Continuous treatment with lenalidomide demonstrated activity in women with late recurrent ovarian cancer, according to results of a phase 2 study.
Frédéric Selle, MD, of the department of medical oncology at Assistance Publique — Hôpitaux de Paris in France, and colleagues assessed the safety and efficacy of continuous, daily 20 mg oral lenalidomide (Revlimid, Celgene) in 45 women with histologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
Women had asymptomatic recurrence 6 months after prior therapy. Seventy-eight percent of women had serous histology; 73% had a single line of prior chemotherapy.
Efficacy assed by disease control at 4 months served as the primary outcome measure. PFS and safety served as secondary outcomes.
Results showed median platinum-free interval (PFI) was 11.3 months (range, 6.9-56.8). The clinical benefit rate at 4 months was 38% (95% CI, 23-53). Researchers reported a higher disease control rate among women PFI longer than 12 months compared with women whose PFI was between 6 and 12 months (59% vs. 24%; P=.023).
Overall, median PFS was 3.4 months (95% CI, 2.4-4.4).
Twenty-one patients achieved stable disease. Four patients demonstrated partial responses as defined by RECIST criteria. Eight patients demonstrated CA125 responses, including one who achieved a complete response.
Eight patients withdrew due to toxicities. Twenty-nine percent of patients developed grade 3 or grade 4 neutropenia. Other common toxicities included fatigue (69%), constipation (53%), abdominal pain (49%), diarrhea (38%), nausea/vomiting (36%) and thrombosis (11%).
“Lenalidomide shows interesting efficacy in late recurrent ovarian cancer patients,” Selle and colleagues wrote. “Future studies will evaluate combination of lenalidomide with chemotherapy agents.”
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.