Among women with newly diagnosed, advanced ovarian cancer, treatment with Hycamtin® (topotecan) and cisplatin prior to standard chemotherapy increases side effects and does not improve progression-free survival. These results were published in the Journal of the National Cancer Institute.
Ovarian cancer has the highest mortality rate of all gynecologic cancers. It is the fifth leading cause of cancer death among U.S. women, with an estimated 21,550 new cases and 14,600 deaths in 2009.
Treatment for ovarian cancer often involves surgery and chemotherapy. Chemotherapy regimens that may be used in the initial treatment of advanced ovarian cancer include cisplatin plus paclitaxel and carboplatin plus paclitaxel. In spite of treatment, outcomes for women diagnosed with advanced disease remain poor, and researchers continue to evaluate new approaches to treatment.
Hycamtin is a drug that has shown activity against recurrent ovarian cancer. To evaluate Hycamtin in the initial treatment of ovarian cancer, researchers conducted a Phase III clinical trial among 819 women with newly diagnosed Stage IIB or greater ovarian cancer.
Study participants were assigned to one of two treatment groups:
1.Hycamtin and cisplatin followed by standard chemotherapy, or
2.Standard chemotherapy alone
Standard chemotherapy consisted of carboplatin and paclitaxel.
- Patients treated with Hycamtin and cisplatin prior to standard chemotherapy experienced more side effects and hospitalizations than patients treated with standard chemotherapy alone.
- Progression-free survival was similar in the two study groups: 14.6 months among patients treated with Hycamtin and cisplatin, and 16.2 months among patients treated with standard chemotherapy alone.
The researchers conclude that Hycamtin and cisplatin, followed by carboplatin and paclitaxel, is more toxic than carboplatin and paclitaxel alone and does not improve treatment outcomes.
Reference: Hoskins P, Vergote I, Cervantes A et al. Advanced ovarian cancer: Phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel vs carboplatin-paclitaxel. Journal of the National Cancer Institute [early online publication]. October 11, 2010.