Department of Gastrointestinal Medical Oncology, University of Texas, M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 426, Houston, TX 77030, USA.
Int J Clin Oncol. 2013 Apr;18(2):226-31. doi: 10.1007/s10147-011-0366-4. Epub 2012 Jan 5.
Preclinical and clinical data suggest synergy for gemcitabine and oxaliplatin. These agents were tested in several known cancers that also comprise the common carcinoma of unknown primary (CUP) subtypes; namely, lung and pancreaticobiliary profiles.
The study enrolled 29 patients of whom 28 patients were eligible for treatment. Gemcitabine was given at 1,000 mg/m(2) as a fixed dose rate infusion and oxaliplatin was infused at 100 mg/m(2) every 2 weeks with restaging performed after 3 cycles at 6 weeks.
The study reported one complete response (CR) (4%), 6 patients with a partial response (PR) (25%), and 13 with stable disease (SD) (54%); and 4 patients had progressive disease (PD) (17%) on restaging. Median overall survival (OS) and progression-free survival were 12.8 months (95% confidence interval [CI] 8.5-18.5) and 3.1 months (95% CI 1.7-6), respectively. The 1-year OS was 54%. The most common grade 3 toxicities were nausea (22%), vomiting (15%), and fatigue (11%). There were no grade 4 toxicities. This study was closed early as we moved from an empiric therapy platform to a more individualized approach.
Gemcitabine and oxaliplatin is a well-tolerated regimen in CUP with similar outcomes to previously documented CUP studies. In selected good performance status patients this combination may serve as a first-line doublet chemotherapy option for CUP patients.
临床前和临床数据表明吉西他滨和奥沙利铂具有协同作用。这些药物已在几种已知的癌症中进行了测试，这些癌症也包括常见的不明原发癌（CUP）亚型；即肺和胰胆管型。
该研究纳入了 29 名患者，其中 28 名患者符合治疗条件。吉西他滨以 1000mg/m²的固定剂量率输注，奥沙利铂以 100mg/m²输注，每 2 周 1 次，每 6 周进行 3 个周期的重新分期。
该研究报告了 1 例完全缓解（CR）（4%），6 例部分缓解（PR）（25%），13 例稳定疾病（SD）（54%）；在重新分期时有 4 例进展（PD）（17%）。中位总生存期（OS）和无进展生存期分别为 12.8 个月（95%置信区间 [CI] 8.5-18.5）和 3.1 个月（95%CI 1.7-6）。1 年 OS 为 54%。最常见的 3 级毒性为恶心（22%）、呕吐（15%）和疲劳（11%）。无 4 级毒性。由于我们从经验性治疗平台转移到更个体化的方法，该研究提前关闭。
吉西他滨和奥沙利铂在 CUP 中是一种耐受性良好的方案，其结果与以前记录的 CUP 研究相似。在选择的一般状况良好的患者中，该联合方案可能是 CUP 患者的一线双药化疗选择。
