Tom[a]
Phase II trial with carboplatin (CBCDA) and etoposide (VP-16) in recurrent high grade gliomas
Giovanna Cavallo, Luciano Scopece, Enrico Franceschi, Roberta Degli Esposti, Elisabetta Setola, Cesare Calandri, Samir Darwish, Lucio Crino, Dept of Oncology - Bellaria Hospital, Bologna, Italy; Div of Oncology - Policlinico Monteluce, Perugia, Italy.
Purpose: To assess the activity and tolerability of the CBCDA + VP-16 regimen as first line chemotherapy in patients with recurrent glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). From January 1996 to February 2000, 30 patients with histologically confirmed GBM (25) and AA (5) were treated at our institution with VP-16 120 mg/m2 and CBCDA 100 mg/m2 for three days every 4 weeks. Median age was 54 years (21-73), ECOG performance score was 0-1 in 25 patients and 2 in 5 patients. All had been previously treated with surgical resection (21 radical resections) followed by radiation therapy (40-60 Gy).
Results: Response to chemotherapy was assessed in all 30 patients : we observed 7( 23.3%) complete responses (CR), 3 (10%) partial responses (PR), 11 (36.7%) stable diseases (SD), with CR+PR = 33.3%. Median TTP was 9.6 months while progression free survival at 6 months and at 12 months was 30% and 23.3% respectively. Median survival time was 14.5 months with 100% of the patients alive at 6 months, 76.7% at 12 months and 33.3% at 18 months. Treatment related haematological toxicity (according to ECOG criteria) occurred in 11 patients: four patients had grade 4, three grade 3 and four grade 2 neutropenia. Second line treatment with Temozolomide was given to 11 patients either refractory or relapsing after CBCDA-VP16. No responses were observed and only 4 patients had stable disease. Conclusion: in this clinical trial CBCDA + VP-16 has shown activity in recurrent AA e GBM, with a good toxicity profile.
Source: ASCO