The clinical efficacy and safety of maintenance therapy (MT) for patients with advanced non-small cell lung cancer (NSCLC) have not been determined in the real word. This retrospective study of real-world data analyzed these issues in patients with advanced NSCLC and stable or responsive tumors after 4–6 cycles of first-line chemotherapy. We classified 158 patients into MT (34 IIIB and 37 IV stage) and non-MT (47 IIIB and 40 IV stage) groups and then compared the clinical outcomes of progression-free survival (PFS) and overall survival (OS). The influences of maintaining chemotherapy or targeted drugs, regimens, and duration on PFS were also investigated. Prognostic factors for OS were identified by univariate and multivariate analyses. Among the patients, 71 received MT and 87 did not. The median PFS and OS were significantly prolonged in the MT group than non-MT group (5.6 and 14.2 vs. 2.8 and 9.8 months, respectively; both p < 0.0001). The PFS was extended when patients were maintained with targeted drugs compared with chemotherapy, > 4 cycles of chemotherapy, and targeted drugs for > 3 months (all P < 0.0001). Patients with adenocarcinoma and without distant metastasis derived a better OS benefit from MT (P = 0.041 and P = 0.037, respectively). Multivariate analysis revealed that female sex and MT were independent prognostic factors for extended OS (P = 0.039 and P < 0.0001, respectively). The major adverse events of MT comprised tolerable hematological toxicity and gastrointestinal reactions. MT was advantageous and tolerable for patients with advanced NSCLC, especially those with adenocarcinomas without distant metastasis who were treated with targeted drugs, which was an independent prognostic factor for OS.

中文翻译：

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晚期非小细胞肺癌维持治疗的临床疗效和安全性：一项回顾性真实世界研究

维持治疗（MT）对晚期非小细胞肺癌（NSCLC）患者的临床疗效和安全性尚未确定。这项对现实世界数据的回顾性研究分析了晚期 NSCLC 患者和经过 4-6 个周期的一线化疗后稳定或有反应的肿瘤患者的这些问题。我们将 158 名患者分为 MT（34 名 IIIB 期和 37 名 IV 期）和非 MT（47 名 IIIB 期和 40 名 IV 期）组，然后比较无进展生存期（PFS）和总生存期（OS）的临床结果。还研究了维持化疗或靶向药物、治疗方案和持续时间对 PFS 的影响。通过单变量和多变量分析确定了 OS 的预后因素。在这些患者中，71 人接受了 MT，87 人没有接受。MT 组的中位 PFS 和 OS 显着延长于非 MT 组（分别为 5.6 和 14.2 个月 vs. 2.8 和 9.8 个月；均 p < 0.0001）。与化疗、化疗> 4个周期、靶向药物> 3个月相比，患者维持靶向药物的PFS延长（均P < 0.0001）。腺癌且无远处转移的患者从 MT 中获得了更好的 OS 获益（分别为 P = 0.041 和 P = 0.037）。多变量分析显示，女性和 MT 是延长 OS 的独立预后因素（分别为 P = 0.039 和 P < 0.0001）。MT的主要不良事件包括可耐受的血液学毒性和胃肠道反应。MT对于晚期NSCLC患者，尤其是接受靶向药物治疗的无远处转移的腺癌患者有利且耐受，是OS的独立预后因素。