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• W2148949897 abstract "Dear Sir, The Bernier [1.Bernier J. Russi E.G. Homey B. et al.Management of radiation dermatitis in patients receiving cetuximab and radiotherapy for locally advanced squamous cell carcinoma of the head and neck: proposals for a revised grading system and consensus management guidelines.Ann Oncol. 2011; 22: 2191-2200doi:10.1093/annonc/mdr139Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar] proposal regarding specifically the new radio-biodermatitis classification has so far been the only article to tackle this topic. Indeed, while an appropriate systemic EGFR-inhibitor toxic effect classification (skin-rash) has been proposed in literature [2.Lacouture M.E. Maitland M.L. Segaert S. et al.A proposed EGFR inhibitor dermatologic adverse event-specific grading scale from the MASCC skin toxicity study group..Support Care Cancer. 2010; 18: 509-522doi:10.1007/s00520-009-0744-xCrossref PubMed Scopus (117) Google Scholar] and accepted by the NCI ‘Cancer Therapy Evaluation Program’ (CTCAE v. 4) [3.Chen A.P. Setser A. Anadkat M.J. et al.Grading dermatologic adverse events of cancer treatments: the common terminology criteria for adverse events version 4.0.J Am Acad Dermatol. 2012; 67: 1025-1039doi:10.1016/j.jaad.2012.02.010Abstract Full Text Full Text PDF PubMed Scopus (216) Google Scholar], there is still no other grading which assesses the severity of Adverse Events (AEs) due to the association of bio-therapy and radiotherapy. To grade toxic effect severity, Bernier added radio-dermatitis lesions to main biotherapy-induced AEs (i.e. crusting, crusting haemorrhagic character and extension in the radiation field). Yet, his proposal did not take into account the impact of AEs on the patient's activities of daily living (ADL), and AE seriousness, including the level of treatment (i.e. invasiveness) and the hospitalization necessity as required by CTCAE v. 4. In order to adapt the Bernier grading to new CTCAE criteria, the undersigned authors of this letter have produced a modified version of it (See Figure 1) that is also intended to overcome some of the limitations of the original proposal. Indeed, the undersigned also added in each grade the unspecific term ‘or other signs/symptoms due to bio-treatment’ in order to include some new possible bio-drug AEs that in future could be used in combination with radiotherapy. This is in order not to limit the new grading only to EGFR inhibitors (EGFRi) as the original proposal considered only EGFRi-linked crusts. Two motivations are behind this proposal:i)The grading of radio-dermatitis is often not applicable to in-field dermatitis as it does not include the associated AEs of bio-treatment. On the other hand, the grading of the systemic bio-treatment effect, which includes the percentage of extension over the whole body skin, is not applicable when the reactions are confined to a limited skin surface such as in the irradiated field. Furthermore, CTCAE v.4 does not include a classification for the painful confluent areas of papulo-pustular rash or ulcerative and haemorrhagic lesions confined to the radiation field. These issues can explain the different bio-radiotherapy ‘in-field toxic effect’ rates reported in different studies. Indeed, severity has often been overestimated or underestimated [4.Bonner J.A. Harari P.M. Giralt J. 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: 21-28doi:10.1016/S1470-2045(09)70311-0Abstract Full Text Full Text PDF PubMed Scopus (1511) Google Scholar].ii)Standard radio-dermatitis grading, and consequently its treatment, does not work in bio-radiation dermatitis. Treatment indications that were positively tested in a pure radio-dermatitis setting were then highly recommended in different settings such as for bio-radio-dermatitis. This occurred without considering the possible interference with the bio-drug component of the double treatment, e.g. high-potency topical steroids were considered evidence level I2 even though this evidence was obtained from a non-EGFRI cancer treatment study [5.Miller R.C. Schwartz D.J. Sloan J.A. et al.Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the north central cancer treatment group N06C4.Int J Radiat Oncol. 2011; 79: 1460-1466doi:16/j.ijrobp.2010.01.031Abstract Full Text Full Text PDF PubMed Scopus (81) Google Scholar]. Consequently, a specific classification is certainly needed to fill the gap in this field in order to standardise treatment strategies (radiation or bio-drug interruption, hospitalization etc.) and make this topic comparable between different studies. In conclusion, the undersigned suggest that the proposed modified grading, the fruit of their own empirical experience, be validated in future trials in order to be included in revised CTCAE versions. The authors have declared no conflicts of interest." @default.
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• W2148949897 date "2013-09-01" @default.
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• W2148949897 title "Bio-radiation dermatitis: the need of a new grading: in regard to Bernier et al: Ann Oncol 2011; 22(10): 2191–2200" @default.
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