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Table 1 Studies on monoclonal EGFR antibodies

From: Radiotherapy and "new" drugs-new side effects?

Substance Author(s) Year Study type N Tumour RT dose/ChTx/technique Toxicity
Cetuximab Bonner et al. [10] 2006 Phase III 211 (cetux-arm) LA-HNSCC 70-78.8 Gy (hyper-fractionated) Significant differences or trend in arms: 8% grade III-V acneiform rash, 1% grade III-V voice alteration, 1% grade III-V infusion reaction
  Koutcher et al. [24] 2009 Retrospective 115 LA-HNSCC 66 Gy/69.96 Gy 3% grade IV radio-dermatitis, 19% grade III radio-dermatitis
  Studer et al. [25] 2011 Prospective 99 HNSCC 66-70 Gy, 30/99 switch from Cis 34% grade II/IV dermatitis
  Hallqvist et al. [28] 2010 Phase II 75 NSCLC 68 Gy, Ind. ChTx Doc/Cis + concomitant Cetux 1% grade V pneumonitis, 4% grade III pneumonitis, 5% grade III + IV hypersensitivity, 15% grade III + IV febrile neutropenia, 4% III skin reactions
  Jensen et al. [122] 2010 Retrospective 73 HNSCC 22 pts Re-RT (50-60 Gy), 66-70 Gy 5% grade III allergic reaction, 4% grade III acneiform rash
  Garcia-Huttenlocher et al. [123] 2009 Retrospective 65 HNSCC Median 66 Gy (IMRT) Grade III: skin toxicity 28%, mucositis 25%
  Rödel et al. [115] 2008 Phase I/II 12/48 Rectal cancer 50,4 Gy +Capecitabine + Oxaliplatin Phase II only Grade IV/V: Leukopenia, thrombocytopenia, Diarrhea, Creatinine elevation, e-lyte derivation, infection each 2%
  Safran et al. [31] 2008 Phase II 60 Esophago-gastric-cancer Cetux/Carbo/Tax + 50.4 Gy 23% grade III rash, 15% grade III/IV esophagitis, 5% III + IV hypersensitivity, 3% grade IV neutropenia (10% grade III), 2% IV anemia (8% grade III)
  Jatoi et al. [124] 2010 Phase II 57 NSCLC 60 Gy 2% grade IV each: dysphagia/hypomagnesemia/dyspnea/headache/thrombosis/GI hemorrhage, 7% grade III rash
  Horisberger et al. [30] 2009 Phase II 50 Rectal cancer 50,4 Gy + Capecitabine + Irinotecan Leukopenia 4% grade III and IV each Grade III: Diarrhea 60%, abdominal pain 8%, ALAT/ASAT elevation 20%, Acneiform skin rash 12%, anemia, nausea/vomiting, bilirubin elevation, proctitis each 4%
  Koutcher et al. [125] 2011 Retrospective 49 LA-HNSCC 69.96 Gy (IMRT) (comparison vs. concomitant Cis) 20% late grade III + IV toxicity
  Walsh et al. [26] 2011 Retrospective 48 (14 excluded because of SIB) HNSCC Cis vs. Cetux (66-70 Gy) 44% ≥ grade III skin toxicity, 52% ≥ grade III mucositis, 6% ≥ grade III acneiform rash
  Buiret et al. [126] 2010 Retrospective multicenter 46 HNSCC Ind. ChTx Doc/Cis/5-FU, RIT (70 Gy) No grade IV toxicity
  Garcia-Huttenlocher et al. [127] 2008 Retrospective 46 HNSCC Median 66 Gy (IMRT) 20% grade III skin toxicity, 4% grade III mucositis
  Merlano et al. [128] 2010 Phase II 45 HNSCC Up to 70 Gy, three cycles Cis/5-FU, split course RT, RT + cetux 2% grade IV leukopenia (38% grade III), 7% grade IV neutropenia (33% grade III), 2% grade IV thrombopenia (13% grade III), 36% grade IV stomatitis (29% grade III), 73% grade III radiodermatitis, 7% grade III rash
  Koukourakis et al. [60] 2010 Phase I 43 LA-HNSCC 21 × 2.7 Gy (56.7 Gy) + amifostine + Cis 16% grade III + IV mucositis, 2% grade III + IV skin toxicity
  Suntharalingam et al. [129] 2011 Phase II 43 LA-HNSCC 70,2 Gy (3D/IMRT) + Paclitaxel, Carboplatin, Grade 3 mucositis (79%), rash (9%), leukopenia (19%), neutropenia (19%), and RT dermatitis (16%)
