Objectives: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancer patients. Methods: All patients had one or two prior regimens with measurable disease. Tumors were at least 50% clear cell histomorphology and negative for WT-1 antigen and estrogen receptor expression by immunohistochemistry. Sunitinib 50 mg per day for 4 weeks was administered in repeated 6-week cycles until disease progression or prohibitive toxicity. Primary end points were progression-free survival (PFS) at 6 months and clinical response. The study was designed to determine if the drug had a response rate of at least 20% or 6-month PFS of at least 25%. Results: Of 35 patients enrolled, 30 were treated and eligible (median age: 51, range: 27–73). Twenty-five (83%) were White, 4 (13%) Asian, and 1 (3%) unknown. The majority 28 (83%) patients, underwent ≤3 but 2 (7%) had 16 courses of study therapy. Five (16.7%) patients had PFS ≥6 months (90% CI: 6.8%–31.9%). Two (6.7%) patients had a partial or complete response (90% CI: 1.2%–19.5%). The median PFS was 2.7 months. The median overall survival was 12.8 months. The most common grade 3 adverse events were fatigue (4), hypertension (4), neutropenia (4), anemia (3), abdominal pain (3), and leukopenia (3). Grade 4–5 adverse events included: thrombocytopenia (5), anemia (2), acute kidney Injury (1), stroke (1), and allergic reaction (1). Conclusion: Sunitinib demonstrated minimal activity in the second- and third-line treatment of persistent or recurrent clear cell ovarian carcinoma. ClinicalTrials.gov number, NCT00979992.
Bibliographical noteFunding Information:
This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group (GOG) Administrative Office ( CA 27469 ), the Gynecologic Oncology Group Statistical Office ( CA 37517 ), NRG Oncology ( 1 U10 CA180822 ) and NRG Operations ( U10CA180868 ), and Pfizer . The following Gynecologic Oncology institutions participated in this study: MD Anderson Cancer Center, UCSF-Mount Zion, Washington University School of Medicine, Duke University Medical Center, Abington Memorial Hospital, Cleveland Clinic Foundation, Seoul National University Hospital, University of Alabama at Birmingham, University of Colorado Cancer Center – Anschutz Cancer Pavilion, University of California Medical Center at Irvine-Orange Campus, Rush University Medical Center, University of Oklahoma Health Sciences Center, Case Western Reserve University, Carolinas Medical Center/Levine Cancer Institute, University of Iowa Hospitals and Clinics and Women and Infants Hospital. We would like to acknowledge The Fisher Family Foundation, Denise Cobb Hale, and Dr. John A. Kerner for their generous administrative research support.
All Science Journal Classification (ASJC) codes
- Obstetrics and Gynaecology