背景:晚期胰腺癌对化疗药物耐药,治疗效果有限,预后不良。化疗吉西他滨和厄洛替尼的联合给药被认为是晚期胰腺癌的潜在一线治疗。然而,它们的相对收益和潜在风险仍不清楚。
目的:评价厄洛替尼联合其他化疗方案治疗晚期胰腺癌的临床疗效和安全性。
方法:通过在线检索有关厄洛替尼联合化疗治疗晚期胰腺癌的临床疗效和安全性的文献。对检索到的文献进行方法学定性评估,并使用RevMan5.3软件进行分析。10项随机对照试验纳入了2444例晚期胰腺癌患者的荟萃分析。
结果:与化疗治疗相比,厄洛替尼联合化疗可显著延长胰腺癌患者的无进展生存期[风险比(HR)=0.78,95CI:0.66~0.92,P=0.003].同时,总生存率(HR=0.99,95CI:0.72-1.37,P=0.95)和疾病控制率(OR=0.93,95CI:0.45-0.91,P=0.84)均无显著改善.在安全方面,与单药化疗相比,厄洛替尼联合化疗与腹泻(OR=3.59,95CI:1.63~7.90,P<0.05)和皮疹(OR=3.63,95CI:1.64~8.01,P<0.05)的风险显著升高.此外,呕吐风险(OR=1.27,95CI:0.62-2.59,P=0.51),反流/厌食(OR=1.61,95CI:0.25-10.31,P=0.62),和感染(OR=0.72,95CI:0.28-1.87,P=0.50)在两组中均无统计学意义。
结论:与单一化疗方式相比,厄洛替尼联合吉西他滨可以延长胰腺癌的无进展生存期,但不能提高生存获益或疾病控制率,并且会增加腹泻和皮疹的风险。
BACKGROUND: Advanced pancreatic cancer is resistant to chemotherapeutic drugs, resulting in limited treatment efficacy and poor prognosis. Combined administration of the chemotherapeutic gemcitabine and erlotinib is considered a potential first-line treatment for advanced pancreatic cancer. However, their comparative benefits and potential risks remain unclear.
OBJECTIVE: To assess the clinical efficacy and safety of erlotinib combined with other chemotherapy regimens for the treatment of advanced pancreatic cancer.
METHODS: Literature on the clinical efficacy and safety of erlotinib combined with chemotherapy for advanced pancreatic cancer was retrieved through an online search. The retrieved literature was subjected to a methodological qualitative assessment and was analyzed using the RevMan 5.3 software. Ten randomized controlled trials involving 2444 patients with advanced pancreatic cancer were included in the meta-analysis.
RESULTS: Compared with chemotherapeutic treatment, erlotinib combined with chemotherapy significantly prolonged the progression-free survival time of pancreatic cancer patients [hazard ratio (HR) = 0.78, 95%CI: 0.66-0.92, P = 0.003]. Meanwhile, the overall survival (HR= 0.99, 95%CI: 0.72-1.37, and P = 0.95) and disease control rate (OR = 0.93, 95%CI: 0.45-0.91, P = 0.84) were not significantly favorable. In terms of safety, the erlotinib and chemotherapy combination was associated with a significantly higher risk of diarrhea (OR = 3.59, 95%CI: 1.63-7.90, P < 0.05) and rash (OR = 3.63, 95%CI: 1.64-8.01, P < 0.05) compared with single-agent chemotherapy. Moreover, the risk of vomiting (OR = 1.27, 95%CI: 0.62-2.59, P = 0.51), regurgitation/anorexia (OR = 1.61, 95%CI: 0.25-10.31, P = 0.62), and infection (OR = 0.72, 95%CI: 0.28-1.87, P = 0.50) were not significant in either group.
CONCLUSIONS: Compared with a single chemotherapeutic modality, erlotinib combined with gemcitabine can prolong progression-free survival in pancreatic cancer, but does not improve survival benefit or disease control rate, and can increase the risk of diarrhea and rash.