107P - Safety and efficacy of trifluridine/tipiracil (FTD/TPI) in previously treated metastatic colorectal cancer (mCRC): Results from the Australian cohort of the phase IIIb, international, open-label, early-access PRECONNECT study

Background

The PRECONNECT study assessed safety and efficacy of FTD/TPI in previously treated mCRC patients in daily practice. This analysis presents the results from the Australian patient cohort.

Methods

Enrolled patients had confirmed mCRC and ECOG PS of 0 or 1, previously treated with, or not considered candidates for available therapies. Patients received FTD/TPI (35 mg/m², orally bid, on days 1–5 and 8–12 in a 28-day cycle) with follow-up to the end of study treatment. Withdrawal criteria included disease progression, unacceptable toxicity and commercial availability of FTD/TPI. The primary endpoint was safety; secondary endpoints were PFS and QoL.

Results

70 Australian patients from 9 centres received at least one dose at cut-off (May 2018). At baseline, median age was 61 years (range 27–77); 57.1% male; 80% Caucasian, 14.3% Asian, 1.4% Black. ECOG PS was 0/1 in 54%/44%. 60% had RAS-mutant cancers; 10% had BRAF-(V600E) mutant cancers. Primaries were left-sided in 71%, right-sided in 14% (14% not specified). Over 98% received prior fluoropyrimidine and/or oxaliplatin, irinotecan, while 91%, 36% and 0% received anti-VEGF, anti-EGFR or regorafenib respectively. Most common any-grade treatment-emergent adverse events (TEAs) were nausea (49%), asthenia/fatigue (40%), neutropenia (34%), vomiting (33%), diarrhoea (26%), Anemia (21%) and constipation (20%). Most common TEAs grade ≥3 were: neutropenia (31%), anaemia (10%), diarrhoea, nausea, vomiting, abdominal pain (3%). TEAs led to patient withdrawal in 7% and dosage reduction in 9%. Median treatment duration was 3 cycles (range 1–16). Median relative dose intensity was 92%. FTD/TPI was associated with a median PFS of 2.7 months (95% CI, 2.4–3.4) and disease control rate of 40% (95% CI, 28.47–52.41). Median time to ECOG PS decline to ³2 was 14 months. Mean QLQC30 GHS at baseline was 67.2 (±17.8) with mean change from baseline to end of therapy of -11.3 (±21.7) points.

Conclusions

Results from the Australian cohort are consistent with the global PRECONNECT population and randomised datasets in previously treated mCRC patients.

Clinical trial identification

NCT03306394.

Editorial acknowledgement

Legal entity responsible for the study

Institut de Recherches Internationales Servier.

Funding

Institut de Recherches Internationales Servier.

Disclosure

G. Tancock: Full/Part-time employment: Servier Australia Pty. Ltd. All other authors have declared no conflicts of interest.