Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Livskvalitet i REGARD

I REGARD-studien upprätthöll fler patienter livkvaliteten om de behandlades med minst 4 cykler ramucirumab jämfört med placebo.



Information from Summary of Product Characteristics

Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.1

Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.1

Study Design

The REGARD trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic or locally advanced gastric or GEJ adenocarcinoma treated previously with fluoropyrimidine- or platinum-based combination therapy with an ECOG PS of 0 or 1. Patients were randomly assigned in a 2:1 ratio (stratified by weight loss, region, and location of the primary tumor) to receive ramucirumab (8 mg/kg every 2 weeks) plus best supportive care (n=238) or placebo (every 2 weeks) plus best supportive care (n=117) until disease progression, unacceptable toxicity, withdrawal, or death.2

QoL Assessment

Quality of life was measured by the EORTC-QLQ-C30 [v3]) at

  • baseline

  • 6 weeks (prior to cycle 4)

  • 12 weeks (prior to cycle 7), and

  • 18 weeks (prior to cycle 10).3

Based on the trial design, patients that discontinued therapy prior to the planned QoL assessments were not required to complete assessments and in those instances no data were available. For each scale on the EORTC-QLQ-C30, patients were classified as improved or worsened at each assessment if the change from baseline was ≥10 points on a 100-point scale, or stable if the change from baseline was <10 points.3

The QLQ-C30 completion rates were >86% at all assessment time points while on therapy. Disease progression accounted for >70% of treatment discontinuations, and treatment discontinuation was the primary reason for missing data assessments.3

Table 1. QoL Response Rates at Week 12 (Cycle 4) includes the QoL response rates for

  • global QoL

  • physical function

  • fatigue, and

  • pain for week 6 (cycle 4).3

The pattern was similar for all other scales and time points except for an increased proportion of patients with no data at later time points. For patients who received at least 4 cycles of therapy, more patients in the ramucirumab group maintained their QoL than patients in the placebo group.3

Table 1. QoL Response Rates at Week 12 (Cycle 4)3


Improved

Stable

Worsened

No Dataa

Improved

Stable

Worsened

No Dataa

Ramucirumab (n=238)
% of Patients

Placebo (n=117)
% of Patients

Global QoL

10

24

12

54

4

9

9

78

Physical functioning

9

24

15

52

4

9

10

77

Fatigue

13

16

16

55

6

8

9

77

Pain

10

17

18

55

4

10

7

79

Abbreviation: QoL = quality of life.

a Based on the trial design, patients who discontinued therapy prior to the planned QoL assessments were not required to complete assessments and in those instances, no data were available.

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39. http://dx.doi.org/10.1016/S0140-6736(13)61719-5

3. Chau I, Passalacqua R, Zalcberg JR, et al. Tolerability and quality-of-life (QoL) results from the phase 3 REGARD study: ramucirumab versus placebo in patients with previously treated gastric or gastroesophageal junction (GEJ) adenocarcinoma. Poster presented at: European Cancer Congress (ECCO); September 27-October 1, 2013; Amsterdam, The Netherlands. http://www.careeducation.ca/news/2013/10/3/ecc-2013-abstract2588-p416-phase-3-regard-study

Glossary

ECOG = Eastern Cooperative Oncology Group

EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer quality-of-life questionnaire

GEJ = gastroesophageal junction

PS = performance status

QoL = quality of life

Datum fӧr senaste ӧversyn 2019 M03 11

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