Radiation and concomitant weekly administration of paclitaxel in patients with glioblastoma multiforme. A phase II study

The present study was conducted to evaluate the activity and toxicity profi le of radiation (RT) and concomitant chemotherapy in patients with glioblas toma multiforme (GBM). Thirty-nine patients were treated postoperatively wi th RT and concomitant administration of paclitaxel. Cranial irradiation was initiated 2-3 weeks postoperatively and was administered in 2.0 fractions, one fraction per day, for 5 consecutive days per week, to a total of 60 Gy . Paclitaxel was delivered at a dose of 100 mg/m(2) over 3-h once weekly fo r 6 weeks. Thirty-three patients received all 6 cycles of paclitaxel according to the protocol. Totally, 217 cycles were delivered all of them at full dose. The median relative dose intensity of paclitaxel was (range 0.88-1.1). Three (7 .5%) patients achieved complete and 9 (23%) partial response, while 12 (30. 5%) patients demonstrated stabilization of the disease. Side effects from c ombined chemoradiotherapy were mainly mild. Grade III toxicity included inf ection (7.5%) and alopecia (5%). Median time to progression was 6 (range 0. 9-27) months and median survival 10.7 (range 0.9-39.5+) months. The present study has clearly shown that 100 mg/m(2) of paclitaxel in 1-h i nfusion weekly can be safely given concomitantly with RT in patients with G BM with manageable toxicity. However, the efficacy of this combined modalit y treatment does not appear to be superior to that of RT alone.