Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Hemoptys i RELAY

Ramucirumab är en antiangiogen terapi vilken kan öka risken för svår blödning. Avbryt ramucirumab/placebo permanent hos patienter som upplever blödning av grad 3 eller 4.

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

Incidence of Pulmonary Hemorrhage/Hemoptysis in RELAY

RELAY exclusion criteria related to pulmonary hemorrhage events included

  • radiologically documented evidence of major blood vessel invasion or encasement by cancer,

  • radiographic evidence of intratumor cavitation, regardless of tumor histology, and

  • a history of gross hemoptysis (defined as the presence of ≥½ teaspoon of gross blood) within 2 months prior to enrollment.1

The investigator could discontinue a patient from ramucirumab/placebo for hemoptysis that exceeded the severity grade present at baseline.1

Treatment-emergent adverse events of pulmonary hemorrhage and hemoptysis are presented in Table 1.

Table 1. Treatment Emergent Adverse Events of Pulmonary Hemorrhage and Hemoptysis in RELAY1

TEAE, n (% of patients)a

Any Grade

Grade ≥3

Any Grade

Grade ≥3

Ramucirumab + Erlotinib 
(n=221)

Placebo + Erlotinib
(n=225)

Pulmonary hemorrhage eventsb

14 (6)

0 (0)

4 (2)

1 (<1)

Hemoptysis

12 (5)

0 (0)

2 (1)

1 (<1)

Abbreviation: TEAE = treatment-emergent adverse event.

a Adverse events of special interest are those associated with ramucirumab treatment in previous clinical trials of non-small-cell lung cancer, gastric cancer, urothelial cancer, and hepatocellular carcinoma.

b One death occurred on study and was because of a pulmonary hemorrhage event of hemothorax.

Ramucirumab is an antiangiogenic therapy and has the potential to increase the risk of severe bleeding. Permanently discontinue ramucirumab/placebo in patients who experience grade 3 or 4 bleeding.1

Efficacy data from RELAY patients who developed pulmonary hemorrhage and/or hemoptysis have not been evaluated.

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

Glossary

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

NSCLC = non-small cell lung cancer

PS = performance status

Datum fӧr senaste ӧversyn 2019 M10 11


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