John K Chan1, William Brady2, Bradley J Monk3, Jubilee Brown4, Mark S Shahin5, Peter G Rose6, Jae-Hoon Kim7, Angeles Alvarez Secord8, Joan L Walker9, David M Gershenson10. 1. Division of Gynecologic Oncology, California Pacific-Palo Alto Medical Foundation, Sutter Research Institute, San Francisco, CA 94115, United States. Electronic address: chanjohn@sutterhealth.org. 2. NRG Oncology/Gynecologic Oncology Group Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: wbrady@gogstats.org. 3. Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix, AZ 85016, United States. Electronic address: Bradley.Monk@usoncology.com. 4. Department of Gynecologic Oncology, MD Anderson Cancer Center, Houston, TX 77230, United States. Electronic address: jubilee.brown@carolinashealthcare.org. 5. Department of Obstetrics & Gynecology, Abington Hospital-Jefferson Health, Abington, PA 19001, United States. Electronic address: Mark.Shahin@jefferson.edu. 6. Department of Gynecologic Oncology, Cleveland Clinic, Cleveland, OH 44195, United States. Electronic address: rosep@ccf.org. 7. Department of Gynecologic Oncology, Gangann Severence Hospital, Seoul 06273, Republic of Korea. Electronic address: jaehoonkim@yuhs.ac. 8. Division of Gynecologic Oncology, Duke Cancer Institute, Durham, NC 27710, United States. Electronic address: secor002@mc.duke.edu. 9. Department of Gynecologic Oncology, Oklahoma University, Stephenson Cancer Center, Oklahoma City, OK 73104, United States. Electronic address: joan-walker@ouhsc.edu. 10. Department of GYN/ONC, Unit 1362, The University of Texas, MD Anderson Cancer Center, Houston, TX 77230, United States. Electronic address: dgershen@mdanderson.org.
Abstract
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.
OBJECTIVES: To determine the efficacy and tolerability of sunitinib in recurrent or persistent clear cell ovarian cancerpatients. 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.
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