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Table 3 Treatment related toxicities

From: Second-line treatment of recurrent HNSCC: tumor debulking in combination with high-dose-rate brachytherapy and a simultaneous cetuximab-paclitaxel protocol

  Total group Study group Control group Salvage surgery Salvage surgery plus BT BT in palliation Cetuximab Paclitaxel
% (n = 94) (n = 18) (n = 18)      
Overall acute and chronic side effects:
CTC overall 26.6 44.4 33.3 36-39 (III,IV,V) 7-23 (III,IV) 13-35 (II,III) 15-41 (III-IV)  
 CTC I 6.4 16.7 5.6      
 CTC II 10.6 16.7 16.7      
 CTC III 9.6 11.1 11.1      
LENT-SOMA overall 14.9 27.8 11.1   7-23 (III,IV) 7-33 (II,III)   
 LENT-SOMA I 3.2 5.6 5.6      
 LENT-SOMA II 7.4 16.7 --      
 LENT-SOMA III 4.3 5.6 5.6      
Acute and chronic side effects in detail:
Mucositis 5.4 11.1 5.6   10 (III) 60 (I,II) 8-56 (III,IV) 17-35 (III,IV)
Lymph edema 10.6 16.7 (II,III) 11.1      21
Pain -- -- --    20 6  
Dysphagia 6.4 22.2 -- 53-58 (III) 32-39 (II,III) 4-16 26 (II,III) 15
Bleeding 3.2 -- 16.7 1-3 (IV,V) 3-14 (II,III,IV) 3-7 (III) 8 (II,II) 14 (III)
Woundheeling disorder 10.6 (II,III) 16.7 (II,III) 5.6 (II,III) 12-17 15-17 (II,III) 4 (III) 11-23 (II,IV)  
Soft tissue necrosis -- -- --   7 (III) 7-28 (II,III)   
Osteoradionecrosis -- -- --   4 (III,IV) 1-17 (II,III)   
Fibrosis 2.1 5.6 --   7-29 (II,III) 2-7 (II,III)   
Skin reaction 3.1 11.1 (III,IV)      9-16 (III,IV) 12
Infusion reaction 1.1 5.5 (III)      2-22 (III,IV)  
Neutropenia 1.1 5.6 (IV)      8 (III,IV) 14-75 (IV)
Renal failure -- --       7 (III,IV)
Neuropathy   --    4-26 (II,III,IV) 7 (III) 4 7 (III,IV)
  1. Shows the toxicity profile of the study group compared to the total group, the control group and to literature. Other studies treating recurrent HNSCC by salvage surgery [3436], salvage surgery combined with Brachytherapy (BT) [32, 4244], single BT in palliation [24, 37, 38, 42, 43, 45, 46] or studies that used Cetuximab [1, 11, 4752] within their regime were listed using the CTC (common toxicity criteria) and LENT (Late Effects Normal Tissue)-SOMA-classifications. The toxicity levels the percentage values from literature refer to were put in brackets