CONTEXT: In patients with brain metastases, it is unclear whether adding up-front whole-brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) has beneficial effects on mortality or neurologic function compared with SRS alone. OBJECTIVE: To determine if WBRT combined with SRS results in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of 132 patients with 1 to 4 brain metastases, each less than 3 cm in diameter, enrolled at 11 hospitals in Japan between October 1999 and December 2003. INTERVENTIONS: Patients were randomly assigned to receive WBRT plus SRS (65 patients) or SRS alone (67 patients). MAIN OUTCOME MEASURES: The primary end point was overall survival; secondary end points were brain tumor recurrence, salvage brain treatment, functional preservation, toxic effects of radiation, and cause of death. RESULTS: The median survival time and the 1-year actuarial survival rate were 7.5 months and 38.5% (95% confidence interval, 26.7%-50.3%) in the WBRT + SRS group and 8.0 months and 28.4% (95% confidence interval, 17.6%-39.2%) for SRS alone (P = .42). The 12-month brain tumor recurrence rate was 46.8% in the WBRT + SRS group and 76.4% for SRS alone group (P<.001). Salvage brain treatment was less frequently required in the WBRT + SRS group (n = 10) than with SRS alone (n = 29) (P<.001). Death was attributed to neurologic causes in 22.8% of patients in the WBRT + SRS group and in 19.3% of those treated with SRS alone (P = .64). There were no significant differences in systemic and neurologic functional preservation and toxic effects of radiation. CONCLUSIONS: Compared with SRS alone, the use of WBRT plus SRS did not improve survival for patients with 1 to 4 brain metastases, but intracranial relapse occurred considerably more frequently in those who did not receive WBRT. Consequently, salvage treatment is frequently required when up-front WBRT is not used. TRIAL REGISTRATION: umin.ac.jp/ctr Identifier: C000000412.
RCT Entities:
CONTEXT: In patients with brain metastases, it is unclear whether adding up-front whole-brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) has beneficial effects on mortality or neurologic function compared with SRS alone. OBJECTIVE: To determine if WBRT combined with SRS results in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of 132 patients with 1 to 4 brain metastases, each less than 3 cm in diameter, enrolled at 11 hospitals in Japan between October 1999 and December 2003. INTERVENTIONS:Patients were randomly assigned to receive WBRT plus SRS (65 patients) or SRS alone (67 patients). MAIN OUTCOME MEASURES: The primary end point was overall survival; secondary end points were brain tumor recurrence, salvage brain treatment, functional preservation, toxic effects of radiation, and cause of death. RESULTS: The median survival time and the 1-year actuarial survival rate were 7.5 months and 38.5% (95% confidence interval, 26.7%-50.3%) in the WBRT + SRS group and 8.0 months and 28.4% (95% confidence interval, 17.6%-39.2%) for SRS alone (P = .42). The 12-month brain tumor recurrence rate was 46.8% in the WBRT + SRS group and 76.4% for SRS alone group (P<.001). Salvage brain treatment was less frequently required in the WBRT + SRS group (n = 10) than with SRS alone (n = 29) (P<.001). Death was attributed to neurologic causes in 22.8% of patients in the WBRT + SRS group and in 19.3% of those treated with SRS alone (P = .64). There were no significant differences in systemic and neurologic functional preservation and toxic effects of radiation. CONCLUSIONS: Compared with SRS alone, the use of WBRT plus SRS did not improve survival for patients with 1 to 4 brain metastases, but intracranial relapse occurred considerably more frequently in those who did not receive WBRT. Consequently, salvage treatment is frequently required when up-front WBRT is not used. TRIAL REGISTRATION: umin.ac.jp/ctr Identifier: C000000412.
Authors: Louis Burt Nabors; Jana Portnow; Mario Ammirati; Henry Brem; Paul Brown; Nicholas Butowski; Marc C Chamberlain; Lisa M DeAngelis; Robert A Fenstermaker; Allan Friedman; Mark R Gilbert; Jona Hattangadi-Gluth; Deneen Hesser; Matthias Holdhoff; Larry Junck; Ronald Lawson; Jay S Loeffler; Paul L Moots; Maciej M Mrugala; Herbert B Newton; Jeffrey J Raizer; Lawrence Recht; Nicole Shonka; Dennis C Shrieve; Allen K Sills; Lode J Swinnen; David Tran; Nam Tran; Frank D Vrionis; Patrick Yung Wen; Nicole R McMillian; Maria Ho Journal: J Natl Compr Canc Netw Date: 2014-11 Impact factor: 11.908
Authors: Roshan S Prabhu; Robert H Press; Danielle M Boselli; Katherine R Miller; Scott P Lankford; Robert J McCammon; Benjamin J Moeller; John H Heinzerling; Carolina E Fasola; Kirtesh R Patel; Anthony L Asher; Ashley L Sumrall; Walter J Curran; Hui-Kuo G Shu; Stuart H Burri Journal: J Neurooncol Date: 2017-12-07 Impact factor: 4.130
Authors: Paul W Sperduto; Wen Jiang; Paul D Brown; Steve Braunstein; Penny Sneed; Daniel A Wattson; Helen A Shih; Ananta Bangdiwala; Ryan Shanley; Natalie A Lockney; Kathryn Beal; Emil Lou; Thomas Amatruda; William A Sperduto; John P Kirkpatrick; Norman Yeh; Laurie E Gaspar; Jason K Molitoris; Laura Masucci; David Roberge; James Yu; Veronica Chiang; Minesh Mehta Journal: Int J Radiat Oncol Biol Phys Date: 2017-03-29 Impact factor: 7.038
Authors: Andrea L Cheville; Jeffrey R Basford; Ian Parney; Ping Yang; Felix E Diehn Journal: Arch Phys Med Rehabil Date: 2016-09-22 Impact factor: 3.966