  De Vita et al. [130] 2011 Phase II 41 Esophageal cancer Ind. FOLFOX4 + 50.4 Gy/Cetux 30% grade II/IV skin toxicity/neutropenia
  Bertolini et al. [117] 2009 Phase II 40 LA rectal cancer 50-50.4 Gy + neoadj. Cetux/Cetux + 5-FU concomitant 8% grade III/IV skin rash, 8% grade III/IV hypersensitivity, 13% grade III/IV GI toxicity, 3% grade III/IV febrile neutropenia
  Kim et al. [98] 2011 Phase II 40 Rectal cancer Capecitabine + Cetux + Irinotecan + 50.4 Gy 3% grade IV leukopenia, 3% grade III rash
  Machiels et al. [119] 2007 Phase I/II 40 Rectal cancer 45 Gy + Capecitabine 3% grade III/IV allergic reaction, 3% grade III/IV dermatitis
  Argiris et al. [131] 2010 Prospective 39 LA-HNC Induction Docetaxel/Cis/Cetux + concurrent Cisplatin/Cetux/70-74 Gy-RT Grade III/IV: oral mucositis 46%, Anemia 21%, in-field dermatitis 23%, Dysphagia 41%, Thrombocytopenia 10%, Neutropenia 31%, febrile neutropenia 5%, infection 18%, fatigue 13%, nausea 10%, vomiting 3%, renal failure 3%, DVT 5%, bleeding 5%.
  Velenik et al. [118] 2010 Phase II 37 Rectal cancer 45 Gy RT + capecitabine (neoadjuvant) Grade III: diarrhea 11%, anorexia 3%, hepatotoxicity 3%, in-field-dermatitis 16%, infection 3%, hypersensitivity 5%.
  Heron et al. [132] 2011 Matched pair retrospective 35 HNSCC SBRT Re-RT No significant increase grade III + IV
  Birnbaum et al. [133] 2010 Phase I 32 LA-HNSCC 66-72 Gy, Ind. Cetux + Carbo/Tax/Cetux concomitant 3% grade III allergic reaction, 3% grade IV metabolic symptom, 69% grade III + IV mucositis, 3% grade IV dysphagia, 59% pts grade III + IV skin toxicity
  Jensen et al. [134] 2011 Phase II 30 NSCLC 66 Gy (IMRT) Pulmonary embolism 3% grade III + 3% grade V endocarditis and myocardial infarction grade V each 3%, 13% grade III/IV pneumonia esophagitis, diarrhea, DVT, exacerbation of COPD, urosepsis, pericardial effusion, pneumonitis grade III each 3%
  Ruhstaller et al. [135] 2011 Phase IB/II 28 Esophageal cancer Induction ChTx Cis/docetaxel + neoadjuvant RCh-immunotherapy 25% grade III/IV esophagitis, 4% grade III/IV rash
  Pfister et al. [136] 2006 Phase I 22 LA-HNSCC 70 Gy RT + Cisplatin Study closed due to significant AEs. Grade V pneumonia and one death of unknown cause, Grade IV: MI 5%, arrhythmia 5%, metabolic 5%, infection 5%
  Hofheinz et al. [137] 2006 Phase I 20 Rectal cancer Capecitabine + Irinotecan + 50.4 Gy No grade IV, no rash, 20% grade III diarrhea
  Kuhnt et al. [138] 2010 Phase I 18 (16 eligible) LA-HNSCC HART (70.6 Gy) + Cis 56% grade III mucositis, 38% ≥ grade III radiodermatitis, 25% ≥ grade III neutropenia, 6% grade III rash
  Pryor et al. [22] 2009 Prospective 13 HNSCC 70 Gy 46% ≥ grade III acneiform rash, 77% ≥ grade III dermatitis
  Hughes et al. [29] 2008 Phase I 12 NSCLC 64 Gy Grade III fatigue, pneumonitis each 8% Grade V Infection 8%
  Zwicker et al. [139] 2011 Phase II 10 HNSCC IMRT 50.4 Gy Re-RT + Cetux 10% grade V mucositis, 10% grade III mucositis, 10% grade IV erythema (20% grade III), 20% grade III acneiform rash
  Jensen et al. [140] 2010 prospective 9 Adenoid cystic carcinoma of HN 5/9: re-RT: median 50,4 Gy, median 65 Gy otherwise (IMRT or C-12 boost) Grade III Mucositis and Grade III Dysphagia
  Balermpas et al. [141] 2009 Prospective 7 HNSCC Re-irradiation 50,4 Gy-54,0 Gy New acute side effects: Grade III: pain 14%, mucositis 71%. Dysphagia 57%. Xerostomia 14%. Fibrosis 14%, acneiform rash 29%.
