Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Kroppsvikt i RELAY

Vid förändring av kroppsvikt ≥10% (ökning eller minskning) sedan den sista dosberäkningen måste ramucirumab/placebo beräknas om.

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

Baseline Body Weight

In RELAY, the first dose of ramucirumab/placebo was dependent on the patient’s baseline body weight in kg. Patients were weighed at the beginning of each cycle. Subsequent doses of ramucirumab/placebo were recalculated if there was a ≥10% change (increase or decrease) in body weight from the last dose calculation. Additionally, subsequent doses may have been recalculated if there was a <10% change (increase or decrease) in body weight from the previous dose calculation.1

For patients undergoing repeated palliative drainage procedures to remove pleural or peritoneal fluid, dry weight was defined as weight obtained after the drainage procedure and before fluid re-accumulation. In this circumstance, dry weight was used for dose calculation if obtained within 30 days prior to dose. If no recent dry weight was available, actual weight was used.1            

Baseline body weight is summarized in Table 1.

Table 1. Baseline Body Weight of Patients in RELAY Part B 2

Weight at Baseline, kg

RAM + Erlotinib
 (N=224)

Placebo + Erlotinib
 (N=225)

Total
(N=449)

Mean (SD)

60.65 (12.12)

60.82 (13.39)

60.73 (12.76)

Median

58.60

58.80

58.80

Abbreviation: RAM = ramucirumab.

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

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 21

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