NRG Oncology/RTOG1205: A Randomized Phase II Trial of Concurrent Bevacizumab and Reirradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

Author(s): Christina I. Tsien, MD1; Stephanie L. Pugh, PhD2; Adam P. Dicker, MD, PhD3; Jeffrey J. Raizer, MD4; Martha M. Matuszak, PhD5; Enrico C. Lallana, MD6; Jiayi Huang, MD7; Ozer Algan, MD8; Nimisha Deb, MD9; Lorraine Portelance, MD10; John L. Villano, MD, PhD11; John T. Hamm, MD12; Kevin S. Oh, MD13; Arif N. Ali, MD14; Michelle M. Kim, MD15; Scott M. Lindhorst, MD16; and Minesh P. Mehta, MD17
Source: DOI: 10.1200/JCO.22.00164 Journal of Clinical Oncology 41, no. 6 (February 20, 2023) 1285-1295.

Dr. Maen Hussein's Thoughts

Interesting enough, a patient asked me this question last week. IT IS DOABLE and seems to help in improving PFS. I hope one of our FCS radiation oncologists will share their thoughts, too.

PURPOSE

To assess whether reirradiation (re-RT) and concurrent bevacizumab (BEV) improve overall survival (OS) and/or progression-free survival (PFS), compared with BEV alone in recurrent glioblastoma (GBM). The primary objective was OS, and secondary objectives included PFS, response rate, and treatment adverse events (AEs) including delayed CNS toxicities.

METHODS

NRG Oncology/RTOG1205 is a prospective, phase II, randomized trial of re-RT and BEV versus BEV alone. Stratification factors included age, resection, and Karnofsky performance status (KPS). Patients with recurrent GBM with imaging evidence of tumor progression ≥ 6 months from completion of prior chemo-RT were eligible. Patients were randomly assigned 1:1 to re-RT, 35 Gy in 10 fractions, with concurrent BEV IV 10 mg/kg once in every 2 weeks or BEV alone until progression.

RESULTS

From December 2012 to April 2016, 182 patients were randomly assigned, of whom 170 were eligible. Patient characteristics were well balanced between arms. The median follow-up for censored patients was 12.8 months. There was no improvement in OS for BEV + RT, hazard ratio, 0.98; 80% CI, 0.79 to 1.23; P = .46; the median survival time was 10.1 versus 9.7 months for BEV + RT versus BEV alone. The median PFS for BEV + RT was 7.1 versus 3.8 months for BEV, hazard ratio, 0.73; 95% CI, 0.53 to 1.0; P = .05. The 6-month PFS rate improved from 29.1% (95% CI, 19.1 to 39.1) for BEV to 54.3% (95% CI, 43.5 to 65.1) for BEV + RT, P = .001. Treatment was well tolerated. There were a 5% rate of acute grade 3+ treatment-related AEs and no delayed high-grade AEs. Most patients died of recurrent GBM.

CONCLUSION

To our knowledge, NRG Oncology/RTOG1205 is the first prospective, randomized multi-institutional study to evaluate the safety and efficacy of re-RT in recurrent GBM using modern RT techniques. Overall, re-RT was shown to be safe and well tolerated. BEV + RT demonstrated a clinically meaningful improvement in PFS, specifically the 6-month PFS rate but no difference in OS.

Author Affiliations

1Johns Hopkins School of Medicine, Baltimore, MD;2NRG Oncology Statistics and Data Management Center, Philadelphia, PA;3Thomas Jefferson University, Philadelphia, PA;4Northwestern University, Chicago, IL;5University of Michigan, Ann Arbor, MI;6Kaiser Permanente Sacramento Medical Center, Sacramento, CA;7Washington University School of Medicine in St Louis-Siteman Cancer Center, St. Louis, MO;8University of Oklahoma Health Sciences Center, Oklahoma City, OK;9St Luke’s University Hospital & Health Network accruals Thomas Jefferson University Hospital, Bethlehem, PA;10University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center, Miami, FL;11University of Kentucky/Markey Cancer Center, Lexington, KY;12Norton Hospital Pavilion and Medical Campus, Louisville, KY;13Dana-Farber/Harvard Cancer Center, Boston, MA;14The Hope Center accruals Emory University/Winship Cancer Institute, Dalton, GA;15University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;16Medical University of South Carolina Minority Underserved NCORP, Charleston, SC;17Miami Cancer Institute, Miami, FL

1 thought on “NRG Oncology/RTOG1205: A Randomized Phase II Trial of Concurrent Bevacizumab and Reirradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma”

  1. Challenging disease; Helpful information to allow offering of a short “palliative” course of XRT re irradiation to slow progression of symptoms during a patient’s often final year of life.

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