Abstract 93P
Background
In the SUNLIGHT trial, the addition of BV to FTD/TPI showed improved progression-free survival (PFS) and overall survival (OS) compared to FTD/TPI alone in pretreated mCRC pts, becoming a new standard of treatment (tx). Here, we present an Italian real-world analysis of effectiveness and safety of this combination.
Methods
Our multicenter retrospective study enrolled pretreated mCRC patients receiving FTD/TPI+BV at 13 Italian centers. Primary endpoints were PFS and OS; secondary endpoint was safety. The Kaplan–Meier method was used to estimate efficacy outcome; log-rank test and Cox-regression model were used to compare the differences, considering a statistically significant p value < 0.05.
Results
A total of 198 pts were enrolled: median age was 65 years (34-89), 102 pts (52%) were male, 138 (70%) had left-sided primary tumor, ECOG PS was 0 in 104 pts (52%). One hundred and seven pts (54%) had received two prior lines of tx and 61 (33%) three or more; all pts were previously exposed to BV. All pts were analyzed for RAS/BRAF status: 120 pts (60%) had a RAS mutated tumor and 7 (4%) a BRAF mutated tumor. Median PFS (mPFS) was 4.5 months (CI 95% 3.8-6.1) and mOS was 11.8 (CI 95% 8.9-Not reached). At the univariate analysis, ECOG PS (0-1 vs 2), number of previous lines (1-2 vs 3 or more) and neutropenia (yes vs no) were associated with both mPFS and mOS; at the multivariate analysis, only neutropenia remained statistically associated with mPFS (HR: 0.48 [CI 95% 0.31-0.74], p=0.001) and mOS (HR: 0.33 [CI 95% 0.18-0.60], p<0.001). RAS/BRAF status was not associated with mPFS and mOS. Any grade adverse events (AEs) occurred in 84% of pts: the most frequent AEs were neutropenia (70%), asthenia (61%) and anemia (46%); the most frequent G3/4 AE was neutropenia (49%). No pts discontinued tx due to toxicity. Post FTD/TPI+BV progression, 61% of pts received at least a further line of tx: the most used tx was regorafenib (54%).
Conclusions
Our real-life data are consistent with those from the SUNLIGHT trial, confirming the safety profile and the efficacy of FTD/TPI+BV in unselected pretreated mCRC pts. In this subset of mCRC pts, neutropenia emerged as a possible predictor factor for efficacy.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.