A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603) Journal Article
| Authors: | 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. |
| Article Title: | 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 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. © AlphaMed Press. |
| Keywords: | adult; cancer survival; aged; major clinical study; overall survival; constipation; fatigue; neutropenia; cancer localization; erlotinib; sunitinib; cancer growth; diarrhea; drug efficacy; drug safety; drug withdrawal; gastrointestinal hemorrhage; hypertension; side effect; skin toxicity; gemcitabine; cancer radiotherapy; anorexia; progression free survival; infection; multiple cycle treatment; pain; phase 2 clinical trial; thrombocyte; bleeding; blood toxicity; kidney disease; lung disease; nausea; stomatitis; thrombocytopenia; vomiting; dehydration; qt prolongation; hypercalcemia; kidney failure; dizziness; drug fever; dyspnea; febrile neutropenia; confusion; hypokalemia; hyponatremia; prothrombin time; survival time; neutrophil; cardiovascular disease; thrombosis; drug response; muscle weakness; pancreas adenocarcinoma; hypoglycemia; metastasis potential; cancer control; heart left ventricle ejection fraction; digestive system perforation; neurologic disease; phase ii; thrombotic thrombocytopenic purpura; vascular disease; hypernatremia; hypocalcemia; refractory; bloating; calgb 80603; gastrointestinal obstruction; respiratory distress; respiratory tract hemorrhage; urinary tract obstruction |
| Journal Title: | The Oncologist |
| Volume: | 15 |
| Issue: | 12 |
| ISSN: | 1083-7159 |
| Publisher: | Oxford University Press |
| Date Published: | 2010-12-01 |
| Start Page: | 1310 |
| End Page: | 1319 |
| Language: | English |
| DOI: | 10.1634/theoncologist.2010-0152 |
| PROVIDER: | scopus |
| PUBMED: | 21148613 |
| PMCID: | PMC3227926 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1" - "Export Date: 20 April 2011" - "CODEN: OCOLF" - "Source: Scopus" |
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