Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.
Department of Clinical Research, University of Southern Denmark, Winsløwparken 19, 3. Sal, 5000, Odense C, Denmark.
Cancer Chemother Pharmacol. 2018 Mar;81(3):573-578. doi: 10.1007/s00280-018-3528-5. Epub 2018 Jan 31.
Gemcitabine has been standard of care in advanced pancreatic adenocarcinomas (PC) for almost two decades. Randomized, primarily Japanese, studies have shown promising efficacy when combined with S-1 (GemS-1); however, no data are published in Caucasian patients. We report the first study with a combination of GemS-1 in an unselected cohort of Caucasian PC patients.
In this observational cohort study, we analyzed efficacy and toxicity prospectively.
From July 2012 to July 2014, 64 patients received at least one cycle of GemS-1. 16 patients started therapy with gemcitabine and capecitabine (GemCap) but switched to GemS-1 after median 3 cycles of GemCap due to toxicity (hand-foot syndrome). 48 patients received GemS-1 as initial therapy. For the complete cohort, median age was 68 years (range 44-80); 22 patients (34%) had locally advanced PC; 42 patients (66%) had metastatic disease. Five patients had received prior adjuvant therapy with gemcitabine and 9 pts had received prior first-line therapy. The most common adverse event was fatigue (86%), however, only grade 3 in 3%. Five patients (8%) developed febrile neutropenia. Median PFS was 8.1 (95% CI 6.9-9.0) months and median OS was 11.7 (95% CI 10.7-13.1) months in the whole GemS-1 population. In the 48 patients starting with GemS-1, median PFS was 7.7 (95% CI 6.7-8.9) months and median OS was 11.5 (95% CI 9.7-12.3) months.
The combination of gemcitabine and S-1 is safe and associated with promising efficacy in a Caucasian population; however, this needs to be confirmed in prospective clinical trials.
吉西他滨在近 20 年来一直是晚期胰腺腺癌（PC）的标准治疗方法。随机的、主要是日本的研究表明，当与 S-1（GemS-1）联合使用时具有有前景的疗效；然而，在高加索患者中没有发表相关数据。我们报告了首例在未经选择的高加索 PC 患者队列中使用 GemS-1 联合治疗的研究。
在这项观察性队列研究中，我们前瞻性地分析了疗效和毒性。
从 2012 年 7 月到 2014 年 7 月，64 名患者接受了至少一个周期的 GemS-1 治疗。由于毒性（手足综合征），16 名患者开始使用吉西他滨和卡培他滨（GemCap）治疗，但在 GemCap 治疗 3 个周期后转为 GemS-1。48 名患者接受 GemS-1 作为初始治疗。对于完整的队列，中位年龄为 68 岁（范围为 44-80）；22 名患者（34%）患有局部晚期 PC；42 名患者（66%）患有转移性疾病。5 名患者曾接受过吉西他滨辅助治疗，9 名患者曾接受过一线治疗。最常见的不良反应是乏力（86%），但只有 3%为 3 级。5 名患者（8%）发生发热性中性粒细胞减少症。在整个 GemS-1 人群中，中位无进展生存期（PFS）为 8.1 个月（95%CI 6.9-9.0），中位总生存期（OS）为 11.7 个月（95%CI 10.7-13.1）。在开始使用 GemS-1 的 48 名患者中，中位 PFS 为 7.7 个月（95%CI 6.7-8.9），中位 OS 为 11.5 个月（95%CI 9.7-12.3）。
吉西他滨与 S-1 的联合使用在高加索人群中是安全的，并具有有前景的疗效；然而，这需要在前瞻性临床试验中得到证实。
