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): EGFR-ALK testning före REVEL

Vid registrering i REVEL-studien var EGFR- och ALK-testning inte nödvändig innan patienter fick ramucirumab.

Study Design

The REVEL trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with pathologically confirmed, squamous or nonsquamous, stage IV NSCLC with disease progression during or after 1 prior platinum-based chemotherapy. Prior treatment with bevacizumab and prior maintenance therapy were allowed and all patients had an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, PS, and previous maintenance therapy) to receive treatment with ramucirumab (10 mg/kg every 3 weeks) plus docetaxel (75 mg/m2 every 3 weeks) (n=628) or placebo plus docetaxel (75 mg/m2 every 3 weeks) (n=625) until disease progression, unacceptable toxicity, withdrawal, or death.1

Testing for EGFR in the REVEL Study

In the REVEL study, patients with known EGFR-positive mutation status and those who received prior therapy with TKIs were eligible as long as they were treated with prior platinum-based chemotherapy.1 During enrollment in the REVEL trial, it was not required for patients to be tested for EGFR and ALK biomarkers.2 In addition, patients were excluded from REVEL if their only prior treatment for advanced disease was a TKI (eg, erlotinib).1

Testing for ALK in the REVEL Study

At the time of initial patient enrollment (2010), no agents were approved for treating patients with ALK translocations, which constitute less than 5% of all NSCLC patients,3 and neither the test nor the ALK testing guidelines were available in routine clinical practice. Therefore, data regarding ALK status were not collected in this study.2

References

1. Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

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

3. Chia PL, Mitchell P, Dobrovic A, John T. Prevalence and natural history of ALK positive non-small-cell lung cancer and the clinical impact of targeted therapy with ALK inhibitors. Clin Epidemiol. 2014;6:423-432. http://dx.doi.org/10.2147/CLEP.S69718.

Glossary

ALK = anaplastic lymphoma kinase 

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PS = performance status

TKI = tyrosine kinase inhibitor

Datum fӧr senaste ӧversyn 2019 M11 20

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