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Clinical Trial
. 2013 Apr 1;85(5):1206-11.
doi: 10.1016/j.ijrobp.2012.10.008. Epub 2012 Nov 22.

RTOG 0211: a phase 1/2 study of radiation therapy with concurrent gefitinib for newly diagnosed glioblastoma patients

Arnab Chakravarti  1 , Meihua Wang, H Ian Robins, Tim Lautenschlaeger, Walter J Curran, David G Brachman, Christopher J Schultz, Ali Choucair, Marisa Dolled-Filhart, Jason Christiansen, Mark Gustavson, Annette Molinaro, Paul Mischel, Adam P Dicker, Markus Bredel, Minesh Mehta
Affiliations
Clinical Trial

RTOG 0211: a phase 1/2 study of radiation therapy with concurrent gefitinib for newly diagnosed glioblastoma patients

Arnab Chakravarti et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: To determine the safety and efficacy of gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with radiation for newly diagnosed glioblastoma (GBM) patients.

Methods and materials: Between March 21, 2002, and May 3, 2004, Radiation Therapy Oncology Group (RTOG) 0211 enrolled 31 and 147 GBM patients in the phase 1 and 2 arms, respectively. Treatment consisted of daily oral gefinitnib started at the time of conventional cranial radiation therapy (RT) and continued post RT for 18 months or until progression. Tissue microarrays from 68 cases were analyzed for EGFR expression.

Results: The maximum tolerated dose (MTD) of gefitinib was determined to be 500 mg in patients on non-enzyme-inducing anticonvulsant drugs (non-EIAEDs). All patients in the phase 2 component were treated at a gefitinib dose of 500 mg; patients receiving EIADSs could be escalated to 750 mg. The most common side effects of gefitinib in combination with radiation were dermatologic and gastrointestinal. Median survival was 11.5 months for patients treated per protocol. There was no overall survival benefit for patients treated with gefitinib + RT when compared with a historical cohort of patients treated with RT alone, matched by RTOG recursive partitioning analysis (RPA) class distribution. Younger age was significantly associated with better outcome. Per protocol stratification, EGFR expression was not found to be of prognostic value for gefitinib + RT-treated patients.

Conclusions: The addition of gefitinib to RT is well tolerated. Median survival of RTOG 0211 patients treated with RT with concurrent and adjuvant gefitinib was similar to that in a historical control cohort treated with radiation alone.

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Figures

Figure 1
Figure 1. Progression-Free Survival
119 patients were identified to have been treated per protocol or with acceptable deviation. The progression free survival at 6 months was 40 %.
Figure 2
Figure 2. Overall survival
The median OS for patients treated on RTOG 0211 per protocol or with acceptable deviation was 11.5 months versus 11.0 months for historical controls treated by RT alone (HR (0211 v. historical control) = 1.14; 95%CI: 0.94 – 1.37; p (one-sided) = 0.91).
See this image and copyright information in PMC

Comment in

  • In regard to Chakravarti et al.
    Vargo JA, Flickinger JC, Beriwal S. Vargo JA, et al. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):398-9. doi: 10.1016/j.ijrobp.2013.02.029. Int J Radiat Oncol Biol Phys. 2013. PMID: 23708078 No abstract available.

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