Liu Chun-Quan, Tian Dan, Wang Ning, Meng Xian-Pu, Yang Jian-Dong, Li Hua-Wei, Zhao Ning, Zhao Su, Liao Fei, Cui Yong
Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Experimental and Translational Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Asia Pac J Clin Oncol. 2018 Apr;14(2):e81-e87. doi: 10.1111/ajco.12778. Epub 2017 Oct 25.
Currently, amrubicin is used as first-line in the treatment of patients with small-cell lung cancer (SCLC). However, the effect of amrubicin-based treatment in extensive-disease (ED) SCLC remains controversial. Thus, we conducted a meta-analysis of randomized controlled trials (RCTs) to assess the efficacy and safety of amrubicin-based regimen in the treatment of patients with ED-SCLC.
RCTs published in PubMed, Web of Science, Embase, and ClinicalTrials.gov were systematically reviewed. Eligible studies were these that evaluated the efficacy and safety profiles of amrubicin-based regimen in ED-SCLC. Outcomes included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and adverse events. Results were expressed with hazard ratio (HR) with 95% confidence intervals (CIs), and risk ratio (RR) with 95% CIs.
Four RCTs involving a total of 740 patients met the inclusion criteria and were included in this meta-analysis. Amrubicin-based regimen was not associated with significantly prolonged PFS (HR = 1.07, 95% CI: 0.90-1.30; P = 0.463) and OS (HR = 1.07, 95% CI: 0.89-1.29; P = 0.443) in patients with ED-SCLC. However, it significantly improved ORR (RR = 1.14, 95% CI: 1.04-1.25; P = 0.008). Subgroup analysis demonstrated that neither amrubicin alone nor in combination with cisplatin prolonged the PFS and OS, and only the combination therapy significantly increased ORR. The incidence of grade ≥3 adverse events was comparable between amrubicin-containing and other treatment groups (RR = 1.42, 95% CI: 0.78-2.58; P = 0.248). However, amrubicin-based treatment induced a significantly higher incidence of febrile neutropenia (RR = 3.32, 95% CI: 2.04-5.41; P < 0.001), anemia (RR = 1.44, 95% CI: 1.06-1.97; P = 0.022), leukopenia (RR = 2.17, 95% CI: 1.41-3.33; P < 0.001), neutropenia (RR = 1.33, 95% CI: 1.04-1.70; P = 0.021), and interstitial lung disease (RR = 1.58, 95% CI: 1.21-1.98; P < 0.001).
Amrubicin-based regimen used as first-line had no survival benefits in patients with ED-SCLC. But it significantly improved ORR. Further well-conducted, large-scale trials are needed to validate these findings.
目前，氨柔比星被用作小细胞肺癌（SCLC）患者的一线治疗药物。然而，基于氨柔比星的治疗方案在广泛期（ED）SCLC中的疗效仍存在争议。因此，我们进行了一项随机对照试验（RCT）的荟萃分析，以评估基于氨柔比星的方案在治疗ED-SCLC患者中的疗效和安全性。
系统检索了发表在PubMed、科学网、Embase和ClinicalTrials.gov上的RCT。符合条件的研究是那些评估基于氨柔比星的方案在ED-SCLC中的疗效和安全性的研究。结局指标包括无进展生存期（PFS）、总生存期（OS）、总缓解率（ORR）和不良事件。结果以风险比（HR）及其95%置信区间（CI），以及风险比（RR）及其95%CI表示。
四项共纳入740例患者的RCT符合纳入标准并被纳入本荟萃分析。基于氨柔比星的方案与ED-SCLC患者的PFS（HR = 1.07，95%CI：0.90-1.30；P = 0.463）和OS（HR = 1.07，95%CI：0.89-1.29；P = 0.443）显著延长无关。然而，它显著提高了ORR（RR = 1.14，95%CI：1.04-1.25；P = 0.008）。亚组分析表明，单独使用氨柔比星或与顺铂联合使用均未延长PFS和OS，只有联合治疗显著提高了ORR。含氨柔比星组和其他治疗组≥3级不良事件的发生率相当（RR = 1.42，95%CI：0.78-2.58；P = 0.248）。然而，基于氨柔比星的治疗导致发热性中性粒细胞减少（RR = 3.32，95%CI：2.04-5.41；P < 0.001）、贫血（RR = 1.44，95%CI：1.06-1.97；P = 0.022）、白细胞减少（RR = 2.17，95%CI：1.41-3.33；P < 0.001）、中性粒细胞减少（RR = 1.33，95%CI：1.04-1.70；P = 0.021）和间质性肺疾病（RR = 1.58，95%CI：1.21-1.98；P < 0.001）的发生率显著更高。
基于氨柔比星的方案作为一线治疗对ED-SCLC患者没有生存益处。但它显著提高了ORR。需要进一步开展设计良好的大规模试验来验证这些发现。
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