CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial

Br J Cancer. 2012 Feb 14;106(4):633-7. doi: 10.1038/bjc.2011.593. Epub 2012 Jan 12.


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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • CA-125 Antigen / analysis*
  • Carboplatin / administration & dosage
  • Disease Progression
  • Disease-Free Survival
  • Doxorubicin / adverse effects
  • Doxorubicin / analogs & derivatives
  • Female
  • Humans
  • Ovarian Neoplasms / diagnostic imaging
  • Ovarian Neoplasms / drug therapy*
  • Paclitaxel / administration & dosage
  • Polyethylene Glycols / adverse effects
  • Recurrence
  • Tomography, X-Ray Computed


  • CA-125 Antigen
  • liposomal doxorubicin
  • Polyethylene Glycols
  • Doxorubicin
  • Carboplatin
  • Paclitaxel