Can Elderly Patients With Newly Diagnosed Glioblastoma be Enrolled in Radiochemotherapy Trials?

Fiorentino, Alba; Boccadoro, Mario; Bonis, Pasquale De; Chiesa, S.; Filippo, L. De; Mangiola, Annunziato; Rose, F. De; Autorino, R.; Rinaldi, C.; Fersino, S.; Diletto, B.; Matteucci, Pietro; Ciurlia, E.; Fusco, Vincenzo; Anile, Carmelo; Valentini, Vincenzo

doi:10.1097/coc.0b013e3182868ea2

Cited by 29 publications

(29 citation statements)

References 55 publications

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“…Hypofractionation is an attractive option for this particular patient group [36, 37]. In addition, there is initial evidence that hypofractionated radiotherapy may be combined with temozolomide and result in a better outcome without the excess toxicity [38, 39]. The NCT00482677 trial, could potentially provide definitive answers.…”

Section: Discussionmentioning

confidence: 99%

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

et al. 2017

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The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.Electronic supplementary materialThe online version of this article (doi:10.1186/s13014-016-0740-5) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

et al. 2017

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“…However, no effect on overall survival was observed. In the elderly, the best treatment strategy is highly influenced by the patient and tumor-related factors and ranges from combined chemoradiotherapy with temozolomide for highly selected patients with good clinical performance status to either radiotherapy or temozolomide treatment alone, and supportive care only 22–28…”

Section: Glioblastomamentioning

confidence: 99%

“…Combined chemoradiotherapy comprising temozolomide might be too toxic for the elderly, with increased side effects 22,131,132. For the elderly with malignant glioma, two recently published Phase III trials have evaluated the place of dose-dense/conventional temozolomide regimes alone as compared with conventional/hypofractionated radiotherapy 25,133.…”

Section: Mgmt For Decision Making In Glioblastoma Patientsmentioning

confidence: 99%

Personalized treatment strategies in glioblastoma: MGMT promoter methylation status

Thon¹,

Kreth²,

Kreth³

2013

OTT

139

102

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The identification of molecular genetic biomarkers considerably increased our current understanding of glioma genesis, prognostic evaluation, and treatment planning. In glioblastoma, the most malignant intrinsic brain tumor entity in adults, the promoter methylation status of the gene encoding for the repair enzyme O6-methylguanine-DNA methyltransferase (MGMT) indicates increased efficacy of current standard of care, which is concomitant and adjuvant chemoradiotherapy with the alkylating agent temozolomide. In the elderly, MGMT promoter methylation status has recently been introduced to be a predictive biomarker that can be used for stratification of treatment regimes. This review gives a short summery of epidemiological, clinical, diagnostic, and treatment aspects of patients who are currently diagnosed with glioblastoma. The most important molecular genetic markers and epigenetic alterations in glioblastoma are summarized. Special focus is given to the physiological function of DNA methylation–in particular, of the MGMT gene promoter, its clinical relevance, technical aspects of status assessment, its correlation with MGMT mRNA and protein expressions, and its place within the management cascade of glioblastoma patients.

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“…Preliminary results are encouraging, with good tolerance profiles. The pooled data of four prospective Phase II trials that included only elderly patients in good general health showed median PFS and OS of 10 and 13 months, respectively, with mild acute toxicity 47. RT with concomitant and adjuvant TMZ for elderly patients was significantly associated with improvement or stability in most quality-of-life domains 48.…”

Section: Managementmentioning

confidence: 99%

High-grade glioma in elderly patients: can the oncogeriatrician help?

Tabouret

Tassy

Chinot

et al. 2013

CIA

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Gliomas are the most frequent primary brain tumors in adults. As the population ages in Western countries, the number of people being diagnosed with glioblastoma is expected to increase. Clinical management of elderly patients with primary brain tumors is difficult, owing to multiple comorbidities, polypharmacy, decreased tolerance to chemotherapy, and an increased risk of radiation-induced neurotoxicity. A few specific randomized studies have shown a benefit for radiotherapy in elderly patients with good performance status. For patients with poor performance status, chemotherapy (temozolomide) has been shown to be associated with prolonged duration of response. Patients with methylated O6-alkylguanine deoxyribonucleic acid alkyltransferase promoter seem to have better outcomes. Oncogeriatrics proposes the geriatric evaluation of elderly patients to improve therapeutic choices and optimize the management of treatment toxicities and comorbidities.

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Can Elderly Patients With Newly Diagnosed Glioblastoma be Enrolled in Radiochemotherapy Trials?

Abstract: Radiochemotherapy is effective and well tolerated by elderly patients when KPS >70 and CCI <3; therefore these criterions should be considered to enroll elderly patients in combined prospective study.

Cited by 29 publications

References 55 publications

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

Current status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.gov

Personalized treatment strategies in glioblastoma: MGMT promoter methylation status

High-grade glioma in elderly patients: can the oncogeriatrician help?

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