Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Bedömning av ECOG PS i REACH-2

För att utvärdera patientens funktion användes TTD som läkar-rapporterad ECOG PS, med försämring förutbestämd som ECOG PS ≥2.

Study Design

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 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 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 

ECOG PS Assessment

Baseline Assessment

Participants were required to have a baseline ECOG PS of 0 or 1 in order to be eligible for participation in the REACH-2 study. Patients were assessed for ECOG PS within 14 days prior to randomization.2

Time-to-Deterioration Assessment

To evaluate patient functioning, TTD in physician-reported ECOG PS was utilized, with deterioration prespecified as ECOG PS ≥2. Time-to-deterioration in ECOG PS was defined as the time from the date of randomization to the first date that ECOG PS ≥2 was observed.2 

Time-to-deterioration was analyzed for the ITT population using

  • the Kaplan-Meier method, and

  • an unstratified log-rank test.2

Additional analyses were performed by using

  • different definitions of deterioration and included observing a change 

    • in ECOG PS to ≥3

    • of ≥2 levels from baseline, and

    • of ≥1 level from baseline, and

  • objective progression (yes vs no) by tumor measurement period to investigate the relationship between objective progression and deterioration in ECOG PS.2

Censoring for the TTD analysis was at

  • event date, the first date observing the required ECOG PS value or deterioration, or

  • time of the last ECOG PS value if no event.2

ECOG PS Scale

The ECOG PS scale utilized in the REACH-2 study is summarized in Table 1.

Table 1. ECOG PS Scale2,3 

Status 

Description 

Fully active, able to carry on all pre-disease performance without restriction. 

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, (eg, light housework, office work). 

Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 

3

Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

4

Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

5

Dead.

Abbreviations: ECOG = Eastern Cooperative Oncology Group; PS = performance status.  

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

3. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. http://journals.lww.com/amjclinicaloncology/Abstract/1982/12000/Toxicity_and_response_criteria_of_the_Eastern.14.aspx

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

ITT = intent-to-treat

PS = performance status

TTD = time-to-deterioration

Datum fӧr senaste ӧversyn 2018 M10 01


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