title: Dermatux: phase IV trial of Cetuximab plus FOLFIRI in first-line metastatic colorectal cancer receiving a pre-defined skin care.
abstract: OBJECTIVE
  Cetuximab-induced skin rash Gd3+ occurs in ≥16% patients (pts) (Heinemann et al., Lancet Oncol 15(10):1065-1075, 2014; Van Cutsem et al. J Clin Oncol 27(19):3117-25; 2009b). Survival, response, and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline.
  
  
  METHODS
  This is a national, multicenter, phase 4, first-line mCRC (K-RAS wt) trial. Pts received irinotecan 180 mg/m² (d1), FA 400 mg/m² (d1), 5-FU 400 mg/m² (d1), 5-FU 2400 mg/m² (d1-2), and cetuximab [400 mg/m² (d1), and then 250 mg/m² qw], prophylactic 0.1% vitamin K1 ointment qd, and oral doxycycline 100 mg bid.
  
  
  OBJECTIVE
  1-year PFS rate; secondary objectives: skin side-effects (grade, onset), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) time, and overall survival (OS) time and safety.
  
  
  RESULTS
  Twenty centers recruited 55 patients. Recruitment started Q1 2011 and ended Q3 2013 due to slow accrual. Characteristics were in line with CRYSTAL trial except for age and colonic location. 1-year PFS rate was 25.9%, mOS 21.8 months (m), and mPFS 8.5 m. ORR was 63.0%, DCR 77.8%. Rash Gd2+ occurred in 42.6% [median onset was 4.0 weeks (w)]; paronychia Gd2+ occurred in 22.2% (median onset 15.4w.); skin fissures Gd2+ occurred in 31.5% (median onset 19.9 weeks) 7% pts abandoned cetuximab treatment due to toxicity.
  
  
  CONCLUSIONS
  Our data reveal encouraging improvements in skin reactions and their time to occurrence due to a pre-defined skin care.
authors.affiliation: Medizinische Klinik II, Klinikum Darmstadt GmbH, Grafenstraße 9, 64283, Darmstadt, Germany. Carl.Schimanski@mail.klinikum-darmstadt.de.|iOMEDICO Clinical Research, Hanferstr. 28, 79108, Freiburg, Germany. Carl.Schimanski@mail.klinikum-darmstadt.de.
authors.forename: Carl Christoph
authors.initials: CC
authors.lastname: Schimanski
authors.affiliation: Medizinische Klinik II, Klinikum Darmstadt GmbH, Grafenstraße 9, 64283, Darmstadt, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Staib
authors.affiliation: Onkologische Gemeinschaftspraxis Dörfel/Göhler, Leipziger Str. 118, 01127, Dresden, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Göhler
authors.affiliation: Klinikum Schwäbisch Gmünd/Stauferklinik, Wetzgauer Straße 85, 73557, Mutlangen, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Hebart
authors.affiliation: Klinikum Dortmund GmbH, Hohe Straße 31, 44137, Dortmund, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Heike
authors.affiliation: Onkologische Gemeinschaftspraxis Dr. M. Neise & Dr. A. Lollert, Marktstraße 186, 47798, Krefeld, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Neise
authors.affiliation: Theresienkrankenhaus, Bassermannstraße 1, 68165, Mannheim, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Rudi
authors.affiliation: Diakoniekrankenhaus Schwäbisch Hall, Diakoniestraße 10, 74523, Schwäbisch Hall, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Geer
authors.affiliation: Onkologische Schwerpunktpraxis Darmstadt, Eschollbrücker Str. 26, 64295, Darmstadt, Germany.
authors.forename: Gerrit
authors.initials: G
authors.lastname: Dingeldein
authors.affiliation: Kliniken der Stadt Köln GmbH, 51058, Köln, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Lang
authors.affiliation: Praxis für Hämatologie und Onkologie Dr. Ehscheidt, Willi-Brückner-Str. 1, 56564, Neuwied, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Ehscheidt
authors.affiliation: Internistische Schwerpunktpraxis Hämatologie/Onkologie, Wallstraße 3-5, 55122, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Flohr
authors.affiliation: Gemeinschaftspraxis Hämatologie/Onkologie a. d. Dt. Klinik für Diagnostik GmbH, Aukammallee 33, 65191, Wiesbaden, Germany.
authors.forename: Klaus Maria
authors.initials: KM
authors.lastname: Josten
authors.affiliation: Städtisches Klinikum München GmbH Klinikum Neuperlach, Oskar-Maria-Graf-Ring 51, 81737, München, Germany.
authors.forename: Meinolf
authors.initials: M
authors.lastname: Karthaus
authors.affiliation: MVZ Ärzteforum Seestraße, Seestraße 64, 13347, Berlin, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.affiliation: Onkologische Schwerpunktpraxis, Speersort 8 3OG, 20095, Hamburg, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Wierecky
authors.affiliation: iOMEDICO Clinical Research, Hanferstr. 28, 79108, Freiburg, Germany.
authors.forename: Emil
authors.initials: E
authors.lastname: Boller
authors.affiliation: iOMEDICO Clinical Research, Hanferstr. 28, 79108, Freiburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Indorf
authors.affiliation: 1. Med. Klinik, Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
authors.forename: Marcus-Alexander
authors.initials: MA
authors.lastname: Wörns
authors.affiliation: 1. Med. Klinik, Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Galle
authors.affiliation: 1. Med. Klinik, Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Moehler
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068818:Cetuximab / Q000008:administration & dosage* / Q000009:adverse effects*; D018890:Chemoprevention / Q000379:methods; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004318:Doxycycline / Q000008:administration & dosage; D003875:Drug Eruptions / Q000517:prevention & control*; D005076:Exanthema / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D009824:Ointments; D017592:Skin Care / Q000379:methods*; D016896:Treatment Outcome; D010837:Vitamin K 1 / Q000008:administration & dosage
chemical_list: D009824:Ointments; D010837:Vitamin K 1; D004318:Doxycycline; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: Cetuximab; Doxycycline; Metastatic colorectal cancer; Phase IV trial; Pre-defined skin care; Rash; Vitamin K1 ointment