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 ◽  
...  

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.

2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi20-vi20
Author(s):  
Masayuki Nitta ◽  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Soko Ikuta ◽  
Hiroshi Iseki ◽  
...  

2013 ◽  
Vol 119 (4) ◽  
pp. 845-852 ◽  
Author(s):  
Yoshihiro Muragaki ◽  
Jiro Akimoto ◽  
Takashi Maruyama ◽  
Hiroshi Iseki ◽  
Soko Ikuta ◽  
...  

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).


2021 ◽  
Vol 3 (Supplement_6) ◽  
pp. vi14-vi14
Author(s):  
Tatsuya Kobayashi ◽  
Masayuki Nitta ◽  
Kazuhide Shimizu ◽  
Taiichi Saito ◽  
Takashi Maruyama ◽  
...  

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.


2020 ◽  
Vol 10 ◽  
Author(s):  
Patrick Schuss ◽  
Felix Lehmann ◽  
Niklas Schäfer ◽  
Christian Bode ◽  
Elisa Scharnböck ◽  
...  

ObjectiveAlthough the treatment of glioblastoma patients is well established in neuro-oncological surgery, precious scarce data is available on patients with glioblastoma requiring postoperative prolonged mechanical ventilation (PMV). Therefore, the aim of the present study was to determine the influence of PMV on overall survival (OS) in patients with glioblastoma.MethodsPatients with newly diagnosed glioblastoma who had undergone surgical therapy and complete subsequent neuro-oncological treatment at the authors’ neuro-oncological center from January 2013 to December 2018 were selected and included in the further analysis. PMV was defined as mechanical ventilation for more than 24 h after surgery. Survival analyses were performed, including established prognostic factors such as age, Karnofsky performance score, MGMT-promoter methylation status and extent of resection.ResultsA total of 240 patients with newly diagnosed glioblastoma and subsequent surgical treatment were identified. 13 patients (5%) suffered from PMV during the treatment course of glioblastoma. All but one patient were successfully weaned from mechanical ventilation. Patients suffering from PMV achieved significantly less often favorable functional outcome after 3, 6, 9, and 12 months compared to patients without PMV. Multivariate analysis revealed PMV to constitute a significant prognostic factor for OS, independent of other prognostic factors (p<0.0001, OR 6.7, 95% CI 3.2–13.8).ConclusionsThe present study identifies PMV as significantly associated with impaired functional outcome and poor OS in patients suffering from newly diagnosed glioblastoma. These findings encourage further efforts to investigate/assess this prognostic factor in future studies.


2016 ◽  
Vol 18 (suppl_6) ◽  
pp. vi10-vi10
Author(s):  
Masayuki Nitta ◽  
Yoshihiro Muragaki ◽  
Takashi Maruyama ◽  
Soko Ikuta ◽  
Hiroshi Iseki ◽  
...  

1989 ◽  
Vol 35 (9) ◽  
pp. 1968-1970 ◽  
Author(s):  
S Copur ◽  
S Kus ◽  
A Kars ◽  
N Renda ◽  
G Tekuzman ◽  
...  

Abstract Concentrations of total lactate dehydrogenase (LDH; EC 1.1.1.27) and LDH isoenzyme patterns were studied in serum of 19 patients with multiple myeloma and in 19 healthy controls. Patients were divided into three groups (pretreatment, nonresponders, and responders to treatment), based on their clinical status at the time of blood sampling for LDH. The LDH values were found to be significantly higher (P less than 0.05) in the pretreatment group and in the nonresponders than in the responders and the control group, the mean +/- SE values being 445 +/- 35 and 532 +/- 75 units/mL vs 349 +/- 75 and 190 +/- 7.1 units/mL, respectively. Compared with responders and healthy controls, newly diagnosed patients and nonresponders had slight diminutions in LDH-1 and LDH-2, but increased LDH-3. We conclude that determination of LDH and its isoenzymes in serum can be of value as prognostic factors in patients with multiple myeloma.


2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 9599-9599 ◽  
Author(s):  
T. Gorlia ◽  
R. Stupp ◽  
E. A. Eisenhauer ◽  
R. O. Mirimanoff ◽  
M. J. Van Den Bent ◽  
...  

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3321-3321
Author(s):  
Olga Pokrovskaya ◽  
Larisa Mendeleeva ◽  
Irina Kaplanskaya ◽  
Elena Parovichnikova ◽  
Sergei Kulikov ◽  
...  

Abstract BACKGROUND. Angiogenesis is a constant hallmark of multiple myeloma (MM) progression. It has also been reported that bone marrow angiogenesis is a predictive factor of poor survival in newly diagnosed myeloma. The aim of the current study was to investigate the dynamics of bone marrow (BM) microvessel density (MVD) in patients undergoing high-dose therapy (HDT) and autologous stem cell transplantation (ASCT). PATIENTS AND METHODS. 36 patients with newly diagnosed MM (22 in stage II and 14 in stage III according to Salmon and Durie) were included in the study – 21 male and 15 female, median age – 51 ys (range 31–67). All patients underwent HDT that included 3–4 cycles of induction therapy (VAD), stem cell mobilization with cyclophosphamide 6 g/m2 and G-CSF 5 mcg/kg, EDAP and single or tandem ASCT with melphalan 200 mg/ m2. The BM biopsies for histological and immunohistochemical analysis were performed at the time of diagnosis, after induction, after stem cell mobilization before the 1st ASCT and after the end of therapy (5 times during the treatment). The Control group consisted of normal BM donors (7 male and 3 female, median age 29, (17–59)) who underwent BM biopsy during BM harvesting for alloBMT. Blood vessels were highlighted by immunostaining of endothelial cells with a monoclonal antibody to CD34 (Novocastra Lab Ltd). The MVD was calculated in 10 fields using an 40x objective and 16x ocular lens. RESULTS. At diagnosis in all MM pts, MVD was extremely high compared to normal donors (152±8 vs 74±4). A significant decrease of BM MVD was observed after each phase of therapy: after the induction therapy the MVD was 124±6; before the 1st ASCT – 109±5 and at the end of treatment – 97±3. There was a statistically significant increase of MVD after stem cell mobilization due to G-CSF (143±4). Although there was a marked decrease of BM MVD in MM pts with CR or VGPR, it nevertheless stayed significantly higher compared with control group (p<0,001). The analysis of probability of CR or VGPR duration after ASCT according to MVD at different phases of therapy showed that MVD at diagnosis and before the 1-st ASCT are important prognostic factors. Probability of duration of CR or VGPR was 63% in group with low MVD before the 1st ASCT compared with 15% in group with high MVD (p<0,02). MVD was revealed to be more powerful prognostic factor for progression free survival (PFS) then CR or VGPR achievement. CONCLUSION. BM angiogenesis is increased in patients with MM. BM MVD is decreased during and after treatment however even after the completion of HDT and ASCT, the MVD is higher then in the normal control group. There is a statistically significant increase of MVD after stem cell mobilization with cyclophosphamide and G-CSF. MVD at the time of diagnosis and before the 1-st ASCT are important prognostic factors for overall-survival and PFS after ASCT. MVD before the 1-st ASCT appears to be a more powerful prognostic factor for PFS then remission rate.


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