A retrospective pooled analysis of response patterns and risk factors in recurrent malignant glioma patients receiving a
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ORIGINAL PAPER
Open Access
A retrospective pooled analysis of response patterns and risk factors in recurrent malignant glioma patients receiving a nitrosourea-based chemotherapy Alessandro Paccapelo1, Ivan Lolli2*, Maria Grazia Fabrini3, Giovanni Silvano4, Beatrice Detti5, Franco Perrone3, Giuseppina Savio6, Matteo Santoni1, Erminio Bonizzoni7, Tania Perrone8 and Silvia Scoccianti5
Abstract Background: At 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. Methods: Recurrent 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. Results: 163 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). Conclusions: FTM 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 treatmentrelated risk factors that were predictive of clinical benefit. Keywords: Fotemustine, Nitrosourea, Recurrent-glioblastoma, Stupp-regimen, Temozolomide
Background Glioblastoma (GBM) is the most common malignant primary brain tumor in adults and is associated with a poor prognosis [1]. 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]. On recurrence of the tumor, patients have few therapeutic options – nitrosoureas, alternative * Correspondence: [email protected] 2 Oncologia Medica, IRCCS “Saverio de Bellis”, 70013 via Turi 27, Castellana Grotte, (Ba), Italy Full list of author information is available at the end of the article
TMZ schedules, and new target therapies, but prognosis remains poor [4]. Novel target therapies, including antiangiogenic drugs, are under investigation, but the role of such drugs in the treatment of GBM
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