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- Title
A Cancer and Leukemia Group B Phase II Study of Sunitinib Malate in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma (CALGB 80603).
- Authors
O'REILLY, EILEEN M.; NIEDZWIECKI, DONNA; HALL, MARGARET; HOLLIS, DONNA; BEKAII-SAAB, TANIOS; PLUARD, TIMOTHY; DOUGLAS, KATHE; ABOU-ALFA, GHASSAN K.; KINDLER, HEDY L.; SCHILSKY, RICHARD L.; GOLDBERG, RICHARD M.
- Abstract
Background. The Cancer and Leukemia Group B (CALGB) conducted a phase II study evaluating sunitinib in patients with progressive metastatic pancreas adenocarcinoma following prior gemcitabine-based therapy (trial CALGB 80603; ClinicalTrials.gov identifier, NCT00397787). The primary endpoint was to determine the disease control rate (DCR) as measured by the Response Evaluation Criteria in Solid Tumors (complete response, partial response [PR], and stable disease) at 6 weeks. Patients and Methods. Patients aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 -2 and with progressive pancreas adenocarcinoma following treatment with gemcitabine were eligible. Sunitinib was dosed at 50 mg orally days 1-28, every 42 days (1 cycle). The statistical plan called for a three-stage design. A DCR ≥15% was considered worthy of further study. Results. In total, 77 patients were enrolled. Forty-two (54.6%) enrollees were male. The median age was 65 years. The ECOG performance status score distribution was: 0, 39%; 1, 50%; 2, 11%. The DCR was 21.6%; one patient (1.4%) had a PR and 15 patients (20.3%) had stable disease as their best response. The progression-free survival time was 1.31 months (95% confidence interval [CI] 1.25-1.38 months) and overall survival time was 3.68 months (95% CI, 3.06-4.24 months). Conclusions. The study met its primary endpoint; however sunitinib had minimal activity and moderate toxicity in a population of gemcitabine-refractory pancreas adenocarcinoma patients. For future studies, limiting enrollment to patients with an ECOG performance status score of 0-1 is recommended.
- Subjects
ADENOCARCINOMA; CLINICAL trials; CONFIDENCE intervals; MEDICAL cooperation; METASTASIS; HEALTH outcome assessment; NEOVASCULARIZATION inhibitors; PANCREATIC tumors; PROGNOSIS; RESEARCH; RESEARCH funding; STATISTICAL power analysis; DRUG dosage; THERAPEUTICS
- Publication
Oncologist, 2010, Vol 15, Issue 12, p1310
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2010-0152