Hearing Preservation After Upfront Gamma Knife Radiosurgery Versus Initial Conservative Management in Patients With Newly Diagnosed Vestibular Schwannoma: Results From a Prospective Randomized Study.

Abstract

To study the effect on tumor control and serviceable hearing in patients with vestibular schwannoma treated with upfront Gamma Knife Radiosurgery (Upfront GKRS group) compared with patients undergoing initial conservative management (Conservative group). Between 2013 and 2017, patients with newly diagnosed Vestibular Schwannoma with a maximum diameter of 20 mm were asked to participate in this single-center, open-label 1:1 randomized clinical trial with parallel group design. Outcomes were assessed by differences in tumor control and hearing preservation at 5-year follow-up between the upfront GKRS group, vs the conservative group, with serviceable hearing defined as Gardner-Robertson class 1-2. Fifty-two patients with serviceable hearing were included and randomly assigned to upfront GKRS group (n = 24) or conservative group (n = 28). The groups were well-balanced at baseline. At 5-year follow-up, 24 of 24 patients in the upfront GKRS group (12 Gy) had tumor control, with 14 of 28 patients in the conservative group needing active treatment. Sixty-five percent of patients in upfront GKRS group had serviceable hearing compared with 50% in the conservative group (P = .388). No major adverse events were registered in either group for the duration of this study. The results of this randomized controlled trial demonstrate tumor control after GKRS in newly diagnosed Vestibular Schwannoma, although no significant difference of hearing preservation was observed in upfront GKRS compared with conservative management. NCT01938677.