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

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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STMO-21 The Outcome of tumor resection followed by photodynamic therapy for recurrent glioblastoma

Neuro-Oncology Advances ◽

10.1093/noajnl/vdab159.053 ◽

2021 ◽

Vol 3 (Supplement_6) ◽

pp. vi14-vi14

Author(s):

Tatsuya Kobayashi ◽

Masayuki Nitta ◽

Kazuhide Shimizu ◽

Taiichi Saito ◽

Takashi Maruyama ◽

...

Keyword(s):

Photodynamic Therapy ◽

Prognostic Factors ◽

Treatment Options ◽

Tumor Resection ◽

Recurrent Glioblastoma ◽

Control Group ◽

Karnofsky Performance Scale ◽

Lower Grade ◽

Talaporfin Sodium ◽

Significant Difference

Abstract Recurrent glioblastoma remains a clinical problem with no standard treatment and quite a few effective treatment options. We evaluated the efficacy of photodynamic therapy (PDT) using talaporfin sodium (TS) as a treatment for recurrent glioblastoma in a retrospective analysis of 70 patients who underwent PDT with surgery (PDT group) between 2014 and 2018, and 38 patients who underwent surgery alone (control group) during the same period. The median overall survival (OS) of the PDT and control groups were 16.03 and 12.75 months, respectively (P=0.0311). The median progression-free survival (PFS) of these two groups were 5.67 and 2.2 months, respectively (P=0.00428). Univariate and multivariate analyses showed PDT with surgery and preoperative Karnofsky Performance Scale as significant independent prognostic factors for both PFS and OS.On the other hand, IDH mutation and previous pathology before recurrence were not significant prognostic factors in this study. In the PDT group, there was no significant difference in PFS and OS between patients with GBM from the previous pathology before recurrence and those with malignant transformation to GBM from lower-grade glioma. Furthermore, there was also no significant difference in TS accumulation in the tumor between these two groups. These results suggest that additional PDT treatment for recurrent glioblastoma can have potential survival benefits and that its efficacy is independent of the pathology before recurrence or IDH status.

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

Journal of Neurosurgery ◽

10.3171/2018.7.jns18422 ◽

2019 ◽

Vol 131 (5) ◽

pp. 1361-1368 ◽

Cited By ~ 18

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.

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