Radiation and Cetuximab

Trial

International Trial by Bonner

Patients

  • Stage III or IV SCCA of the
      • oropharynx
      • hypopharynx
      • larynx

Treatment

Regimen Total Radiation Dose Once-Daily Fractions Twice-Daily Fractions
Once daily 70.0 Gy in 35 fractions 2.0 Gy/fraction; 5 fractions/ wk for 7 wk Not applicable
Twice daily 72.0–76.8 Gy in 60–64 fractions Not applicable 1.2 Gy/fraction; 10 fractions/wk for 6.0–6.5 wk
Concomitant boost 72.0 Gy in 42 fractions 32.4 Gy; 1.8 Gy/fraction; 5 fractions/wk for 3.6 wk Morning dose: 21.6 Gy; 1.8 Gy/ fraction; 5 fractions/wk for 2.4 wk

Afternoon dose: 18.0 Gy; 1.5 Gy/ fraction; 5 fractions/wk for 2.4 wk
Radiation Only Cetuximab + RT p-value
Median OS
- 3-yr OS
29.3 mo.
45%
49 mo.
55%
0.03 (log-rank test)
Grade 3/4 mucositis 52% 56% 0.5 (Fisher's exact)
Grade 3/4 infusion reaction 0 3% 0.01 (Fisher's exact)
Grade 3/4 skin reaction 18% 23% <0.01 (Fisher's exact)

Conclusions (Foote)

  • addition of cetuximab to high dose radiation in patients with locoregionally advanced SCC of H&N demonstrated a statistically significant prolongation in overall survival.
  • Cetuximab certainly could be considered for use now in patients considered too frail for concurrent RT and cisplatin based chemotherapy.
Bibliography
1. Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.
N Engl J Med. 2006 Feb 9;354(6):567-78.
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