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

2013 ◽  
Vol 119 (4) ◽  
pp. 845-852 ◽  
Author(s):  
Yoshihiro Muragaki ◽  
Jiro Akimoto ◽  
Takashi Maruyama ◽  
Hiroshi Iseki ◽  
Soko Ikuta ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Brain Tumors ◽  
Semiconductor Laser ◽  
Positive Impact ◽  
Radiation Power ◽  
Combined Treatment ◽  
Tumor Control ◽  
Study Cohort ◽  
Newly Diagnosed ◽  
Talaporfin Sodium

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 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).

scholarly journals Role of photodynamic therapy using talaporfin sodium and a semiconductor laser in patients with newly diagnosed glioblastoma

2019 ◽  
Vol 131 (5) ◽  
pp. 1361-1368 ◽  
Author(s):  
Masayuki Nitta ◽  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Hiroshi Iseki ◽  
Takashi Komori ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Prognostic Factors ◽  
Local Recurrence ◽  
Semiconductor Laser ◽  
Tumor Recurrence ◽  
Multivariate Analyses ◽  
Control Group ◽  
Newly Diagnosed ◽  
Talaporfin Sodium ◽  
Newly Diagnosed Glioblastoma

OBJECTIVEIn this study on the effectiveness and safety of photodynamic therapy (PDT) using talaporfin sodium and a semiconductor laser, the long-term follow-up results of 11 patients with glioblastoma enrolled in the authors’ previous phase II clinical trial (March 2009–2012) and the clinical results of 19 consecutive patients with newly diagnosed glioblastoma prospectively enrolled in a postmarket surveillance (March 2014–December 2016) were analyzed and compared with those of 164 patients treated without PDT during the same period.METHODSThe main outcome measures were the median overall survival (OS) and progression-free survival (PFS) times. Moreover, the adverse events and radiological changes after PDT, as well as the patterns of recurrence, were analyzed and compared between the groups. Kaplan-Meier curves were created to assess the differences in OS and PFS between the groups. Univariate and multivariate analyses were performed to identify the prognostic factors, including PDT, among patients with newly diagnosed glioblastoma.RESULTSThe median PFS times of the PDT and control groups were 19.6 and 9.0 months, with 6-month PFS rates of 86.3% and 64.9%, respectively (p = 0.016). The median OS times were 27.4 and 22.1 months, with 1-year OS rates of 95.7% and 72.5%, respectively (p = 0.0327). Multivariate analyses found PDT, preoperative Karnofsky Performance Scale score, and IDH mutation to be significant independent prognostic factors for both OS and PFS. Eighteen of 30 patients in the PDT group experienced tumor recurrence, including local recurrence, distant recurrence, and dissemination in 10, 3, and 4 patients, respectively. Conversely, 141 of 164 patients in the control group experienced tumor recurrence, including 101 cases of local recurrence. The rate of local recurrence tended to be lower in the PDT group (p = 0.06).CONCLUSIONSThe results of the present study suggest that PDT with talaporfin sodium and a semiconductor laser provides excellent local control, with few adverse effects even in cases of multiple laser irradiations, as well as potential survival benefits for patients with newly diagnosed glioblastoma.

scholarly journals ACTR-90. ROLE OF PHOTODYNAMIC THERAPY (PDT) USING TALAPORFIN SODIUM AND SEMICONDUCTOR LASER ON PROGNOSIS OF PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi20-vi20
Author(s):  
Masayuki Nitta ◽  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Soko Ikuta ◽  
Hiroshi Iseki ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Semiconductor Laser ◽  
Newly Diagnosed ◽  
Talaporfin Sodium ◽  
Newly Diagnosed Glioblastoma

scholarly journals ACTR-39. PHOTODYNAMIC THERAPY USING TALAPORFIN SODIUM AND SEMICONDUCTOR LASER COMBINED WITH MAXIMUM TUMOR RESECTION IMPROVES PROGNOSIS OF PATIENTS WITH GLIOBLASTOMA

2016 ◽  
Vol 18 (suppl_6) ◽  
pp. vi10-vi10
Author(s):  
Masayuki Nitta ◽  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Soko Ikuta ◽  
Hiroshi Iseki ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Semiconductor Laser ◽  
Tumor Resection ◽  
Talaporfin Sodium

scholarly journals STMO-17 Treatment outcome of photodynamic therapy using talaporfin sodium for recurrent high-grade glioma

2021 ◽  
Vol 3 (Supplement_6) ◽  
pp. vi14-vi14
Author(s):  
Makoto Ohno ◽  
Daisuke Kawauchi ◽  
Yoshiharu Hayashi ◽  
Kaishi Satomi ◽  
Yasuji Miyakita ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Treatment Outcome ◽  
Treatment Outcomes ◽  
High Grade Glioma ◽  
Local Tumor Control ◽  
Tumor Control ◽  
High Grade ◽  
Local Tumor ◽  
Limit Of Quantification ◽  
Talaporfin Sodium

