Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Användning av antikoagulantia i RELAY

Ingen koppling fanns i RELAY-studien mellan hemorragiska händelser och samtidig eller nyligen använd antikoagulantbehandling.

Study Design

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.1

Relevant Protocol Inclusion and Exclusion Criteria in RELAY

Patients were eligible for participation if they had adequate coagulation function as defined by

  • INR ≤1.5 or PT ≤1.5 times the ULN, and

  • PTT/aPTT ≤1.5 times the ULN.2

Patients were also permitted to participate if receiving 

  • LMWH, or

  • once daily aspirin (maximum dose 325 mg/day).2

Patients with venous thrombosis were permitted to enroll provided that the patient was clinically stable, asymptomatic, and adequately treated with anticoagulants in the opinion of the investigator.2 

Patients were excluded if they were receiving chronic therapy, within 7 days prior to first dose of study treatment, with

  • NSAIDs (eg, indomethacin, ibuprofen, naproxen, or similar agents), or

  • other antiplatelet agents (eg, clopidogrel, ticlopidine, dipyridamole, or anagrelide).2

Treatment of Thrombotic Events in RELAY

Patients diagnosed with an asymptomatic VTE, or following a symptomatic event, may have continued study therapy if, in the opinion of the investigator, the event could be adequately treated with LMWH anticoagulation therapy.2

Patients were warranted for discontinuation of study therapy if they experienced 

  • grade 3 or 4 ATEs

  • any PE/DVT that intensified during anticoagulant therapy

  • grade 3 or 4 VTE that in the opinion of the investigator is considered to be

    • life-threatening, or

    • symptomatic and cannot be adequately treated by anticoagulant therapy.2

Anticoagulant Use in RELAY

The concomitant use of anticoagulants in the RELAY trial is summarized in Table 1.

Table 1. Summary of Concomitant Anticoagulant Use in RELAY2

 

Ramucirumab + Erlotinib 
(n=221)

n (%)

Placebo + Erlotinib
(n=225)

n (%)

Anticoagulants

19 (8.6)

12 (5.3)

Heparins (unfractionated and low molecular weight)

16 (7.2)

10 (4.4)

Factor XA inhibitors

4 (1.8)

5 (2.2)

Thrombomodulin alfa

1 (0.5)

0

In RELAY, there was no association between concomitant or recent (within previous 2 weeks) use of anticoagulant therapy and bleeding/hemorrhagic events.2

Efficacy and Safety

In RELAY, efficacy and safety were not assessed separately in patients who received or did not receive anticoagulant treatment.

References

1. Nakagawa 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

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

Glossary

aPTT = activated partial thromboplastin time

ATE = arterial thromboembolic event

DVT = deep vein thrombosis

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

INR = international normalized ratio

LMWH = low-molecular-weight heparin

NSAID = nonsteroidal anti-inflammatory drug

NSCLC = non-small cell lung cancer

PE = pulmonary embolism

PS = performance status

PT = prothrombin time

PTT = partial thromboplastin time

ULN = upper limit of normal

VTE = venous thromboembolic event

Datum fӧr senaste ӧversyn 2019 M11 04


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