Tom[a]
Concurrent chemoradiotherapy in chemo- naive operated glioblastoma multiforme: a phase II study
Bhawana S Awasthy, Renita Bhamrah, Omana Nair, Rajvir Singh, Goura K Rath, Chitra Sarkar, Veer S Mehta, Pramod K Julka, All India Institute of Medical Sciences, New Delhi, India.
Purpose:
Amongst all malignant brain tumors, glioblastoma multiforme (GBM) is associated with the poorest prognosis. Chemotherapy (CT) has been shown to have a positive impact when added to surgery and radiotherapy (RT). The optimal timing of CT is still unknown. Docetaxel is a potent radio sensitizer and has been shown to be safe when given as 23mg/sq m biweekly with radiation in GBM. We conducted a phase II study to determine the feasibility and efficacy of conventional External Beam RT (EBRT) and concurrent weekly docetaxel.
Material and Methods:
Thirty-one patients with a histological diagnosis of GBM were enrolled from February 2000 to Feb 2001. Total EBRT dose was 66Gy (200cGy per fraction), 5 days a week with the field size reduced to include gross disease with margin only after 50 Gy. Docetaxel was administered at a dose of 40 mg/sq m weekly on the first treatment day of each RT week.
Results:
All the patients were evaluable. Median age was 51 years (range 18 to 70 years). Median KPS at study entry was 80. Gross total resection was performed in 42% of patients. The mean tumor volume was 85 cc. Twenty-nine patients (94%) completed therapy as per the protocol. There were no grade 3 or 4 neutropenia, thrombocytopenia or non-hematological toxicities. The observed response rate was 52%, with 8 (26%) CR and 8 (26%) PR. 45% demonstrated progressive disease. Median survival is 64 weeks. Mature time to event analysis would be presented.
Conclusion:
Concurrent full dose EBRT and weekly docetaxel is feasible in the majority of GBM patients. Acute toxicity is acceptable; median survival is comparable to reports in literature using adjuvant chemotherapy after EBRT. Large, randomised studies on concurrent chemoradiation are warranted.
Source: ASCO