title: Is surgery at progression a prognostic marker for improved 6-month progression-free survival or overall survival for patients with recurrent glioblastoma?
abstract: Historically, the North American Brain Tumor Consortium used 6-month progression-free survival (PFS6) as the primary outcome for recurrent glioma phase II clinical trials. In some trials, a subset of patients received the trial treatment before surgery to assess tumor uptake and biological activity. We compared PFS6 and overall survival (OS) for patients with glioblastoma undergoing surgery at progression to results for those without surgery to evaluate the impact of surgical intervention on these outcomes. Two data sets were analyzed. The first included 511 patients enrolled during the period 1998-2005, 105 of whom had surgery (excluding biopsies) during the study or ≤ 30 days prior to registration. Analysis was stratified on the basis of whether temozolomide was part of the protocol treatment regimen. The second data set included 247 patients enrolled during 2005-2008, 103 of whom underwent surgery during the clinical trial or immediately prior to study registration. A combined data set consisting of all patients who did not receive temozolomide was also compiled. No statistically significant difference in PFS6 or OS was found between the surgery and nonsurgery groups in either data set alone or in the combined data set (P > .45). We conclude that PFS6 and OS results for patients with and without surgical intervention at the time of progression are similar, allowing data from these patients to be combined in assessing the benefit of new treatments without the need for stratification or other statistical adjustment.
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, 400 Parnassus Avenue, A-808, San Francisco, CA 94143-0372, USA. clarkej@neurosurg.ucsf.edu
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Clarke
authors.forename: Michele M
authors.initials: MM
authors.lastname: Ennis
authors.forename: W K Alfred
authors.initials: WK
authors.lastname: Yung
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Cloughesy
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Deangelis
authors.forename: H Ian
authors.initials: HI
authors.lastname: Robins
authors.forename: Frank S
authors.initials: FS
authors.lastname: Lieberman
authors.forename: Howard A
authors.initials: HA
authors.lastname: Fine
authors.forename: Lauren
authors.initials: L
authors.lastname: Abrey
authors.forename: Mark R
authors.initials: MR
authors.lastname: Gilbert
authors.forename: Minesh
authors.initials: M
authors.lastname: Mehta
authors.forename: John G
authors.initials: JG
authors.lastname: Kuhn
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Aldape
authors.forename: Kathleen R
authors.initials: KR
authors.lastname: Lamborn
authors.forename: Michael D
authors.initials: MD
authors.lastname: Prados
mesh_terms: D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000401:mortality* / Q000601:surgery*; D017322:Clinical Trials, Phase II as Topic; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000401:mortality* / Q000601:surgery*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality* / Q000601:surgery*; D011379:Prognosis