|The following article features coverage from the European Society for Medical Oncology (ESMO) 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
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 BEACON-Neuroblastoma clinical trial (ClinicalTrials.gov Identifier: NCT02308527), according to results reported at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.
It has been estimated that approximately one-half of patients treated for high-risk neuroblastoma will experience recurrence of disease. The absence of a standard treatment option for these patients represents an unmet medical need.
In this phase 2 study, patients with relapsed or refractory neuroblastoma aged 1 year to 21 years were randomly assigned to receive treatment with 1 active comparator arm (temozolomide) and 5 experimental arms: temozolomide-bevacizumab; irinotecan-temozolomide; irinotecan-temozolomide-bevacizumab; temozolomide-topotecan; and topotecan-temozolomide.
The primary end point for part 1 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.
Of the 106 patients enrolled in part 1 of the study, 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.
Following an amendment of the BEACON-Neuroblastoma clinical trial protocol to include part 2 of the study, which involved enrollment of 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 not, respectively.
Longer follow-up will be necessary to determine whether addition of bevacizumab to temozolomide-based therapy has an impact on PFS or overall survival (OS).
The rate of grade 3 or higher adverse events was 86% and 58% for patients receiving chemotherapy with or without bevacizumab, respectively. Of these, a decrease in platelet count and anemia were most common in patients treated with bevacizumab.
Disclosure: This study was funded by Roche, and some of the authors disclosed payments from the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.
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Moreno L, Moroz V, Owens C, et al. Bevacizumab for children with relapsed & refractory high-risk neuroblastomoa (RR-HRNB): Results of the BEACON-neuroblastoma randomized phase II trial – A European ITCC-SIOPEN trial. Presented at: European Society for Medical Oncology (ESMO) Congress 2019; September 27-October 1, 2019: Barcelona, Spain. Abstract LBA64.