Prospective feasibility and safety assessment of surgical biopsy for patients with newly diagnosed diffuse intrinsic pontine glioma.
Authors of this article are:
Gupta N1, Goumnerova LC2,3, Manley P2,3, Chi SN2,3, Neuberg D2, Puligandla M2, Fangusaro J4, Goldman S4, Tomita T4, Alden T4, DiPatri A4, Rubin JB5, Gauvain K5, Limbrick D5, Leonard J5, Geyer JR6, Leary S6, Browd S6, Wang Z7, Sood S7, Bendel A8, Nagib M8, Gardner S9, Karajannis MA9, Harter D9, Ayyanar K10, Gump W10, Bowers DC11, Weprin B11, MacDonald TJ12, Aguilera D12, Brahma B12, Robison NJ13, Kiehna E13, Krieger M13, Sandler E14, Aldana P14, Khatib Z15, Ragheb J15, Bhatia S15, Mueller S1, Banerjee A1, Bredlau AL16, Gururangan S17, Fuchs H17, Cohen KJ18, Jallo G18, Dorris K19, Handler M19, Comito M20, Dias M20, Nazemi K21, Baird L21, Murray J22, Lindeman N23, Hornick JL23, Malkin H2, Sinai C2, Greenspan L2, Wright KD2,3, Prados M1, Bandopadhayay P2,3,24, Ligon KL2,23, Kieran MW2,3.
A summary of the article is shown below:
Background: Diagnosis of diffuse intrinsic pontine glioma (DIPG) has relied on imaging studies, since the appearance is pathognomonic, and surgical risk was felt to be high and unlikely to affect therapy. The DIPG Biology and Treatment Study (DIPG-BATS) reported here incorporated a surgical biopsy at presentation and stratified subjects to receive FDA-approved agents chosen on the basis of specific biologic targets.Methods: Subjects were eligible for the trial if the clinical features and imaging appearance of a newly diagnosed tumor were consistent with a DIPG. Surgical biopsies were performed after enrollment and prior to definitive treatment. All subjects were treated with conventional external beam radiotherapy with bevacizumab, and then stratified to receive bevacizumab with erlotinib or temozolomide, both agents, or neither agent, based on O6-methylguanine-DNA methyltransferase status and epidermal growth factor receptor expression. Whole-genome sequencing and RNA sequencing were performed but not used for treatment assignment.Results: Fifty-three patients were enrolled at 23 institutions, and 50 underwent biopsy. The median age was 6.4 years, with 24 male and 29 female subjects. Surgical biopsies were performed with a specified technique and no deaths were attributed to the procedure. Two subjects experienced grade 3 toxicities during the procedure (apnea, n = 1; hypertension, n = 1). One subject experienced a neurologic deficit (left hemiparesis) that did not fully recover. Of the 50 tumors biopsied, 46 provided sufficient tissue to perform the study assays (92%, two-stage exact binomial 90% CI: 83%-97%).Conclusions: Surgical biopsy of DIPGs is technically feasible, associated with acceptable risks, and can provide biologic data that can inform treatment decisions.
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