Info

🌱 來自: Metastatic Colon Cancer

RAISE

Ramucirumab plus FOLFIRI for metastatic colorectal cancer: a phase 3 randomised double-blind study

Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study - The Lancet Oncology

• Design:

  • Multicentre, randomised, double-blind, phase 3 RAISE trial
  • Randomised (1:1) via a centralised, interactive voice-response system to receive 8 mg/kg intravenous ramucirumab plus FOLFIRI or matching placebo plus FOLFIRI every 2 weeks until disease progression, unacceptable toxic effects, or death.
  • Stratified by region, KRAS mutation status, and time to disease progression after starting first-line treatment.

• Number of patients: 1072 patients (536 in each group)

• Patients characteristics: Patients with metastatic colorectal cancer with disease progression during or within 6 months of the last dose of first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

• Agent: Ramucirumab

• Treatment line: Second-line FOLFIRI (leucovorin, fluorouracil, and irinotecan)

• Trial Name: RAISE trial (NCT01183780)

• Comparison of two groups in a markdown table:

  Outcome Measures	Ramucirumab + FOLFIRI	Placebo + FOLFIRI
  Median overall survival (months)	13.3 (95% CI 12.4-14.5)	11.7 (10.8-12.7)
  Hazard ratio	0.844 95% CI 0.730-0.976	-
  Log-rank p-value	0.0219	-
  Neutropenia (≥Grade 3)	203 (38%)	123 (23%)
  Febrile neutropenia incidence	18 (3%)	13 (2%)
  Hypertension (≥Grade 3)	59 (11%)	15 (3%)
  Diarrhoea (≥Grade 3)	57 (11%)	51 (10%)
  Fatigue (≥Grade 3)	61 (12%)	41 (8%)

• TLDR: OS: 13.6

• Other findings in this trial:

  • Survival benefit was consistent across subgroups of patients who received ramucirumab plus FOLFIRI.

• Summary: The RAISE trial shows that ramucirumab plus FOLFIRI significantly improves overall survival compared to FOLFIRI with placebo in patients with metastatic colorectal cancer who had disease progression during or within 6 months of the last dose of first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. The survival benefit was consistent across subgroups of patients who received ramucirumab plus FOLFIRI.