Abstract 458
Background
Regorafenib (160 mg daily 3 weeks on/1 week off) is approved for the treatment of patients with mCRC refractory to standard therapies. Global results from the prospective, observational CORRELATE study, which assessed 1037 patients from Europe, Asia, and Latin America in the real-world setting, showed that treatment-emergent adverse events (TEAEs) and outcomes were generally consistent with results of phase 3 trials. We present a subgroup analysis of patients enrolled from Taiwan in CORRELATE.
Methods
CORRELATE included patients with mCRC who were previously treated with approved therapies according to the local health authority approved label. The primary endpoint was the incidence of TEAEs (NCI-CTCAE v4.03). Overall survival (OS) and progression-free survival (PFS) were secondary endpoints.
Results
A total of 128 patients from Taiwan received treatment. At study entry, most patients were ECOG performance status 0–1 (90%), 67% had KRAS mutations and 27% did not, 90% had prior anti-VEGF treatment, 42% had prior anti-EGFR, and the most common metastatic sites were liver (60%) and lung (59%). Regorafenib 160 mg/day was the initial daily dose in 28% of patients and the final dose in 15% (Table). Overall, 38% of patients had no treatment modifications, 39% had dose reductions, and 50% had an interruption/delay. TEAEs of any grade and grade ≥3 occurred in 89% and 52% of patients, respectively, and were considered regorafenib related in 64% and 23%, respectively. Grade 5 TEAEs occurred in 14% of patients of which none were considered regorafenib related. Median OS was 11.6 months and median PFS was 2.1 months.
Table: 109P
| Taiwan cohort N = 128 | |
|---|---|
| Median age, years (range) | 64 (36–89) |
| Sex, male % | 66 |
| Median BMI, kg/m2 | 23.1 |
| Median treatment duration, months (range) | 2.3 (0.2–20.6) |
| Initial daily dose, % 160 mg/120 mg/80 mg | 28/48/23 |
| Final daily dose, % 160 mg/120 mg/80 mg | 15/43/38 |
| TEAEs*, % (all grade/grade ≥3) Any Hand–foot skin reaction Fatigue Anorexia Diarrhea | 89/52 36/10 28/2 23/2 22/4 |
| Median OS, months (95% CI) | 11.6 (8.4, 13.8) |
| Median PFS, months (95% CI) | 2.1 (1.8, 2.7) |
Irrespective of relation to study drug
Conclusions
In patients from Taiwan enrolled in CORRELATE, AEs were generally consistent with the known safety profile of regorafenib in Asian patients with mCRC. OS in this subgroup was longer than in phase 3 trials.
Editorial acknowledgement
Editorial assistance in the preparation of this abstract was provided by Katrin Gudmundsdottir of SuccinctChoice Medical Communications (London, UK), with financial support from Bayer.
Clinical trial identification
NCT02042144.
Legal entity responsible for the study
Bayer.
Funding
Bayer.
Disclosure
K-H. Yeh: Advisory board honorarium: Novartis, Boehringer Ingelheim, Bayer, Takeda, Bristol-Myers Squibb, Ono Pharmaceutical, Merck Serono, Merck Sharp & Dohme, Lilly, Amgen. C-W. Duann, Y-S. Li: Full time employment: Bayer. S. Fiala-Buskies: Full time employment, stock shareholder: Bayer. M. Ducreux: Grants/research support: Roche, Merck Serono; Advisory board membership: Roche, Merck Serono, Celgene, Bayer, Servier, Amgen, Ipsen; Honoraria: Bayer, Roche, Merck Serono, Servier, Amgen, Novartis, Ipsen, Lilly; Travel, accommodations, expenses: Roche, Ipsen, Merck Serono, Merck Sharp & Dohme, Lilly, Amgen. All other authors have declared no conflicts of interest.