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): Biverkningar av bevacizumab före RAISE

Vid inskrivning till RAISE-studien med Cyramza (ramucirumab) uteslöts patienter från deltagande om de hade vissa biverkningar under tidigare bevacizumab behandling.

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.1

Exclusion Criteria

Patients were excluded from participation if during prior treatment with bevacizumab they had experienced

  • arterial thrombotic/thromboembolic event

  • grade 4 hypertension

  • grade 3 proteinuria

  • grade 3/4 bleeding event, or

  • bowel perforation.1

Reference

1. 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

AE = adverse event

FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil 

IV = intravenous

KRAS = Kirsten rat sarcoma viral oncogene

mCRC = metastatic colorectal cancer

PD = progressive disease

Datum fӧr senaste ӧversyn 2019 M05 19


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