title: CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial.
abstract: BACKGROUND
  CA-125 as a tumour progression criterion in relapsing ovarian cancer (ROC) trials remains controversial. CALYPSO is a large randomised trial incorporating CA-125 (GCIG criteria) and symptomatic deterioration in addition to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (radiological) to determine progression.
  
  
  METHODS
  In all, 976 patients with platinum-sensitive ROC were randomised to carboplatin-paclitaxel (C-P) or carboplatin-pegylated liposomal doxorubicin (C-PLD). CT-scan and CA-125 were performed every 3 months until progression.
  
  
  RESULTS
  In all, 832 patients (85%) progressed, with 60% experiencing a first radiological progression, 10% symptomatic progression, and 28% CA-125 progression without evidence of radiological or symptomatic progression. The benefit of C-PLD vs C-P in progression-free survival was not influenced by type of first progression (hazard ratio 0.85 (95% confidence interval (CI): 0.66-1.10) and 0.84 (95% CI: 0.72-0.98) for CA-125 and RECIST, respectively). In patients with CA-125 first progression who subsequently progressed radiologically, a delay of 2.3 months was observed between the two progression types. After CA-125 first progression, median time to new treatment was 2.0 months. In all, 81%of the patients with CA-125 or radiological first progression and 60% with symptomatic first progression received subsequent treatment.
  
  
  CONCLUSIONS
  CA-125 and radiological tests performed similarly in determining progression with C-PLD or C-P. Additional follow-up with CA-125 measurements was not associated with overtreatment.
authors.affiliation: Département d'Oncologie Médicale, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, Paris, France. jerome.alexandre@htd.aphp.fr
authors.forename: J
authors.initials: J
authors.lastname: Alexandre
authors.forename: C
authors.initials: C
authors.lastname: Brown
authors.forename: D
authors.initials: D
authors.lastname: Coeffic
authors.forename: N
authors.initials: N
authors.lastname: Raban
authors.forename: J
authors.initials: J
authors.lastname: Pfisterer
authors.forename: J
authors.initials: J
authors.lastname: Mäenpää
authors.forename: H
authors.initials: H
authors.lastname: Chalchal
authors.forename: B
authors.initials: B
authors.lastname: Fitzharris
authors.forename: B
authors.initials: B
authors.lastname: Volgger
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.forename: C
authors.initials: C
authors.lastname: Pisano
authors.forename: A
authors.initials: A
authors.lastname: Ferrero
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000032:analysis*; D016190:Carboplatin / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000009:adverse effects; D012008:Recurrence; D014057:Tomography, X-Ray Computed
chemical_list: D018394:CA-125 Antigen; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel