Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Efterföljande behandling

Totalt sett fick 26,9% patienter i ramucirumab-armen och 28,4% patienter i placebo-armen ytterligare anti-cancer systemisk behandling after avslutad terapi i REACH-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 

Post Discontinuation Treatment

Per protocol, there was no unblinding at the time of disease progression. The use of PDT was not specified per protocol and, following study therapy discontinuation, patients could receive additional anticancer therapy at the discretion of the investigator.2  The most commonly used PDT was chemotherapy (11.2% of patients in the ramucirumab arm; 15.8% of patients in the placebo arm), followed by targeted small molecules (13.7% of patients in the ramucirumab arm; 6.3% of patients in the placebo arm). Anticancer systemic PDT for the ITT population is summarized in Table 1.

Table 1. Selected Post Discontinuation Anticancer Therapy ITT Population2  

Post Discontinuation Therapy

Ramucirumab + BSC
(n=197)
n (%)

Placebo + BSC
(n=95)
n (%)

Total
(n=292)
n (%)

Systemic therapy

53 (26.9)

27 (28.4)

80 (27.4)

Radiotherapy

19 (9.6)

10 (10.5)

29 (9.9)

Surgical procedure

2 (1.0)

5 (5.3)

7 (2.4)

Selected Systemic Therapy    

Chemotherapy

22 (11.2)

15 (15.8)

37 (12.7)

Capecitabine

5 (2.5)

2 (2.1)

7 (2.4)

Cisplatin

7 (3.6)

2 (2.1)

9 (3.1)

Cyclophosphamide

1 (0.5)

1 (1.1)

2 (0.7)

Doxorubicin

4 (2.0)

3 (3.2)

7 (2.4)

Epirubicin

0 (0.0)

1 (1.1)

1 (0.3)

Etoposide

0 (0.0)

2 (2.1)

2 (0.7)

Fluorouracil

8 (4.1)

1 (1.1)

9 (3.1)

FOLFOX-4

1 (0.5)

0 (0.0)

1 (0.3)

Gemcitabine

5 (2.5)

6 (6.3)

11 (3.8)

Gimeracil w/ oteracil potassium/tegafur

3 (1.5)

1 (1.1)

4 (1.4)

Irinotecan

1 (0.5)

0 (0.0)

1 (0.3)

Mitoxantrone

3 (1.5)

0 (0.0)

3 (1.0)

Oxaliplatin

5 (2.5)

7 (7.4)

12 (4.1)

Uracil/tegafur

1 (0.5)

1 (1.1)

2 (0.7)

Immunotherapy/Immunomodulatory

13 (6.6)

6  (6.3)

19 (6.5)

Atezolizumab

1 (0.5)

1 (1.1)

2 (0.7)

CC-122

1 (0.5)

0 (0.0)

1 (0.3)

Ipilimumab

3 (1.5)

0 (0.0)

3 (1.0)

Lirilumab

1 (0.5)

0 (0.0)

1 (0.3)

Mogamulizumab

1 (0.5)

0 (0.0)

1 (0.3)

Monoclonal antibodies

0 (0.0)

1 (1.1)

1 (0.3)

Nivolumab

11 (5.6)

1 (1.1)

12 (4.1)

Peginterferon Alfa-2a

1 (0.5)

0 (0.0)

1 (0.3)

Pembrolizumab

0 (0.0)

1 (1.1)

1 (0.3)

Thalidomide

1 (0.5)

2 (2.1)

3 (1.0)

Targeted Small Molecule

27 (13.7)

6 (6.3)

33 (11.3)

Cabozantinib

5 (2.5)

0 (0.0)

5 (1.7)

Lenvatinib

1 (0.5)

0 (0.0)

1 (0.3)

Protein kinase inhibitors

2 (1.0)

0 (0.0)

2 (0.7)

Regorafenib

17 (8.6)

5 (5.3)

22 (7.5)

Sorafenib

6 (3.0)

3 (3.2)

9 (3.1)

Abbreviations: BSC = best supportive care; FOLFOX-4 = oxaliplatin, folinic acid and 5-fluorouracil; ITT = intent to treat; w/ = with. 

Effect on Efficacy

Overall, use of PDT was balanced (26.9% in the ramucirumab arm; 28.4% in the placebo arm), and the use of most specific anticancer treatments was similar between treatment arms. A post hoc exploratory analysis of OS censoring at PDT was consistent with the results of the primary unadjusted OS analysis.2 

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

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

ITT = intent-to-treat

OS = overall survival

PDT = post-discontinuation therapy

PS = performance status

Datum fӧr senaste ӧversyn 2018 M07 01


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