Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Användning vid Hepatocellulär cancer

Cyramza (ramucirumab) monoterapi är indicerat för behandling av vuxna patienter med avancerad eller icke-resercerbar HCC som har ett serum AFP ≥400 ng / ml och som tidigare har behandlats med sorafenib.

Phase 3 Studies

REACH-2

A global, randomized, double-blind, placebo-controlled study compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.1

Patients were eligible for participation if they had

  • diagnosis of HCC (histological or radiological imaging confirmation) or in the absence of histological confirmation a diagnosis of cirrhosis and HCC with classical imaging characteristics 

  • BCLC stage C or stage B refractory or not amenable to locoregional therapy

  • Child-Pugh Class A

  • ECOG PS score of 0 or 1

  • baseline AFP ≥400 ng/mL

  • prior sorafenib treatment (discontinued due to progression or intolerance), and

  • adequate hematologic and biochemical parameters.1

Patients were randomly assigned in a 2:1 ratio (stratified by geographic region, baseline ECOG PS, and macrovascular invasion) to receive ramucirumab 8 mg/kg plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.1 

The primary endpoint was OS. A significant improvement in OS was observed among patients who received ramucirumab plus BSC compared with patients who received placebo plus BSC (8.5 vs 7.3 months; HR=0.710 (95% CI: 0.531-0.949); p=.0199).1

Any grade TEAEs that occurred while on treatment and due to any cause in ≥20% of patients who received ramucirumab plus BSC were

  • fatigue

  • peripheral edema

  • hypertension

  • decreased appetite

  • liver injury/failure

  • bleeding/hemorrhagic events

  • abdominal pain, and

  • proteinuria.1

More detailed information on the REACH-2 study is available upon request. 

REACH

A multicenter, randomized, double-blind, placebo-controlled trial was conducted in patients with advanced HCC following first-line treatment with sorafenib.2

Patients were eligible for participation if they had

  • diagnosis of HCC (histological or radiological imaging confirmation)

  • BCLC stage C or stage B refractory or not amenable to locoregional therapy

  • Child-Pugh Class A

  • ECOG PS score 0 or 1

  • prior sorafenib treatment (discontinued due to progression or intolerance)

  • adequate hematological, and

  • biochemical parameters.2

Patients were randomly assigned in a 1:1 ratio (stratified by geographic region and etiology of liver disease) to receive ramucirumab (8 mg/kg IV every 2 weeks) plus BSC (n=283) or placebo (every 2 weeks) plus BSC (n=282) until disease progression, unacceptable toxicity, withdrawal of consent, or death.2

Overall survival was the primary endpoint. The median OS was 9.2 months in the ramucirumab arm compared to 7.6 months in the placebo arm (HR=0.87; 95% CI: 0.72 - 1.05; p=.14).2

Grade ≥3 adverse events occurring in ≥5% of patients in either treatment arm were

  • hypertension

  • malignant neoplasm progression

  • ascites

  • asthenia

  • increased aspartate aminotransferase

  • thrombocytopenia

  • increased blood bilirubin, and

  • hyperbilirubinemia.2

More detailed information on the REACH study is available upon request.

Phase 2 Study

A first-line, single-arm study was conducted to assess the use of ramucirumab in patients with advanced HCC.3

Patients were eligible for participation if they had

  • Child-Pugh A or B liver disease

  • CLIP score 0 to 3, and

  • ECOG PS of 0 or 1.3

Patients (n=42) received treatment with ramucirumab 8 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity.3

The primary endpoint of PFS was 4.0 months (95% CI: 2.6-5.7).3

The most common grade ≥3 TEAEs that occurred included

  • hypertension

  • gastrointestinal hemorrhage

  • infusion-related reactions, and

  • fatigue.3

References

1. Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(2):282-296. http://dx.doi.org/10.1016/S1470-2045(18)30937-9

2. Zhu AX, Park JO, Ryoo B-Y et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015;16(7):859-870. http://dx.doi.org/10.1016/S1470-2045(15)00050-9

3. Zhu AX, Finn RS, Mulcahy M, et al. A phase II and biomarker study of ramucirumab, a human monoclonal antibody targeting the VEGF receptor-2, as first-line monotherapy in patients with advanced hepatocellular cancer. Clin Cancer Res. 2013;19(23):6614-6623. http://dx.doi.org/10.1158/1078-0432.CCR-13-1442.

Glossary

AFP = alpha-fetoprotein

BCLC = Barcelona Clinic Liver Cancer

BSC = best supportive care

CLIP = Cancer of the Liver Italian Programme

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

HR = hazard ratio

IV = intravenous

OS = overall survival

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2019 M03 12

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