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一项更新的荟萃分析与系统评价:吉西他滨联合氟嘧啶对比单用吉西他滨治疗晚期不可切除胰腺癌是否为更佳疗法?

An Updated Meta-analysis and System Review:is Gemcitabine+Fluoropyrimidine in Combination a Better Therapy Versus Gemcitabine Alone for Advanced and Unresectable Pancreatic Cancer?

作者信息

Tu Chao, Zheng Feng, Wang Jin-Yu, Li Yuan-Yuan, Qian Ke-Qing

机构信息

Oncology Institute, The Affiliated Hospital of Nanjing Medical University, Changzhou No. 2 People's Hospital, Changzhou, China E-mail :

出版信息

Asian Pac J Cancer Prev. 2015;16(14):5681-6. doi: 10.7314/apjcp.2015.16.14.5681.

DOI:10.7314/apjcp.2015.16.14.5681
PMID:26320435
Abstract

BACKGROUND

Pancreatic cancer ranks fourth in deaths caused by cancers throughout the world. Gemcitabine chemotherapy is the primary method of treatment of advanced pancreatic cancer, and in asco2014, it is still first- line chemotherapy. However gemcitabine+fluorouracil regimens are also licensed and widely used worldwide. Clinical trials are the best way to evaluate drug efficacy. In this study, we performed a systematic review and a meta-analysis of randomized controlled trials (RCTs) to assess whether gemcitabine+fluoropyrimidine combination therapy improves the prognosis of unresectable pancreatic cancer compared with gemcitabine treatment alone.

MATERIALS AND METHODS

A quantitative up-to-date meta-analysis was undertaken to investigate the efficacy of gemcitabine-based combination treatment compared with gemcitabine monotherapy for locally advanced or metastatic pancreatic cancer. Inclusion was limited to high-quality randomized clinical trials.

RESULTS

A total of 12 studies were included in the present analysis, with a total of 3,038 patients recruited. The studies were divided into three subgroups including 5-FU / CAP / S-1 combined with gemcitabine. For the primary endpoint of overall survival (OS), gemcitabine-based combination therapy demonstrated significantly better outcome (HR, 0.88; 95% CI, 0.81-0.95) than gemcitabine monotherapy. The analysis of progression free survival (PFS) also provided a significant result for the combined therapy in a total of 8 trials (2,130 patients) (HR, 0.74; 95% CI, 0.63-0.86). With subgroup analysis according to the method of dosing delivery, we found that in the injection group with 3 trials (889 patients), a negative result was found (HR, 0.93; 95% CI, 0.77-1.12); while a positive result was observed in the oral group with 9 trials (2,149 patients) (HR, 0.87; 95% CI, 0.80-0.95).

CONCLUSIONS

Gemcitabine combination therapy provides a modest improvement of survival, but is associated with more toxicity compared with gemcitabine monotherapy.

摘要

背景

胰腺癌在全球癌症致死病因中位列第四。吉西他滨化疗是晚期胰腺癌的主要治疗方法,在2014年美国临床肿瘤学会年会上,它仍是一线化疗方案。然而,吉西他滨联合氟尿嘧啶方案也已获批并在全球广泛应用。临床试验是评估药物疗效的最佳方式。在本研究中,我们对随机对照试验(RCT)进行了系统综述和荟萃分析,以评估与单纯吉西他滨治疗相比,吉西他滨联合氟嘧啶联合疗法是否能改善不可切除胰腺癌的预后。

材料与方法

进行了一项最新的定量荟萃分析,以研究基于吉西他滨的联合治疗与吉西他滨单药治疗相比,对局部晚期或转移性胰腺癌的疗效。纳入标准仅限于高质量的随机临床试验。

结果

本分析共纳入12项研究,共招募了3038名患者。这些研究分为三个亚组,包括5 - FU / CAP / S - 1与吉西他滨联合。对于总生存期(OS)这一主要终点,基于吉西他滨联合疗法的结果显著优于吉西他滨单药治疗(风险比[HR],0.88;95%置信区间[CI],0.81 - 0.95)。在总共8项试验(2130名患者)中,对无进展生存期(PFS)的分析也显示联合疗法有显著结果(HR,0.74;95% CI,0.63 - 0.86)。根据给药方式进行亚组分析时,我们发现在3项试验(889名患者)的注射组中结果为阴性(HR,0.93;95% CI,0.77 - 1.12);而在9项试验(2149名患者)的口服组中观察到阳性结果(HR,0.87;95% CI,0.80 - 0.95)。

结论

吉西他滨联合疗法能适度提高生存率,但与吉西他滨单药治疗相比,毒性更大。

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