Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.
Onco Targets Ther. 2013 May 8;6:491-6. doi: 10.2147/OTT.S43287. Print 2013.
The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.
We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM) alone, S-1 (tegafur, gimeracil, and oteracil potassium) alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible) or the ineligible group (arm ineligible). We evaluated the efficacy and the safety of the chemotherapy.
A total of 23 patients out of 75 (31%) belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS) was 3.5 months, and the median overall survival (OS) was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.
The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.
本研究旨在评估临床实践中晚期胰腺癌患者的治疗结局，并评估不符合临床试验入组标准的患者接受化疗是否具有临床获益。
我们回顾性分析了 75 例于 2006 年 4 月至 2011 年 9 月期间接受一线化疗的胰腺癌患者的病历。患者接受吉西他滨（GEM）单药、替吉奥（S-1，替加氟、吉美嘧啶和奥替拉西钾）单药或 GEM 联合 S-1 治疗。患者分为符合临床试验入组标准组（arm eligible）或不符合组（arm ineligible）。我们评估了化疗的疗效和安全性。
75 例患者中共有 23 例（31%）属于不符合组，原因如下：20 例患者体能状态差，8 例患者有大量腹水，1 例患者合并同时性恶性肿瘤，1 例患者有黄疸。所有患者的中位无进展生存期（PFS）为 3.5 个月，中位总生存期（OS）为 6.7 个月。在 arm eligible 组，中位 PFS 为 4.5 个月，中位 OS 为 10.5 个月。在 arm ineligible 组，中位 PFS 为 1.1 个月，中位 OS 为 2.9 个月。
不符合入组标准的患者的治疗结局非常差。选择可能从化疗或最佳支持治疗中获益的患者非常重要。
