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Cyramza Summary of Product Characteristics (SmPC)
Patients were excluded from REVEL if they had a history of gross hemoptysis within 2 months prior to randomization.
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
1. Hemoptysis-Related Exclusion Criteria in the REVEL Study1,2
evidence of major blood vessel invasion or encasement by cancer
major blood vessel (defined as: pulmonary arteries, pulmonary
trunk, pulmonary veins, descending and ascending aorta [including
aortic arch], and superior vena cava) was of irregular shape or
appeared impinged or deformed, or surrounded to ≥180º by
evidence of intratumor cavitation regardless of tumor histology
cavitation ≥10 mm on the axial computerized tomography
of gross hemoptysis within 2 months prior to randomization
red blood or ≥½ teaspoon
of a pulmonary lesion or vascular association with a pulmonary
lesion in the patient rendered him/her at increased risk for
severe pulmonary hemorrhage or pulmonary hemoptysis
appearance, and location of the lesion or cavitation relative to
the blood vessel was of concern based on the physician’s
patients discontinued treatment due to hemoptysis (1 patient in the
ramucirumab plus docetaxel arm; 2 patients in the placebo plus
docetaxel arm) and
patient deaths were attributed to hemoptysis (2 patients in each
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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review:October 30, 2019
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