Konference: 2012 37th Congress ESMO – účast ČR
Kategorie: Kolorektální karcinom
Téma: Poster, Poster presentation III
Číslo abstraktu: 665TiP
Autoři: doc. MUDr. Radek Lakomý, Ph.D.; MD Wojciech Rogowski; Dr. Béla Pikó; MD Csilla András, PhD; E. Molnar
Registry Number 20080618
Background
Panitumumab (Pmab; Vectibix®) is a fully human monoclonal antibody, which binds specifically to the human epidermal growth factor receptor (EGFr). Skin toxicity (ST), a pharmacological effect observed with EGFr inhibitors, appears in almost all patients (pts) treated with Pmab and is usually mild to moderate in severity. The VECTIS study was designed to determine the safety and efficacy of Pmab as monotherapy in daily practice with special reference to ST and its management.
Methods
This is an open-label, prospective, non-interventional study collecting data from pts from CEE countries, aged ≥18 years, who have EGFr expressing mCRC with wild type KRAS gene tumour status receiving Pmab monotherapy (6 mg/kg Q2W) after failure of chemotherapy regimens containing 5-FU, oxaliplatin and irinotecan. This interim analysis includes the data collected between 12/2008 and 06/2011 from pts in Hungary, Poland, and the CzechRepublic. The observation period was limited to 18 cycles.
Results
At the time of reporting, 177/205 (86.3%) enrolled pts have experienced a total of 266 ST events with an incidence rate (IR) (events per pt per year) of 3.47 (95% confidence interval [CI] = 3.07, 3.91); 15 pts experienced Grade 3 ST with an IR of 0.20 (95% CI = 0.11, 0.32) and no pts had ST Grade ≥4. Of the recorded ST events, 25.9% have resolved; 3.4% have resolved with consequences; 19.9% continue but are improving; and 50.8% have not resolved. Overall, 69.8% of pts required therapeutic measures for ST. Four serious Adverse Drug Reactions (ADRs) were reported. Of 6 deaths that occurred, none was related to Pmab. Four pts have stopped Pmab therapy due to ADRs including ST or other toxicity.
| Overall (N = 205) % (95% CI) | ST Grade ≥ 2 (N = 112) % (95% CI) | |
| Tumor response | 26.8 (20.9, 33.4) | 30.4 (22.0, 39.8) |
| Disease control rate | 67.8 (60.9, 74.1) | 70.5 (61.2, 78.8) |
| Free from progression (18 cycles) | 12.7 (8.5, 18.0) | 13.4 (7.7, 21.1) |
A statistically significant positive correlation was observed between severity of ST and the best response (r = 0.13) as well as tumor response (r = 0.15).
Conclusion
In clinical practice, Pmab monotherapy appears to be well tolerated and effective in pts who have heavily pre-treated mCRC with wild-type KRAS status. This study is sponsored by Amgen GmbH CEE Headquarters.
Disclosure
R. Lakomy: Vectis study.
W. Rogowski: Vectis study, Pegfilgrastim study.
B. Pikó: Vectis study, Pegfilgrastim study.
C. András: Vectis study, Pegfilgrastim study, Amgen sponsored scientific event speaker.
E. Molnar: employment possition Amgen, stock
Datum přednesení příspěvku: 1. 10. 2012
