A Phase III study of radiation therapy (RT) and O super(6)-benzylguanine + BCNU versus RT and BCNU alone and methylation status in newly diagnosed glioblastoma and gliosarcoma: Southwest Oncology Group (SWOG) study S0001

• Published in: International journal of clinical oncology 2015-08, Vol.20 (4), p.650-658
• Main Authors: Blumenthal, Deborah T, Rankin, Cathryn, Stelzer, Keith J, Spence, Alexander M, Sloan, Andrew E, Moore, Dennis F, Padula, Gilbert DA, Schulman, Susan B, Wade, Mark L, Rushing, Elisabeth J
• Format: Article
• Language: English
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-014-0769-0

Aims: To determine the efficacy of methylguanine methyltransferase (MGMT) depletion + BCNU [1,3-bis(2-chloroethyl)-1- nitrosourea: carmustine] therapy and the impact of methylation status in adults with glioblastoma multiforme (GBM) and gliosarcoma. Methods: Methylation analysis was performed on GBM patients with adequate tissue samples. Patients with newly diagnosed GBM or gliosarcoma were eligible for this Phase III open-label clinical trial. At registration, patients were randomized to Arm 1, which consisted of therapy with O super(6)-benzylguanine (O super(6)-BG) + BCNU 40 mg/m super(2) (reduced dose) + radiation therapy (RT) (O6BG + BCNU arm), or Arm 2, which consisted of therapy with BCNU 200 mg/m super(2) + RT (BCNU arm). Results: A total of 183 patients with newly diagnosed GBM or gliosarcoma from 42 U.S. institutions were enrolled in this study. Of these, 90 eligible patients received O super(6)-BG + BCNU + RT and 89 received BCNU + RT. The trial was halted at the first interim analysis in accordance with the guidelines for stopping the study due to futility (