Abstract 2597
Background
REG 160 mg/day 3 weeks on/1 week off is approved for the treatment of patients with treatment-refractory mCRC. This final analysis of the prospective, observational CORRELATE study describes REG real-world dosing in mCRC.
Methods
CORRELATE (NCT02042144) was conducted in 13 countries across Europe, Latin American, and Asia and enrolled patients with mCRC for whom the decision to treat with REG was made by the treating physician. The primary aim was to assess safety.
Results
Of 1037 patients, 57% started treatment at 160 mg, 30% at 120 mg, and 13% at ≤ 80 mg. The mean and median percent of the approved dose was 75%. At baseline, median age was 65 years, most patients were ECOG performance status (PS) 0–1 (87%), and 56% had KRAS mutations; age and ECOG PS was similar between dose groups (160 vs 120 mg; Table). Dose reductions were more frequent in the 160 versus 120 mg group, while the proportion of patients having an interruption/delay or treatment modification was similar. Treatment modifications were most commonly due to treatment-emergent adverse events (TEAEs) (66%). Overall, most discontinuations (49%) were due to radiologic disease progression, whereas 19% were due to REG-related TEAEs. Overall, TEAEs of any grade occurred in 95% of patients, and were deemed REG related in 80%. Grade ≥3 TEAEs occurred in 62% of patients, and were attributed to REG in 36%. The most common REG-related grade ≥3 TEAEs were fatigue (9%), hand–foot skin reaction (7%), and hypertension (6%). Grade 5 TEAEs occurred in 17% of patients and were considered REG related in 1%. Median overall survival (OS) was 7.6 months (95% CI 7.1–8.2) and the estimated 1-year OS was 34%.Table: 463P
| % | Starting dose 160 mg | Starting dose 120 mg | Total |
|---|---|---|---|
| (N = 591) | (N = 315) | (N = 1037) | |
| Median age* | 64 (24–85) | 65 (33–89) | 65 (24–93) |
| Sex, male/female | 58/42 | 66/34 | 61/39 |
| ECOG PS 0–1/2–4 | 89/4 | 85/9 | 87/6 |
| Metastatic site at study entry, liver/lung | 73/57 | 69/57 | 72/57 |
| Median treatment duration† | 2.6 (0.03–29.5) | 2.4 (0.03–20.6) | 2.5 (0.03–29.5) |
| Treatment modification | 65 | 63 | 65 |
| Dose reduction | 47 | 34 | 40 |
| Treatment interruption/delay | 50 | 47 | 48 |
| Treatment modification due to AEs | 76 | 58 | 66 |
years (range);
†months (range)
Conclusions
In this real-world, observational study, the starting dose of REG for nearly half of patients was less than 160 mg/day. Common TEAEs were generally consistent with the known safety profile of REG in mCRC.
Clinical trial identification
NCT02042144.
Legal entity responsible for the study
Bayer.
Funding
Bayer.
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.
Disclosure
J.M. O’Connor: Advisory board attendance: Merck Serono, Bayer, Servier; Speaker's bureau: Merck Serono, Bayer, Servier. M. Ducreux: Grants/research support: Roche, Merck Serono; Advisory board attendance: Roche, Merck Serono, Celgene, Bayer, Servier, Amgen, Ipsen; Honoraria: Bayer, Roche, Merck Serono, Servier, Amgen, Novartis, Ipsen and Lilly; Travel, accommodations, expenses: Roche, Ipsen, Merck Serono, Merck Sharp & Dohme, Lilly, Amgen. J-P. Metges: Honoraria from Lilly, Sanofi, Novartis, Merck Serono. J.W. de Groot: Advisory board attendance, Bayer, Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, Servier, Roche. J-Y. Wang: Grants/research support: Roche; Advisory board attendance: Bayer; Speaker's bureau: Bayer, Merck Serono, Pfizer, Roche. B. García Paredes: Advisory board: Sanofi. E. Dochy: Full-time employment: Bayer. S. Fiala-Buskies: Full-time employee, Stock ownership: Bayer. A. Cervantes: Grants, Research support: Roche, Merck Serono, Servier; Advisory board: Bayer, Roche and Merck Serono; Honoraria: Bayer, Amgen, Roche, Lilly, Merck Serono, Servier, Novartis, Takeda, BeiGene, Astellas Pharma. A. Falcone: Grants, Research support: Amgen, Roche, Merck Serono, Servier, Bayer Merck Sharp & Dohme; Advisory board: Amgen, Roche, Merck Serono, Servier, Bayer Bristol-Myers Squibb; Honoraria: Amgen, Roche, Merck Serono, Servier, Bayer. All other authors have declared no conflicts of interest.