Cyramza® (Ramucirumab)

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Ramucirumab: Prior EGFR-Therapy in the RAISE Trial

During enrollment in the RAISE trial, patients who had received prior anti-EGFR were excluded from participation and receiving Cyramza (ramucirumab).

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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 included in the RAISE trial had experienced disease progression during or within 6 months of the last dose of first-line combination therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine for mCRC. Based on these criteria there was minimal exposure to EGFR therapy prior to study enrollment.1,2

References

1Tabernero 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

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

EGFR = epidermal growth factor receptor

FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil 

IV = intravenous

KRAS = Kirsten rat sarcoma viral oncogene

mCRC = metastatic colorectal cancer

PD = progressive disease

Fecha de la última revisión: 2020 M04 10


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