Abstract 427P
Background
TAS-102 is approved for patients with refractory mCRC. It remains to be defined which patients may benefit from this drug in real-life clinical practice.
Methods
Multicenter retrospective observational analysis of mCRC patients receiving TAS-102 in Spanish centers from November 2015 to the present.
Results
222 patients were included. Median age of 62 yr(31-83); 62.6% male. TAS-102 was mostly used in 3º (54.5%), 4º line(29.3%). TAS-102 was very well tolerated. Dose reduction was required in 34.7% but only 4.1% discontinued therapy. Toxicity included neutropenia 74.1%(>G3 20.2%), fatigue 57.8%(G3 5.1%), diarrhea 21.5%(G3 0.5%) and nausea 24.7%(G3 0.9%). Among patients who had SD/PR, 70.7% had neutropenia>G2 with respect to those who did not (p = 0.02). Median of 3 cycles(2-23), median duration of treatment 4.4 months(1.2-26.2), disease control rate(DCR) 33.8% (PR achieved in 1.8%). Median PFS 3.9m (95% CI 3.5-4.2) and median OS 9.3m (95% CI 7.9-10.67). There was no statistically significant difference of PFS/OS according to primary tumor location or RAS/BRAF mutation status, although MMRp tumors was associated with longer PFS (6.1 vs 3.4m, p=0.002) and OS (14.2 vs 6.3, p=0.001). Patients with low-volume metastatic disease(LVMD), defined as no massive hepatic metastasis or simultaneous liver and lung involvement had better DCR than patients with high volume(44,9% vs 24,2%, respectively, p=0.03). PFS (4.1 vs 3.5m, respectively, p=0.024, HR 1.73 95%CI 1.04-1.81) and OS (11.7 vs 7.8m, p=0.012 HR 1.49 95%CI 1.08-2.3) were also significantly better for patients with LVMD. In the subgroup of who received prolonged treatment (>6 cycles;N=51), 43.1% were <65 years, 60.8% had LVMD and 54.9% of patients had received TAS102 as second/third line. Almost all patients in this subgroup (92.2%) presented SD and PFS was significantly higher than in subgroup of patients >5 cycles (9.3 vs 3.36 m, p<0.001, HR 0.15 95%CI 0.1-0.2) and higher OS (15.9 vs 7.46m, p< 0.001, HR 0.35 95%ci 0.24-0.52).
Conclusions
OS and PFS observed in our real-world experience were slightly higher than the RECOURSE trial. In our series, the subgroup with LVMD achieved one of the best rates described in Spanish series. TAS-102 showed a reasonable safety profile.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.