Metastatic CRC: adding 5-FU/LV boosts panitumumab maintenance

  • Pietrantonio F & al.
  • JAMA Oncol
  • 3 Jul 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Adding 5-fluorouracil-leucovorin (5-FU/LV) to maintenance panitumumab extends PFS after oxaliplatin-based induction in patients with RAS wild-type metastatic colorectal cancer (CRC).

Why this matters

  • Findings shed light on optimal anti-epidermal growth factor receptor-based maintenance therapy in this population.

Study design

  • Randomized, phase 2 noninferiority trial of 229 patients (median age, 64 years; 66.8% male) receiving frontline panitumumab plus FOLFOX-4 for 8 cycles followed by maintenance therapy with panitumumab ± 5-FU/LV.
  • Funding: Amgen.

Key results

  • Adding 5-FU/LV to panitumumab maintenance significantly improved 10-month PFS (59.9% vs 49.0%) and median PFS (12.0 vs 9.9 months; log-rank test, P=.006; HR stratified by prior adjuvant therapy and number of disease sites, 1.51; P=.009).
  • There was no difference in OS or disease control rate between the 2 groups.
  • In per-protocol analysis (n=164), adding 5-FU/LV to panitumumab yielded significantly improved 10-month PFS (70.3% vs 59.0%) and median PFS (14.1 vs 10.8 months; HR, 1.50; P=.04).
    • There was no significant difference in OS.
  • The combination arm had a higher incidence of diarrhea (24.7% vs 10.1%), stomatitis (32.9% vs 7.6%), panitumumab-related toxic effects (76.5% vs 41.8%), and neurotoxicity (37.2% vs 3.1%).

Limitations

  • Open-label design.

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