Abstract 453P
Background
In metastatic colorectal cancer (mCRC), the main aim of treatment is to prolong overall survival (OS) without impairing quality of life (QoL). The RECOURSE trial demonstrated that trifluridine/tipiracil (FTD/TPI) significantly improved OS versus placebo in pretreated mCRC patients. QoL was not assessed in this phase III trial.
Methods
From 497 mCRC patients who were treated with FTD/TPI, clinical data was obtained from the population-based Netherlands Cancer Registry. From 169 patients, additional QoL (EORTC QLQ-C30) data was collected monthly from start of FTD/TPI in the QUALITAS cohort, a substudy of the Prospective Dutch CRC cohort (PLCRC). We calculated the QLQ-C30 Summary Score (QoL-SS). Differences in scores were deemed clinically relevant if ≥10 points.
Results
Median time on FTD/TPI treatment of the complete cohort (n=497) was 2.7 months (IQR 1.8-3.8). Median time from mCRC diagnosis to start FTD/TPI was 17.7 months (IQR 11.5-27.9). Median OS from initiation of FTD/TPI was 5.1 months (95% CI 4.6-5.6). To date, QoL results are available for 68 patients. Results of the total cohort will follow in the next 3 months. Patients who were treated with FTD/TPI for at least 3 months (n=24) reported clinically relevant less fatigue, appetite loss and higher QoL at treatment start than patients with shorter treatment duration (n=44): 28.2±20.2 vs. 46.6±27.5 (p=0.003), 4.2±14.9 vs. 31.1±36.2 (p<0.0001), and 84.4±10.3 vs. 74.8±18.1 (p=0.007), respectively. In the total group, no clinically relevant deterioration of QoL during FTD/TPI treatment was observed. QoL-SS at baseline was 78.3±16.3, after 2 months of treatment 80.8±14.6, after 3 months 84.3±13.8, and after 4 months 80.4±17.3. Also, fatigue, appetite loss, and nausea/vomiting did not deteriorate over time. Final QoL results will be presented at the ESMO Congress.
Conclusions
Overall survival in almost 500 patients from start of FTD/TPI is comparable to other population-based studies. Our results suggest that fewer symptoms at start of FTD/TPI treatment are associated with longer treatment duration. QoL was maintained during FTD/TPI treatment, which supports its use in clinical practice.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Servier Nederland Farma BV.
Disclosure
G. Vink: Research grant/Funding (institution), Travel/Accommodation/Expenses: Servier Farma; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Merck. M. Koopman: Honoraria (institution), Research grant/Funding (institution): BMS; Honoraria (institution), Research grant/Funding (institution): Nordic Pharma; Honoraria (institution), Research grant/Funding (institution): Servier Farma; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Merck-Serono; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Sirtex; Research grant/Funding (institution): Sanofi-Aventis; Travel/Accommodation/Expenses: Congress-Care - Dutch oncology society (NVMO). All other authors have declared no conflicts of interest.