title: Prospective study of the short-term adverse effects of gamma knife radiosurgery.
abstract: Purpose of this study is to determine the types, incidence, and severity of acute complications of intracranial stereotactic radiosurgery (SRS), specifically Gamma Knife (GK). Patients who had never had previous SRS were eligible for this prospective IRB-approved study. The questionnaire used applicable questions from CTCAE v.3.0, the Brief Pain Questionnaire (Short Form), Brief Fatigue Inventory, and the Tinnitus Handicap Inventory. Questionnaires were obtained prior to Gamma Knife (GK), 1 week, 1 month, and 2 months to assess complications. Seventy-six eligible patients (median age of 62 years) had complete data and were analyzed. Diagnoses included: 26 (34%) with brain metastases, 15 (20%) with trigeminal neuralgia, 12 (16%) with schwannoma, 10 (13%) with meningioma, 7 (9%) with arteriovenous malformation, 3 (4%) with pituitary adenoma, and 3 (4%) with other. At 1 week, 24% developed minimal scalp numbness (p =0.0004 baseline compared to 1 week). Only 13% had minimal scalp numbness at 1 month and 2% at 2 months (both p=NS compared to baseline). There was no difference in scalp tingling between baseline and the various time points. Thirteen percent developed pin site pain at 1 week with a median intensity level of 2 out of 10. By one month, only 3% had pin site pain with a median intensity level of 3 out of 10. Four percent developed pin-site infection at 1 week and none at 1 and 2 months. There was no significant difference in nausea from baseline at 1 week, but there was worsening nausea at 1 month (p =0.0114). By 1 month, 10% reported new local hair loss. 23%, 16%, and 15% complained of new/worsening fatigue at 1 week, 1 month, and 2 months, respectively, but 40% reported fatigue at baseline. Balance improved following SRS over all time periods (for all comparisons, p <0.009). 1%, 6%, and 3% developed new tinnitus at 1 week, 1 month, and 2 months, respectively, which was significant when comparing baseline to non-baseline (p =0.0269). Thirty-two patients were employed prior to SRS. Three (9%) patients did not return to work. Twenty-seven (84%) patients returned to work a median of 4 days after SRS. Two people did not report their employment status after SRS. There was no significant difference in face swelling, headache, eye pain, vomiting, seizures, or passing out at any intervals compared to baseline. This prospective study demonstrates that GK is well tolerated with few patients developing major acute effects. Many patients are able to return to work shortly after GK.
authors.affiliation: Rose Ella Burkhardt Brain Tumor and Neuro-oncology Center, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, USA. chaos@ccf.org
authors.forename: Samuel T
authors.initials: ST
authors.lastname: Chao
authors.forename: Vipul V
authors.initials: VV
authors.lastname: Thakkar
authors.forename: Gene H
authors.initials: GH
authors.lastname: Barnett
authors.forename: Michael A
authors.initials: MA
authors.lastname: Vogelbaum
authors.forename: Lilyana
authors.initials: L
authors.lastname: Angelov
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Weil
authors.forename: Peter
authors.initials: P
authors.lastname: Rasmussen
authors.forename: Alwyn M
authors.initials: AM
authors.lastname: Reuther
authors.forename: Betty
authors.initials: B
authors.lastname: Jamison
authors.forename: Gennady
authors.initials: G
authors.lastname: Neyman
authors.forename: John H
authors.initials: JH
authors.lastname: Suh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000150:complications / Q000556:secondary / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008577:Meningeal Neoplasms / Q000150:complications / Q000556:secondary / Q000601:surgery*; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D016634:Radiosurgery / Q000009:adverse effects*; D055815:Young Adult