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): Ett och två års överlevnad i REVEL

I REVEL var överlevnaden efter ett år 43% jämfört med 38%, och efter två år 21% jämfört med 18%, för ramucirumab plus docetaxel jämfört med placebo plus docetaxel.

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

Survival Results

The OS rate at 1 and 2 years is presented in Table 1.

Table 1. Overall Survival at 1 and 2 Years in the REVEL Study2

Endpoint

Ramucirumab + Docetaxel
n=628

Placebo + Docetaxel
n=625

1-year overall survival, % (95% CI)

42.9 (38.9-46.9)

37.7 (33.8-41.5)

2-year overall survival, % (95% CI)

20.9 (17.0-25.1)

17.5 (13.8-21.5)

Safety Results

In the ramucirumab-plus-docetaxel group compared to the placebo-plus-docetaxel group

  • grade ≥3 TEAEs were reported in 495 (79%) patients vs 444 (71%) patients 

  • TEAEs with an outcome of death were reported in 34 (5%) patients vs 35 (6%) patients, and

  • dose adjustments occurred in 204 (33%) of 627 patients vs 139 (23%) of 618 patients.1

TEAEs (including all grades) for which there was a ≥5% higher incidence in the ramucirumab-plus-docetaxel group than in the placebo-plus-docetaxel group were neutropenia, febrile neutropenia, thrombocytopenia, stomatitis, mucosal inflammation, peripheral edema, increased lacrimation, fatigue, diarrhea, and hypertension; bleeding/hemorrhage events overall, and epistaxis.1

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

OS = overall survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M11 20


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