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晚期非小细胞肺癌中连续或转换策略的维持治疗:系统评价和荟萃分析。

Maintenance therapy with continuous or switch strategy in advanced non-small cell lung cancer: a systematic review and meta-analysis.

机构信息

Department of Health Statistics, Second Military Medical University, Shanghai, China.

Respiratory Department, Changhai Hospital, Second Military Medical University, Shanghai, China.

出版信息

Chest. 2011 Jul;140(1):117-126. doi: 10.1378/chest.10-2745. Epub 2011 Mar 24.

Abstract

BACKGROUND

Maintenance therapy for patients with non-small cell lung cancer (NSCLC) has gained extensive interest. Varying results for this treatment underpin the need for a synthesis of evidence.

METHODS

Trials investigating maintenance therapy with either a continuous or a switch strategy for patients with nonprogressing NSCLC compared with placebo or observation were identified. The primary outcome was overall survival (OS), and secondary outcomes included progression-free survival (PFS) and toxicity.

RESULTS

Eight trials of 3,736 patients were included in the analysis. Switch maintenance therapy substantially improved OS compared with placebo or observation (hazard ratio [HR], 0.85; 95% CI, 0.79-0.92; P < .001). A similar trend of improved OS was found in continuous maintenance therapy, despite lacking statistical significance (HR, 0.88; 95% CI, 0.74-1.04; P = .124). The interaction test suggested that the difference in OS between the two maintenance strategies was not statistically significant (P = .777). Clinically substantial and statistically significant improvement in PFS was found with both maintenance strategies (switch maintenance therapy HR, 0.67; 95% CI, 0.57-0.78; continuous maintenance therapy HR, 0.53; 95% CI, 0.43-0.65; interaction P = .128). Subgroup analyses revealed no statistically significant differences in OS or PFS between switch maintenance therapy with cytotoxic agents and that with tyrosine kinase inhibitor agents. Toxicity was greater in maintenance therapy.

CONCLUSIONS

Maintenance therapy with either a continuous or a switch strategy significantly increases OS and PFS compared with placebo or observation. However, the benefits must be balanced against toxicity.

摘要

背景

非小细胞肺癌(NSCLC)患者的维持治疗引起了广泛关注。这种治疗方法的结果各不相同,这使得有必要对证据进行综合分析。

方法

我们确定了调查非进展性 NSCLC 患者采用连续或转换策略进行维持治疗与安慰剂或观察相比的维持治疗试验。主要结局是总生存期(OS),次要结局包括无进展生存期(PFS)和毒性。

结果

共纳入了 8 项涉及 3736 例患者的试验。与安慰剂或观察相比,转换维持治疗显著改善了 OS(风险比[HR],0.85;95%CI,0.79-0.92;P<0.001)。尽管缺乏统计学意义,但连续维持治疗也显示出 OS 改善的趋势(HR,0.88;95%CI,0.74-1.04;P=0.124)。交互检验表明,两种维持策略之间的 OS 差异无统计学意义(P=0.777)。两种维持策略都显著改善了 PFS(转换维持治疗 HR,0.67;95%CI,0.57-0.78;连续维持治疗 HR,0.53;95%CI,0.43-0.65;交互 P=0.128)。亚组分析显示,与细胞毒性药物相比,转换维持治疗与酪氨酸激酶抑制剂药物在 OS 或 PFS 方面没有统计学上的显著差异。维持治疗的毒性更大。

结论

与安慰剂或观察相比,连续或转换策略的维持治疗可显著提高 OS 和 PFS。然而,必须权衡毒性与益处。

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