Evaluation of photodynamic therapy with talaporfin sodium on relapse controlling efficacy at laser irradiation sites in 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.

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

Neuro-Oncology ◽

10.1093/neuonc/nox168.075 ◽

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

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

Journal of Neurosurgery ◽

10.3171/2013.7.jns13415 ◽

2013 ◽

Vol 119 (4) ◽

pp. 845-852 ◽

Cited By ~ 102

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).

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Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial

Journal of Neuro-Oncology ◽

10.1007/s11060-021-03718-6 ◽

2021 ◽

Author(s):

Maximilien Vermandel ◽

Clément Dupont ◽

Fabienne Lecomte ◽

Henri-Arthur Leroy ◽

Constantin Tuleasca ◽

...

Keyword(s):

Clinical Trial ◽

Photodynamic Therapy ◽

Preliminary Analysis ◽

Newly Diagnosed ◽

Newly Diagnosed Glioblastoma

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PS02.034: EFFICACY AND SAFETY OF SALVAGE PHOTODYNAMIC THERAPY USING TALAPORFIN SODIUM FOR LOCAL FAILURE AFTER CHEMORADIOTHERAPY IN PATIENTS WITH ESOPHAGEAL CANCER

Diseases of the Esophagus ◽

10.1093/dote/doy089.ps02.034 ◽

2018 ◽

Vol 31 (Supplement_1) ◽

pp. 129-129

Author(s):

Yusuke Amanuma ◽

Shinya Ohashi ◽

Masashi Tamaoki ◽

Takahiro Horimatsu ◽

Manabu Muto

Keyword(s):

Esophageal Cancer ◽

Photodynamic Therapy ◽

Laser Irradiation ◽

Conflicts Of Interest ◽

Balloon Dilation ◽

Local Failure ◽

Laser Exposure ◽

Efficacy And Safety ◽

Talaporfin Sodium ◽

Failure Patterns

Abstract Background We previously conducted an investigator-initiated trial of photodynamic therapy (PDT) using talaporfin sodium (talaporfin-PDT) and laser irradiation (PD-laser) against local failure after chemoradiotherapy (CRT) in patients with esophageal cancer (EC) and reported a high local complete response rate (L-CR) (88.5%) (Yano et al., Oncotarget 2017). Thereafter, talaporfin-PDT has been applied clinically as a salvage treatment for local failure after CRT in Japan since October 2015. The current study retrospectively reviewed the efficacy and safety of talaporfin-PDT in patients who underwent this treatment in our clinical practice. Methods This study was a single-center retrospective observational study. Patients who received salvage talaporfin-PDT for local failure of EC limited to T1–2 after definitive CRT or radiotherapy from May 2011 to July 2017 in our hospital were included. PDT was applied with an intravenous administration of talaporfin sodium (40 mg/kg) followed 4 h later by diode laser irradiation at 100 J/cm2. The primary and secondary endpoints were the rate of L-CR and the safety of PDT, respectively. The criteria for L-CR were as follows: 1) no residual tumor, 2) disappearance of post-PDT ulcer and scar formation, and 3) disappearance of cancer cells as assessed histologically. Results Thirty-one patients were analyzed in this study (26 men, 5 women, median age: 68 years). Histological types were squamous cell carcinoma and adenocarcinoma (30 and 1 patients, respectively). The failure patterns of lesions after CRT were recurrence after achieving a CR and residual lesion just after CRT (25 and 6 patients, respectively). The recurrent T stages were T1a, T1b, and T2 (1, 18, and 12 patients, respectively). The median total laser exposure dose was 500 J (range: 200–900). The L-CR rates were 84.2% (16/19), 41.7% (5/12), and 61.3% (19/31) in patients with T1, T2, and all stages, respectively. No severe adverse events greater than grade 3 related to PDT were observed. Although four patients had grade 2 esophageal stenosis after PDT, the stenosis was controlled by endoscopic balloon dilation. Conclusion Salvage talaporfin-PDT is a safe and curative treatment for local failure, especially stage T1, after CRT in patients with EC. Disclosure All authors have declared no conflicts of interest.

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