scholarly journals Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingjing Wang ◽  
Ying Wang ◽  
Yan He ◽  
Hui Guan ◽  
Ling He ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
World Health ◽  
Controlled Clinical Trial ◽  
Low Grade ◽  
Who Grade ◽  
Low Grade Gliomas ◽  
High Risk Patients ◽  
Randomized Controlled ◽  
Risk Patients

Abstract Background It has been reported that radiation therapy (RT) followed by procarbazine, lomustine, and vincristine (PCV) chemotherapy could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk World Health Organization (WHO) grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide (TMZ) to treat these patients, although large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in high-risk patients with low-grade gliomas (LGGs). Methods/design This is a two-group, randomized controlled trial (RCT) enrolling patients who have LGGs (WHO grade 2) and are aged 40 years or older without regard to the extent of resection or are aged younger than 40 years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive RT alone or RT plus TMZ chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to the RT group or the chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is PFS, and it will be analyzed by the intention-to-treat approach. Secondary outcomes include OS, adverse events, and cognitive function. Discussion The objective of our research is to assess the effect of radiotherapy coupled with TMZ in high-risk patients with LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined, and a corresponding subgroup analysis will be conducted. Our data can provide evidence for postoperative adjuvant therapy in patients with high-risk LGGs in China. Trial registration Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13 March 2018.

scholarly journals Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery:Study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Jingjing Wang ◽  
Xingchen Peng ◽  
Yan He ◽  
Hui Guan ◽  
Xiaoli Mu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
High Risk ◽  
Progression Free Survival ◽  
Controlled Clinical Trial ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Low Grade Gliomas ◽  
Randomized Controlled

Abstract Abstract Background It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide (TMZ) can improve PFS and OS in patients with high-risk low-grade gliomas (LGGs). Methods/design This is a two-group, randomized controlled trial (RCT) enrolling patients who have low-grade (WHO grade 2) gliomas aged 40 years or older without regard to the extent of resection or younger than 40 years old with subtotal resection or biopsy. Eligible participants will be randomly assigned to receive radiation therapy (RT) alone or RT plus temozolomide chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to RT group or chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is progression-free survival and it will be analyzed by intention-to-treat (ITT). Secondary outcomes include OS, adverse events and cognitive function (CF). Discussion The objective of our research is to assess the effect of radiotherapy coupled with temozolomide in high-risk LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined and subgroup analysis will be conducted based on them. Our data can provide evidence for postoperative adjuvant therapy in Chinese high-risk LGGs. Trial Registration Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13th March, 2018. http://www.chictr.org.cn

scholarly journals Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery:Study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Jingjing Wang ◽  
Ying Wang ◽  
Yan He ◽  
Hui Guan ◽  
Ling He ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Progression Free Survival ◽  
Controlled Clinical Trial ◽  
Subtotal Resection ◽  
Low Grade ◽  
Who Grade ◽  
Free Survival ◽  
Low Grade Gliomas ◽  
Randomized Controlled

Abstract Background It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide (TMZ) can improve PFS and OS in patients with high-risk low-grade gliomas (LGGs). Methods/design This is a two-group, randomized controlled trial (RCT) enrolling patients who have low-grade (WHO grade 2) gliomas aged 40 years or older without regard to the extent of resection or younger than 40 years old with subtotal resection or biopsy. An estimated 250 patients will be enrolled. Eligible participants will be randomly assigned to receive radiation therapy (RT) alone or RT plus temozolomide chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to RT group or chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is progression-free survival and it will be analyzed by intention-to-treat (ITT). Secondary outcomes include OS, adverse events and cognitive function (CF). Discussion The objective of our research is to assess the effect of radiotherapy coupled with temozolomide in high-risk LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined and subgroup analysis will be conducted based on them. Our data can provide evidence for postoperative adjuvant therapy in Chinese high-risk LGGs.

Concordance between RTOG and EORTC prognostic criteria in low-grade gliomas

2019 ◽  
Vol 15 (22) ◽  
pp. 2595-2601
Author(s):  
Enrico Franceschi ◽  
Antonella Mura ◽  
Giuseppe Lamberti ◽  
Dario De Biase ◽  
Alicia Tosoni ◽  
...  
Keyword(s):  
High Risk ◽  
Radiation Therapy Oncology Group ◽  
Low Risk ◽  
Molecular Characteristics ◽  
Low Grade ◽  
European Organization ◽  
Low Grade Gliomas ◽  
High Risk Patients ◽  
Eortc Criteria ◽  
Risk Patients

Aim: European Organization for Research and Treatment of Cancer (EORTC) and the Radiation Therapy Oncology Group (RTOG) criteria are used to choose treatment in low-grade gliomas. However, no data exist on their concordance. Methods: Low-grade glioma patients treated at our institution from 1998 to 2015 and assessable for both RTOG and EORTC criteria were included to analyze their concordance. Surgery extension, postsurgical treatments, molecular characteristics ( IDH mutation, MGMT methylation and 1p/19q codeletion) were recorded. Results: We included 99 patients. The concordance was low (50.5%; K = 0.127; p = 0.021) but for two subgroups: EORTC high-risk patients were also RTOG high-risk patients (concordance: 97.5%) and RTOG low-risk patients were also EORTC low-risk patients (concordance: 90.9%). Conclusion: The concordance between RTOG and EORTC criteria is low. Thus, clinical trials adopting different risk criteria are not comparable.

