Posted on: 01/12/2010

 J Neurooncol. 2009 Dec 4. [Epub ahead of print]

Phase II trial of erlotinib with temozolomide and radiation in patients with newly diagnosed glioblastoma multiforme.

Peereboom DM, Shepard DR, Ahluwalia MS, Brewer CJ, Agarwal N, Stevens GH, Suh JH,
Toms SA, Vogelbaum MA, Weil RJ, Elson P, Barnett GH.

Brain Tumor and Neuro-Oncology Center, Neurological Institute, Cleveland Clinic, 
9500 Euclid Ave, Cleveland, OH, 44195, USA,

Approximately 40-50% of glioblastomas (GBM) overexpress epidermal growth factor
receptor (EGFR). Erlotinib is a specific and potent EGFR tyrosine kinase
inhibitor active against refractory GBM. Patients with non-small cell lung cancer
and >/=grade 2 erlotinib-induced rash have improved survival. This phase 2 study 
assessed the efficacy and safety of concurrent radiation therapy (RT) and
temozolomide with pharmacodynamic dose escalation of erlotinib in patients with
newly diagnosed GBM. Patients received RT 60 Gy in 30 fractions with concurrent
temozolomide 75 mg/m(2)/day x 42 days, followed in four weeks by temozolomide
150-200 mg/m(2)/day x 5, every 28 days for 12 cycles. Patients received
erlotinib, 50 mg/day and increased by 50 mg/day every 2 weeks until the
occurrence of grade 2 rash or to a maximum dose of 150 mg/day, from day 1 until
disease progression. Twenty-seven patients were treated in this study. Twenty-two
(81%) patients came off study for progressive disease (18 [67%]) or adverse
events (4 [15%]). Eighteen patients (67%) have died. Median progression-free
survival was 2.8 months, and the median overall survival was 8.6 months. Five
patients remain on study with a median follow-up of 16 months. Grade 3/4
toxicities included thrombocytopenia, anemia, lymphopenia, fatigue, and febrile
neutropenia. There were four deaths on study, three definitely treatment-related;
therefore, the trial was terminated after accrual of 27 of 30 planned patients.
Erlotinib co administered with RT and temozolomide was not efficacious and had an unacceptable toxicity.

PMID: 19960228 [PubMed - as supplied by publisher]


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