Table 2. Incidence of Common Dermatologic Toxicities of Approved EGFR Inhibitors in Selected Pivotal Studies.

Drug Tumor Phase N Regimen Dermatologic Side Effects
Gefitinib 500mg/day 250mg/day Placebo
Herbst et al, 2004 INTACT 2 NSCLC 3 1037 Paclitaxel + carboplatin ± gefitinib
Rash % 67.3(Gr 3/4:11.7) 54.4 (Gr 3/4 3.2) 37.5 (Gr 3/4: 1.5)
Acne % 26.3 (Gr 3/4: 5.0) 19.9 (Gr 3/4: 0.9) 7.3 ( Gr 3/4: 0)
Pruritis % 20.5 (Gr 3/4: 1.8) 15.2 (Gr 3/4: 0.3) 12.6 (Gr 3/4: 0.3)
Giaccone G et al, 2004 INTACT 1 NSCLC 3 1093 Cisplatin + gemcitabine ± gefitinib
Rash % 56.7 (Gr3/4:12.6) 44.5 (Gr 3/4 3.6) 21.4 (Gr 3/4: 1.1)
Acne % 28.2 (Gr 3/4: 5.9) 18.2 (Gr 3/4: 1.4) 5.1 (Gr 3/4: 0.3)
Pruritis % 12.6 (Gr 3/4: 2.0) 7.5 (Gr 3/4: 0.0) 12.4 (Gr 3/4: 0.0)
Kris et al, 2002 IDEAL 2 (Lead to approval) NSCLC 2 216 Monotherapy - gefitinib (500 or 250 mg) Grade 1/2 reversible rash
Cetuximab
Trigo et al, 2005 H & N 2 96 Cetuximab combined with platinum Skin reactions 80% (Gr 3/4: 1%); Acne like rash 72%; Gr 3/4: 1%
Bonner et al, 2004 H & N 3 424 Combined with RT Rash 97% overall; 34% grade 3/4
Cunningham et al CRC 2 329 Monotherapy or with irinotecan Acne like rash, Overall 80%; Grade 3/4 5.2% monotherapy; 9.4% in Combined
Erlotinib
Gatzemeier et al, 2004 TALENT NSCLC 3 1172 Gemcitabine + cisplatin ± erlotinib Grade 3/4 skin rash: 10%
Shepherd et al, 2005 NSCLC 3 731 Monotherapy Overall rash 76%; Placebo 17%
Moore et al, 2005 Pancreas 3 569 Gemcitabine ± erlotinib Grade 1/2 rash higher in the Erlotinib arm
Panitumumab
Peeters et al, 2006 MCC 3 463 Panitumumab + BSC(BSC = best supportive care) 6 mg/kg Q 2 wks + BSC 91% Placebo (BSC alone) 15%

Sources: 10,22,23,24,25,26,27,28,29,30