To treat or not to treat? A retrospective multicenter assessment of survival in patients with IDH-mutant low-grade glioma based on adjuvant treatment

2020 ◽  
Vol 133 (2) ◽  
pp. 273-280 ◽  
Author(s):  
Andrej Paľa ◽  
Jan Coburger ◽  
Moritz Scherer ◽  
Hajrullah Ahmeti ◽  
Constantin Roder ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Low Grade Glioma ◽  
Histopathological Diagnosis ◽  
Low Grade ◽  
Who Grade ◽  
High Risk Patients ◽  
Risk Patients ◽  
Grade Ii

OBJECTIVEThe level of evidence for adjuvant treatment of diffuse WHO grade II glioma (low-grade glioma, LGG) is low. In so-called “high-risk” patients most centers currently apply an early aggressive adjuvant treatment after surgery. The aim of this assessment was to compare progression-free survival (PFS) and overall survival (OS) in patients receiving radiation therapy (RT) alone, chemotherapy (CT) alone, or a combined/consecutive RT+CT, with patients receiving no primary adjuvant treatment after surgery.METHODSBased on a retrospective multicenter cohort of 288 patients (≥ 18 years old) with diffuse WHO grade II gliomas, a subgroup analysis of patients with a confirmed isocitrate dehydrogenase (IDH) mutation was performed. The influence of primary adjuvant treatment after surgery on PFS and OS was assessed using Kaplan-Meier estimates and multivariate Cox regression models, including age (≥ 40 years), complete tumor resection (CTR), recurrent surgery, and astrocytoma versus oligodendroglioma.RESULTSOne hundred forty-four patients matched the inclusion criteria. Forty patients (27.8%) received adjuvant treatment. The median follow-up duration was 6 years (95% confidence interval 4.8–6.3 years). The median overall PFS was 3.9 years and OS 16.1 years. PFS and OS were significantly longer without adjuvant treatment (p = 0.003). A significant difference in favor of no adjuvant therapy was observed even in high-risk patients (age ≥ 40 years or residual tumor, 3.9 vs 3.1 years, p = 0.025). In the multivariate model (controlled for age, CTR, oligodendroglial diagnosis, and recurrent surgery), patients who received no adjuvant therapy showed a significantly positive influence on PFS (p = 0.030) and OS (p = 0.009) compared to any other adjuvant treatment regimen. This effect was most pronounced if RT+CT was applied (p = 0.004, hazard ratio [HR] 2.7 for PFS, and p = 0.001, HR 20.2 for OS). CTR was independently associated with longer PFS (p = 0.019). Age ≥ 40 years, histopathological diagnosis, and recurrence did not achieve statistical significance.CONCLUSIONSIn this series of IDH-mutated LGGs, adjuvant treatment with RT, CT with temozolomide (TMZ), or the combination of both showed no significant advantage in terms of PFS and OS. Even in high-risk patients, the authors observed a similar significantly negative impact of adjuvant treatment on PFS and OS. These results underscore the importance of a CTR in LGG. Whether patients ≥ 40 years old should receive adjuvant treatment despite a CTR should be a matter of debate. A potential tumor dedifferentiation by administration of early TMZ, RT, or RT+CT in IDH-mutated LGG should be considered. However, these data are limited by the retrospective study design and the potentially heterogeneous indication for adjuvant treatment.

scholarly journals The Role of Extent of Resection in IDH1 Wild-Type or Mutant Low-Grade Gliomas

Neurosurgery ◽  
2017 ◽  
Vol 82 (6) ◽  
pp. 808-814 ◽  
Author(s):  
Toral Patel ◽  
Evan D Bander ◽  
Rachael A Venn ◽  
Tiffany Powell ◽  
Gustav Young-Min Cederquist ◽  
...  
Keyword(s):  
Cox Regression ◽  
Extent Of Resection ◽  
World Health ◽  
Low Grade ◽  
Wild Type ◽  
Who Grade ◽  
Cox Regression Analysis ◽  
Low Grade Gliomas ◽  
Grade Ii ◽  
The Impact

Abstract BACKGROUND Maximizing extent of resection (EOR) improves outcomes in adults with World Health Organization (WHO) grade II low-grade gliomas (LGG). However, recent studies demonstrate that LGGs bearing a mutation in the isocitrate dehydrogenase 1 (IDH1) gene are a distinct molecular and clinical entity. It remains unclear whether maximizing EOR confers an equivalent clinical benefit in IDH mutated (mtIDH) and IDH wild-type (wtIDH) LGGs. OBJECTIVE To assess the impact of EOR on malignant progression-free survival (MPFS) and overall survival (OS) in mtIDH and wtIDH LGGs. METHODS We performed a retrospective review of 74 patients with WHO grade II gliomas and known IDH mutational status undergoing resection at a single institution. EOR was assessed with quantitative 3-dimensional volumetric analysis. The effect of predictor variables on MPFS and OS was analyzed with Cox regression models and the Kaplan–Meier method. RESULTS Fifty-two (70%) mtIDH patients and 22 (30%) wtIDH patients were included. Median preoperative tumor volume was 37.4 cm3; median EOR of 57.6% was achieved. Univariate Cox regression analysis confirmed EOR as a prognostic factor for the entire cohort. However, stratifying by IDH status demonstrates that greater EOR independently prolonged MPFS and OS for wtIDH patients (hazard ratio [HR] = 0.002 [95% confidence interval {CI} 0.000-0.074] and HR = 0.001 [95% CI 0.00-0.108], respectively), but not for mtIDH patients (HR = 0.84 [95% CI 0.17-4.13] and HR = 2.99 [95% CI 0.15-61.66], respectively). CONCLUSION Increasing EOR confers oncologic and survival benefits in IDH1 wtLGGs, but the impact on IDH1 mtLGGs requires further study.

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