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Am J Clin Oncol. 2018 Feb;41(2):159-162. doi: 10.1097/COC.0000000000000247.

PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study: BrUOG 244.

Author information

1
Department of Neuro-oncology, The Brown University Oncology Research Group, Providence, RI.
2
Penn State Hershey Medical Center, Hershey, PA.
3
Department of Neuro-oncology, The University of Washington Medical Center, Seattle, WA.
4
UCSD Moores Cancer Center, La Jolla, CA.
5
Department of Neuro-oncology, Thomas Jefferson University, Philadelphia, PA.
6
Department of Neuro-oncology, University of Texas Southwestern Medical Center, Dallas, TX.
7
Department of Neuro-oncology, University of Massachusetts Memorial Medical Center, Worcester, MA.
8
Department of Neuro-oncology, SUNY Upstate Medical University, Syracuse, NY.
9
Maine Center for Cancer Medicine, Portland, ME.

Abstract

PURPOSE:

Efficacy signals but substantial myelosuppression were demonstrated in a single arm phase II study of paclitaxel poliglumex (PPX) in combination with temozolomide (TMZ) and radiation therapy (RT) for first-line treatment of glioblastoma. The objective of this randomized phase II trial was to assess the efficacy and safety of single-agent PPX with RT (PPX/RT) versus TMZ with RT (TMZ/RT) for glioblastoma without O-methylguanine-DNA methyltransferase (MGMT) methylation.

MATERIALS AND METHODS:

Patients with glioblastoma with unmethylated MGMT without prior chemotherapy or RT were eligible. Patients were randomly assigned 2:1 to PPX, 50 mg/m/wk for 6 weeks, or standard TMZ, with concurrent 60.0 Gy RT. One month after completion of chemoradiation all patients received standard maintenance TMZ. The primary endpoint was progression-free survival (PFS).

RESULTS:

Of the 164 patients enrolled, 86 were MGMT unmethylated. Of these, 63 patients were randomized (42 to PPX/RT and 21 to TMZ/RT). Fifty-nine patients could be analyzed. The median PFS was 9 months in the PPX/RT group and 9.5 months in the TMZ/RT group (hazard ratio in the PPX/RT group, 1.10; 95% confidence interval, 0.79-2.08; P=0.75). Median overall survival was 16 versus 14.8 months for PPX/RT and TMZ/RT groups, respectively (hazard ratio, 1.44; 95% confidence interval, 0.75-2.77; P=0.27). In the PPX and TMZ groups 44% versus 22% of patients, respectively, experienced one or more grade 3 or higher toxicities during chemoradiation.

CONCLUSIONS:

PPX/RT did not improve PFS or overall survival. This study provides an effective trial design for screening RT sensitizers in glioblastoma.

PMID:
26658237
DOI:
10.1097/COC.0000000000000247
[Indexed for MEDLINE]

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