探讨白蛋白结合型紫杉醇治疗吉西他滨为基础的一线化疗失败的转移性胰腺癌的有效性和安全性。

选择2014年1月至2020年7月在北京怀柔医院经穿刺病理确诊为转移性胰腺癌且吉西他滨为基础的一线化疗失败的50例患者，其中对照组25例，采用mFOLFOX6方案治疗；观察组25例，采用白蛋白结合型紫杉醇方案治疗。回顾性分析两组患者的临床特征、治疗方法、近远期疗效及不良反应发生情况。

治疗2周期后，对照组完全缓解（CR）0例，部分缓解（PR）10例，疾病稳定（SD）12例，疾病进展（PD）3例，客观缓解率（ORR）为40.0%，疾病控制率（DCR）为88.0%。观察组CR 0例，PR 12例，SD 11例，PD 2例，ORR为48.0%，DCR为92.0%。两组ORR、DCR差异无统计学意义（χ²=0.325，P=0.569；χ²=0.222，P=0.637）。对照组和观察组中位无进展生存期（PFS）分别为4.2个月（95% CI：3.711~4.692个月）和4.6个月（95% CI：3.765~5.435个月），中位总生存期（OS）分别为7.4个月（95% CI：7.050~7.750个月）和7.9个月（95% CI：7.679~8.121个月），两组PFS和OS差异均无统计学意义（χ²=0.419，P=0.517；χ²=2.978，P=0.084）。观察组的化疗耐受性优于对照组，不良反应主要为嗜中性粒细胞减少（16.0%）、贫血（12.0%）、感觉神经毒性（40.0%）、乏力（20.0%）、肝功能损伤（12.0%）、恶心（8.0%）和腹泻（12.0%），其3、4级不良反应发生率显著低于对照组，差异均有统计学意义（P<0.05）。

对于吉西他滨为基础的一线化疗失败的转移性胰腺癌，白蛋白结合型紫杉醇方案与mFOLFOX6方案疗效相当，且不良反应较低。

To investigate the efficacy and safety of albumin bound paclitaxel in the treatment of metastatic pancreatic cancer with first-line gemcitabine based chemotherapy failure.

A total of 50 patients with metastatic pancreatic cancer after first-line gemcitabine based chemotherapy failure in Huairou Hospital of Beijing from January 2014 to July 2020 were divided into two groups according to different treatment regimens. 25 cases in the control group were treated with mFOLFOX6 regimen, while 25 cases in the observation group were treated with albumin bound paclitaxel regimen. The clinical characteristics, treatment methods, short-and long-term effects and adverse reactions of the two groups were analyzed retrospectively.

After two cycles of treatment, there were 0 case of complete remission (CR), 10 cases of partial remission (PR), 12 cases of stable disease (SD), and 3 cases of disease progression (PD), the objective response rate (ORR) was 40.0%, and the disease control rate (DCR) was 88.0% in the control group. In the observation group, there were 0 case of CR, 12 cases of PR, 11 cases of SD and 2 cases of PD, ORR was 48.0%, DCR was 92.0%. There were no significant differences in ORR and DCR between the two groups (χ²=0.325, P=0.569; χ²=0.222, P=0.637). The median progression free survival (PFS) of the control group and the observation group were 4.2 months (95% CI: 3.711-4.692 months) and 4.6 months (95% CI: 3.765-5.435 months), respectively. The median overall survival (OS) was 7.4 months (95% CI: 7.050-7.750 months) and 7.9 months (95% CI: 7.679-8.121 months), respectively. There were no significant differences in PFS and OS of the two groups ( χ²=0.419, P=0.517; χ²=2.978, P=0.084). The chemotherapy tolerance of the observation group was better than that of the control group. The main adverse reactions were neutropenia (16.0%), anemia (12.0%), sensory neurotoxicity (40.0%), asthenia (20.0%), liver function damage (12.0%), nausea (8.0%) and diarrhea (12.0%). The incidence of grade 3 and 4 adverse reactions in the observation group was significantly lower than that in the control group (P<0.05).

Albumin bound paclitaxel regimen is comparable to the mFOLFOX6 regimen in the treatment of first-line resistant metastatic pancreatic cancer and the adverse reactions are low.