A Cancer and Leukemia Group B Phase II Study of Sunitinib Malate in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma (CALGB 80603)
A Cancer and Leukemia Group B Phase II Study of Sunitinib Malate in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma (CALGB 80603)
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DOI：
10.1634/theoncologist.2010-0152
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发表时间：
2010-12-01
期刊：
影响因子：
5.8
通讯作者：
Goldberg, Richard M.
中科院分区：
文献类型：
--
作者：
O'Reilly, Eileen M.;Niedzwiecki, Donna;Goldberg, Richard M.
背景癌症和白血病组B（CALGB）进行了一项II期研究，评价舒尼替尼在既往接受基于吉西他滨治疗的进展性转移性胰腺癌患者中的疗效（试验CALGB 80603; ClinicalTrials.政府标识符，NCT 00397787）。主要终点是确定6周时根据实体瘤反应评价标准（完全反应、部分反应[PR]和疾病稳定）测量的疾病控制率（DCR）。年龄≥ 18岁、东部肿瘤协作组（ECOG）体力状态评分为0-2分且在吉西他滨治疗后患有进展性胰腺癌的患者符合资格。舒尼替尼50 mg口服给药，第1-28天，每42天一次（1个周期）。统计计划要求分三个阶段设计。DCR >= 15%的病例值得进一步研究。共入组77例患者。42例（54.6%）入组者为男性。中位年龄为65岁。ECOG体能状态评分分布为：0，39%; 1，50%; 2，11%。DCR为21.6%; 1例患者（1.4%）的最佳缓解为PR，15例患者（20.3%）的最佳缓解为疾病稳定。无进展生存期为1.31个月（95%CI 1.25-1.38个月），总生存期为3.68个月（95%CI 3.06-4.24个月）。该研究达到了其主要终点;然而，舒尼替尼在吉西他滨难治性胰腺癌患者群体中具有最小活性和中度毒性。对于未来的研究，建议将入组限制在ECOG体能状态评分为0-1的患者。肿瘤学家2010;15：1310-1319
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 progres-sion-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. The Oncologist 2010;15:1310-1319