time relationship of an infrared pulsed laser device (IPLD) treatment in patients with advanced neoplasias. Karnofsky performance status (KPS), Spitzer quality of life index (QLI), and potential antitumor activity, if any, were also assessed.

Experimental Design: Seventeen patients (n = 17) received a daily IPLD radiant exposure of 4.5 x 10⁵ J/m² (904 nm pulsed at 3 MHz) under a one-dose schedule and procedure design. Toxicity was evaluated under the parameters of the WHO; indirect toxic ocular effects were also monitored. KPS and QLI measurements were conducted before treatment and at six 3-months intervals. Scores for the seventh interval are the last available (range, 19–39 months). For statistical purposes, patients were classified into group 1, those alive at the end of the study, and group 2, those who had died.

Results: Dose-limiting toxicity was not observed. Five patients (n = 5) reported occasional headaches (grade 2), and four (n = 4) referred local pain (grade 2). In group 1 (n = 7), statistically significant increases in KPS and QLI were observed in all of the follow-up intervals compared with pretreatment values. One patient had a complete response, 1 a partial response, 4 stable diseases 12 months, and 1 progressive disease. In group 2 (n = 10), statistically significant increases in QLI were observed during the first two intervals. Eight patients had stable disease 6 months and 2 had uninterrupted progressive diseases.

Conclusions: The IPLD treatment studied is safe for clinical use and may have potential effects on KPS, QLI, and antitumor activity in patients with advanced neoplasias.