4CPS-089 Comparative effectiveness of nintedanib plus docetaxel versus docetaxel monotherapy in adenocarcinoma non-small cell lung cancer

Background and importance Nintedanib is indicated in combination with docetaxel for the treatment of non-small cell lung cancer (nSCLC) with adenocarcinoma histology after failure of firstline chemotherapy. Aim and objectives To evaluate the effectiveness of nintedanib in nSCLC, according to the conditions of use indicated in the data sheet, and to compare the health results obtained against an historical control of real word data from monotherapy with docetaxel. Material and methods A retrospective observational study was designed which included all patients treated with docetaxel monotherapy (DOm) or nintedanib+docetaxel (Ni-DO) from January 2013 to December 2018 as secondline or later treatment for nSCLC, in a reference hospital in oncology that covers a population of 600 000 inhabitants. The main variable was overall survival (OS). Other variables were progression free survival (PFS), duration of treatment (DT) and response, and demographic data of the patients. A Kaplan–Meier analysis and Cox regression were performed for dependent variables (OS and PFS) and frequency analysis, or with measures of central tendency and dispersion. Results Fifty-five patients (78.2% men) were included: 21 were treated with Ni-DO and the rest with DOm. Performance status at the beginning of treatments was ECOG=1 (n=27 patients, 51.9%), ECOG=0 (n=17, 32.7%) and ECOG=2 (n=8, 15.4%). Thirty-seven patients (71.1%) were smokers at diagnosis, 19.2% ex-smokers and 9.6% non-smokers. At the time of the analysis, no patient was being treated in either of the two arms. Mean DT was 2.5 months (σ=2.6) in the DOm arm and 5.2 months (σ=5.6) in the Ni-DO arm (p=0.016). Median OS was 6.9 months in the DOm arm and 8.3 months in the Ni-DO arm (p=0.08) (HR=0.59; 95% CI 0.33–1.07). For PFS, median values were 2.8 months and 4.7 months (p=0.038) in the DOm and NI-DO groups, respectively (HR=0.50; 95% CI 0.26–0.98). Only 22.7% of evaluable patients achieved partial a response to treatment and 27.3% achieved stabilisation. Conclusion and relevance In our geographic area we were not able to find a significant difference in the effectiveness of Ni-DO versus DOm in terms of OS although PFS and DT for the treatments were significantly higher in the Ni-DO arm. References and/or acknowledgements No conflict of interest.