Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): RAINBOW-studien

Patienter som fick ramucirumab och paklitaxel hade en signifikant längre medianöverlevnad än patienter som fick enbart paclitaxel (p = .017).



Information from Summary of Product Characteristics

Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.1

Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.1

Study Design

The RAINBOW trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic or locally advanced nonresectable gastric or GEJ adenocarcinoma following disease progression during or within 4 months after last dose of first-line platinum plus fluoropyrimidine combination chemotherapy with or without an anthracycline and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by region, measurable vs nonmeasurable disease, and time to progression on first-line therapy) to receive ramucirumab (8 mg/kg days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=330) or placebo (days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=335) of a 28-day cycle until disease progression, unacceptable toxicity, withdrawal, or death.2

Results

Efficacy

  • Patients who received ramucirumab plus paclitaxel had a significantly longer median

    • OS than patients who received placebo plus paclitaxel (9.6 months vs 7.4 months; HR=0.807; 95% CI: 0.678-0.962; p=.017), and 

    • PFS than patients who received placebo plus paclitaxel (4.4 months vs 2.9 months; HR=0.635; 95% CI: 0.536-0.752; p<.0001).2

The ORR was 28% in the patients treated with ramucirumab plus paclitaxel and 16% in the patients treated with placebo plus paclitaxel (p=.0001). The DCR was 80% in the patients treated with ramucirumab plus paclitaxel and 64% in the patients treated with placebo plus paclitaxel (p<.0001).2

Safety

Grade ≥3 TEAEs were reported by 82% of patients in the ramucirumab plus paclitaxel group and by 63% of patients in the placebo plus paclitaxel group. A higher incidence of grade 3 or 4 neutropenia and leucopenia, and grade 3 hypertension, abdominal pain, and fatigue was reported in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group.2

Febrile neutropenia occurred at a similar rate between treatment groups (ramucirumab plus paclitaxel, 3.1%; placebo plus paclitaxel, 2.4%). Deaths related to TEAEs with a causal relationship between any study drug were similar between the ramucirumab plus paclitaxel group (n=6, septic shock; malabsorption; GI hemorrhage; death of unknown origin; PE; and sepsis) and placebo plus paclitaxel group (n=5, acute renal failure; cardiac failure; febrile neutropenia, septic shock, and PE; PE; cerebral hemorrhage).2

References

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

2. Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235. http://dx.doi.org/10.1016/S1470-2045(14)70420-6

Glossary

DCR = disease control rate

ECOG = Eastern Cooperative Oncology Group

GEJ = gastroesophageal junction

GI = gastrointestinal

HR = hazard ratio

ORR = objective response rate

OS = overall survival

PE = pulmonary embolism

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M05 13

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