The role of paclitaxel in the management of patients with carcinoma of the cervix.

The major role for systemic therapy in the management of carcinoma of the cervix is to treat those patients with advanced or recurrent disease. While 19 single agents have activity, defined as a response rate > or = 15%, the agents that have attracted the greatest attention are the platinum compounds and ifosfamide. Combinations of these two drugs have produced high response rates in phase II trials. A recent randomized trial found that a combination of ifosfamide/cisplatin yielded a superior response rate to cisplatin alone (33% v 19%), although no differences in progression-free or overall survival were observed. While ongoing randomized trials continue to explore platinum/ifosfamide combinations, current attention also is directed to paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), which has demonstrated activity in a phase II trial (18% response rate). The Gynecologic Oncology Group plans to conduct a phase II trial of a platinum/paclitaxel combination and may follow it with a phase III trial of the same combination if the phase II results suggest enhanced therapeutic benefit. Randomized trials in patients with less advanced (stages IIB to IVA) disease have demonstrated superior response rates and overall survival with concomitant chemoradiation. Regimens of demonstrated efficacy in this setting include hydroxyurea plus radiation and cisplatin/5-fluorouracil plus radiation. The Gynecologic Oncology Group currently is conducting a phase I trial of concomitant paclitaxel plus radiation and may consider a paclitaxel-based regimen in future phase III trials of concomitant chemoradiation or possibly neoadjuvant chemotherapy in patients with limited disease (stages IIB to IVA).