Differentiation of irradiation and cetuximab induced skin reactions in patients with locally advanced head and neck cancer undergoing radioimmunotherapy: The HICARE protocol (Head and neck cancer: ImmunoChemo and Radiotherapy with Erbitux) - a multicenter phase IV trial

BMC Cancer

Volumn 13, Issue , 2013, Pages

  Habl, G ^a   Potthoff, K ^a   Haefner, M F ^a   Abdollahi, A ^b   Hassel, J C ^a   Boller, E ^c   Indorf, M ^c   Debus, J ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^c iOMEDICO   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; MONOCLONAL ANTIBODY;

ARTICLE; CANCER RADIOTHERAPY; CANCER RESEARCH; CLINICAL PROTOCOL; DRUG ERUPTION; GERMANY; HEAD AND NECK CANCER; HUMAN; INTENSITY MODULATED RADIATION THERAPY; LOADING DRUG DOSE; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PHASE 4 CLINICAL TRIAL (TOPIC); PROSPECTIVE STUDY; QUALITY OF LIFE; RADIATION DERMATITIS; RADIOIMMUNOTHERAPY; SKIN MANIFESTATION; THREE DIMENSIONAL RADIATION THERAPY; TREATMENT RESPONSE; CARCINOMA, SQUAMOUS CELL; CHEMORADIOTHERAPY; CLINICAL TRIAL; HEAD AND NECK NEOPLASMS; METHODOLOGY; MULTICENTER STUDY; PATHOLOGY; PHASE 4 CLINICAL TRIAL; RADIOTHERAPY; SKIN DISEASES;

ANTIBODIES, MONOCLONAL, HUMANIZED; CARCINOMA, SQUAMOUS CELL; CHEMORADIOTHERAPY; HEAD AND NECK NEOPLASMS; HUMANS; RADIODERMATITIS; RADIOTHERAPY; RESEARCH DESIGN; SKIN DISEASES;

EID: 84880092970     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-345     Document Type: Article

