Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Var Cyramza® (ramucirumab) effektiv som monoterapi efter paklitaxel utsättande i RAINBOW?

Patienter som avbröt paklitaxel hade en median total överlevnad (OS) på 15,7 månader och progressionsfri överlevnad (PFS) på 8,5 månader.

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Patients Who Discontinued Treatment with Paclitaxel and Continued Treatment with Ramucirumab

31 of 330 patients discontinued paclitaxel due to toxicity and received ramucirumab alone. In the placebo group, 11 patients discontinued paclitaxel and continued on placebo alone.1,2

Please interpret the following results with caution due to the small number of patients. The efficacy outcomes for these patients are summarized inEfficacy Outcomes for Patients who Discontinued Treatment with Paclitaxel Due to Adverse Events vs patients who continued on the planned course .

Efficacy Outcomes for Patients who Discontinued Treatment with Paclitaxel Due to Adverse Events vs patients who continued on the planned course1 

Outcome

Ramucirumab + Paclitaxel

n=31

Placebo + Paclitaxel

n=11

Median OS, months (95% CI)

15.7 (12.6-NA)

10.9 (5.7-14.9)

1-year OS (95% CI)

73.3% (53.5-85.7)

45.5% (16.7-70.7)

Median PFS, months (95% CI)

8.5 (5.7-9.7)

5.6 (2.6-7.8)

6-month PFS (95% CI)

64.2% (44.7-78.4)

36.4% (11.2-62.7)

 Abbreviations: NA = not available; OS = overall survival; PFS = progression-free survival.

The number of additional cycles of ramucirumab that patients who discontinued paclitaxel received are summarized in  Additional Cycles of Single-Agent Ramucirumab after Discontinuation of Paclitaxel.

 Additional Cycles of Single-Agent Ramucirumab after Discontinuation of Paclitaxel1

Additional Cycles

Ramucirumab + Paclitaxel (n=31)

Number of patients (%)

Additional 1 cycle

10 (32.3)

Additional 2 cycles

8 (25.8)

Additional 3 cycles

4 (12.9)

Additional 4 cycles

2 (6.5)

Additional 6 cycles

2 (6.5)

Additional 8 cycles

1 (3.2)

Additional 9 cycles

2 (6.5)

Additional 11 cycles

1 (3.2)

Additional 14 cycles

1 (3.2)

Rainbow Study Design

The RAINBOW trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic or locally advanced nonresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. 

Patients had to have disease progression during or within 4 months after the last dose of first-line platinum plus fluoropyrimidine combination chemotherapy with or without an anthracycline.

All patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Patients were randomly assigned in a 1:1 ratio, stratified by

  • region,
  • measurable vs nonmeasurable disease, and
  • time-to-progression (TTP) on first-line therapy

to receive either

  • ramucirumab (8 mg/kg days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=330) or
  • placebo (days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=335)

of a 28-day cycle until disease progression, unacceptable toxicity, withdrawal, or death.2

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235. http://dx.doi.org/10.1016/S1470-2045(14)70420-6

Datum fӧr senaste ӧversyn 2021 M09 15


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