Promising Survival for Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concomitant Radiation Plus Temozolomide Followed by Adjuvant Temozolomide

Stupp, Roger

doi:10.1200/jco.20.5.1375

Cited by 475 publications

(305 citation statements)

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“…About half of grade IV tumors (18 of 34) versus almost all grade III tumors (29 of 30) were treated with PCV (Table 1), raising the possibility that the observed difference between grades in the association Ap endo activity with TTP might reflect an association with PCV therapy rather than with tumor 7 For example, an HR of 1.06 indicates that a glioma with an Ap endo activity of 0.046 is 1.06 times more likely to progress at any moment in time than a glioma with an activity of 0.036, all other things being equal. Note, however, that a difference of 0.01 in activity is relatively small.…”

Section: Resultsmentioning

confidence: 98%

“…In a univariate Cox proportional hazards regression model, with Ap endo activity entered as a continuous variable, the HR increased by a factor of 1.061 for every 0.01 increase in activity {P ϭ 0.013, 95% confidence interval (CI) ϭ [1.013, 1.112]}. 7 Hence, greater Ap endo activity was associated with an increasing hazard for progression (i.e., patients with higher activity had, on average, shorter time to progression). The inverse association between Ap endo activity as a continuous variable and TTP can be illustrated by dividing Ap endo activity into categories and graphically displaying the progression curves within each category: HRs are calculated separately for the 2nd, 3rd, and 4th quartiles of activity relative to the first (i.e., the quartile with the lowest activity).…”

Section: Resultsmentioning

confidence: 99%

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Apurinic Endonuclease Activity in Adult Gliomas and Time to Tumor Progression after Alkylating Agent-Based Chemotherapy and after Radiotherapy

Bobola

Emond

Blank

et al. 2004

Clinical Cancer Research

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Results: In a univariate model with Ap endo activity entered as a continuous variable, the hazard ratio (HR) for progression after alkylator therapy in 30 grade III gliomas increased by a factor of 1.061 for every 0.01 increase in activity (P ‫؍‬ 0.013). Adjusting for age, gender, extent of resection, and prior treatment strengthened slightly the association (HR ‫؍‬ 1.094; P ‫؍‬ 0.003). Similarly, the HR for progression after radiotherapy in 44 grade II and III tumors increased by a factor of 1.069 (P ‫؍‬ 0.008). Adjusting for the aforementioned variables had little effect on the association. In contrast, we observed no association between activity and TTP in grade IV gliomas after either alkylator therapy in 34 tumors or radiotherapy in 26 tumors.Conclusions: Our data suggest that Ap endo activity mediates resistance to alkylating agents and radiation and may be a useful predictor of progression after adjuvant therapy in a subset of gliomas.

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Section: Resultsmentioning

confidence: 98%

Section: Resultsmentioning

confidence: 99%

Apurinic Endonuclease Activity in Adult Gliomas and Time to Tumor Progression after Alkylating Agent-Based Chemotherapy and after Radiotherapy

Bobola

Emond

Blank

et al. 2004

Clinical Cancer Research

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“…Despite recent advances in radiation therapy, chemotherapy, and surgical resectioning, the prognosis for patients with malignant glioma is still very poor (1,2). Therefore, the development of a new treatment modality is extremely important.…”

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confidence: 99%

Clinical Evaluation of Dendritic Cell Vaccination for Patients with Recurrent Glioma: Results of a Clinical Phase I/II Trial