References (48)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics. CA Cancer J Clin 2007, 57:43-66. 10.3322/canjclin.57.1.43, 17237035.
2. Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer. N Engl J Med 2010, 363(1):24-35. 10.1056/NEJMoa0912217, 2943767, 20530316.
3. Folprecht G, Lutz MP, Schoffski P, Seufferlein T, Nolting A. Pollert PCetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma. Ann Oncol 2006, 17(3):450-456. 10.1093/annonc/mdj084, 16303861.
4. Salomon DS, Brandt R, Ciardiello F. Normanno NEpidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995, 19(3):183-232. 10.1016/1040-8428(94)00144-I, 7612182.
5. Wilke H, Glynne-Jones R, Thaler JMABEL. A large multinational study of cetuximab plus irinotecan in irinotecan resistant metastatic colorectal cancer. J Clin Oncol 2006, 24(18S):3549.
6. Ang KK, Berkey BA, Tu X, Zhang HZ, Katz R, Hammond EH, Fu KK, Milas L. Impact of epidermal growth factor receptor expression on survival and pattern of relapse in patients with advanced head and neck carcinoma. Cancer Res 2002, 62:7350-7356.
7. Licitra E, Felip E. On behalf of the ESMO Guidelines Working Group Squamous cell carcinoma of the head and neck: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009, 20(4):121. 10.1093/annonc/mdp149, 19454430, On behalf of the ESMO Guidelines Working Group.
8. Grégoire V, Lefebvre JL, Licitra L, Felip E. On behalf of the EHNS-ESMO-ESTRO Guidelines Working Group Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21(5):184-186. 10.1093/annonc/mdq185, 19889617, On behalf of the EHNS-ESMO-ESTRO Guidelines Working Group.
9. Bernier J, Schneider D. Cetuximab combined with radiotherapy: an alternative to chemoradiotherapy for patients with locally advanced squamous cell carcinomas of the head and neck?. Eur J Cancer 2007, 43:35-45. 10.1016/j.ejca.2006.08.035, 17098420.
10. Rowan K. Should Cetuximab replace cisplatin in head and neck cancer?. J Natl Cancer Inst 2010, 102:74-75. 10.1093/jnci/djp531, 20054019.
11. Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol 2010, 11:21-28. 10.1016/S1470-2045(09)70311-0, 19897418.
12. 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, Youssoutian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006, 354:567-578. 10.1056/NEJMoa053422, 16467544.
13. Baselga J. The EGFR as a target for anticancer therapy--focus on cetuximab. Eur J Cancer 2001, 37(4):16-22.
14. Fan Z, Baselga J, Masui H. Mendelsohn JAntitumor effect of anti-epidermal growth factor receptor monoclonal antibodies plus cis-diamminedichloroplatinum on well established A431 cell xenografts. Cancer Res 1993, 53(19):4637-4642.
15. Milas L, Mason K, Hunter N, Petersen S, Yamakawa M. Ang KIn vivo enhancement of tumor radioresponse by C225 antiepidermal growth factor receptor antibody. Clin Cancer Res 2000, 6(2):701-708.
16. Caudell JJ, Sawrie SM, Spencer SA, Desmoid RA, Carroll WR, Peters GE, et al. Locoregionally advanced head and neck cancer treated with primary radiotherapy: a comparison of the addition of cetuximab or chemotherapy and the impact of protocol treatment. Int J Radiat Oncol Biol Phys 2008, 71:676-681. 10.1016/j.ijrobp.2007.10.040, 18355979.
17. Li T, Perez-Soler R. Skin toxicities associated with epidermal growth factor receptor inhibitors. Target Oncol 2009, 4:107-109. 10.1007/s11523-009-0114-0, 19452131.
18. Segaert S, Van Cutsem E. Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Ann Oncol 2005, 16:1425-1433. 10.1093/annonc/mdi279, 16012181.
19. Segaert S. Management of skin toxicity of epidermal growth factor receptor inhibitors. Target Oncol 2008, 3:245-251.
20. Perez-Soler R. Skin toxicities associated with epidermal growth factor receptor inhibitors. Target Oncol 2009, 4:107-109. 10.1007/s11523-009-0114-0, 19452131.
21. Potthoff K, Hofheinz R, Hassel JC, Volkenandt M, Lordick F, Hartmann JT, Karthaus M, Riess H, Lipp HP, Hauschild A, Trarbach T, Wollenberg A. Interdisciplinary management of EGFR-inhibitor-induced skin reactions: a German expert opinion. Ann Oncol 2011, 22(3):524-535. 10.1093/annonc/mdq387, 20709812.
22. Garcia-Huttenlocher HI, Timke C, Dinkel J, Huber PE, Debus J, Muenter MW. Acute Toxicity of Skin and Mucosa in Patients with Head and Neck Cancer Receiving Radiotherapy Alone or in Combination with Chemotherapy or Cetuximab. Proceedings of the 5th Annual ASTRO Meeting. Budach W, Bölke E, Homey B.
23. Budach W, Bölke E, Homey B. Severe cutaneous reaction during radiation therapy with concurrent cetuximab. N Engl J Med 2007, 357:514-515. 10.1056/NEJMc071075, 17671265.
24. Mitchell EP, Perez-Soler R, Van Cutsem E, Lacouture ME. Clinical presentation and pathophysiology of EGFRI dermatologic toxicities. Oncology (Williston Park) 2007, 11(5):4-9.
25. Saltz LB, Meropol NJ, Loehrer PJ, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J ClinOncol 2004, 1(7):1201-8. Apr 1.
