Neoadjuvant phase II multicentre study of new agents in patients with malignant glioma after minimal surgery. Report of a cohort of 187 patients treated with temozolomide

Abstract

The phase II study design of primary chemotherapy in patients with malignant glioma following biopsy alone is feasible and provides as objective a method of assessment of efficacy as is currently available. The baseline data on temozolomide provide a benchmark for assessment of efficacy of other agents and combinations.

The role of temozolomide in the management of patients with newly diagnosed anaplastic astrocytoma: a comparison of survival in the era prior to and following the availability of temozolomide

“…However, in one study initial pathologic interpretation of WHO grade III glioma was ultimately re-interpreted to GBM in 25 % and low-grade glioma in 23 % of patients by central pathologic review [17]. Objective responses were reported following neoadjuvant TMZ in patients with high-grade gliomas for which anaplastic lesions accounted for a substantial number [19, 20]. In the setting of recurrent anaplastic glioma, a pivotal single-arm phase II study of 162 patients treated with TMZ monotherapy demonstrated a 46 % 6-month PFS and 24 % 12-month PFS [21].…”

Randomized Study of Postoperative Radiotherapy and Simultaneous Temozolomide without Adjuvant Chemotherapy for Glioblastoma

“…In addition, many factors will probably change during the course of the disease. Therefore, the optimal treatment schedule including neoadjuvant [2,6], metronomic [15] or dose-intensified TMZ [31] application can only be determined in large, randomized trials such as those which have been performed for anaplastic oligodendrogliomas [5,28]. As a consequence, a 4-arm trial in anaplastic astrocytoma which will allow to separate the effects of adjuvant and concurrent TMZ has been started (EORTC 26503, CATNON-trial), and a 2-arm trial in glioblastoma (RTOG trial 0525) that examines the effect of dose-intensified adjuvant TMZ has been performed.…”

Clinical course of high-grade glioma patients with a “biopsy-only” surgical approach: a need for individualised treatment

“…They constitute almost 30% of our patients and a larger proportion have an adequate KPS to be included in trials of promising agents detected in phase II studies on recurrent patients. The neo-adjuvant design of two or three cycles before radiotherapy has not worsened the results on survival of 'biopsy-only' patients and minimises the confounding factor of surgery in the response evaluation [21][22][23]. Antiangiogenic therapy seems to be especially promising for reaching these objectives [24].…”