Clinical efficacy and safety of maintenance therapy for advanced non-small cell lung cancer: a retrospective real-world study.

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.