Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur Hanterades Utslag i RELAY-Studien av Cyramza® (ramucirumab) i Kombination med Erlotinib?

Utslag av Grad 2 eller 3 behandlades med lokal och oral medicinering, medan outhärdliga utslag ledde till avbrott eller dosreduktion i kombination med lokal och oral behandling. För alla utslag av Grad 4 avbröts erlotinib.

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Management of Rash in RELAY

Erlotinib dose modification table and management for rash.1

Rash Grade 

Erlotinib Dose Modifications            

Guidelines for management

Tolerable rash (Grade 2 or 3)

None

Any of the following: minocycline, topical tetracycline, topical clindamycin, topical silver sulfadiazine, diphenhydramine, oral prednisone (short course)

Intolerable rash

Consider interruption or dose reduction if unresponsive to symptomatic management

Manage as for Grade 1

Grade 4

Discontinue erlotinib treatment

Manage as for Grade 1

Where dose reductions were needed, the daily dose of erlotinib was decreased in 50-mg decrements to a minimum dose of 50 mg daily. 1 The dose reduction table is shown in Erlotinib Dose Reduction Schedule

Erlotinib Dose Reduction Schedule1

Starting Dose

First Reduction 

Second Reduction

150 mg/day

100 mg/day

50 mg/day

 Dose modification criteria and guidelines for management of common erlotinib toxicities.

Incidence of Rash in RELAY

Grades 1-4 treatment-emergent adverse events related to rash or other skin-associated adverse events which occurred in at least 20% of patients in either treatment group (safety population) are shown in  Treatment-emergent adverse events relating to rash or other skin conditions occurring in at least 20% of participants, n (%)..2

 Treatment-emergent adverse events relating to rash or other skin conditions occurring in at least 20% of participants, n (%).2

Ramucirumab plus erlotinib group (n=221)          

Placebo plus erlotinib group (n=225)


Grades 1-2

Grade 3

Grade 4

Grades 1-2

Grade 3

Grade 4

Dermatitis acneiform

116 (52%)

33 (15%)

0

133 (59%)

20 (9%)

0

Dry skin

82 (37%)

1 (<1%)

0

86 (38%)

5 (2%)

0

Pruritus

49 (22%)

2 (1%)

0

64 (28%)

2 (1%)

0

Rash

37 (17%)

2 (1%)

0

49 (22%)

5 (2%)

0

The most common rash-related treatment-emergent adverse events leading to discontinuation in RELAY were dermatitis acneiform (n=2) in the ramucirumab plus erlotinib group and pustular rash (n=2) in the placebo plus erlotinib group.2

Dose modifications in RELAY due to rash or other skin-related adverse events

 Dose modifications relating to rash or other skin conditions in RELAY (safety population)1

RamucirumabErlotinib (N=221)

PlaceboErlotinib (N=225)

 

Erlotinib

Ramucirumab or

Placebo

Erlotinib

Ramucirumab or

Placebo

Patients with at least 1 dose adjustment

 

 

 

 

Dermatitis acneiform

32 (14·5)

0

29 (12·9)

0

Rash

4 (1·8)

0

5 (2·2)

0

Rash maculo-papular

2 (0·9)

0

5 (2·2)

0

Dose delays due to AEs (≥2%)*

 

 

 

 

Dermatitis acneiform

0

7 (3·2)

0

3 (1·3)

Patients with dose omissions due to AEs (≥2%)

 

 

 

 

Dermatitis acneiform

30 (13·6)

0

32 (14·2)

0

Pruritis

2 (0·9)

0

5 (2·2)

0

Rash maculo-papular

3 (1·4)

0

6 (2·7)

0

Data shown as no (%). AEs=adverse events. *There were no dose delays for erlotinib, since it was to be taken once daily.

For further information about erlotinib, please contact the manufacturer. 

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

Datum fӧr senaste ӧversyn September 16, 2021


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