scholarly journals Efficacy And Safety of Ramucirumab and Docetaxel In Previously Treated Patients With Squamous Cell Lung Cancer: A Multicenter Retrospective Cohort Study

Author(s):  
Hayato Kawachi ◽  
Motohiro Tamiya ◽  
Kinnosuke Matsumoto ◽  
Akihiro Tamiya ◽  
Takafumi Yanase ◽  
...  

Abstract 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 confirm the efficacy 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 significant 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 significant 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, efficacy and safety data of RAM/DOC were confirmed in a real-world setting and were similar to non-Sq. Ramucirumab is the only vascular endothelial growth factor-blocker available for Sq.

2020 ◽  
Author(s):  
Eduard Vrdoljak ◽  
Marko Jakopović ◽  
Lajos Geczi ◽  
Krisztina Bogos ◽  
Lidija Bosković ◽  
...  

Abstract Background: There is a lack of real-world data on the safety and efficacy of nivolumab in patients with previously treated advanced non-small-cell lung cancer (NSCLC) especially in South East Europe, a region with particularly high incidence and an unfavorable mortality-to-incidence ratio for lung cancer. Methods: This is a multicenter, retrospective cohort study on patients with stage IIIB or IV disease with at least one previous systemic treatment who received nivolumab through an expanded-access program between 2015 and 2017 in Croatia, Malta and Hungary. The primary endpoint was the proportion of patients whose therapy was discontinued because of toxicity. Secondary endpoints were incidence of adverse events (AEs), objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS). Results: We analyzed data on 239 patients with a median (IQR) age of 62 (57-68), and 33% of them were women. Treatment was discontinued because of toxicity in 11.6% (95% CI 7.8% to 16.5%) of patients. The PFS was 6.4 (95% CI 5.2 to 8.6) months, and the median OS was 14.1 (10.6 to 18.0) months. Conclusions: The safety and efficacy of nivolumab in previously treated patients with advanced NSCLC in the real-world South East Europe clinical settings were consistent with the results of randomized clinical trials and comparable to the results from other countries.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Eduard Vrdoljak ◽  
Marko Jakopović ◽  
Lajos Geczi ◽  
Krisztina Bogos ◽  
Lidija Bošković ◽  
...  

Background. There is a lack of real-world data on the safety and efficacy of nivolumab in patients with previously treated advanced non-small-cell lung cancer (NSCLC) especially in South East Europe, a region with particularly high incidence and an unfavorable mortality-to-incidence ratio for lung cancer. Objectives. To evaluate the real-world safety and efficacy of nivolumab in patients with previously treated advanced squamous and nonsquamous NSCLC in South East Europe. Methods. This is a multicenter, retrospective cohort study on patients with stage IIIB or IV disease with at least one previous systemic treatment who received nivolumab through an expanded-access program between 2015 and 2017 in Croatia, Malta, and Hungary. The primary endpoint was the proportion of patients whose therapy was discontinued because of toxicity. Secondary endpoints were the incidence of adverse events (AEs), objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results. We analyzed data on 239 patients with a median (IQR) age of 62 (57–68), and 33% of them were women. Treatment was discontinued because of toxicity in 11.6% (95% CI 7.8% to 16.5%) of patients. The PFS was 6.4 (95% CI 5.2 to 8.6) months, and the median OS was 14.1 (10.6 to 18.0) months. Conclusions. The safety and efficacy of nivolumab in previously treated patients with advanced NSCLC in the real-world South East Europe clinical settings were consistent with the results of randomized clinical trials and comparable to the results from other countries.


2020 ◽  
Vol 21 (5) ◽  
pp. e380-e387 ◽  
Author(s):  
Claudio Martin ◽  
Lorena Lupinacci ◽  
Florencia Perazzo ◽  
Carlos Bas ◽  
Omar Carranza ◽  
...  

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