Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFβ<i>2</i>-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up.

The group with favorable responses showed a strong trend for having been treated with higher cumulative total doses of OT101 than the cumulative doses received by the non-responders ( p -Value = 0.06).

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The median OS for the 30 patients representing the top third of at risk patients within the mITT population relative to the total dose of OT101 (range: 53–152 mg/m 2 ) was 447 (95% CI: 402–1079) days and showed a trend towards better outcome (log-rank χ 2 = 3.5, p -Value = 0.06) when compared to the median OS of 221.5 (95% CI: 152–406) days for the 30 patients representing the bottom third of at risk patients (range: 1.1–14 mg/m 2 ) ( Table 3 ).

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A comparison of corticosteroid treatment patterns revealed highly significant differences between the 26-patient group with favorable responses vs. the non-responders.

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A greater (albeit only at a statistical trend level) portion of the evaluable 24 patients within the 26-patient group with favorable responses had failed after first-line therapy radiation alone or in combination with the temozolomide in first-line vs. other radiation plus other chemotherapy agents (paclitaxel, nitrosoureas, carboplatin, topoisomerase inhibitors, and anthracyclines) than 54 evaluable patients within the 63-patient non-responder population (13/24 [54%] vs. 19/54 [35%], G = 6.99. p = 0.07).

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