Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Effektivitet och säkerhet enligt kön i REACH-2

Inga kliniskt signifikanta säkerhetsskillnader observerades mellan manliga och kvinnliga deltagare i REACH-2-studien.

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 

Enrollment According to Gender

In the REACH-2 study, 233 patients (79.8%) were male and 59 patients (20.2%) were female.

Among patients who received ramucirumab plus BSC

  • 154 patients (78.2%) were male, and

  • 43 patients (21.8%) were female.

Among patients who received placebo plus BSC

  • 79 patients (83.2%) were male, and

  • 16 patients (16.8%) were female.1 

Efficacy

No significant differences in efficacy were observed between male and female participants.2 Efficacy results according to gender are summarized in Table 1.

Table 1. Efficacy Results According to Gender2


RAM + BSC
(n=154)

PBO + BSC
(n=79)

RAM + BSC
(n=43)

PBO + BSC
(n=16)

Male

Female

Median OSa, mo (95% CI)

 8.08 (6.74-10.58)

6.60 (5.22-8.97)

8.80 (5.82-13.37)

9.07 (5.88-17.94)

HRb (95% CI); p valuec

0.696 (0.509-0.952); p=.0234

1.206 (0.591-2.459); p=NS

Interaction p valued

p=NS 

Median PFSa, mo (95% CI)

2.83 (2.73-4.14) 

1.54 (1.45-2.56)

2.92 (2.63-4.17) 

2.73 (1.41-2.79) 

HRb (95% CI); p valuec

0.457 (0.338-0.619); p<.0001 

0.532 (0.278-1.020); p=.0520 

Interaction p valued

p=NS 

ORR, n (%)

6 (3.9)

1 (1.3)

3 (7)

0

DCR, n (%)

90 (58.4)

29 (36.7)

28 (65.1)

8 (50.0)

Abbreviations: BSC = best supportive care; DCR = disease control rate; HR = hazard ratio; NS = not significant; ORR = overall response rate; OS = overall survival; PBO = placebo; PFS = progression-free survival; RAM = ramucirumab. 

a Estimated using the Kaplan-Meier method.

b Hazard ratio and 95% CI (Wald) were estimated from unstratified Cox model.

c Two-sided p value from unstratified log-rank test.

d Wald test of treatment-by-subgroup interaction from unstratified Cox model.

Safety

No clinically relevant differences were seen in terms of TEAE profile or differences between treatment arms in males and females. Any grade TEAEs that occurred in at least 20% of patients in the ramucirumab arm (summarized by gender) are summarized in Table 2.

Table 2. Any Grade TEAEs in ≥20% of Patients who Received Ramucirumab Plus BSC2

MedDRA Preferred Term

RAM + BSC
(n=154)

PBO + BSC
(n=79)

RAM + BSC
(n=43)

PBO + BSC
(n=16)

Male

Female

Fatigue

29.9 

17.7

18.6 

12.5

Hypertension

24.7

13.9

23.3 

6.3 

Decreased appetite

24.0

22.8

20.9 

6.3 

Peripheral edema

24.0

16.5

30.2 

Nausea

20.8

10.1

11.6 

18.8

Abdominal pain

20.1

11.4

18.6 

18.8

Proteinuria

19.5

3.8

23.3

6.3

Ascites

14.9

7.6

27.9

6.3

Urinary tract infection

1.3

1.3

20.9

0

Abbreviations: BSC = best supportive care; MedDRA = Medical Dictionary of Regulatory Activities; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event. 

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.

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

CI = confidence interval

DCR = disease control rate

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

HR = hazard ratio

MedDRA = Medical Dictionary for Regulatory Activities

OS = overall survival

PBO = placebo

PFS = progression-free survival

PS = performance status

TEAE = treatment-emergent adverse event

Datum fӧr senaste ӧversyn 2018 M07 01


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