Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Exponering för dosintensitet i RAISE

Median relativ dosintensitet hos Cyramza (ramucirumab) liknade den för placebo.



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

Dose Intensity in the RAISE Study

The median relative dose intensity in the RAISE study is summarized in Table 1. Median Relative Dose Intensity in the RAISE Study.

Table 1. Median Relative Dose Intensity in the RAISE Study2

Drug

Overall Relative Dose Intensity, Median (%)

RAM+FOLFIRI
(n=529)

PBO+FOLFIRI
(n=528)

RAM or PBO

88.2

93.8

5-Fluorouracil 

70.8

82.4

Folinic acid

83.4

88.8

Irinotecan

77.0

85.9

Abbreviations: FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil; PBO = placebo; RAM = ramucirumab.

  • Median number of cycles was 8 for all components.

  • Median duration of therapy was similar for all components and ranged between 18.0 and 19.3 weeks.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

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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