Info

🌱 來自: Metastatic Colon Cancer

PARADIGM

1. Design:
   • Randomized, open-label, phase 3 clinical trial
   • Multi-center trial conducted at ↣ 197 sites in Japan
   • Tested the effect of adding panitumumab vs bevacizumab to standard first-line chemotherapy
   • Primary endpoint: overall survival
   • Secondary endpoints: progression-free survival, response rate, duration of response, and curative resection rate
2. Number of patients: 823 patients
   • 802 patients in the as-treated population
3. Patients characteristics:
   • Chemotherapy-naive RAS wild-type, unresectable metastatic colorectal cancer
   • Median age: 66 years
   • 35.2% women
   • 604 (75.3%) had left-sided tumors
4. Agent:
   • Panitumumab (an anti-EGFR monoclonal antibody) or bevacizumab (an anti-VEGF monoclonal antibody)
   • Given with modified fluorouracil, l-leucovorin, and oxaliplatin (mFOLFOX6) every 14 days
5. Treatment line: First-line chemotherapy
6. Trial Name: NCT02394795
7. Comparison of two groups (panitumumab vs bevacizumab) in the as-treated population:

Endpoint	Panitumumab	Bevacizumab	Difference (95% CI)
Progression-free survival (months) - Left-sided tumors	13.1	11.9	0.2 (-0.27 to 0.67)
Progression-free survival (months) - Overall population	12.2	11.4	0.8 (-0.09 to 1.70)
Response rate - Left-sided tumors	80.2%	68.6%	11.2% (4.4% to 17.9%)
Response rate - Overall population	74.9%	67.3%	7.7% (1.5% to 13.8%)
Duration of response (months) - Left-sided tumors	13.1	11.2	1.9 (-0.14 to 3.94)
Duration of response (months) - Overall population	11.9	10.7	1.2 (-0.18 to 2.62)
Curative resection rate - Left-sided tumors	18.3%	11.6%	6.6% (1.0% to 12.3%)
Curative resection rate - Overall population	16.5%	10.9%	5.6% (1.0% to 10.3%)

• Overall survival: Panitumumab vs bevacizumab
  • Left-sided tumors: median overall survival of 37.9 months vs 34.3 months, hazard ratio for death, 0.82 (95.798% CI, 0.68-0.99; P = 0.03)
  • Overall population: median overall survival of 36.2 months vs 31.3 months, hazard ratio for death, 0.84 (95% CI, 0.72-0.98; P = 0.03)