title: Phase I trial of an infrared pulsed laser device in patients with advanced neoplasias.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Seventeen patients (n = 17) received a daily IPLD radiant exposure of 4.5 x 10(5) J/m(2) (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 > or =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 > or =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.
authors.affiliation: Fundalas, Foundation for Interdisciplinary Research and Development, Caracas, 1020, Venezuela.
authors.forename: Luis A
authors.initials: LA
authors.lastname: Santana-Blank
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Rodríguez-Santana
authors.forename: Fernando
authors.initials: F
authors.lastname: Vargas
authors.forename: Heberto
authors.initials: H
authors.lastname: Reyes
authors.forename: Pablo
authors.initials: P
authors.lastname: Fernández-Andrade
authors.forename: Saide
authors.initials: S
authors.lastname: Rukos
authors.forename: Karin E
authors.initials: KE
authors.lastname: Santana-Rodríguez
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007259:Infrared Rays; D017567:Karnofsky Performance Status; D053685:Laser Therapy; D007834:Lasers / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D013997:Time Factors; D016896:Treatment Outcome