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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2597 - Real-world dosing of regorafenib (REG) in metastatic colorectal cancer (mCRC): final results from the prospective, observational CORRELATE study

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Juan Manuel O'Connor

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

J.M. O'Connor1, M. Ducreux2, L.N. Petersen3, L. Öhler4, F. Bergamo5, J. Metges6, J.W. de Groot7, J. Wang8, B. García Paredes9, E. Dochy10, S. Fiala-Buskies11, A. Cervantes12, A. Falcone13

Author affiliations

  • 1 Department Of Clinical Oncology, Institute Alexander Fleming, C1426ANZ - Buenos Aires/AR
  • 2 Gastrointestinal Oncology Unit, Gustave Roussy Cancer Campus Grand Paris, Villejuif/FR
  • 3 Department Of Oncology, Rigshospitalet, Copenhagen/DK
  • 4 Internal Medicine I, Department Of Oncology, St. Josef Krankenhaus, Vienna/AT
  • 5 Medical Oncology Unit 1, Department Of Clinical And Experimental Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua/IT
  • 6 Service D'oncologie Et De Radiothérapie, CHU de Brest – Hôpital Morvan, Brest/FR
  • 7 Department Of Medical Oncology, Isala, Zwolle/NL
  • 8 Division Of Colorectal Surgery, Department Of Surgery, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City/TW
  • 9 Medical Oncology, Hospital Clínico San Carlos, Madrid/ES
  • 10 Global Medical Affairs Oncology, Bayer HealthCare Pharmaceuticals, Whippany/US
  • 11 Development, Integrated Analysis, Bayer AG, Wuppertal/DE
  • 12 Dept. Medical Oncology, University Hospital of Valencia, Valencia/ES
  • 13 Department Of Medical Oncology, University of Pisa, Pisa/IT
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Resources

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 mgStarting dose 120 mgTotal
(N = 591)(N = 315)(N = 1037)
Median age*64 (24–85)65 (33–89)65 (24–93)
Sex, male/female58/4266/3461/39
ECOG PS 0–1/2–489/485/987/6
Metastatic site at study entry, liver/lung73/5769/5772/57
Median treatment duration2.6 (0.03–29.5)2.4 (0.03–20.6)2.5 (0.03–29.5)
Treatment modification656365
Dose reduction473440
Treatment interruption/delay504748
Treatment modification due to AEs765866
*

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.

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