title: Cetuximab rechallenge in metastatic colorectal cancer patients: how to come away from acquired resistance?
abstract: BACKGROUND
  Scientific data provide the evidence that secondary K-RAS mutations do not occur during anti-epidermal growth factor receptor therapy in colorectal cancer patients. This multicenter phase II prospective study aims to investigate the activity of a retreatment with a cetuximab-based therapy.
  
  
  METHODS
  We enrolled 39 irinotecan-refractory patients who had a clinical benefit after a line of cetuximab- plus irinotecan-based therapy and then a progression of disease for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same cetuximab- plus irinotecan-based therapy.
  
  
  RESULTS
  Median number of therapeutic lines before accrual was 4. Median interval time between last cycle of first cetuximab-based therapy and first cycle of the retreatment was 6 months. Overall response rate was 53.8% with 19 partial responses (48.7%) and 2 complete responses (5.1%). Disease stabilization was obtained in 35.9% of patients and progression in four patients (10.2%). Median progression-free survival was 6.6 months. The correlation between skin toxicity during first cetuximab therapy and during cetuximab rechallenge was significant (P = 0.01).
  
  
  CONCLUSIONS
  Rechallenge with the same cetuximab-based therapy may achieve a new important clinical benefit further delaying the progression of disease and improving the therapeutic options.
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: D
authors.initials: D
authors.lastname: Santini
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: B
authors.initials: B
authors.lastname: Vincenzi
authors.affiliation: Department of Oncology, S Giovanni di Dio Hospital, Frattaminore, Naples.
authors.forename: R
authors.initials: R
authors.lastname: Addeo
authors.affiliation: Department of Medical Oncology, Regina Elena Cancer Institute, Rome.
authors.forename: C
authors.initials: C
authors.lastname: Garufi
authors.affiliation: Medical Oncology Unit-Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa.
authors.forename: G
authors.initials: G
authors.lastname: Masi
authors.affiliation: Department of Medical Oncology, AO Ospedali Riuniti-Università Politecnica delle Marche, Ancona.
authors.forename: M
authors.initials: M
authors.lastname: Scartozzi
authors.affiliation: Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Mancuso
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: A M
authors.initials: AM
authors.lastname: Frezza
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: O
authors.initials: O
authors.lastname: Venditti
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: M
authors.initials: M
authors.lastname: Imperatori
authors.affiliation: Department of Medical Oncology, Erasmus University Medical Center - Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Schiavon
authors.affiliation: Department of Surgical and Oncological Sciences, University of Palermo, Palermo, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Bronte
authors.affiliation: Department of Oncology, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo (Foggia), Italy.
authors.forename: G
authors.initials: G
authors.lastname: Cicero
authors.affiliation: Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Recine
authors.affiliation: Department of Oncology, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo (Foggia), Italy.
authors.forename: E
authors.initials: E
authors.lastname: Maiello
authors.affiliation: Department of Medical Oncology, AO Ospedali Riuniti-Università Politecnica delle Marche, Ancona.
authors.forename: S
authors.initials: S
authors.lastname: Cascinu
authors.affiliation: Department of Surgical and Oncological Sciences, University of Palermo, Palermo, Italy. Electronic address: antonio.russo@usa.net.
authors.forename: A
authors.initials: A
authors.lastname: Russo
authors.affiliation: Medical Oncology Unit-Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa.
authors.forename: A
authors.initials: A
authors.lastname: Falcone
authors.affiliation: Department of Medical Oncology, Università Campus Bio-Medico, Rome.
authors.forename: G
authors.initials: G
authors.lastname: Tonini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin