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Abstract
BackgroundAt recurrence the use of nitrosoureas is widely-used as a therapeutic option for glioblastoma (GBM) patients. The efficacy of fotemustine (FTM) has been demonstrated in phase II clinical trials; however, these papers report a wide range of progression-free-survival (PFS-6 m) rates, ranging from 21% to 52%. We investigated whether FTM could have a different response pattern in respect to time to adjuvant temozolomide failure, or whether specific independent risk factors could be responsible for the wide range of response rates observed.MethodsRecurrent GBM patients have been treated with fotemustine 75-100 mg/sqm at day 1, 8, 15 and after 4/5 weeks of rest with 100 mg/sqm every 21 days. Patients were stratified in 4 groups according to time to temozolomide failure: before starting (B0), during the first 6 months (B1), after more than 6 months of therapy (B2), and after a treatment-free interval (B3). Primary endpoint was PFS-6 m. A multivariable analysis was performed to identify whether gender, time after radiotherapy, second surgery and number of TMZ cycles could be independent predictors of the clinical benefit to FTM treatment.Results163 recurrent GBM patients were included in the analysis. PFS-6 m rates for the B0, B1, B2 and B3 groups were 25%, 28%, 31.1% and 43.8%, respectively. The probability of disease control was higher in patients with a longer time after radiotherapy (p = 0.0161) and in those who had undergone a second surgery (p = 0.0306).ConclusionsFTM is confirmed as a valuable therapeutic option for patients with recurrent GBM and was active in all study patient groups. Time after the completion of radiotherapy and second surgery are independent treatment-related risk factors that were predictive of clinical benefit.
Highlights
At recurrence the use of nitrosoureas is widely-used as a therapeutic option for glioblastoma (GBM) patients
One hundred and sixty-three patients with a diagnosis of recurrent GBM were included in the analysis
All patients followed a Stupp regimen as first line treatment; all patients were treated with a combination of radiotherapy and TMZ, 87.7% (143/163) received adjuvant TMZ, and 12.3% (20/163) of patients experienced a recurrence immediately following the conclusion of radiotherapy and were evaluated as the B0 group
Summary
At recurrence the use of nitrosoureas is widely-used as a therapeutic option for glioblastoma (GBM) patients. We investigated whether FTM could have a different response pattern in respect to time to adjuvant temozolomide failure, or whether specific independent risk factors could be responsible for the wide range of response rates observed. Radiotherapy, plus concomitant and adjuvant temozolomide (TMZ), is the standard first line treatment given to GBM patients, as defined in the EORTC trial [2,3]. Novel target therapies, including antiangiogenic drugs, are under investigation, but the role of such drugs in the treatment of GBM is still being debated [5]. Perry and colleagues [10] have demonstrated that time to adjuvant temozolomide failure seems to be linked to a high-dose TMZ treatment. Continuous high-dose TMZ is used in patients who relapse after standard therapy, notably in those patients with early or late progression after standard therapy
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