Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Säkerhet vid användning i kombination med FOLFIRI hos patienter med metastaserande kolorektal cancer

De vanligaste biverkningarna av alla grader hos patienter som behandlades med Cyramza (ramucirumab) var diarré, neutropeni, minskad aptit, epistax och stomatit.

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

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
(N=529)

FOLFIRI + Placebo
(N=528)

FOLFIRI + Ramucirumab
(N=529)

FOLFIRI + Placebo
(N=528)

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.

References

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


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