Abstract Objective: Photodynamic therapy (PDT) using Talaporfin Sodium (TS) is a novel therapeutic strategy to improve local tumor control in high-grade glioma. TS is a photosensitizer that accumulates in tumor cells and produces highly toxic free radicals by intraoperative irradiation of laser with a 664nm wavelength. However, little is known about the treatment outcomes of PDT in recurrent high-grade gliomas (rHGG). In this study, we investigated the treatment outcome of PDT in rHGG and evaluated the correlation between intratumoral TS accumulation and outcomes. Methods: We included 21 patients with rHGG and 22 tumors, who were treated by PDT between June 2016 and March 2021. TS was transvenously administered 22–26 hours before PDT. Intratumoral TS concentrations were measured by liquid chromatography using frozen tissue. Results: The rHGGs included 10 glioblastoma, IDH1/2-wildtype (GBM, IDH1/2-WT: 45.5%), 3 GBM, IDH1/2-mutant (GBM, IDH1/2-Mut: 13.6%), 7 anaplastic oligodendroglioma, IDH1/2-Mut/codel (AO, IDH1/2-Mut/codel: 31.8%), 1 anaplastic astrocytoma, IDH1/2-WT (AA, IDH1/2-WT: 4.5%), 1 high-grade astrocytoma, IDH1/2-WT (4.5%). The median local progression free survival (PFS) time after PDT was 3.6 months and the median survival time from PDT was 19.4 months. The intratumoral TS concentrations of 7 tumors (TS(-): 31.8%) were below the limit of quantification, and the intratumoral TS concentrations of the remaining 15 tumors (TS(+)) were 43.5 ng/mg-protein (14.7–132 ng/mg-protein). The intratumoral TS concentrations were not significantly associated with IDH1/2 mutation status, cellularity, tumor grade, and pattern of enhancement. The median PFS from PDT tended to be longer in TS(+) than in TS(-) (TS(+): 6.3 vs TS(-): 1.4 months, p = 0.054). Conclusions: We found that the intratumoral TS concentrations were heterogeneous and 31.8% were below the limit of quantification. TS(+) tended to have better local tumor control than TS(-), suggesting the intratumoral TS accumulation have an impact of treatment outcomes of PDT.

scholarly journals Photodynamic Therapy (PDT) With a New Photosensitizer (Talaporfin Sodium) and a Semiconductor Laser in the Esophagus: A Preclinical Study

2011 ◽  
Vol 140 (5) ◽  
pp. S-669
Author(s):  
Takahiro Horimatsu ◽  
Manabu Muto ◽  
Yusuke Yoda ◽  
Yasumasa Ezoe ◽  
Tomonori Yano ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Semiconductor Laser ◽  
Preclinical Study ◽  
Talaporfin Sodium

COMBINED TREATMENT FOR KLATSKIN NON-RESECTABLE TUMOR USING INTRA-FLOW PHOTODYNAMIC THERAPY AND REGIONAL CHEMOTHERAPY

2018 ◽  
Vol 64 (4) ◽  
pp. 485-489
Author(s):  
Vladimir Polysalov ◽  
Dmitriy Granov ◽  
A. Gapbarov ◽  
A. Polekhin
Keyword(s):  
Photodynamic Therapy ◽  
Survival Rate ◽  
Radiation Power ◽  
Combined Treatment ◽  
Celiac Trunk ◽  
Regional Chemotherapy ◽  
Response To Treatment ◽  
Dose Fractionation ◽  
Klatskin Tumor ◽  
Average Life Span

The experience of treatment of 28 patients with Klatskin tumor is summarized. Bile ducts tumor of stages III-IV was diagnosed in 25 patients. A total of 97 sessions of intra-flow photodynamic therapy and 74 courses of regional chemotherapy were conducted. One patient due to a full response to treatment there was performed orthotopic liver transplantation from a cadaver donor. In all observations the diagnosis was confirmed morphologically by means of intraflow biopsy or after investigation of the removed specimen. All patients at the time of the beginning of treatment underwent percutaneous cholangiodrainage. Intra-flow photodynamic therapy was performed in the dose-fractionation mode by the “LAKHTA-MILON” diode laser device using quartz optic fiber systems and a catheter with a cylindrical diffuser at a radiation power at the fiber output of one watt. The density of the supplied energy was 200 J/cm2. Radachlorin or Photon preparations were used as photosensitizers. Subsequently, in 2-4 days, visceral angiography of the hepatopancreatoduodenal zone with the arterial catheter inserted into the celiac trunk or the common hepatic artery to carry out regional chemotherapy by GemOx mode was performed. 21 (71,4%) patients died at the time from 8 to 42 months. 7 (28.6%) patients who undergo repeated courses of combined treatment at intervals of 1,5 to 3 months are alive and under observation from 10 to 26 months. The median survival is 21 months, the average life span is 15,4 + 0,8 months. A one-year survival rate is 78%, a two-year survival rate - 18%, a three-year survival rate - 4%. Survival of patients (according to Kaplan-Meier) is 18 months.

LOCAL HYPERTHERMIA IN TREATMENT FOR MALIGNANT BRAIN TUMORS

2018 ◽  
Vol 64 (1) ◽  
pp. 54-61
Author(s):  
A. Ryabova ◽  
O. Gribova ◽  
V. Novikov ◽  
E. Choinzonov ◽  
Zh. Starceva ◽  
...  
Keyword(s):  
Experimental Data ◽  
Radiation Therapy ◽  
Brain Tumors ◽  
Tumor Cells ◽  
Combined Treatment ◽  
Complex Treatment ◽  
Local Hyperthermia ◽  
Malignant Brain Tumors ◽  
Sensitizing Effect ◽  
Methods Of Treatment

Unsatisfactory results of complex treatment for malignant brain tumors stimulate search of new effective methods of treatment. Radiation therapy is an integral part of the combined treatment but often does not influence lethally on resistant tumor cells. Thereby in recent decades there has been an active search for different modifiers, which can increase the sensitivity of tumors to chemotherapy and radiotherapy. One of the universal sensitizers is the local hyperthermia. Experimental data showed that the effect of high temperatures had both a direct damaging effect on tumor cells and a sensitizing effect. The literature review given in the article provides an overview of the existing methods of the local hyperthermia for brain tumors treatment.

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