title: Monoclonal antibody-induced papulopustular rash: Clinical course, communication to health-care professionals and reactive measures as reported by patients.
abstract: OBJECTIVE
  The primary end-point was to describe the clinical course of monoclonal antibody-induced papulopustular rash (mAB-induced PPR), when patients alert health-care providers and the subsequent reactive measures employed. Exploring the predictors affecting PPR grading was the secondary end-point.
  
  
  METHODS
  A multicentre retrospective study involving six Italian oncology outpatient departments was conducted. Thirty-nine patients with cancer undergoing cetuximab or panitumumab treatment were included. Information was collected through medical records and face-to-face interviews. mAB-induced PPR was scored by patients' self-reported Common Terminology Criteria for Adverse Eventsv4.02 and was defined as severe when the grade ≥3.
  
  
  RESULTS
  Thirty-five (89.7%) patients developed a rash, which was severe in nine cases. The rash usually appeared within the first week after starting the drug (22, 62.8%), peaked in severity during the first month (26, 74.3%) and resolved 4-8 weeks after the end of mABs therapy (15, 45.7%). At the time of the interviews, the rash was not still resolved in almost half (n = 16) of the patients. Twenty-six (74.3%) patients reported sequelae and the mostly common were erythema (21, 81%) and dry skin (14, 54%). Only half of the patients informed health-care professionals as soon as the rash appeared. All the patients treated the rash topically and mAB therapy was modified in 16 (45.7%) cases (reduction, n = 10; discontinuation, n = 9; withdrawal, n = 2). No association between male gender, age, fair skin, current smokers during therapy and PPR grading escalation was found.
  
  
  CONCLUSIONS
  The clinical course of the rash was pathognomonic. Patients should be further encouraged to communicate the onset of a rash to health-care professionals as soon as it appears to avoid grading escalation and sequelae. The adoption of CTCAE as a patient-reported outcome may become an instrument to help health-care providers in tailoring treatment measures.
authors.affiliation: School of Nursing, Udine University, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Cignola
authors.affiliation: Department of Public Health and Community Medicine, University of Verona, Verona, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Gonella
authors.affiliation: Oncology Department, Teaching Hospital, Udine, Italy.
authors.forename: Bin
authors.initials: B
authors.lastname: Alessandra
authors.affiliation: Department of Medical and Biological Sciences, Udine University, Italy. Electronic address: alvisa.palese@uniud.it.
authors.forename: Alvisa
authors.initials: A
authors.lastname: Palese
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D000068818:Cetuximab / Q000009:adverse effects* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003875:Drug Eruptions / Q000209:etiology*; D005076:Exanthema / Q000139:chemically induced*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000068818:Cetuximab
keywords: Epidermal Growth Factor; Monoclonal antibodies; Nursing care; Patient education; Receptor; Skin diseases; Skin rash