Adding bevacizumab to temozolomide-based therapy in neuroblastoma

The addition of bevacizumab to temozolomide-based therapy was associated with an improvement in overall response (OR) in children with relapsed/refractory neuroblastoma enrolled in the phase 2 BEACON-Neuroblastoma clinical trial.

Patients with relapsed or refractory neuroblastoma aged 1- 21 years were randomly assigned to receive treatment in 5 experimental arms: temozolomide-bevacizumab; irinotecan-temozolomide; irinotecan-temozolomide-bevacizumab; temozolomide-topotecan; and topotecan-temozolomide.

The primary end point for part 1 (n=106) of the study was best response, with at least 4 more responses in the bevacizumab plus chemotherapy arms compared with the chemotherapy alone arms set as the criterion for a positive result. In total, 17 of 52 patients (33%) receiving chemotherapy plus bevacizumab and 8 of 54 patients (15%) receiving chemotherapy alone had an objective response to treatment, meeting the criterion for a positive study.

The BEACON-Neuroblastoma clinical trial protocol was amended to include part 2 of the study, which enrolled an additional 40 patients and inclusion of a coprimary end point of progression-free survival. Available data again showed a positive result with respect to overall response, with responses observed in 21 of 77 patients (27%) and 13 of 77 (17%) of those patients receiving bevacizumab vs those who did not receive bevacizumab, respectively.

Longer follow-up is required to determine whether addition of bevacizumab to temozolomide-based therapy has an impact on progression-free or overall survival.

The rate of grade 3 or higher adverse events was 86% in patients receiving bevacizumab and 58% for patients who did not. A decrease in platelet count and anaemia were most common in patients treated with bevacizumab.

1. Moreno L et al. ESMO Congress 2019. Abstract LBA64.

Posted on 26 November, 201925 March, 2024