Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): RAISE - Varför FOLFIRI som kontrollarm?

I RAISE-studien valdes FOLFIRI som kontrollarm baserat på fastställda riktlinjer vid tidpunkten för studiestart.

Rationale for FOLFIRI Control Arm

When the RAISE trial was initiated, FOLFIRI was selected as the control arm because at that time

  • oxaliplatin- and irinotecan-based treatments were considered equally effective and interchangeable for the first- and second-line treatment of mCRC

  • FOLFIRI was a globally-accepted standard of care in the second-line setting after progression on an oxaliplatin-based first-line treatment regimen, and

  • there was no standard combination of targeted therapy plus FOLFIRI after progression on an oxaliplatin plus bevacizumab regimen.1,2

Study Design

The RAISE trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated FOLFIRI and ramucirumab vs FOLFIRI and placebo in the second-line treatment of patients with mCRC who had progressed on first-line combination therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Patients were randomly assigned in a 1:1 ratio (stratified by region, KRAS mutation status, and time to PD after beginning first-line treatment) to receive IV infusions of either FOLFIRI plus ramucirumab 8 mg/kg (n=536) or FOLFIRI plus placebo (n=536) once every 2 weeks.3

References

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology Colon Cancer (version 2.2015, 03Oct2014). http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed 22Dec2014.

2. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D on behalf of the ESMO Guidelines Working Group. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(suppl 3):iii1-iii9. http://dx.doi.org/10.1093/annonc/mdu260

3. Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015;16(5):499-508. http://dx.doi.org/10.1016/S1470-2045(15)70127-0

Glossary

FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil

IV = intravenous

KRAS = Kirsten rat sarcoma virus 

mCRC = metastatic colorectal cancer

PD = progressive disease

Datum fӧr senaste ӧversyn 2020 M10 01


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss