Cyramza® (Ramucirumab)

Para consultar la información para prescribir completa de Cyramza® (Ramucirumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Ramucirumab: Duration of Bleeding Events in Phase 3 Gastric Cancer Studies

The duration of bleeding among patients who experienced a bleeding event in the phase 3 gastric/GEJ studies was assessed retrospectively.

MX_cFAQ_RAM112_BLEEDING_DURATION_GASTRIC_STUDIES
MX_cFAQ_RAM112_BLEEDING_DURATION_GASTRIC_STUDIES
es-MX

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

Duration of Bleeding/Hemorrhage Events

The duration of bleeding among patients who experienced a bleeding/hemorrhage event in the phase 3 gastric/GEJ cancer studies is summarized in Duration of Bleeding/Hemorrhage Among Patients Who Experienced a Bleeding Event in Phase 3 Gastric/GEJ Studies (Safety Population).

Duration of Bleeding/Hemorrhage Among Patients Who Experienced a Bleeding Event in Phase 3 Gastric/GEJ Studies (Safety Population)4


Duration of Bleeding/Hemorrhage Events

Na (eventsb)

Median Duration, days (95% CI)

REGARD (second-line gastric/GEJ cancer)

Ramucirumab (n=236)

30 (25)

7.0 (2.0-24.0)

Placebo (n=115)

13 (10)

3.0 (1.0-28.0)

RAINBOW (second-line gastric/GEJ cancer)

Ramucirumab + Paclitaxel (n=327)

123 (82)

87.0 (35.0-141.0)

Paclitaxel + Placebo (n=329)

44 (31)

21.0 (10.0-45.0)

RAINFALL (first-line gastric/GEJancer)

Ramucirumab + Capecitabine + Cisplatin (n=323)

82 (59)

17.0 (11.0-64.0)

Capecitabine + Cisplatin + Placebo (n=315)

45 (35)

14.0 (5.0-31.0)

Abbreviation: AE = adverse event.

aN is the number or patients who experienced a bleeding/hemorrhage event. If a patient had more than one occurrence of the same event, the event with the longest duration was used in this analysis.

bEvents is defined as the number of patients that had their bleeding/hemorrhage event resolved by the cutoff date. If an AE was not resolved, then that AE was censored at the cutoff date.

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

3Fuchs 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

4Data 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

Fecha de la última revisión: 2018 M11 19


Contáctenos para saber más de la información Médica de Lilly

Contacto vía correo electrónico

Correo electrónico: infomed@lilly.com

Envíe su consulta

Escriba su consulta