A Cancer and Leukemia group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603)

Eileen M. O'reilly, Donna Niedzwiecki, Margaret Hall, Donna Hollis, Tanios Bekaii-Saab, Timothy Pluard, Kathe Douglas, Ghassan K. Abou-Alfa, Hedy L. Kindler, Richard L. Schilsky, Richard M. Goldberg

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55 Scopus citations

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 gemcitabinebased 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.

Original languageEnglish (US)
Pages (from-to)1310-1319
Number of pages10
JournalOncologist
Volume15
Issue number12
DOIs
StatePublished - Dec 1 2010

Keywords

  • CALGB 80603
  • Pancreas adenocarcinoma
  • Phase II
  • Refractory
  • Sunitinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    O'reilly, E. M., Niedzwiecki, D., Hall, M., Hollis, D., Bekaii-Saab, T., Pluard, T., Douglas, K., Abou-Alfa, G. K., Kindler, H. L., Schilsky, R. L., & Goldberg, R. M. (2010). A Cancer and Leukemia group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603). Oncologist, 15(12), 1310-1319. https://doi.org/10.1634/theoncologist.2010-0152