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 förbehandling med bevacizumab?

RAISE-studien var utformad för att utvärdera om behandling med Cyramza (ramucirumab) förbättrade total överlevnad efter sjukdomsprogression vid eller under initial behandling med bevacizumab.

Information from Summary of Product Characteristics

Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.1

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 progressive disease 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.2

Rationale for Pretreatment with Bevacizumab

When the RAISE trial was initiated, patients were required to be pretreated with bevacizumab because at that time

  • bevacizumab, in combination with chemotherapy, was considered an emerging standard of care3, and  

  • a fundamental question posed by the study was whether or not treatment with ramucirumab may be associated with efficacy following initial treatment with another antiangiogenic agent.2

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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

3. 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. Accessed 22Dec2014.

Glossary

FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil

IV = intravenous

KRAS = Kirsten rat sarcoma virus 

mCRC = metastatic colorectal cancer

Datum fӧr senaste ӧversyn 2018 M01 02


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