Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Rationale för kombinerad analys av REACH och REACH-2

En kombinerad analys för REACH och REACH-2 var möjligt på grund av liknande studiedesign.

Study Designs

REACH-2

A multicenter, randomized, double-blind, placebo-controlled trial was conducted to compare ramucirumab plus BSC vs 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)

  • 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)

  • adequate hematologic, and

  • biochemical parameters.1

Patients were stratified by

  • geographic region (Americas, Europe, Israel, and Australia vs Asia [except Japan] vs Japan)

  • baseline ECOG PS (0 vs 1), and

  • macrovascular invasion (yes vs no).1

Patients were randomly assigned (2:1) to receive ramucirumab 8 mg/kg IV 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

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

Rationale for Combined Analysis

A combined analysis of the data for REACH and REACH-2 was possible because both studies

  • had similar eligibility criteria

  • assessed the same treatment regimen

  • used similar protocol procedures, and

  • were global, randomized, multicenter, placebo-controlled trials.3

A combined analysis was acceptable from a statistical and scientific perspective because 

  • REACH-2 confirmed results seen previously in the REACH high-AFP prespecified subgroup, and

  • the pooling was prespecified prior to the database lock and unblinding of REACH-2.3 

By using the larger patient population in the pooled analysis, the precision of the estimates of the ramucirumab-treatment benefit and safety assessments in the target population was increased.3

References

1. Zhu AX, Kang YK, Yen CJ, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. Presented as an oral presentation at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract #4003. https://meetinglibrary.asco.org/record/159169/abstract

2. [DO NOT USE] xxZhu AX, xxPark JO, xxRyoo BY, 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. Accompanied by supplementary appendix https://ars.els-cdn.com/content/image/1-s2.0-S1470204515000509-mmc1.pdf available as a pdf file.

3. Zhu AX, Finn RS, Galle PR, et al. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP) following first-line sorafenib: Pooled efficacy and safety across two global randomized phase 3 studies (REACH-2 and REACH). Presented as an oral presentation at: 20th Annual Meeting of the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer; June 20-23, 2018; Barcelona, Spain. Abstract #LBA-001. https://www.postersessiononline.eu/pr/aula_poster.asp?congreso=519481837&direccion_posters=Seleccion&pagina_posters=1&ordenacion=n_poster&cod_congreso_integracion=&pst_clave=&buscar=&swAcceso=&swAccesoAdmin=&cod_congreso_aula_rel=&busqueda_rapida=&tipo=autor&texto=&texto2=&grupo2_aula=&grupo=&texto_ident=

Glossary

AFP = alpha-fetoprotein

BCLC = Barcelona Clinic Liver Cancer

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

IV = intravenous

PS = performance status

Datum fӧr senaste ӧversyn 2018 M08 01

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