Abstract 446P
Background
Ramucirumab plus paclitaxel combination (Ram/Pac) has been established as a second-line treatment, and new clinical trials use it as a standard of care. We previously reported retrospective real-world data (RWD) of Ram/Pac (K-RWE) in 2021. Considering the limitations of retrospective study, we conducted a prospective real-world study.
Methods
We prospectively collected RWD including efficacy, and adverse events (AE) of patients who received Ram/Pac for gastric or gastroesophageal cancer (Prospective cohort) in 18 institutes in Korea. In order to compared with the prospective cohort, data from clinically matched patients who received second-line chemotherapy before Ram/Pac (eg, paclitaxel monotherapy or FOLFIRI) was introduced in Korea were also obtained (Retrospective cohort). Additionally, the outcomes of prospective cohort were compared with those of RAINBOW study using matching adjusted indirect comparison (MAIC).
Results
From June 2021 to July 2022, a total 222 patients were enrolled in the prospective cohort. Retrospective cohort was comprised of 222 matched patients who received second-line chemotherapy between 2006 to 2021. Overall survival (OS) was significantly longer in the prospective compared to the retrospective cohort (median 10.5 vs. 6.7 months, HR 0.65, 95% CI 0.52-0.81, p< 0.001). Progression-free survival (PFS) was also superior in the prospective cohort (median 6.2 vs. 3.4 months, HR 0.53, 95% CI 0.43-0.65, p< 0.001). Objective response rate was 30% (CR 2% and PR 28%). Grade 3 or higher AE occurred in 54.1% of patients included neutropenia (30.2%), anemia (7.2%) neuropathy (1.4%) and hypertension (1.4%). In the MAIC analysis, OS was similar between data from prospective cohort and RAINBOW study (median OS: 10.1 vs 9.8 months, HR 0.93, 95% CI 0.73-1.17, p= 0.526). Longer PFS was observed in the prospective cohort (median PFS: 6.0 vs 4.3 months, HR 0.68, p< 0.001).
Conclusions
Our prospective data showed significant survival benefit of Ram/Pac as a second-line treatment confirming the results of RAINBOW study in the real-word setting. No new signals were detected in terms of safety.
Clinical trial identification
NCT04915807.
Legal entity responsible for the study
Korean Cancer Study Group (KCSG).
Funding
Korean Health Insurance Review & Assessment Service.
Disclosure
All authors have declared no conflicts of interest.