Division of Hematology-Oncology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Am J Clin Oncol. 2012 Oct;35(5):446-50. doi: 10.1097/COC.0b013e31821862fb.
Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC.
The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m(2) over 100 min) on day 1, oxaliplatin (100 mg/m(2)) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m(2) on cycle 1 day 1 and 250 mg/m(2) thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control).
A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS.
GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.
胰腺癌（PC）的治疗进展甚微。本研究评估了吉西他滨、奥沙利铂和西妥昔单抗（GOC）在局部晚期或转移性 PC 患者中的临床疗效。
本研究的主要终点是无进展生存期（PFS）。入组的、未经化疗的 PC 患者接受吉西他滨（1000mg/m2 静脉滴注 100min），第 1 天；奥沙利铂（100mg/m2），第 2 天；每 2 周一次；以及每周西妥昔单抗（第 1 周期第 1 天给予负荷剂量 400mg/m2，此后给予 250mg/m2）。预计 GOC 治疗将使中位 PFS 从 5.8 个月延长至 7.54 个月，与吉西他滨和奥沙利铂（历史对照）相比，相对增加 30%。
共纳入 41 例可评估患者。总缓解率为 24%。中位 PFS 时间为 6.9 个月，中位总生存期（OS）为 11.3 个月。局部进展期患者的中位 PFS（12.4 个月 vs. 4.7 个月）和 OS（15.7 个月 vs. 6.4 个月）均长于转移性疾病患者。最常见的 3 级和 4 级毒性包括中性粒细胞减少症（32%）、感染（伴有或不伴有中性粒细胞减少症，为 1 级或 2 级，占 24%）、神经病变（17%）、乏力（15%）和皮疹（7%）。5 例（12%）患者在无疾病进展的情况下停止了研究治疗。皮疹不是影响 PFS 或 OS 的显著预后因素。
GOC 是一种可行的联合方案，具有可接受的毒性特征。然而，GOC 并没有显著延长总体患者人群的 PFS，因此不考虑进一步开发。
