Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Tidigare TKI-behandling i REVEL

I REVEL-studien fick 23 patienter i ramucirumab + docetaxelarmen samt 7 patienter i docetaxelarmen, tidigare TKI-behandling.

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

Prior TKI Therapy

Patients were excluded from participation in the REVEL study if their only prior treatment for advanced disease was a TKI (eg, erlotinib).1 The number of patients who received prior TKI therapy in addition to one prior platinum-based chemotherapy regimen in the REVEL study is presented in Table 1

Table 1. Prior TKI Therapy in the REVEL Study2  

Prior Systemic Therapy

Ramucirumab + Docetaxel
n=628
# of Patients

Placebo + Docetaxel
n=625
# of Patients

Any TKI inhibitor

23

25

Erlotinib

19

11

Gefitinib

3

10

Abbreviation: TKI = tyrosine kinase inhibitor.  

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.

Glossary

ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

PS = performance status

TKI = tyrosine kinase inhibitor

Datum fӧr senaste ӧversyn 2019 M11 20

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