Cyramza® (Ramucirumab)

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Ramucirumab: Safety in Patients with Gastric-GEJ Adenocarcinoma

In REGARD, the most common ARs in ramucirumab-treated patients were hypertension and diarrhea. In RAINBOW, they were fatigue, neutropenia, diarrhea, and epistaxis.

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The information contained in this letter may not completely match the current local labeling for RAMUCIRUMAB. Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.

Study Designs

The REGARD Study

The REGARD trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic or locally advanced gastric or GEJ adenocarcinoma treated previously with fluoropyrimidine- or platinum-based combination therapy with an ECOG PS of 0 or 1. Patients were randomly assigned in a 2:1 ratio (stratified by weight loss, region, and location of the primary tumor) to receive ramucirumab (8 mg/kg every 2 weeks) plus BSC (n=238) or placebo (every 2 weeks) plus BSC (n=117) until disease progression, unacceptable toxicity, withdrawal, or death.1

The RAINBOW Study

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 TTP 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

Safety

The REGARD Study

The frequency and severity of ARs that have been reported at an incidence rate of ≥5% in patients who received ramucirumab in the REGARD study are presented in Adverse Reactions That Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in the REGARD Trial.

Adverse Reactions That Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in the REGARD Trial1,3

Adverse Reactions (MedDRA) System Organ Class

All Grades
(Frequency %)

Grade 3-4
(Frequency %)

All Grades
(Frequency %)

Grade 3-4
(Frequency %)

Ramucirumab
(n=236)

Placebo
(n=115)

Gastrointestinal Disorders    

Abdominal paina

28.8

5.9

27.8

2.6

Diarrhea

14.4

0.8

8.7

1.7

Metabolism and Nutrition Disorders

Hypokalemia

5.9

2.1

5.2

0.9

Hyponatremia

5.5

3.4

1.7

0.9

Nervous System Disorders

Headache

9.3

0

3.5

0

Vascular Disorders

Hypertensionb

16.1

7.6

7.8

2.6

Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities. 

aIncludes hepatic pain.

bMedDRA-preferred terms included are blood pressure increased and hypertension.

Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab-treated patients in the REGARD trial were

  • neutropenia
  • ATEs
  • intestinal obstruction
  • epistaxis, and
  • rash.3

The RAINBOW Study

The frequency and severity of ARs that have been reported at an incidence rate of ≥5% in patients who received ramucirumab in combination with paclitaxel in the RAINBOW study are presented in Adverse Reactions That Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in Combination With Paclitaxel in the RAINBOW Trial .

Adverse Reactions That Occurred at an Incidence Rate of ≥5% in Patients who Received Ramucirumab in Combination With Paclitaxel in the RAINBOW Trial3 

Adverse Reactions (MedDRA) System Organ Class

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

All Grades
(Frequency %)

Grade ≥3
(Frequency %)

Ramucirumab + Paclitaxel
(n=327)

Placebo + Paclitaxel
(n=329)

Blood and Lymphatic System Disorders     

Leukopenia

33.9

17.4

21.0

6.7

Neutropenia

54.4

40.7

31.0

18.8

Thrombocytopenia

13.1

1.5

6.1

1.8

Gastrointestinal disorders    

Diarrhea

32.4

3.7

23.1

1.5

Gastrointestinal hemorrhage eventsa

10.1

3.7

6.1

1.5

Stomatitis

19.6

0.6

7.3

0.6

General Disorders and Administration-Site Disorders    

Fatigue/Asthenia

56.9

11.9

43.8

5.5

Peripheral edema

25.1

1.5

13.7

0.6

Metabolism and Nutrition Disorders    

Hypoalbuminemia

11.0

1.2

4.9

0.9

Renal and Urinary Disorders    

Proteinuria

16.8

1.2

6.1

0

Respiratory, Thoracic, and Mediastinal Disorders    

Epistaxis

30.6

0

7.0

0

Vascular Disorders    

Hypertensionb

25.1

14.7

5.8

2.7

Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities. 

aMedDRA preferred terms included anal hemorrhage, diarrhea hemorrhage, gastric hemorrhage, gastrointestinal hemorrhage, hematemesis, hematochezia, hemorrhoidal hemorrhage, Mallory-Weiss syndrome, melena, esophageal hemorrhage, rectal hemorrhage, and upper gastrointestinal hemorrhage.

bIncludes hypertensive cardiomyopathy.

Clinically relevant ADRs reported in ≥1% and <5% of the ramucirumab plus paclitaxel-treated patients in the RAINBOW trial were

  • GI perforation (1.2% for ramucirumab plus paclitaxel vs 0.3% for placebo plus paclitaxel) and
  • sepsis (3.1% for ramucirumab plus paclitaxel vs 1.8% for placebo plus paclitaxel).3

References

1Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39. http://dx.doi.org/10.1016/S0140-6736(13)61719-5

2Wilke 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

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ADR = adverse drug reaction

AR = adverse reaction

ATE = arterial thromboembolic event

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

GEJ = gastroesophageal junction

GI = gastrointestinal

PS = performance status

TTP = time-to-progression

Fecha de la última revisión: 2020 M01 02


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