Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Äldre patienter i REVEL-studien

En trend mot mindre effekt med ökad ålder har observerats hos patienter som fick Cyramza (ramucirumab) plus docetaxel för behandling av avancerad NSCLC.

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

In the pivotal studies there is limited evidence that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old. No dose reductions are recommended.1

A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy.1

Comorbidities associated with advanced age, performance status and the likely tolerability to chemotherapy should therefore be thoroughly evaluated prior to the initiation of treatment in the elderly.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

Age was not a stratification factor in the REVEL study. Compared with the placebo plus docetaxel arm, more patients in the ramucirumab plus docetaxel arm were ≥65 years old (37.7% vs 34.9%, respectively).3

Efficacy

The OS results among elderly patients in the REVEL study are presented in Table 1 and Table 2.

Table 1. Overall Survival Results According to Age of 65 Years3


RAM + DOC
(n=237)

PBO + DOC
(n=218)

RAM + DOC
(n=391)

PBO + DOC
(n=407)

Age ≥65 Year

Age <65 Year

Median OS, mo (95% CI)

9.20 (7.62-10.32)

9.26 (8.54-10.97)

11.33 (10.28-12.55)

8.90 (7.36-10.18)

HR (95% CI)

1.10 (0.89-1.36); p=.393

0.74 (0.62-0.87); p<.001

Interaction p valuea

p=.004

Abbreviations: DOC = docetaxel; HR = hazard ratio; OS = overall survival; PBO = placebo; RAM = ramucirumab.

a P value for interaction term from a model with arm, the subgroup variable, and arm × subgroup interaction term.

Table 2. Overall Survival Results According to Age of 70 Years3


RAM + DOC

(n=127)

PBO + DOC

(n=125)

RAM + DOC

(n=501)

PBO + DOC

(n=500)

Age >70 Year

Age <70 Year

Median OS, mo (95% CI)

8.84 (6.64-10.55)

9.00 (7.43-10.97)

10.94 (9.95-11.86)

9.13 (8.05-10.02)

HR (95% CI)

1.07 (0.80-1.43); p=.662

0.81 (0.70-0.94); p=.006

Interaction p valuea

p=.106

Abbreviations: DOC = docetaxel; HR = hazard ratio; OS = overall survival; PBO = placebo; RAM = ramucirumab.

a P value for interaction term from a model with arm, the subgroup variable, and arm × subgroup interaction term.

Safety

No clinically relevant differences were observed in terms of adverse event profile between treatment arms according to age 3. Treatment-emergent adverse events divided by age group that occurred in at least 20% of patients in the ramucirumab plus docetaxel arm are summarized in Table 3.

Table 3. Treatment-Emergent Adverse Events in ≥20% of Patients Aged <65 Years or ≥65 Years3

Adverse Event Term 

RAM + DOC
(n=237)
% of Patients

PBO + DOC
(n=214)
% of Patients

RAM + DOC
(n=390)
% of Patients

PBO + DOC
(n=404)
% of Patients

Age ≥65 Years

Age <65 Years

Fatiguea

58.2

56.5

52.6

46.5

Neutropeniaa

54.4

52.8

55.4

42.3

Neuropathya

19.4

22.0

25.4

19.6

Leukopeniaa

20.3

18.2

22.1

19.3

Anemiaa

24.5

30.4

18.7

27.0

Diarrhea

34.2

28.0

30.3

27.5

Nausea

30.0

29.4

25.1

26.5

Decreased appetite

32.9

33.2

26.7

20.5

Alopecia

26.6

25.2

25.4

25.2

Stomatitis

24.9

14.0

22.3

12.4

Dyspnea

25.7

24.3

19.7

24.0

Cough

19.8

15.9

22.1

23.3

Epistaxis

15.2

8.4

20.5

5.4

Abbreviations: DOC = docetaxel; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; RAM = ramucirumab.

a Consolidated term, based on MedDRA version 16.1.

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

HR = hazard ratio

NSCLC = non-small cell lung cancer

OS = overall survival

PS = performance status

Datum fӧr senaste ӧversyn 2019 M10 30


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