Ramucirumab+Docetaxel Post Immune Checkpoint Inhibitors (ICIS) and Platinum-Based Chemotherapy (CHEMO) in Advanced or Metastatic Non-Small Cell Lung Cancer (ANSCLC): Learnings from the Treat-Lung Observational Study
Author(s)
Pennell N1, Clarke JM2, Liu S3, Gutierrez M4, Batus M5, Bauman J6, Fidler MJ5, Marmarelis ME7, Feliciano J8, Barzi A9, Lopes G10, Molife C11, Verma S12, Stefaniak VJ11, Winfree KB11, Belli A13, Cui Z11, Kim S11, Manion C11, Afolabi M12, Caria N11, Bonomi P5
1Cleveland Clinic, Cleveland, OH, USA, 2Duke Cancer Institute, Durham, NC, USA, 3Georgetown University, Washington, DC, USA, 4Hackensack University Medical Center, Hackensack, NJ, USA, 5Rush University Medical Center, Chicago, IL, USA, 6Fox Chase Cancer Center, Philadelphia, PA, USA, 7University of Pennsylvania, Philadelphia, PA, USA, 8Johns Hopkins University School of Medicine, Baltimore, MD, USA, 9City of Hope Comprehensive Cancer Centre, Duarte, CA, USA, 10University of Miami, Miami, FL, USA, 11Eli Lilly and Company, Indianapolis, IN, USA, 12STATinMED Research, Inc., Plano, TX, USA, 13COTA, Inc., Boston, MA, USA
Presentation Documents
OBJECTIVES
: Adding ramucirumab to docetaxel after failure of chemo improves response rates and survival in aNSCLC. TREAT-LUNG aimed to characterize real-world use of ramucirumab+docetaxel or docetaxel, following ICIs and chemo for aNSCLC.METHODS
: Retrospective study of real-world data abstracted/aggregated from 3 EHR databases (Flatiron/COTA/IQVIA). Eligible patients had received second-line (primary-2L-cohort) or third-line (3L-cohort) ramucirumab+docetaxel or docetaxel for aNSCLC, following ICIs and chemo, between 03/2015-12/2019. Primary endpoint was real-world objective response rate (rwORR) among patients with evaluable tumor response assessment data. Minimum required sample size for primary analysis of rwORR was 286, based on a priori power analysis. Treatment-group comparisons were adjusted using propensity-score stratification.RESULTS
: After adjustment, real-world tumor response assessment was unknown/missing for 121 of 243 patients (50%) in the primary-2L-cohort, 206 of 361 patients (57%) in the 3L-cohort, and 311 of 557 patients (56%) in the combined-(2L+3L)-cohort. Among the subset of the 2L-cohort with evaluable real-world tumor response data (n=121), rwORR was 43% in ramucirumab+docetaxel-group (n=78) and 39% in docetaxel-group (n=43), odds ratio, 1.20; 95% confidence interval, 0.54-2.65. This lack of significant difference between groups was consistent for disease control rates and across 3L (n=155) and combined-(n=246)-cohorts. Secondary effectiveness outcomes such as real-world PFS and OS among all eligible patients were similar between groups (data to be presented). Patterns of adverse events were consistent with established safety profiles for ramucirumab and docetaxel, with some (≤5%) occurrence of immune-related toxicities in both groups. CONCLUSION rwORR differences between groups did not reach statistical significance. Findings must be interpreted in context of study limitations including insufficient sample size for primary and secondary analyses, potential selection bias inherent in passively collected EHR datasets, and residual confounding despite propensity adjustment. Perhaps, more importantly, the high rate of missing tumor response data (>50% overall) may have implications for the design of real-world data studies.Conference/Value in Health Info
Value in Health, Volume 25, Issue 6, S1 (June 2022)
Code
CO154
Topic
Clinical Outcomes, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy, Electronic Medical & Health Records, Missing Data
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology