Is surgery at progression a prognostic marker for improved 6-month progression-free survival or overall survival for patients with recurrent glioblastoma? Journal Article

   

Authors:	Clarke, J. L.; Ennis, M. M.; Yung, W. K. A.; Chang, S. M.; Wen, P. Y.; Cloughesy, T. F.; Deangelis, L. M.; Robins, H. I.; Lieberman, F. S.; Fine, H. A.; Abrey, L.; Gilbert, M. R.; Mehta, M.; Kuhn, J. G.; Aldape, K. D.; Lamborn, K. R.; Prados, M. D.
Article 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. © The Author(s) 2011.
Keywords:	adult; controlled study; aged; cancer surgery; unclassified drug; major clinical study; overall survival; thalidomide; review; sorafenib; erlotinib; cancer combination chemotherapy; cancer growth; cancer patient; temozolomide; antineoplastic agent; imatinib; carboplatin; progression free survival; recurrence; carmustine; irinotecan; temsirolimus; glioblastoma; gefitinib; tipifarnib; aflibercept; pazopanib; surgery; cancer registry; retinoic acid; lapatinib; thymidine; fenretinide; phase 2 clinical trial (topic); pfs6; desipeptide; emd0121974
Journal Title:	Neuro-Oncology
Volume:	13
Issue:	10
ISSN:	1522-8517
Publisher:	Oxford University Press
Date Published:	2011-10-01
Start Page:	1118
End Page:	1124
Language:	English
DOI:	10.1093/neuonc/nor110
PROVIDER:	scopus
PMCID:	PMC3177665
PUBMED:	21813511
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-80755159093&partnerID=40&md5=dbc19f3068b36feb9dd32b93777c3933
Notes:	--- - "Export Date: 9 December 2011" - "CODEN: NEURJ" - "Source: Scopus"

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