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Subgroup analysis of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) in the phase 3b CONSIGN trial who had progression-free survival (PFS) >4 months (m)

Date

08 Oct 2016

Session

Poster Display

Presenters

Rocio Garcia-Carbonero

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

R. Garcia-Carbonero1, E. van Cutsem2, F. Ciardiello3, M. Ychou4, J. Seitz5, R.D. Hofheinz6, Y. Arriaga7, U. Verma7, A. Grothey8, A. Miriyala9, J. Kalmus10, C. Kappeler11, A. Falcone12, A. Zaniboni13

Author affiliations

  • 1 Department Of Medical Oncology, Hospital Universitario Doce de Octubre, 28041 - Madrid/ES
  • 2 Digestive Oncology, University Hospitals Leuven, Leuven/BE
  • 3 Department Of Experimental And Clinical Medicine And Surgery, Second University of Naples, Naples/IT
  • 4 Department Of Digestive Oncology, Institut Régional du Cancer de Montpellier (ICM), Montpellier/FR
  • 5 Department Of Digestive Oncology, Aix-Marseille University, Assistance Publique Hôpitaux, Marseille/FR
  • 6 Interdisziplinären Tumorzentrum, University Hospital Mannheim, Mannheim/DE
  • 7 Division Of Hematology And Oncology, University of Texas Southwestern Medical Center, Dallas/US
  • 8 Department Of Oncology, Mayo Clinic, Rochester/US
  • 9 Global Pharmacovigilance And Risk Management, Bayer Pharma AG, Berlin/DE
  • 10 Global Clinical Development Oncology, Ophthalmology & Neurology, Bayer Pharma AG, Berlin/DE
  • 11 Clinical Statistics Eu, Bayer Pharma AG, Berlin/DE
  • 12 Department Of Medical Oncology, University of Pisa, Pisa/IT
  • 13 Department Of Oncology, Fondazione Poliambulanza, Brescia/IT
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Background

In the phase 3 randomized CORRECT trial, REG improved survival vs placebo in treatment-refractory mCRC; 19% of REG-treated patients had PFS >4 m. In the single-arm phase 3b CONSIGN trial (NCT01538680) of REG, adverse events (AEs) and PFS were consistent with phase 3 trials in mCRC. We performed a retrospective analysis of CONSIGN patients with PFS >4 m (long PFS) and ≤4 m (short PFS).

Methods

Patients with treatment-refractory mCRC received REG 160 mg QD for 3 wks on/1 wk off until disease progression, death, or unacceptable toxicity. Treatment beyond progression was at the investigator's discretion. PFS (investigator assessed) was the time from treatment assignment to progression or death. Of 2872 patients assigned to REG, 674 (23%) had long PFS and 2198 (77%) had short PFS. Descriptive statistics are reported.

Results

Compared to the short PFS group, the long PFS group had a higher proportion of patients with ECOG PS 0, with no liver metastases, and ≥18 m since diagnosis of metastatic disease (Table). Long PFS patients received a median of 7 cycles (2–29); 75% ≥6 cycles; 34% ≥9 cycles. Short PFS patients received a median of 2 cycles (1–33). Dose reductions due to AEs (long PFS, short PFS) were 65%, 40%; actual mean daily doses were 136 mg, 149 mg, respectively. The most common drug-related NCI-CTCAE v4 grade ≥3 AEs (long PFS, short PFS) were hypertension (20%, 14%), hand–foot skin reaction (19%, 12%), fatigue (13%, 13%), diarrhea (8%, 4%), and hypophosphatemia (8%, 4%).

Long PFS (n = 674) Short PFS (n = 2198)
Median age, yrs (range) 62 (27–86) 62 (19–89)
Age, % ≥70 yrs ≥75 yrs 19 8 23 10
ECOG PS, % 0 1 58 41 44 56
Liver metastases, % No Yes 32 67 20 80
KRAS status, % mutant wild-type 47 49 52 43
Primary site of disease, % Colon Rectum Both 66 28 6 64 28 8
No. of prior regimens on or after diagnosis of metastatic disease, % 0–2 3 ≥4 22 28 50 28 27 45
Time since first diagnosis of metastatic disease to treatment assignment, %

Conclusions

This exploratory analysis suggests that among patients with mCRC treated with regorafenib, the long PFS (>4 months) subgroup tended to have a higher proportion of patients with better performance status, with no liver involvement, and a longer time since diagnosis of metastatic disease. Higher rates of some AEs and dose reductions in the long PFS group may be related to longer treatment duration.

Clinical trial identification

NCT01538680

Legal entity responsible for the study

Bayer

Funding

Bayer

Disclosure

R. Garcia-Carbonero: Advisory board: Roche, Amgen, Merck, Sanofi, Lilly, Boehringer Ingelheim, Bayer, Novartis, Ipsen. E. Van Cutsem: Corporate-sponsored research: Bayer. F. Ciardiello: Advisory board: Bayer, Roche, Merck Serono, Lilly, Sanofi, AstraZeneca. Corporate-sponsored research: AstraZeneca, Merck Serono, Roche, Bayer. M. Ychou: Advisory board: Bayer, Roche, Merck. J-F. Seitz: Advisory board: Roche, Sanofi-Aventis. R.D. Hofheinz: Corporate-sponsored research: Amgen, Medac, Merck, Roche, Sanofi. U. Verma: Advisory board: Bayer. Speakers bureau: Intramed. A. Grothey: Advisory board: Bayer Corporate-sponsored research: Bayer (institute). A. Miriyala, J. Kalmus, C. Kappeler: Stock ownership: Bayer. Other substantive relationships: Bayer (employee). A. Falcone: Advisory board: Amgen, Roche, Bayer, Lilly, Sanofi, Servier, Merck. Corporate-sponsored research: Roche, Amgen, Bayer, Merck, Sanofi. All other authors have declared no conflicts of interest.

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