Background: Docetaxel (DOC) plus ramucirumab (RAM) has been recommended as an optimal therapy for previously treated patients with non-small cell lung cancer (NSCLC). In a clinical setting, there are few reports about DOC plus RAM, therefore its effect on factors such as Eastern Cooperative Oncology Group (ECOG) performance status (PS) and metastatic sites is still unknown. Methods:We recruited NSCLC patients who received DOC plus RAM in four medical facilities in Japan from June 2016 to March 2020. We retrospectively investigated the overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) of DOC plus RAM and conducted univariate and multivariate analyses using PFS as a dependent factor. Patients were followed up until June 30, 2020.

Objective: Ramucirumab plus docetaxel therapy (RAM/DOC) is currently the standard for previously treated advanced non-small cell lung cancer (NSCLC), irrespective of histology. However, the safety data of anti-angiogenic agents for squamous cell NSCLC (Sq) is lacking, with a higher reported rate of severe hemoptysis in a clinical trial setting. We conducted a multicenter retrospective cohort study to con rm the e cacy and safety of RAM/DOC for Sq in real-world settings. Methods: We retrospectively analyzed previously treated patients with advanced NSCLC who underwent RAM/DOC at four institutions. Clinical data on the initiation of RAM/DOC were collected from medical records. Treatment outcomes of RAM/DOC were assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1. Incidence of pulmonary hemorrhage was assessed according to the Common Terminology Criteria for Adverse Events version 5.0.Results: Overall, 237 patients with NSCLC were included and 38 (16%) had squamous cell carcinoma.There were no signi cant differences in median progression-free survival and overall survival between Sq and non-Sq patients (5.8 months vs. 4.3 months, P=0.0937; 15.2 months vs. 13.4 months, P=0.714, respectively). Of all patients, 13 (5%) developed pulmonary hemorrhage. According to histology, there was no signi cant difference in pulmonary hemorrhage proportion between Sq and non-Sq cohorts (2/38 vs. 11/199, respectively, P=0.947). Conclusion:For previously treated patients with Sq, e cacy and safety data of RAM/DOC were con rmed in a real-world setting and were similar to non-Sq. Ramucirumab is the only vascular endothelial growth factor-blocker available for Sq.

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