ROCKVILLE, MarylandThe FDA has approved Hycamtin (topotecan, GlaxoSmithKline) in combination with cisplatin for the treatment of women with late-stage (IVB) cervical cancer that surgery or radiation appears unlikely to cure. The agency acted on the basis of a single phase III trial that showed a significant 2.9-month survival advantage in women treated with the combination vs whose who received cisplatin alone.
Hycamtin is a semisynthetic derivative of camptothecin with topoisomerase I-inhibiting activity. FDA initially approved Hycamtin for the treatment of ovarian cancer in 1996, and approved its use for small-cell lung cancer in 1998.
The phase III, randomized, multi-center trial submitted by GlaxoSmith-Kline was designed and conducted by the Gynecologic Oncology Group. Researchers enrolled 293 women for what they intended as a three-arm effort. The patients all had measurable, histological proven stage IVB, recurrent, or persistent carcinoma of the cervix, and had recovered from the effects or prior surgery, radiation, or chemoradiation. The study protocol called for assigning the participants to receive cisplatin as a single agent; Hycamtin plus cisplatin; or methotrexate, visblastine, doxorubicin, and cisplatin (MVAC). However, researchers closed the MVAC arm because of excessive toxicity after enrolling 64 patients.
Median survival among eligible patients treated with Hycamtin/cisplatin was 9.4 months vs 6.5 months for cisplatin alone (P = .033). The unadjusted hazard ratio for overall survival was 0.76.