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Second-Line Chemotherapy With Irinotecan Plus Carmustine in Glioblastoma Recurrent or Progressive After First-Line Temozolomide Chemotherapy: A Phase II Study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

From the Departments of Medical Oncology, Neuroradiology, Radiotherapy, Neurological Sciences, University Hospital of Padova, Department of Radiochemotherapy, San Raffaele Hospital, Milan, Department of Medical Oncology, Ospedale S. Chiara, Trento, Italy

Address reprint requests to Alba A. Brandes, MD, Department of Medical Oncology, University Hospital, Via Gattamelata 64, Padova, Italy; e-mail: aabrandes{at}unipd.it

PURPOSE: Glioblastoma multiforme (GBM), the most frequent brain tumor in adults, is not considered chemosensitive. Nevertheless, there is widespread use of first-line chemotherapy, often with temozolomide, as a therapeutic option in patients with progressive disease after surgery and radiotherapy. However, at the time of second recurrence and/or progression, active and noncross-resistant chemotherapy regimens are required. The aim of the present multicenter phase II trial, therefore, was to ascertain the efficacy of second-line carmustine (BCNU) and irinotecan chemotherapy.

PATIENTS AND METHODS: Patients with histologically confirmed GBM, recurring or progressing after surgery, standard radiotherapy and a first-line temozolomide-based chemotherapy, were considered eligible. The primary end-point was progression-free survival at 6 months (PFS-6), and secondary end-points included response rate, toxicity, and survival. All patients were on enzyme-inducing antiepileptic prophylaxis. Chemotherapy consisted of BCNU (100 mg/m² on day 1) plus irinotecan (175 mg/m²/weekly for 4 weeks), every 6 weeks, for a maximum of eight cycles. In the absence of grade 2 toxicity, the irinotecan dose was increased to 200 mg/m².

RESULTS: A total of 42 patients (median age, 53.4 years; median Karnofsky performance status, 80; range, 60 to 90) were included in the study. PFS-6 was 30.3% (95% CI, 18.5% to 49.7%). Median time to progression was 17 weeks (95% CI, 11.9 to 23.9). Nine partial responses (21.4%; 95% CI, 9% to 34%) were obtained. Toxicity was manageable.

CONCLUSION: The BCNU plus irinotecan regimen seems active and non–cross-resistant in patients with GBM with recurrence after temozolomide-based chemotherapy.

Presented in part at the Poster Discussion Session of the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, June 5-8, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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