Objectives – To assess possible improved efficacy of Boron Neutron Capture Therapy (BNCT) for glioblastoma multiforme (GBM) using prolonged infusion and a correspondingly higher dose of l-boronophenylalanine, as the fructose complex (BPA-f). Materials and methods – The benefit of prolonged infusion was analyzed by comparing the results from a Phase II study using 6 h infusion of BPA-f with those obtained from a Phase I ⁄ II study using 2 h of infusion. Median survival time (MST) from diagnosis, patient baseline characteristics, salvage treatment and severe adverse events were considered in the comparison. Results – MST increased significantly, from 12.8 (95% confidence interval or CI: 10.3–14.0) months with 2 h infusion to 17.7 (95% CI: 13.6–19.9) months with 6 h of infusion. The fraction of patients with WHO grade 3–4 adverse events was similar in the two studies at 13% and 14%, respectively. Conclusion – Prolonged infusion was found to be beneficial for the efficacy of BNCT and it is suggested that 6 h infusion of BPA-f should be used in future trials of BNCT for GBM. BNCT, which is a single-day treatment with mild side effects, should be assessed in a controlled trial, as an alternative to 30 daily fractions of conventional fractionated photon therapy over a period of 6 weeks.
Boron neutron capture therapy for glioblastoma multiforme: advantage of prolonged infusion of BPA-f
GIUSTI, VALERIO;
2010-01-01
Abstract
Objectives – To assess possible improved efficacy of Boron Neutron Capture Therapy (BNCT) for glioblastoma multiforme (GBM) using prolonged infusion and a correspondingly higher dose of l-boronophenylalanine, as the fructose complex (BPA-f). Materials and methods – The benefit of prolonged infusion was analyzed by comparing the results from a Phase II study using 6 h infusion of BPA-f with those obtained from a Phase I ⁄ II study using 2 h of infusion. Median survival time (MST) from diagnosis, patient baseline characteristics, salvage treatment and severe adverse events were considered in the comparison. Results – MST increased significantly, from 12.8 (95% confidence interval or CI: 10.3–14.0) months with 2 h infusion to 17.7 (95% CI: 13.6–19.9) months with 6 h of infusion. The fraction of patients with WHO grade 3–4 adverse events was similar in the two studies at 13% and 14%, respectively. Conclusion – Prolonged infusion was found to be beneficial for the efficacy of BNCT and it is suggested that 6 h infusion of BPA-f should be used in future trials of BNCT for GBM. BNCT, which is a single-day treatment with mild side effects, should be assessed in a controlled trial, as an alternative to 30 daily fractions of conventional fractionated photon therapy over a period of 6 weeks.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
