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Cyramza ® (ramucirumab)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
The design of the study can be found in the section The RAINBOW Study Design.
Patients who received ramucirumab plus paclitaxel had a significantly longer median
Overall Survival (OS) than patients who received placebo plus paclitaxel (9.6 months vs 7.4 months; hazard ratio (HR)=0.807; 95% CI: 0.678-0.962; p=.017), and
Progression-free Survival (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).1
The Overall Response Rate (ORR) was 28% in the patients treated with ramucirumab plus paclitaxel and 16% in the patients treated with placebo plus paclitaxel (p=.0001).
The Disease Control Rate (DCR) was 80% in the patients treated with ramucirumab plus paclitaxel and 64% in the patients treated with placebo plus paclitaxel (p<.0001).1
In the ramucirumab plus paclitaxel group, 82% of patients reported Grade ≥3 treatment-emergent adverse events (TEAE). For the patients in the placebo plus paclitaxel group, this figure was 63%. A higher incidence of grade 3 or 4 neutropenia and leucopenia, and grade 3 hypertension, abdominal pain, and fatigue were reported in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group.1
Febrile neutropenia occurred at a similar rate between treatment groups (ramucirumab plus paclitaxel, 3.1%; placebo plus paclitaxel, 2.4%).
In the ramicirumab plus paclitaxel group, there were six deaths from the following causes: septic shock; malabsorption; gastrointestinal (GI) hemorrhage; death of unknown origin; pulmonary embolism (PE); and sepsis.
In the placebo plus paclitaxel group, there were five deaths from the following causes: septic shock; malabsorption; acute renal failure; cardiac failure; febrile neutropenia, septic shock, and PE; PE; cerebral hemorrhage.1
The RAINBOW 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 gastroesophageal junction (GEJ) adenocarcinoma.
All patients had to progress during first-line platinum plus fluoropyrimidine combination therapy with or without anthracycline, or within 4 months after the last dose thereof. Additionally, patients had to have an ECOG PS of 0 or 1.
Patients were randomly assigned in a 1:1 ratio, stratified by region, measurable vs. non-measurable disease, and time to progression on first-line therapy:
330 patients received ramucirumab (8 mg/kg days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) of a 28-day cycle
335 patients received placebo (days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) of a 28-day cycle
The study continued until disease progression, unacceptable toxicity, withdrawal, or death.1
1. 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
Datum fӧr senaste ӧversyn 2019 M05 13