Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Första Linjens Platinumbehandling i REVEL

Patienter var berättigade till REVEL-studien om de hade sjukdomsprogression under eller efter en tidigare platinumbaserad kemoterapibehandling.

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

Inclusion Criteria

Patients were eligible for participation if they had

  • disease progression during or after 1, and only 1, prior first-line platinum-based chemotherapy regimen with or without maintenance therapy (defined as as therapy given within 42 days after the last dose of platinum-based chemotherapy in patients with ongoing clinical benefit [CR, PR, or SD] after platinum-based, first-line induction chemotherapy) for advanced/metastatic disease.1

Patients were also eligible for participation if they had

  • recurrent disease after adjuvant or neoadjuvant therapy, or

  • received combined chemotherapy and radiation for locally advanced disease, if they had progressive disease

    • within 6 months after completion of adjuvant (considered the patient's 1 and only prior first-line, platinum-based chemotherapy) or neoadjuvant platinum-based therapy, or

    • more than 6 months after completion of therapy AND had developed progressive disease on or after 1 subsequent chemotherapy regiment for advanced/metastatic disease.1

Prior Platinum-Based Therapy

All patients enrolled in the REVEL study received prior platinum-based chemotherapy.1 Additional details on the specific platinum agent further divided by histology are summarized in Table 1.

Table 1. Prior Platinum Therapy Among Patients in the REVEL Study by Histology2

Prior Therapy Classification

Ramucirumab + Placebo
(n=157)
n (%)

Placebo + Docetaxel
(n=171)
n (%)

Ramucirumab + Docetaxel
(n=465)
n (%)

Placebo + Docetaxel
(n=447)
n (%)

Squamous
n=328

Nonsquamous
n=912

Carboplatina

85 (54.1)

81 (47.4)

247 (53.1)

240 (53.7)

Cisplatinb

73 (46.5)

100 (58.5)

233 (50.1)

222 (49.7)

Neoplatinc

0

0

1 (0.2)

0

Paraplatin

4 (2.5)

3 (1.8)

2 (0.4)

5 (1.1)

Platinold

1 (0.6)

0

2 (0.4)

2 (0.4)

Othere

0

0

1 (0.2)

0

a Carboplatin defined as: CARBO /00740901/, CARBOPLATIN, CARBOPLATINA, CARBOPLATINE, CARBOPLATINO, CARBOPLATINUM, CARPLAN.

b Cisplatin defined as: CDDP, CISPATIN, CISPLATIN, CISPLATINA, CISPLATINE, CISPLATINO, CISPLATINUM.

c Neoplatin defined as: NEOPLATIN/00412101/.

d Platinol defined as: PLATINOL, PLATINOL AQ.

e Other defined as: PLATINUM COMPOUNDS.

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

CR = complete response

ECOG = Eastern Cooperative Oncology Group

NSCLC = non-small cell lung cancer

PR = partial response

PS = performance status

SD = stable disease

Datum fӧr senaste ӧversyn 2020 M07 15


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