Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Hemoptys i REVEL

Patienter med allvarlig hemoptys inom 2 månader före randomisering uteslöts från att delta i REVEL-studien.

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

Relevant Study Exclusion Criteria

Patients were excluded from participation if any of the following criteria in Table 1 were met.

Table 1. Hemoptysis-Related Exclusion Criteria in the REVEL Study1,2

Hemoptysis-Related Exclusion Criteria

Defined As…

Radiologically-documented evidence of major blood vessel invasion or encasement by cancer

  • A 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 the lesion

Radiographic evidence of intratumor cavitation regardless of tumor histology

  • Apparent cavitation ≥10 mm on the axial computerized tomography

History of gross hemoptysis within 2 months prior to randomization

  • Bright red blood or ≥½ teaspoon

Physician clinical decision

  • Cavitation 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

  • Size, appearance, and location of the lesion or cavitation relative to the blood vessel was of concern based on the physician’s assessment

Incidence of Hemoptysis in the REVEL Study

The incidence of hemoptysis in the REVEL study is summarized below in Table 2.

Table 2. Incidence of Hemoptysis in the REVEL Study1

TEAE

Any Grade
n (%)

Grade > 3
n (%)

Any Grade
n (%)

Grade > 3
n (%)

 

RAM + DOC
N=627

PBO + DOC
N=618

Hemoptysis

36 (6)

4 (1)

32 (5)

4 (1)

Abbreviations: DOC = docetaxel; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.

In the REVEL study,

  • 3 patients discontinued treatment due to hemoptysis (1 patient in the ramucirumab plus docetaxel arm; 2 patients in the placebo plus docetaxel arm) and

  • 4 patient deaths were attributed to hemoptysis (2 patients in each arm).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.

Datum fӧr senaste ӧversyn 2019 M10 30


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