Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Läkemedelsavbrott och varaktighet i REVEL

Det finns inga effektdata för patienter med Cyramza (ramucirumab) efter avslutad docetaxel eller för de som fortsatte docetaxel efter avslutad ramucirumab i REVEL.

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

Discontinuation of One Study Drug

The percentage of patients that continued on one drug (ramucirumab or docetaxel) after discontinuation of the other drug is illustrated in Table 1. Discontinuation of One Drug and Continuation of One Drug in REVEL.

Table 1. Discontinuation of One Drug and Continuation of One Drug in REVEL2

 

Ramucirumab+Docetaxel
(n=627)

Placebo+Docetaxel
(n=618)

Number of patients (%)

Number of patients (%)

Discontinued docetaxel and continued on RAM/PLC

38 (6.1)

20 (3.2)

Discontinued RAM/PLC and continued on docetaxel

6 (1.0)

3 (0.5)

Abbreviations: PLC = placebo; RAM = ramucirumab.

The duration of treatment (in weeks) after discontinuation of one study drug is illustrated in Table 2. Duration of Treatment after Discontinuation of One Study Drug in REVEL.

Table 2. Duration of Treatment after Discontinuation of One Study Drug in REVEL2

 

Ramucirumab+Docetaxel
(n=627)

Placebo+Docetaxel
(n=618)

Duration of RAM/PLC after docetaxel discontinued (weeks)  

Mean

17.56

20.89

Median

12.00

13.14

Range

5.57-61.86

3.00-87.00

Duration of docetaxel after RAM/PLC discontinued (weeks)  

Mean

18.40

20.57

Median

16.43

8.86

Range

10.00-33.57

6.00-22.71

Abbreviations: PLC = placebo; RAM = ramucirumab. 

There is no information on the efficacy outcome of the subset of patients who continued on ramucirumab after discontinuation of docetaxel, or continued on docetaxel after discontinuation of ramucirumab in REVEL. The sample size in these subsets of patients is too small to allow for any meaningful conclusions from an analysis of the efficacy outcomes, therefore no analyses were performed on this subgroup.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.

Glossary

ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

PS = performance status

Datum fӧr senaste ӧversyn 2019 M11 15

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