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-6m) 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 75-100mg/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-6m. 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-6m 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 treatment-related risk factors that were predictive of clinical benefit.
| Original language | English |
|---|---|
| Pages (from-to) | 90 |
| Number of pages | 1 |
| Journal | Journal of Translational Medicine |
| DOIs | |
| Publication status | Accepted/In press - May 14 2012 |
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ASJC Scopus subject areas
- Medicine(all)
- Biochemistry, Genetics and Molecular Biology(all)
Cite this
A retrospective pooled analysis of response patterns and risk factors in recurrent malignant glioma patients receiving a nitrosourea-based chemotherapy. / Paccapelo, Alessandro; Lolli, Ivan; Fabrini, Maria Grazia; Silvano, Giovanni; Detti, Beatrice; Perrone, Franco; Savio, Giuseppina; Bonizzoni, Erminio; Perrone, Tania; Scoccianti, Silvia.
In: Journal of Translational Medicine, 14.05.2012, p. 90.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A retrospective pooled analysis of response patterns and risk factors in recurrent malignant glioma patients receiving a nitrosourea-based chemotherapy
AU - Paccapelo, Alessandro
AU - Lolli, Ivan
AU - Fabrini, Maria Grazia
AU - Silvano, Giovanni
AU - Detti, Beatrice
AU - Perrone, Franco
AU - Savio, Giuseppina
AU - Bonizzoni, Erminio
AU - Perrone, Tania
AU - Scoccianti, Silvia
PY - 2012/5/14
Y1 - 2012/5/14
N2 - 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-6m) 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 75-100mg/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-6m. 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-6m 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 treatment-related risk factors that were predictive of clinical benefit.
AB - 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-6m) 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 75-100mg/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-6m. 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-6m 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 treatment-related risk factors that were predictive of clinical benefit.
UR - http://www.scopus.com/inward/record.url?scp=84860806033&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84860806033&partnerID=8YFLogxK
U2 - 10.1186/1479-5876-10-90
DO - 10.1186/1479-5876-10-90
M3 - Article
C2 - 22583678
AN - SCOPUS:84860806033
SP - 90
JO - Journal of Translational Medicine
JF - Journal of Translational Medicine
SN - 1479-5876
ER -