Om du vill rapportera en biverkning gällande en av Lillys produkter, kontakta oss via e-post på DK_PHv@lilly.com eller på telefon +45 4526 6040. Har du ytterligare medicinska frågor gällande en av Lillys produkter, kontakta oss via länken ovan.
Cyramza ® (ramucirumab)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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
Safety Results
All grade TEAEs that occurred in ≥20% of patients in either treatment arm and grade ≥3 TEAEs are presented in Table 1.
Table 1. Any Grade TEAEs That Occurred in ≥20% of Patients in Either Treatment Arm and Grade ≥3 TEAEs1,2
|
NCI-CTC Adverse Event |
Any Grade |
Grade ≥3 |
||||||
|
FOLFIRI
+ Ramucirumab |
FOLFIRI
+ Placebo |
FOLFIRI
+ Ramucirumab |
FOLFIRI
+ Placebo |
|||||
|
n |
% |
n |
% |
n |
% |
n |
% |
|
|
Neutropeniaab |
311 |
58.8 |
241 |
45.6 |
203 |
38.4 |
123 |
23.3 |
|
Anemiab |
86 |
16.3 |
110 |
20.8 |
8 |
1.5 |
19 |
3.6 |
|
Thrombocytopeniab |
150 |
28.4 |
72 |
13.6 |
16 |
3.0 |
4 |
0.8 |
|
Abdominal painb |
140 |
26.5 |
139 |
26.3 |
18 |
3.4 |
19 |
3.6 |
|
Alopecia |
155 |
29.3 |
165 |
31.3 |
NA |
NA |
NA |
NA |
|
Bleeding/hemorrhagic events |
232 |
43.9 |
120 |
22.7 |
13 |
2.5 |
9 |
1.7 |
|
Constipation |
151 |
28.5 |
120 |
22.7 |
5 |
0.9 |
8 |
1.5 |
|
Decreased appetite |
198 |
37.4 |
144 |
27.3 |
13 |
2.5 |
10 |
1.9 |
|
Diarrhea |
316 |
59.7 |
271 |
51.3 |
57 |
10.8 |
51 |
9.7 |
|
Epistaxis |
177 |
33.5 |
79 |
15.0 |
0 |
0 |
0 |
0 |
|
Fatigueb |
305 |
57.7 |
275 |
52.1 |
61 |
11.5 |
41 |
7.8 |
|
Hypertensionb |
138 |
26.1 |
45 |
8.5 |
59 |
11.2 |
15 |
2.8 |
|
Nausea |
262 |
49.5 |
271 |
51.3 |
13 |
2.5 |
14 |
2.7 |
|
Peripheral edema |
108 |
20.4 |
48 |
9.1 |
1 |
0.2 |
0 |
0 |
|
Stomatitis |
163 |
30.8 |
110 |
20.8 |
20 |
3.8 |
12 |
2.3 |
|
Vomiting |
154 |
29.1 |
144 |
27.3 |
15 |
2.8 |
13 |
2.5 |
Abbreviations: FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil; MedDRA = Medical Dictionary for Regulatory Activities; NA = not applicable; NCI-CTC = National Cancer Institute Common Terminology Criteria; TEAEs = treatment‑emergent adverse events.
a The rate of any grade of febrile neutropenia was 4% in the ramucirumab + FOLFIRI group and 3% in the FOLFIRI + placebo group.
b Consolidated category comprising synonymous MedDRA preferred terms or adverse event of special interest grouping.
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
2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil
IV = intravenous
KRAS = Kirsten rat sarcoma viral oncogene
mCRC = metastatic colorectal cancer
PD = progressive disease
TEAE = treatment-emergent adverse event
Datum fӧr senaste ӧversyn 2020 M01 24