Department of Epidemiology, Meinian Institute of Health, Beijing, China.
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
BMC Cancer. 2020 Oct 21;20(1):1021. doi: 10.1186/s12885-020-07527-4.
Both intermittent intravenous (IIV) infusion and continuous intravenous (CIV) infusion of Endostar are widely used for NSCLC in China. We aimed to compare the efficacy and safety of CIV of Endostar versus IIV in combination with first-line chemotherapy for patients with advanced NSCLC.
RCTs, NRCTs and cohort studies which compared CIV of Endostar with IIV in advanced NSCLC patients and reported efficacy or safety outcomes were eligible. Two reviewers independently screened records, extracted data and assessed risk of bias. Pooled risk ratios (RRs) with 95% confidence intervals were calculated using random effects meta-analysis for short-term efficacy and safety outcomes, and hazard ratios (HRs) for survival outcomes.
Finally nine studies involving 597 patients were included, containing two RCTs, three NRCTs and four cohort studies. For short-term efficacy, moderate quality of evidence showed that there were no significant differences between CIV of Endostar and IIV in objective response rate (ORR; RR 1.34, 95% CI 0.91-1.98, P = 0.14) and disease control rate (DCR; RR 1.11, 95% CI 0.94-1.30, P = 0.21). Very low quality of evidence indicated that CIV of Endostar significantly improved both overall survival (OS; HR 0.69, 95% CI 0.48-0.99, P = 0.046) and progression-free survival (PFS; HR 0.71, 95% CI 0.55-0.93, P = 0.01) compared with IIV. As for safety outcomes, moderate quality of evidence found that CIV of Endostar significantly reduced the risk of myelosuppression (RR 0.55, 95% CI 0.32-0.96, P = 0.03) and cardiovascular toxicity (RR 0.21, 95% CI 0.06-0.78, P = 0.02) compared with IIV.
In advanced NSCLC, compared with IIV, CIV of Endostar had similar short-term efficacy, and substantially lower risk of myelosuppression and cardiovascular toxicity. Although very low quality of evidence supported the survival benefit of CIV compared with IIV, large RCTs with long-term follow-up are needed to demonstrate survival benefits. Caution should be given for off-label use of CIV of Endostar.
在中国，恩度的间歇性静脉输注（IIV）和连续静脉输注（CIV）均被广泛用于非小细胞肺癌（NSCLC）的治疗。本研究旨在比较 CIV 与 IIV 联合一线化疗治疗晚期 NSCLC 患者的疗效和安全性。
纳入比较 CIV 与 IIV 治疗晚期 NSCLC 患者的疗效或安全性结局的随机对照试验（RCT）、非随机对照试验（NRCT）和队列研究。两位评价者独立筛选文献、提取数据并评估偏倚风险。采用随机效应模型进行荟萃分析，以评估短期疗效和安全性结局的汇总风险比（RR），并评估生存结局的风险比（HR）。
最终纳入 9 项研究共 597 例患者，其中包括 2 项 RCT、3 项 NRCT 和 4 项队列研究。对于短期疗效，中质量证据表明，CIV 与 IIV 在客观缓解率（ORR；RR 1.34，95%CI 0.91-1.98，P=0.14）和疾病控制率（DCR；RR 1.11，95%CI 0.94-1.30，P=0.21）方面无显著差异。极低质量证据表明，CIV 较 IIV 显著改善了总生存（OS；HR 0.69，95%CI 0.48-0.99，P=0.046）和无进展生存（PFS；HR 0.71，95%CI 0.55-0.93，P=0.01）。安全性结局方面，中质量证据表明，CIV 较 IIV 显著降低了骨髓抑制（RR 0.55，95%CI 0.32-0.96，P=0.03）和心血管毒性（RR 0.21，95%CI 0.06-0.78，P=0.02）的发生风险。
在晚期 NSCLC 患者中，CIV 与 IIV 的短期疗效相当，但 CIV 的骨髓抑制和心血管毒性发生风险显著降低。虽然极低质量证据支持 CIV 较 IIV 有生存获益，但仍需要开展大型 RCT 并进行长期随访以证实生存获益。CIV 的应用应严格遵循适应证。
