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

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

J Alexandre  1 , C Brown, D Coeffic, N Raban, J Pfisterer, J Mäenpää, H Chalchal, B Fitzharris, B Volgger, I Vergote, C Pisano, A Ferrero, E Pujade-Lauraine
Affiliations
Clinical Trial

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

J Alexandre et al. Br J Cancer. .

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.

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.

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Figures

Figure 1
Figure 1
Cumulative incidence of type of progression.
Figure 2
Figure 2
Differences between C-PLD and C-P arms according to type of first progression. *Indicates time to radiological progression post-CA-125 elevation including time to RECIST failure for those patients without prior CA-125 elevation. Abbreviations: C-P=carboplatin–paclitaxel; C-PLD=carboplatin-pegylated liposomal doxorubicin; RECIST=response evaluation criteria in solid tumours.
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References

    1. Bast RC, Thigpen JT, Arbuck SG, Basen-Engquist K, Burke LB, Freedman R, Horning SJ, Ozols R, Rustin GJ, Spriggs D, Wenzel LB, Pazdur R (2007) Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop. Gynecol Oncol 107: 173–176 - PubMed
    1. Burger RA, Brady MF, Bookman MA, Walker JL, Homesley HD, Fowler J, Monk BJ, Greer BE, Boente M, Liang SX (2010) Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): a Gynecologic Oncology Group study. J Clin Oncol 28(Suppl): 18s (abstr. LBA1)
    1. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45: 228–247 - PubMed
    1. Goonewardene TI, Hall MR, Rustin GJS (2007) Management of asymptomatic patients on follow-up for ovarian cancer with rising CA-125 concentrations. Lancet Oncol 8: 813–821 - PubMed
    1. Hennessy BT, Coleman RL, Markman M (2009) Ovarian cancer. Lancet 374: 1371–1382 - PubMed

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