吉西他滨联合卡培他滨治疗晚期或转移性胰腺癌的疗效和安全性：系统评价和荟萃分析。

Efficacy and safety of gemcitabine plus capecitabine in the treatment of advanced or metastatic pancreatic cancer: a systematic review and meta-analysis.

机构信息

Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai , China.

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

Ann Palliat Med. 2020 Jul;9(4):1631-1642. doi: 10.21037/apm-20-45. Epub 2020 Jun 22.

DOI:10.21037/apm-20-45

PMID:32576005

Abstract

BACKGROUND

Gemcitabine combined the oral fluoropyrimidine capecitabine (GemCap) is an active antitumor therapy in the treatment of advanced or metastatic pancreatic cancer, and has been shown potential synergistic activity in previous clinical trials. In this study, we sought to systematically review and synthesize the efficacy and safety of GemCap in the treatment of advanced or metastatic pancreatic cancer.

METHODS

A systematic review was performed through PubMed, Cochrane Library, EMBASE, and Web of Science databases up to Jul 10, 2019 to identify clinical trials that included advanced or metastatic pancreatic cancer patients treated with GemCap. Data of overall survival (OS), progression-free survival (PFS), 1-year survival rate, objective response rate (ORR), disease control rate (DCR) and adverse events were extracted and meta-analyzed.

RESULTS

Fifteen studies were identified for systematic review, of which 13 were included in the metaanalysis. In comparison with Gem monotherapy, the pooled hazard ratios (HR) of GemCap treatment for OS and PFS were 0.85 (95% CI: 0.75-0.95, P=0.007) and 0.80 (95% CI: 0.72-1.04, P=0.0002). The pooled 1-year survival rate, ORR and DCR of GemCap were, respectively, 33.1% (95% CI: 28.7-37.5), 22.9% (95% CI: 17.6-28.3) and 65.7% (95% CI: 56.7-74.8). GemCap combination therapy showed significantly higher ORR (OR: 1.98, 95% CI: 1.34-2.67, P=0.0003) and DCR (OR: 1.41, 95% CI: 1.05- 1.88, P=0.02) compared to Gem monotherapy. The most common grade ≥3 hematological toxicities in patients treated with GemCap combination therapy were neutropenia (19.7%), leucocytopenia (7.9%) and anemia (4.9%). The most common grade ≥3 non-hematological toxicities were hand-foot syndrome (6.3%), fatigue (5.7%) and nausea (4.8%).

CONCLUSIONS

GemCap combination therapy had an encouraging activity and might be a better treatment strategy compared with Gem alone in the first-line treatment for patients with advanced or metastatic pancreatic cancer.

摘要

背景

吉西他滨联合口服氟嘧啶卡培他滨（GemCap）是一种在治疗晚期或转移性胰腺癌方面具有活性的抗肿瘤疗法，并且在之前的临床试验中显示出潜在的协同活性。在这项研究中，我们旨在系统地回顾和综合评估 GemCap 在治疗晚期或转移性胰腺癌中的疗效和安全性。

方法

通过 PubMed、Cochrane 图书馆、EMBASE 和 Web of Science 数据库系统地检索截至 2019 年 7 月 10 日的临床试验，以确定纳入接受 GemCap 治疗的晚期或转移性胰腺癌患者的临床试验。提取并进行荟萃分析总生存期（OS）、无进展生存期（PFS）、1 年生存率、客观缓解率（ORR）、疾病控制率（DCR）和不良事件的数据。

结果

系统综述确定了 15 项研究，其中 13 项纳入荟萃分析。与吉西他滨单药治疗相比，GemCap 治疗的 OS 和 PFS 的合并风险比（HR）分别为 0.85（95%CI：0.75-0.95，P=0.007）和 0.80（95%CI：0.72-1.04，P=0.0002）。GemCap 的 1 年生存率、ORR 和 DCR 分别为 33.1%（95%CI：28.7-37.5）、22.9%（95%CI：17.6-28.3）和 65.7%（95%CI：56.7-74.8）。GemCap 联合治疗与吉西他滨单药治疗相比，ORR（OR：1.98，95%CI：1.34-2.67，P=0.0003）和 DCR（OR：1.41，95%CI：1.05-1.88，P=0.02）显著更高。接受 GemCap 联合治疗的患者最常见的≥3 级血液学毒性为中性粒细胞减少症（19.7%）、白细胞减少症（7.9%）和贫血（4.9%）。最常见的≥3 级非血液学毒性为手足综合征（6.3%）、疲劳（5.7%）和恶心（4.8%）。