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): Hjärnmetastas hos patienter i RELAY-studien

Patienter med kända hjärnmetastaser utesluts från deltagande i RELAY-studien.

Study Design

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Exclusion Criteria Related to Brain Metastasis

All patients were required to have brain imaging prior to enrollment and patients with known CNS metastases were excluded from participation in RELAY.1

CNS Metastasis as Disease Progression

In the RELAY study, 10 patients developed CNS metastasis as first site of progression including

  • 2 patients (0.9%) in the ramucirumab plus erlotinib arm, and 

  • 8 patients (3.6%) in the placebo plus erlotinib arm.1

Considering the small subset of patients who developed brain metastases, no conclusions with regard to efficacy or safety can be drawn at this time. 

References

1. Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

Datum fӧr senaste ӧversyn 2019 M07 24


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss