Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): Incidens av hematuri efter avslutad behandling

Incidensen av alla grader hematuri bland patienter som fick ramucirumab i fas 3 kliniska studier av magcancer och avbröt behandlingen var låg (<2%).

Study Designs

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

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

RAINFALL Study

The RAINFALL trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic gastric or GEJ adenocarcinoma with no prior therapy for metastatic disease and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by primary tumor location, region, baseline ECOG PS, and disease measurability) to receive cisplatin (80 mg/m2 IV day 1) and capecitabine (1000 mg/m2 orally twice daily on days 1 to 14) plus either ramucirumab (8 mg/kg IV on days 1 and 8) or placebo. Treatment with 5-FU (800 mg/m2/day IV days 1 to 5) was allowed for patients not able to swallow capecitabine. Patients were treated until disease progression, intolerable toxicity, withdrawal or death.3

Please note, Cyramza is not approved in the first-line setting of gastric cancer.

Incidence of Hematuria After Study Discontinuation

The incidence of hematuria among patients in the phase 3 gastric cancer studies who discontinued treatment is summarized in Table 1.

Table 1. Incidence of Hematuria in the Safety Population After Study Discontinuation in Phase 3 Gastric/GEJ Cancer Studies4 



Hematuria After Study Discontinuationa

Any Grade
n (%)

Grade ≥3
n (%)

REGARD (second-line gastric/GEJ cancer)

Ramucirumab (n=236)

3 (1.3)

1 (0.4)

Placebo (n=115)

2 (1.7)

0 (0)

RAINBOW (second-line gastric/GEJ cancer)

Ramucirumab + Paclitaxel (n=327)

2 (0.6)

0 (0)

Paclitaxel + Placebo (n=329)

2 (0.6)

0 (0)

RAINFALL (first-line gastric/GEJ cancer)

Ramucirumab + Capecitabine + Cisplatin (n=323)

1 (0.3)

0 (0)

Capecitabine + Cisplatin + Placebo (n=315)

0 (0)

0 (0)

Abbreviation: GEJ = gastroesophageal junction; TEAEs = treatment-emergent adverse events.

a Includes TEAEs within 30 days of treatment discontinuation or at any time point after discontinuation if defined as treatment-related based on the investigator assessment.

References

1. Fuchs 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

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

3. Fuchs CS, Shitara K, Di Bartolomeo, et al. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(3):420-435. https://doi.org/10.1016/S1470-2045(18)30791-5

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

Glossary

BSC = best supportive care

5-FU = 5-fluorouracil

ECOG = Eastern Cooperative Oncology Group

GEJ = gastroesophageal junction

IV = intravenous

PS = performance status

TTP = time-to-progression

Datum fӧr senaste ӧversyn 2018 M11 19

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