吉西他滨联合替吉奥治疗晚期转移性胰腺癌的临床疗效和安全性评价

Effect and safety study of gemcitabine combined with tegafur in the treatment of advanced metastasis pancreatic cancer

目的评价吉西他滨（GEM）联合替吉奥（tegafur）方案与GEM单药方案治疗晚期转移性胰腺癌的临床疗效及安全性。方法入选晚期转移性胰腺癌患者51例,随机分为GEM组24例和GEM＋tegafur组27例。GEM组给予静脉滴注吉西他滨1 g·m-2,第1,8,15天给药,28 d为1周期,连续4个周期;GEM＋tegafur组静脉滴注吉西他滨1 g·m-2,第1,15天给药,同时口服替吉奥80 mg·m^-2·d^-1,28 d为1周期,连续4个周期。疗程结束后,分析比较2组患者客观疗效及不良反应发生率。结果 GEM组客观有效率为25.0%,疾病控制率为45.8%;GEM＋tegafur组客观有效率为37.0%,疾病控制率为74.1%。2组患者客观有效率差异无统计学意义（P〉0.05）,但GEM＋tegafur组疾病控制率高于GEM组,差异有统计学意义（P〈0.05）。GEM＋tegafur组Ⅲ~Ⅳ级粒细胞减少、恶心呕吐及腹泻发生率分别为7.4%,11.1%和3.7%;GEM组为8.3%,12.5%和4.2%,2组患者的主要不良反应发生率差异无统计学意义（P〉0.05）。结论吉西他滨联合替吉奥可提高晚期转移性胰腺癌的疾病控制率,且不增加不良反应。

Objective To evaluate the clinical effect and safety of gemcitabine（ GEM） combined with tegafur versus gemcitabine alone regimen on advanced metastasis pancreatic cancer. Methods Fifty- one patients with locally advanced metastasis pancreatic cancer were recruited in our hospital and randomized divided into GEM group（ n = 24） and GEM ＋ tegafur group（ n = 27）. Patients in GEM group were given gemcitabine 1 g·m^- 2through intravenous infusion on day 1,8 and 15,and patients in the GEM ＋ tegafur group received gemcitabine 1 g·m^- 2plus tegafur 80 mg·m^-2·d^-1 day 1 and 15. The treatment lasted for 4cycles（ 28 days as a cycle）. At the end of this study,the data of objective response rate（ ORR）,disease control rate（ DCR） and adverse reactions were recorded and compared between the two groups. Results The objective response rate and disease control rate were 25. 0% and 45. 8% in the GEM group,and 37. 0% and 74. 1% in the GEM ＋ tegafur group. The DCR in the GEM ＋ tegafur group was significantly higher than that in GEM group（ P〈0. 05）. The main adverse reactions included hematological toxicity and gastrointestinal reactions. The incidences of granulocytopenia,nausea and diarrhea in GEM ＋ tegafur group and GEM group were as follows： 7. 4% vs 8. 3%,11. 1% vs 12. 5% and3. 7% vs 4. 2%（ P〈0. 05）. Conclusion GEM plus tegafur can improve the DCR without increasing the adverse reactions in the treatment of metastasis pancreatic cancer.