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Am J Clin Oncol ; 41(2): 159-162, 2018 02.
Article in English | MEDLINE | ID: mdl-26658237

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.


Subject(s)
Brain Neoplasms/mortality , Brain Neoplasms/therapy , DNA Modification Methylases/metabolism , DNA Repair Enzymes/metabolism , Glioblastoma/mortality , Glioblastoma/therapy , Paclitaxel/analogs & derivatives , Polyglutamic Acid/analogs & derivatives , Tumor Suppressor Proteins/metabolism , Academic Medical Centers , Adult , Aged , Aged, 80 and over , Brain Neoplasms/pathology , DNA Methylation , Disease-Free Survival , Dose-Response Relationship, Drug , Dose-Response Relationship, Radiation , Female , Follow-Up Studies , Glioblastoma/pathology , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasm Invasiveness/pathology , Neoplasm Staging , Paclitaxel/administration & dosage , Polyglutamic Acid/administration & dosage , Radiotherapy, Adjuvant , Single-Blind Method , Survival Analysis , Treatment Outcome , United States
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