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

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.

Conflict of interest statement

Disclosures: Eileen M. O'Reilly: None; Donna Niedzwiecki: None; Margaret Hall: None; Donna Hollis: None; Tanios Bekaii-Saab: Research funding/contracted research: Pfizer; Timothy Pluard: None; Kathe Douglas: None; Ghassan K. Abou-Alfa: None; Hedy L. Kindler: Research funding/contracted research: Pfizer; Richard L. Schilsky: None; Richard M. Goldberg: Research funding/contracted research: Pfizer.

Sunitinib malate is not an approved drug for the treatment of pancreas adenocarcinoma.

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

Figures

Figure 1.

PFS in patients treated with sunitinib in the setting of prior gemcitabine treatment for metastatic pancreas adenocarcinoma. Abbreviations: CI, confidence interval; PFS, progression-free survival.

Figure 2.

OS in patients treated with sunitinib in the setting of prior gemcitabine treatment for metastatic pancreas adenocarcinoma. Abbreviations: CI, confidence interval; OS, overall survival.