title: Chemotherapy outcome predictive effectiveness by the Oncogramme: pilot trial on stage-IV colorectal cancer.
abstract: BACKGROUND
  Colorectal cancer (CRC) remains a major public concern. While conventional chemotherapeutic regimens have proved useful against advanced/metastatic diseases, progresses are to be made to effectively cure the large portion of patients not benefiting from these treatments. One direction to improve response rates is to develop chemosensitivity and resistance assays (CSRAs) efficiently assisting clinicians in treatment selection process, an already long preoccupation of oncologists and researchers. Several methods have been described to this day, none achieving yet sufficient reliability for recommended use in the clinical routine.
  
  
  METHODS
  We led a pilot study on 19 metastatic CRC patients evaluating capacity of the Oncogramme, a standardized process using tumor ex vivo models, to provide chemosensitivity profiles and predict clinical outcome of patients receiving standard CRC chemotherapeutics. Oncogramme responses were categorized according to the method of percentiles to assess sensitivity, specificity and concordance.
  
  
  RESULTS
  We report from a primary analysis a success rate of 97.4 %, a very good sensitivity (84.6 %), a below-average specificity (33.3 %), along with a global agreement of 63.6 % and a concordance between Oncogramme results and patients' responses (Kappa coefficient) of 0.193. A supplementary analysis, focusing on CRC patients with no treatment switch over a longer time course, demonstrated improvement in specificity and concordance.
  
  
  CONCLUSIONS
  Results establish feasibility and usefulness of the Oncogramme, prelude to a larger-scale trial. Advantages and drawbacks of the procedure are discussed, as well as the place of CSRAs within the future arsenal of methods available to clinicians to individualize treatments and improve patient prognosis.
  
  
  BACKGROUND
  ClinicalTrials.gov database, registration number: NCT02305368.
authors.affiliation: Oncomedics SAS, ESTER technopole, 1 avenue d'Ester, 87069, Limoges, France. c.du-puch@oncomedics.com.
authors.forename: Christophe
authors.initials: C
authors.lastname: Bounaix Morand du Puch
authors.affiliation: Centre d'Investigation Clinique, INSERM 1435, Centre hospitalier régional universitaire de Limoges Dupuytren, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. michelle.nouaille@chu-limoges.fr.
authors.forename: Michelle
authors.initials: M
authors.lastname: Nouaille
authors.affiliation: Oncomedics SAS, ESTER technopole, 1 avenue d'Ester, 87069, Limoges, France. s.giraud@oncomedics.com.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Giraud
authors.affiliation: Centre d'Épidémiologie, de Biostatistique et de Méthodologie de la Recherche, Centre hospitalier régional universitaire de Limoges Dupuytren, 2 rue du Dr Marcland, 87025, Limoges Cedex, France. anais.labrunie@unilim.fr.
authors.forename: Anaïs
authors.initials: A
authors.lastname: Labrunie
authors.affiliation: Centre d'Épidémiologie, de Biostatistique et de Méthodologie de la Recherche, Centre hospitalier régional universitaire de Limoges Dupuytren, 2 rue du Dr Marcland, 87025, Limoges Cedex, France. sandrine.luce@unilim.fr.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Luce
authors.affiliation: Centre d'Épidémiologie, de Biostatistique et de Méthodologie de la Recherche, Centre hospitalier régional universitaire de Limoges Dupuytren, 2 rue du Dr Marcland, 87025, Limoges Cedex, France. pierre-marie.preux@unilim.fr.
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Preux
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'anatomopathologie, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. francois.labrousse@chu-limoges.fr.
authors.forename: François
authors.initials: F
authors.lastname: Labrousse
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service de chirurgie digestive, 2 rue du Dr Marcland, 87025, Limoges, France. alain.gainant@chu-limoges.fr.
authors.forename: Alain
authors.initials: A
authors.lastname: Gainant
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'oncologie médicale, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. nicole.tubiana-mathieu@chu-limoges.fr.
authors.forename: Nicole
authors.initials: N
authors.lastname: Tubiana-Mathieu
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'oncologie médicale, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. valerie.lebrun@chu-limoges.fr.
authors.forename: Valérie
authors.initials: V
authors.lastname: Le Brun-Ly
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service de chirurgie viscérale, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. denis.valleix@chu-limoges.fr.
authors.forename: Denis
authors.initials: D
authors.lastname: Valleix
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'anatomopathologie, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. dr.guillaudeau@gmail.com.
authors.forename: Angélique
authors.initials: A
authors.lastname: Guillaudeau
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'anatomopathologie, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. laura.mesturoux@chu-limoges.fr.
authors.forename: Laura
authors.initials: L
authors.lastname: Mesturoux
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service d'anatomopathologie, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. bema_coulibaly@yahoo.fr.
authors.forename: Béma
authors.initials: B
authors.lastname: Coulibaly
authors.affiliation: Oncomedics SAS, ESTER technopole, 1 avenue d'Ester, 87069, Limoges, France. c.lautrette@oncomedics.com.
authors.forename: Christophe
authors.initials: C
authors.lastname: Lautrette
authors.affiliation: Centre hospitalier régional universitaire de Limoges Dupuytren, service de chirurgie digestive générale et endocrinienne, 2 avenue Martin Luther King, 87042, Limoges Cedex, France. muriel.mathonnet@unilim.fr.|Université de Limoges, Institut 145 GEIST, EA 3842 "Homéostasie cellulaire et pathologies", Facultés de médecine et de pharmacie, 2 rue du Dr Marcland, 87025, Limoges Cedex, France. muriel.mathonnet@unilim.fr.
authors.forename: Muriel
authors.initials: M
authors.lastname: Mathonnet
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents