Bullock Andrea, Stuart Keith, Jacobus Susanna, Abrams Thomas, Wadlow Raymond, Goldstein Michael, Miksad Rebecca
Beth Israel Deaconess Medical Center, Boston, MA, USA.
Lahey Hospital and Medical Center, Burlington, MA, USA.
J Gastrointest Oncol. 2017 Dec;8(6):945-952. doi: 10.21037/jgo.2017.06.06.
There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). We conducted a phase II study evaluating the efficacy and safety of capecitabine/oxaliplatin (CAPOX) in patients with locally advanced and metastatic PDAC treated in the first and second lines.
Forty subjects with advanced PDAC and ECOG performance status ≥2 were enrolled. Treatment consisted of capecitabine 2,000 mg/m orally in two divided doses daily for 14 days and oxaliplatin 130 mg/m intravenously day 1 every 21 days. The primary endpoint was response rate (RR); secondary endpoints included safety analysis, progression free survival (PFS) and overall survival (OS).
The overall RR was 12.5% (N=3); the disease control rate was 67% (N=16). Due to the protocol definition for eligibility of response evaluation, only 60% (N=24) were evaluable for the primary endpoint. Median progression free survival (mPFS) was 3.8 months (95% CI: 1.3, 6.2); median OS (mOS) was 7.4 months (95% CI: 4.8, 12.2). The most common grade 3/4 toxicities included: fatigue (19%), nausea (17%), and diarrhea (14%).
CAPOX is an active regimen in patients with advanced PDAC and is associated with acceptable toxicity. Careful consideration should be given to response endpoints and outcome measures when studying this characteristically ill population.
晚期胰腺导管腺癌（PDAC）患者的治疗选择有限。我们开展了一项II期研究，评估卡培他滨/奥沙利铂（CAPOX）用于一线和二线治疗的局部晚期和转移性PDAC患者的疗效和安全性。
纳入40例ECOG体能状态≥2的晚期PDAC患者。治疗方案为卡培他滨2000mg/m²，口服，每日分两次给药，共14天，奥沙利铂130mg/m²，静脉滴注，第1天给药，每21天重复一次。主要终点为缓解率（RR）；次要终点包括安全性分析、无进展生存期（PFS）和总生存期（OS）。
总RR为12.5%（n = 3）；疾病控制率为67%（n = 16）。由于缓解评估的方案定义，仅60%（n = 24）的患者可用于主要终点评估。中位无进展生存期（mPFS）为3.8个月（95%CI：1.3，6.2）；中位OS（mOS）为7.4个月（95%CI：4.8，12.2）。最常见的3/4级毒性包括：疲劳（19%）、恶心（17%）和腹泻（14%）。
CAPOX是晚期PDAC患者的一种有效治疗方案，且毒性可接受。在研究这一特殊患病群体时，应仔细考虑缓解终点和结局指标。
