替吉奥单药对比吉西他滨单药一线治疗老年晚期胰腺癌的临床研究

Clinical study of S-1 alone compared to gemcitabine alone in elderly patients with advanced pancreatic cancer

目的:比较替吉奥单药与吉西他滨单药一线治疗老年人晚期胰腺癌的近期疗效、无进展生存和安全性。方法:回顾性分析我院自2009年1月-2014年8月收治的老年晚期胰腺癌患者44例,一线采用替吉奥单药或吉西他滨单药化疗。替吉奥组21例,吉西他滨组23例。每例患者至少接受化疗2个周期以上。每2个周期复查CT,根据实体瘤疗效评价标准(Response Evaluation Criteria In Solid Tu m o r s,R ECI ST)和美国国家癌症研究所化疗毒性分级标准(Nat i o n a l Ca n c e r In s t i t u te Co m m o n Te r m i n o l o g y C r i t e r i a Fo r A d v e r s e Ev e n t s,N C I-C TC A E)对两组治疗的近期疗效、无进展生存(progression-f ree sur v ival,PFS)和不良反应进行评估。结果:44例老年晚期胰腺癌患者经替吉奥或吉西他滨单药化疗,两组的有效率(objective response rate,ORR)及疾病控制率(disease control rate,D CR)相似,差异无统计学意义(P>0.05)。替吉奥组中位PFS3.6月,吉西他滨组中位PFS4.0月,差异无统计学意义(P>0.05)。替吉奥组的骨髓抑制情况明显低于吉西他滨组,其中中性粒细胞减少差异有统计学意义(P=0.01)。其它的药物相关不良反应主要为1-2级胃肠道反应和肝功能异常。结论:替吉奥单药对比吉西他滨单药一线治疗老年晚期胰腺癌,两组疗效相似,但替吉奥的化疗毒性反应明显较小,患者能耐受,口服给药方便,可推荐作为老年晚期胰腺癌的一线化疗方案,尤其可能适用于PS评分2分的不能耐受吉西他滨或其他联合方案的老年晚期胰腺癌患者。

Objective： The purpose of the study was to compare the clinical efficacy and adverse effect of S-1 alone and gemcitabine alone in elderly patients with advanced pancreatic cancer. Methods： From January 2009 to August 2014, a total of 44 elderly patients with advanced pancreatic cancer were analyzed retrospectively, who received S-1 alone（n=21） or gemcitabine alone（n=23）. Each patient had chemotherapy for at least 2 cycles. The CT scan was taken every two cycles. Response Evaluation Criteria In Solid Tumors（RECIST） was used to assess the short-term efficacy and PFS of the treatment and National Cancer Institute Common Terminology Criteria For Adverse Events（NCI CTC-AE, was used to describe adverse events. Results： There was no statistically significant difference in the objective response rate（ORR） and the disease control rate（DCR） between the two groups（P〉0.05）. The median progression-free survival（PFS） was 3.6 months in S-1 group and 4.0 months in gemcitabine group, which had no statistically significant difference（P〉0.05）. The drug-related neutropenia in S-1 group was lower than in gemcitabine group, which had statistically significant difference（P=0.01）. Other drugrelated adverse events were gastrointestinal response and abnormal liver function most of witch were grade 1 to 2. Conclution： S-1 may be recommended as first-line chemotherapy for elderly patients with advanced pancreatic cancer because of its safety, efficacy and convenience, especially for elderly patients with PS 2 who could not tolerate gemcitabine or other combination programmes.