title: Comparison of response evaluation criteria in solid tumours and Choi criteria for response evaluation in patients with advanced soft tissue sarcoma treated with trabectedin: a retrospective analysis.
abstract: BACKGROUND
  To assess the additional value of density measurement using contrast-enhancement sequences (Choi assessment) in a real-life cohort of adult soft tissue sarcoma patients treated with trabectedin.
  
  
  METHODS
  Eligibility criteria included adults (age ⩾18) treated between 01/2007 and 12/2011, with at least two trabectedin cycles after failure or intolerance to doxorubicin/ifosfamide. Baseline and first computed tomography (CT)-scans were centrally reviewed by an experienced radiologist.
  
  
  RESULTS
  The retrospective cohort consists of 134 (73 female) patients treated with trabectedin 1.5 mg/m(2) given as a 24-h infusion every 3 weeks. Patients received a median of five trabectedin cycles (range: 2-33) and the main cause of discontinuation was progressive disease (PD) (n = 105, 78.4%). Response Evaluation Criteria in Solid Tumours (RECIST) assessment was feasible in 128 (95.5%) patients, with Choi assessment performed in 92 (68.7%) patients, generally due to inadequate sequences or exclusive lung metastases. Concordance between both methods was fair (Kappa = 0.290). We identified five patients with false PD (i.e. PD according to RECIST but stable disease/partial response as per Choi). Univariate analysis did not identify any predictive factors for false PD. Median overall survival (OS) of patients with PD as per RECIST but stable disease/partial response (SD/PR) according to Choi was better than for patients with PD according to both RECIST and Choi (14 months versus 8 months; p = 0.052).
  
  
  CONCLUSIONS
  Choi assessment may identify patients with false PD who achieved improved efficacy outcomes, suggesting that trabectedin may delay tumour progression even in the case of non-dimensional response. Dual size and tumour density assessment may be more suitable to evaluate responses to trabectedin in sarcoma patients as well as to improve the decision-making strategies for the continuation of trabectedin therapy.
authors.affiliation: Radiology Department, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex, France. Electronic address: S-Taieb@o-lambret.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Taieb
authors.affiliation: Medical Oncology Department, Centre Antoine Lacassagne, 33 Avenue Valombrose, 06100 Nice, France. Electronic address: Esma.SAADA-BOUZID@nice.unicancer.fr.
authors.forename: Esma
authors.initials: E
authors.lastname: Saada-Bouzid
authors.affiliation: Biostatistics and Methodology Unit, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex , France. Electronic address: e.tresch@o-lambret.fr.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Tresch
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex, France. Electronic address: t-ryckewaert@o-lambret.fr.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ryckewaert
authors.affiliation: Medical Oncology Department, Institut de Cancérologie de l'Ouest, Boulevard Jacques Monod, 44805 Saint Herblain cedex, France. Electronic address: Emmanuelle.Bompas@ico.unicancer.fr.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bompas
authors.affiliation: Medical Oncology Department, Institut Bergonié, 229 Cours de l'Argonne, 33000 Bordeaux, France. Electronic address: italiano@bergonie.org.
authors.forename: Antoine
authors.initials: A
authors.lastname: Italiano
authors.affiliation: Medical Oncology Department, Centre Henri Becquerel, Rue d'Amiens, 76000 Rouen, France. Electronic address: cecile.guillemet@chb.unicancer.fr.
authors.forename: Cécile
authors.initials: C
authors.lastname: Guillemet
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex, France. Electronic address: c-peugniez@o-lambret.fr.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Peugniez
authors.affiliation: Medical Oncology Department, Institut Curie, 26 Rue d'Ulm, 75005 Paris, France. Electronic address: sophie.piperno-neumann@curie.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Piperno-Neumann
authors.affiliation: Medical Oncology Department, Centre Antoine Lacassagne, 33 Avenue Valombrose, 06100 Nice, France. Electronic address: antoine.thyss@nice.unicancer.fr.
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.affiliation: Orthopedics Unit A, University Hospital, Hôpital Roger Salengro, 59035 Lille cedex, France. Electronic address: Carlos.MAYNOU@CHRU-LILLE.FR.
authors.forename: Carlos
authors.initials: C
authors.lastname: Maynou
authors.affiliation: Clinical Research Unit, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex, France; Clinical Resarch and Methodological Platform, SIRIC OncoLille, Lille, France. Electronic address: s-clisant@o-lambret.fr.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Clisant
authors.affiliation: Medical Oncology Department, Centre Oscar Lambret, 3 rue Combemale, 59020 Lille cedex, France; Clinical Resarch and Methodological Platform, SIRIC OncoLille, Lille, France. Electronic address: n-penel@o-lambret.f.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000627:therapeutic use; D004149:Dioxoles / Q000008:administration & dosage / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted / Q000379:methods*; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000706:statistics & numerical data; D066066:Response Evaluation Criteria in Solid Tumors; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed / Q000379:methods; D000077606:Trabectedin; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
keywords: Response assessment; Sarcoma; Trabectedin