Yamanaka

Homma

Yajima

et al. 2005

Clinical Cancer Research

288

218

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Purpose: To investigate the safety and the immunologic and clinical responses of dendritic cell therapy for patients with recurrent malignant glioma. Experimental Design: Twenty-four patients with recurrent malignant glioma (6 grade 3 and 18 grade 4 patients) were evaluated in a phase I/II clinical study of dendritic cell therapy. All patients were resistant to the standard maximum therapy. The patient's peripheral blood dendritic cells were generated with granulocyte macrophage colony-stimulating factor, plus interleukin 4 with or without OK-432, and pulsed with an autologous tumor lysate. Dendritic cells were injected intradermally, or both intratumorally and intradermally every 3 weeks. Results: The protocols were well tolerated with only local redness and swelling at the injection site in several cases. Clinical responses were as follows: 1patient with partial response, 3 patients with minor response, 10 patients with stable disease, and 10 patients with progressive disease. The patients whose dendritic cells were matured with OK-432 had longer survival times than the dendritic cells from patients without OK-432 maturation. The patients with both intratumoral and intradermal administrations had a longer survival time than the patients with intradermal administration only. Increased ELISPOT and delayed-type hypersensitivity responses after vaccination could provide good laboratory markers to predict the clinical outcome of patients receiving dendritic cell vaccination. The overall survival of patients with grade 4 glioma was 480 days, which was significantly better than that in the control group. Conclusions: This study showed the safety and clinical response of autologous tumor lysatepulsed dendritic cell therapy for patients with malignant glioma. Dendritic cell therapy is recommended for further clinical studies in malignant glioma patients.

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“…[2][3][4][5][6] Two Phase I studies characterized the toxicity profile and maximum tolerated dose of temozolomide when administered on a 5-day schedule to children. 7,8 Like adult trials, these pediatric studies showed that myelosuppression was the main side effect of temozolomide.…”

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confidence: 99%

Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children

Broniscer

Iacono

Chintagumpala

et al. 2004

Cancer

100

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BACKGROUNDThe role of chemotherapy in the treatment of children with newly diagnosed diffuse brainstem glioma is uncertain. In the current study, the authors tested the efficacy of temozolomide treatment after radiotherapy (RT) in this setting.METHODSPatients ages 3–21 years were eligible for the current multiinstitutional study. An optional window therapy regimen consisting of 2 cycles of intravenous irinotecan (10 doses of 20 mg/m2 per day separated by 2 days of rest per cycle) was delivered over 6 weeks and was followed by conventionally fractionated RT. The 5‐day schedule of temozolomide (200 mg/m2 per day) was initiated 4 weeks after RT and was continued for a total of 6 cycles. The pharmacokinetics of temozolomide and its active metabolite, 5‐(3‐methyltriazen‐1‐yl)imidazole‐4‐carboxamide (MTIC), were analyzed during Cycles 1 and 3.RESULTSThirty‐three patients (median age at diagnosis, 6.4 years) were enrolled. Of the 16 patients who received window therapy, 6 had irinotecan treatment discontinued due to clinical progression (n = 5) or toxicity (n = 1); the remaining 10 experienced disease stabilization after 2 cycles. All patients completed RT (median dose, 55.8 gray). Twenty‐nine patients received a combined total of 125 cycles of temozolomide. Grade 3/4 neutropenia and thrombocytopenia occurred in 33% and 29% of all temozolomide cycles, respectively. In approximately one‐third of the cycles, dose reduction was required due to myelosuppression. No correlation was demonstrated between temozolomide/MTIC exposure and myelosuppression at the conclusion of Cycle 1. All patients died of disease progression (median survival, 12 months). The estimated 1‐year survival rate was 48% (standard error, 8%).CONCLUSIONSThe administration of temozolomide after RT did not alter the poor prognosis associated with newly diagnosed diffuse brainstem glioma in children. Cancer 2005. © 2004 American Cancer Society.

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Promising Survival for Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concomitant Radiation Plus Temozolomide Followed by Adjuvant Temozolomide

Abstract: Continuous daily temozolomide and concomitant radiation is safe. This regimen of concomitant chemoradiotherapy followed by adjuvant chemotherapy may prolong the survival of patients with glioblastoma. Further investigation is warranted, and a randomized trial is ongoing.

Cited by 475 publications

References 0 publications

Apurinic Endonuclease Activity in Adult Gliomas and Time to Tumor Progression after Alkylating Agent-Based Chemotherapy and after Radiotherapy

Apurinic Endonuclease Activity in Adult Gliomas and Time to Tumor Progression after Alkylating Agent-Based Chemotherapy and after Radiotherapy

Clinical Evaluation of Dendritic Cell Vaccination for Patients with Recurrent Glioma: Results of a Clinical Phase I/II Trial

Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children

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