Cilengitide with metronomic temozolomide, procarbazine, and standard radiotherapy in patients with glioblastoma and unmethylated MGMT gene promoter in ExCentric, an open-label phase II trial.

Mustafa Khasraw, Adrian Lee, Sally McCowatt, Zoltan Kerestes, Marc Buyse, Michael Back, Ganessan Kichenadasse, Stephen Ackland, Helen Wheeler

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    21 Citations (Scopus)

    Abstract

    Newly diagnosed glioblastoma multiforme with unmethylated MGMT promoter has a poor prognosis, with a median survival of 12 months. This phase II study investigated the efficacy and safety of combining the selective integrin inhibitor cilengitide with a combination of metronomic temozolomide and procarbazine for these patients. Eligible patients (newly diagnosed, histologically confirmed supratentorial glioblastoma with unmethylated MGMT promoter) were entered into this multicentre study. Cilengitide (2000 mg IV twice weekly) was commenced 1 week prior to radiotherapy combined with daily temozolomide (60 mg/m2) and procarbazine (50 or 100 mg) and, after 4 weeks’ break, followed by six adjuvant cycles of temozolomide (50–60 mg/m2) and procarbazine (50 or 100 mg) on days 1–20, every 28 days. Cilengitide was continued for up to 12 months or until disease progression or unacceptable toxicity. The primary endpoint for efficacy was a 12-month overall survival rate of 65 %. Twenty-nine patients completed study treatment. Sixteen patients survived for 12 months or more, an overall survival rate of 55 %. The median overall survival was 14.5 months (95 % CI 11.1–19.6) and the median progression-free survival was 7.4 months (95 % CI 6.1–8). Cilengitide combined with metronomic temozolomide and procarbazine in MGMT-promoter unmethylated glioblastoma did not improve survival compared with historical data and does not warrant further investigation.

    Original languageEnglish
    Pages (from-to)163-171
    Number of pages9
    JournalJOURNAL OF NEURO-ONCOLOGY
    Volume128
    Issue number1
    DOIs
    Publication statusE-pub ahead of print - 2016

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