Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Effekt hos patienter som tidigare fått behandling med taxaner i REVEL

I REVEL-studien observerades ingen signifikant skillnad i total överlevnad mellan patienter som tidigare fått behandling med taxaner och de som inte fått behandling med taxaner.

Information from Summary of Product Characteristics

Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.1

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.2

In the REVEL study, 24% of patients in each arm received prior taxane therapy (n=153 in the ramucirumab plus docetaxel arm and n=149 in the placebo plus docetaxel arm).2

Protocol Requirements Related to Prior Taxane Therapy

Patients were excluded from the REVEL trial if they had received prior therapy with docetaxel.2

Efficacy

Table 1 describes the OS and PFS results according to prior taxane therapy in the REVEL study.

Table 1. Overall and Progression-Free Survival Results According to Prior Taxane Therapy3  

  

RAM + DOC
(n=153)

PBO + DOC
(n=149)

RAM + DOC
(n=475)

PBO + DOC
(n=476)

Prior Taxane

No Prior Taxane

Median OS, mo (95% CI)

10.81 (8.90-12.42)

10.35 (7.82-12.12)

10.32 (9.30-11.27)

9.03 (8.05-9.79)

HR (95% CI)

0.81 (0.62-1.07); p=NS

0.87 (0.75-1.01); p=NS

Interaction p value

NS

Median PFS, mo (95% CI)

4.44 (3.61-5.52)

3.61 (2.76-4.30)

4.50 (4.17-5.39)

2.92 (2.76-3.81)

HR (95% CI)

0.90 (0.71-1.15); p=NS

0.74 (0.64-0.84); p<.001

Interaction p value

NS

Abbreviations: DOC = docetaxel; HR = hazard ratio; NS = not significant; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab. 

Safety

Table 2 describes any grade TEAEs that occurred in at least 20% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane).   presents grade ≥3 TEAEs that occurred in at least 10% of patients in the ramucirumab plus docetaxel arm (summarized according to prior taxane).

Table 2. Any Grade Treatment-Emergent Adverse Events in ≥20% of Patients Who Received Ramucirumab Plus Docetaxel According to Prior Taxane3  

Any Grade TEAE, Regardless of Causalitya  

RAM + DOC
(n=154)
% of Patients

PBO + DOC
(n=147)
% of Patients

RAM + DOC
(n=473)
% of Patients

PBO + DOC
(n=471)
% of Patients

Prior Taxane 

No Prior Taxane 

Fatigue

44.2

36.7

46.7

43.3

Neutropenia

41.6

40.1

38.1

31.0

Nausea

29.9

29.9

26.0 

26.8

Diarrhea

29.2

29.9

32.6 

27.0

Decreased appetite

27.9

27.9

29.4

24.0

Dyspnea

22.7

25.2

21.8 

23.8

Anemia

21.4

28.6

20.7

27.4

Cough

17.5

20.4

22.4 

20.8

Alopecia

14.9

14.3

29.4

28.7

Stomatitis 

18.8

6.8

24.7

14.9

Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event. 

a MedDRA preferred term.

Table 3. Grade ≥3 Treatment-Emergent Adverse Events in ≥20% of Patients who Received Ramucirumab Plus Docetaxel According to Prior Taxane3 

Grade ≥3 TEAE, Regardless of Causalitya  

RAM + DOC
(n=154)
% of patients

PBO + DOC
(n=147)
% of patients

RAM + DOC
(n=473)
% of patients

PBO + DOC
(n=471)
% of patients

Prior Taxane 

No Prior Taxane 

Fatigue

13.6 

6.1

10.6 

8.7

Neutropenia

36.4 

29.9

34.5 

27.4

Neutrophil count decreased

15.6

11.6

15.4

13.6

Febrile neutropenia

13.6

12.9

16.7

9.1

Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event. 

a MedDRA preferred term.

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. 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

3. 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

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M12 06

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