Ma Wenhua, Zhao Fugang, Zhou Changpeng, Zhang Yongqian, Zhao Yingchun, Li Na, Xie Peng
Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.
Department of Traditional Chinese Medicine, The First Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China.
Onco Targets Ther. 2019 Jan 3;12:379-390. doi: 10.2147/OTT.S183304. eCollection 2019.
To evaluate efficacy and safety of lapatinib or trastuzumab alone or both plus chemotherapy for the treatment of breast cancer patients with positive HER-2 expression.
Cochrane Central Register of Controlled Trials, PubMed, MEDLINE, OVID, Embase, Chinese Biomedical Literature Database, and China Academic Journals Database were searched from 1994 through December 2017 using the keywords "breast cancer", "preoperative", "neo-adjuvant", "lapatinib", "pertuzumab", "Herceptin", and "trastuzumab".
Meta-analysis found that pathological complete response (PCR; risk ratio [RR]=0.82, 95% CI: 0.72-0.93) and tall PCR (tPCR; RR=0.77, 95% CI: 0.67-0.88) of chemotherapy plus lapatinib were significantly less effective or safe compared to that of chemotherapy plus trastuzumab (<0.05). PCR (RR=1.30, 95% CI: 1.15-1.47) and tPCR (RR=1.32, 95% CI: 1.16-1.50) of chemotherapy plus both lapatinib and trastuzumab were significantly superior to that of chemotherapy plus trastuzumab alone (<0.05). However, there was no significant difference in breast reservation rate between chemotherapy plus lapatinib vs chemotherapy plus trastuzumab (RR=0.91, 95% CI: 0.72-1.16) or chemotherapy plus both lapatinib and trastuzumab (RR=1.11, 95% CI: 0.73-1.68, >0.05). Incidence of diarrhea, hepatic toxicity, and skin rash in the groups of chemotherapy plus lapatinib or chemotherapy plus both lapatinib and trastuzumab was significantly higher than that in chemotherapy plus trastuzumab (<0.05).
Efficacy of lapatinib was less than that of trastuzumab, but incidence of adverse effect of lapatinib was higher than that of trastuzumab. Combination of chemotherapy plus both lapatinib and trastuzumab could significantly increase PCR and tPCR in breast cancer patients, but rate of breast conservation, event-free survival, and overall survival was not significantly improved. Incidence of diarrhea, hepatic toxicity, and skin rash was significantly increased in the groups using lapatinib.
评估拉帕替尼或曲妥珠单抗单药治疗或两者联合化疗用于治疗HER-2表达阳性乳腺癌患者的疗效与安全性。
检索Cochrane对照试验中心注册库、PubMed、MEDLINE、OVID、Embase、中国生物医学文献数据库和中国学术期刊数据库，检索时间从1994年至2017年12月，使用关键词“乳腺癌”“术前”“新辅助”“拉帕替尼”“帕妥珠单抗”“赫赛汀”和“曲妥珠单抗”。
荟萃分析发现，与化疗联合曲妥珠单抗相比，化疗联合拉帕替尼的病理完全缓解（PCR；风险比[RR]=0.82，95%CI：0.72-0.93）和高病理完全缓解（tPCR；RR=0.77，95%CI：0.67-0.88）的疗效或安全性显著降低（<0.05）。化疗联合拉帕替尼和曲妥珠单抗的PCR（RR=1.30，95%CI：1.15-1.47）和tPCR（RR=1.32，95%CI：1.16-1.50）显著优于单纯化疗联合曲妥珠单抗（<0.05）。然而，化疗联合拉帕替尼与化疗联合曲妥珠单抗之间的保乳率无显著差异（RR=0.91，95%CI：0.72-1.16），化疗联合拉帕替尼和曲妥珠单抗与化疗联合曲妥珠单抗之间的保乳率也无显著差异（RR=1.11，95%CI：0.73-1.68，>0.05）。化疗联合拉帕替尼组或化疗联合拉帕替尼和曲妥珠单抗组的腹泻、肝毒性和皮疹发生率显著高于化疗联合曲妥珠单抗组（<0.05）。
拉帕替尼的疗效低于曲妥珠单抗，但拉帕替尼的不良反应发生率高于曲妥珠单抗。化疗联合拉帕替尼和曲妥珠单抗可显著提高乳腺癌患者的PCR和tPCR，但保乳率、无事件生存率和总生存率未显著改善。使用拉帕替尼的组中腹泻、肝毒性和皮疹的发生率显著增加。