  Berger et al. [19] 2008 Case report 1 HNSCC 72 Gy., regimen change to cetuximab from 5-FU/MMC Grade IV Dermatitis
Trastuzumab Halyard et al. [48] 2009 Phase III 1503 Breast cancer Median 50,4 Gy, previous OP + ChTx Skin toxicity grade III: 4% (simultaneous) -6% (adjuvant), cardiac events 2% (simultaneous)-3% (adjuvant)
  Belkacemi et al. [49] 2008 Multicentric study 146 Breast cancer Median 50 Gy > grade II esophagitis (12%), 1 pt grade III esophagitis, 5% grade III dermatitis, ≥ grade II LVEF (10%)
  Caussa et al. [142] 2011 Prospective 106 Breast cancer 50 Gy (2 Gy) + 16 Gy boost 2% grade III skin reaction, 1% grade III esophagitis
  Anderson [143] 2009 Matched case control study 85 Breast cancer n. r. Grade III dermatotoxicity 2%, 1% ≥ grade II LVEF decrease (reversible)
  Shaffer et al. [50] 2009 retrospective 44 Breast cancer 40-50.4 Gy In 14% stopped because of cardiac toxicity
  Chargari et al. [144] 2011 Phase I 31 Brain mets breast cancer 30 Gy (3 Gy) WBRT No grade > II
  Horton et al. [145] 2010 Phase II 12 Locally recurrent breast cancer 50 Gy, ChTx refractory 17% grade III skin toxicity, 8% grade III lymphopenia, no cardiac toxicity
Panitumumab Pinto et al. [35] 2011 Phase II 60 Rectal cancer 5-fluorouracil-oxaliplatin + RT Grade 3-4 toxicity: diarrhea (39%, one toxic death), cutaneous reactions (19%), nausea, neutropenia (2%), others.
  Wirth et al. [34] 2010 Phase I 19 LA-HNSCC 70 Gy + Carbo/Tax (2 Gy) IMRT 1 pt grade III febrile neutropenia, 84% grade III + IV mucositis, 95% grade III dysphagia, 42% grade III dermatitis, 11% grade III rash, 21% grade III nausea
Nimotuzumab (h-R3) Rodriguez et al. [38] 2010 Prospective randomized 106 HNSCC n. r. III/IV not reported
  Crombet et al. [146] 2004 Phase I 24 HNSCC 66 Gy (2 Gy) 4% grade III somnolence, 13% grade III dysphagia, 21% grade III mucositis, 13% grade III dermatitis, 4% grade III laryngitis
  Bebb et al. [39] 2011 Phase I 18 NSCLC 36/30 Gy (3 Gy) 50% grade III + IV
  Choi et al. [40] 2010 Phase I 15 NSCLC 36/30 Gy (3 Gy) 7% grade IV febrile neutropenia/pneumonia, 40% grade III lymphopenia
  1. N-number of patients, pt(s)-patient(s), n. r.-not reported, ChTx-chemotherapy, HCC-hepatocellular carcinoma, RCC-renal cell cancer, GBM-glioblastoma multiforme, DVT-deep vein thrombosis, Fx-fractions, SRS-stereotactic radiosurgery, DLT-dose limiting toxicity, LA-locally advanced, Gem-gemcitabine, Tax-Taxol (paclitaxel), Tx-therapy, TMZ-temozolomide, PCP-Pneumocystis pneumonia, Cis-cisplatin, Eto-etoposide, Doc-docetaxel