First-line chemotherapy with paclitaxel and platinum for advanced and recurrent cancer of the cervix - A phase II study

Objective. The aim of this study was to assess the role of first-line chemo therapy with paclitaxel and platinum in the treatment of advanced or recurr ent cervix cancer. Methods. Twenty patients with advanced or recurrent cancer of the cervix wi th no prior chemotherapy and measurable disease were entered in a phase LT trial from September 1995 to September 1998. Seventeen patients were treate d with paclitaxel at 135 mg/m(2) over 24 h followed by cisplatin at 75 mg/m (2) every 4 weeks. Three patients with impaired renal function were treated with paclitaxel at 135 mg/m(2) over 3 h with carboplatin at 300 mg/m(2). Results. A clinical response rate of 45% was noted (two complete responses and seven partial responses) with a median duration of 6 months (range: 1.5 -9). The median progression-free interval and overall survival in patients with a clinical response was 10.5 and 13 months, respectively, compared to 4 (P = 0.015) and 6 months in the nonresponders (P = 0.14). Seven of nine p atients (77.8%) with a clinical response are alive. Patients with recurrenc es outside the radiation field had twice the response rate (60%) than that of those within the radiated field. The chemotherapy was well tolerated; th e most significant toxicity was grade 3/4 neutropenia (55%). No patient had discontinuation of chemotherapy due to toxicity. Conclusions. First-line chemotherapy with paclitaxel and platinum for advan ced and recurrent cervix cancer is promising and deserves consideration for large phase III trials. (C) 1999 Academic Press.