A Phase II Study of Patupilone (EPO906) in Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer

Abstract

Background

Patients with ovarian cancer whose disease relapses or progresses within 6 months after frontline platinum- and taxane-containing therapy have a poor prognosis and limited treatment options. In this phase II study, the activity and safety profiles of patupilone, a novel microtubule-targeting agent, were assessed in patients with platinum-resistant or -refractory ovarian, primary fallopian tube, or primary peritoneal cancer.

Patients and Methods

Patients whose disease relapsed while they were either receiving or within 6 months after completion of their most recent platinum-based therapy were given patupilone 10 mg/m² by a 20-minute intravenous infusion once every 3 weeks (q3w). The primary study endpoint was the overall response rate (ORR), defined as the percentage of patients with a complete or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).

Results

Patients (N = 112) received a median of 4 cycles of patupilone. Median overall survival was 11.2 months. The ORR was 6.3%. Disease control according to RECIST was observed in 57 (50.9%) patients (7 [6.3%] PRs, 50 [44.6%] stable disease). Median duration of disease control was 5.4 months, whereas median progression-free survival was 2.8 months. Diarrhea, the most common adverse event (AE) regardless of relationship to study drug (55.4% grade 1/2, 25.0% grade 3/4), was predictable and generally manageable. Other AEs, including nausea, vomiting, fatigue, and peripheral neuropathy, were generally mild.

Conclusion

Patupilone was well tolerated and demonstrated an encouraging disease control rate in these patients with platinum-resistant or -refractory disease; this is a challenging population with a poor prognosis.