Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors

Yoshihiro Muragaki, Jiro Akimoto, Takashi Maruyama, Hiroshi Iseki, Soko Ikuta, Masayuki Nitta, Katsuya Maebayashi, Taiichi Saito, Yoshikazu Okada, Sadao Kaneko, Akira Matsumura, Toshihiko Kuroiwa, Katsuyuki Karasawa, Yoichi Nakazato, Takamasa Kayama

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

Object. 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/m2) 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/cm2 and a radiation energy density of 27 J/cm2. 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 progressionfree 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).

Original languageEnglish
Pages (from-to)845-852
Number of pages8
JournalJournal of Neurosurgery
Volume119
Issue number4
DOIs
Publication statusPublished - 2013 Oct
Externally publishedYes

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Semiconductor Lasers
Photochemotherapy
Brain Neoplasms
Survival
Cohort Studies
Radiation
Neoplasms
Photosensitizing Agents
Clinical Studies
Talaporfin
Residual Neoplasm
Erythema
Blister
Glioblastoma
Exanthema
Skin Tests
Intravenous Injections
Survival Rate
Clinical Trials
Safety

Keywords

  • Malignant brain tumor
  • Malignant glioma
  • Oncology
  • Outcome
  • Photodynamic therapy
  • Talaporfin sodium

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors. / Muragaki, Yoshihiro; Akimoto, Jiro; Maruyama, Takashi; Iseki, Hiroshi; Ikuta, Soko; Nitta, Masayuki; Maebayashi, Katsuya; Saito, Taiichi; Okada, Yoshikazu; Kaneko, Sadao; Matsumura, Akira; Kuroiwa, Toshihiko; Karasawa, Katsuyuki; Nakazato, Yoichi; Kayama, Takamasa.

In: Journal of Neurosurgery, Vol. 119, No. 4, 10.2013, p. 845-852.

Research output: Contribution to journalArticle

Muragaki, Y, Akimoto, J, Maruyama, T, Iseki, H, Ikuta, S, Nitta, M, Maebayashi, K, Saito, T, Okada, Y, Kaneko, S, Matsumura, A, Kuroiwa, T, Karasawa, K, Nakazato, Y & Kayama, T 2013, 'Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors', Journal of Neurosurgery, vol. 119, no. 4, pp. 845-852. https://doi.org/10.3171/2013.7.JNS13415
Muragaki, Yoshihiro ; Akimoto, Jiro ; Maruyama, Takashi ; Iseki, Hiroshi ; Ikuta, Soko ; Nitta, Masayuki ; Maebayashi, Katsuya ; Saito, Taiichi ; Okada, Yoshikazu ; Kaneko, Sadao ; Matsumura, Akira ; Kuroiwa, Toshihiko ; Karasawa, Katsuyuki ; Nakazato, Yoichi ; Kayama, Takamasa. / Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors. In: Journal of Neurosurgery. 2013 ; Vol. 119, No. 4. pp. 845-852.
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T1 - Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors

AU - Muragaki, Yoshihiro

AU - Akimoto, Jiro

AU - Maruyama, Takashi

AU - Iseki, Hiroshi

AU - Ikuta, Soko

AU - Nitta, Masayuki

AU - Maebayashi, Katsuya

AU - Saito, Taiichi

AU - Okada, Yoshikazu

AU - Kaneko, Sadao

AU - Matsumura, Akira

AU - Kuroiwa, Toshihiko

AU - Karasawa, Katsuyuki

AU - Nakazato, Yoichi

AU - Kayama, Takamasa

PY - 2013/10

Y1 - 2013/10

N2 - Object. 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/m2) 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/cm2 and a radiation energy density of 27 J/cm2. 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 progressionfree 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).

AB - Object. 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/m2) 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/cm2 and a radiation energy density of 27 J/cm2. 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 progressionfree 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).

KW - Malignant brain tumor

KW - Malignant glioma

KW - Oncology

KW - Outcome

KW - Photodynamic therapy

KW - Talaporfin sodium

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