26. Peeters M, Siena S, Van Cutsem E, et al. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer 2009, 115:1544-1554. 10.1002/cncr.24088, 19189371.
27. Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 2007, 25:2171-2177. 10.1200/JCO.2006.06.7447, 17538161.
28. Bonner JA, Ang K. More on severe cutaneous reaction with radiotherapy and cetuximab. N Engl J Med 2007, 357:1872. 3. Author reply 1873.
29. Giro C, Berger B, Bölke E, Ciernuk IF, Duprez F, Locati L, Maillard S, Ozsahin M, Pfeffer R, Robertson G, Langendijk JA. Budach WHigh rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: Results of a survey in EORTC institutes. Radiother Oncol 2009, 90:166-171. 10.1016/j.radonc.2008.09.007, 18977050.
30. Erbitux Summary of product characteristics 2012, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/000558/WC500029119.pdf, Erbitux.
31. Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol 2008, 26:3128-3137. 10.1200/JCO.2007.12.7662, 2744895, 18474878.
32. Lassen P, Eriksen JG, Hamilton-Dutoit S, Tramm T, Alsner J, Overgaard J. Effect of HPV-associated p16INK4A expression on response to radiotherapy and survival in squamous cell carcinoma of the head and neck. J Clin Oncol 2009, 27:1992-1998. 10.1200/JCO.2008.20.2853, 19289615.
33. Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 2010, 363:45-35. 10.1056/NEJMsa0910881, 2924574, 20463332.
34. Common Terminology Criteria for Adverse Events v4.02 (CTCAE) 2012, http://evs.nci.nih.gov/ftp1/CTCAE/Archive/CTCAE_4.02_2009-09-15_QuickReference_5x7_Locked.pdf.
35. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 2012, http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
36. Eisenhauer EA, Therasse P, Bogaerts J, Schwartzd LH, Sargente D, Fordf R, Danceyg J, Arbuckh S, Gwytheri S, Mooneyg M, Rubinsteing L, Shankarg L, Doddg L, Kaplanj R, Lacombec D, Verweij J. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247. 10.1016/j.ejca.2008.10.026, 19097774.
37. NCCN guidelines for physicians 2012, http://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf.
38. Marur S, et al. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol 2010, 11:781-789. 10.1016/S1470-2045(10)70017-6, 20451455.
39. Erber R, Conradt C, Homann N, Enders C, Finckh M, Dietz A, Weidauer H, Bosch FX. TP53 DNA contact mutations are selectively associated with allelic loss and have a strong clinical impact in head and neck cancer. Oncogene 1998, 16(13):1671-1679. 10.1038/sj.onc.1201690, 9582015.
40. Cabelguenne A, Blons H, De Waziers I, Carnot F, Houllier AM, Soussi T, Brasnu D, Beaune P, Laccourreye O, Laurent-Puig P. p53 alterations predict tumor response to neoadjuvant chemotherapy in head and neck squamous cell carcinoma: a prospective series. J Clin Oncol 2000, 18(7):1465-1473.
41. Temam S, Flahault A, Perie S, Monceaux G, Coulet F, Callard P, Bernaudin JF, St Guily JL, Fouret P. p53 gene status as a predictor of tumor response to induction chemotherapy of patients with locoregionally advanced squamous cell carcinomas of the head and neck. J Clin Oncol 2000, 18(2):385-394.
42. Poeta ML, Manola J, Goldwasser MA, Forastiere A, Benoit N, Califano JA, Ridge JA, Goodwin J, Kenady D, Saunders J, Westra W, Sidransky D, Koch WM. TP53 mutations and survival in squamous-cell carcinoma of the head and neck. N Engl J Med 2007, 357(25):2552-2561. 10.1056/NEJMoa073770, 2263014, 18094376.
43. Forastiere A, Koch W, Trotti A, et al. Head and neck cancer. N Engl J Med 2001, 345(26):1890-1900. 10.1056/NEJMra001375, 11756581.
44. Saltz L, Kies M, Abbruzeese JL, et al. Presence and intensity of the cetuximab-induced acne-rash predicts increased survival in studies across multiple malignancies. Proc Am Soc Clin Oncol 2003, 22:204.
45. Wong SF, Lloyd K, Vasko C, et al. A pilot cross-over study to evaluate the use of Regenecare topical gel in patients with cutaneous toxicity caused by epidermal growth factor receptor (HER1/EGFR) inhibitors. Oncol Nurs Forum 2007, 34:216-217.
46. Wacker B, Nagrani T, Weinberg J, et al. Correlation between development of rash and efficacy in patients treated with the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in two large phase III studies. Clin Cancer Res 2007, 13:391.
47. Perez-Soler R, Saltz L. Cutaneous adverse effects with HER1/EGFR-targeted agents: is there a silver lining?. J Clin Oncol 2005, 23:5235-5246. 10.1200/JCO.2005.00.6916, 16051966.
48. Racca P, Fanchini L, Caliendo V, Ritorto G, Evangelista W, Volpatto R, Milanesi E, Ciorba A, Paris M, Facilissimo I, Macripò G, Clerico M, Ciuffreda L. Efficacy and skin toxicity management with cetuximab in metastaticcolorectal cancer: outcomes from an oncologic/dermatologic cooperation. Clin Colorectal Cancer 2008, 7(1):48-54. Jan, 10.3816/CCC.2008.n.007, 18279577.