title: Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors.
abstract: OBJECTIVE
  The objective of the present study was to perform a prospective evaluation of the potential efficacy and safety of intraoperative photodynamic therapy (PDT) using talaporfin sodium and irradiation using a 664-nm semiconductor laser in patients with primary malignant parenchymal brain tumors.
  
  
  METHODS
  In 27 patients with suspected newly diagnosed or recurrent primary malignant parenchymal brain tumors, a single intravenous injection of talaporfin sodium (40 mg/m(2)) was administered 1 day before resection of the neoplasm. The next day after completion of the tumor removal, the residual lesion and/or resection cavity were irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm(2) and a radiation energy density of 27 J/cm(2). The procedure was performed 22-27 hours after drug administration. The study cohort included 22 patients with a histopathologically confirmed diagnosis of primary malignant parenchymal brain tumor. Thirteen of these neoplasms (59.1%) were newly diagnosed glioblastomas multiforme (GBM).
  
  
  RESULTS
  Among all 22 patients included in the study cohort, the 12-month overall survival (OS), 6-month progression-free survival (PFS), and 6-month local PFS rates after surgery and PDT were 95.5%, 91%, and 91%, respectively. Among patients with newly diagnosed GBMs, all these parameters were 100%. Side effects on the skin, which could be attributable to the administration of talaporfin sodium, were noted in 7.4% of patients and included rash (2 cases), blister (1 case), and erythema (1 case). Skin photosensitivity test results were relatively mild and fully disappeared within 15 days after administration of photosensitizer in all patients.
  
  
  CONCLUSIONS
  Intraoperative PDT using talaporfin sodium and a semiconductor laser may be considered as a potentially effective and sufficiently safe option for adjuvant management of primary malignant parenchymal brain tumors. The inclusion of intraoperative PDT in a combined treatment strategy may have a positive impact on OS and local tumor control, particularly in patients with newly diagnosed GBMs. Clinical trial registration no.: JMA-IIA00026 (https://dbcentre3.jmacct.med.or.jp/jmactr/App/JMACTRS06/JMACTRS06.aspx?seqno=862).
authors: Faculty of Advanced Techno-Surgery, Institute of Advanced Biomedical Engineering and Science, and.
authors: Yoshihiro
authors: Y
authors: Muragaki
authors: Jiro
authors: J
authors: Akimoto
authors: Takashi
authors: T
authors: Maruyama
authors: Hiroshi
authors: H
authors: Iseki
authors: Soko
authors: S
authors: Ikuta
authors: Masayuki
authors: M
authors: Nitta
authors: Katsuya
authors: K
authors: Maebayashi
authors: Taiichi
authors: T
authors: Saito
authors: Yoshikazu
authors: Y
authors: Okada
authors: Sadao
authors: S
authors: Kaneko
authors: Akira
authors: A
authors: Matsumura
authors: Toshihiko
authors: T
authors: Kuroiwa
authors: Katsuyuki
authors: K
authors: Karasawa
authors: Yoichi
authors: Y
authors: Nakazato
authors: Takamasa
authors: T
authors: Kayama
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D005910:Glioma / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D006801:Humans; D053685:Laser Therapy; D054023:Lasers, Semiconductor; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017319:Photosensitizing Agents; D011166:Porphyrins; C053434:Talaporfin