OBJECTIVES:
To
evaluate in a large phase III recurrent ovarian cancer trial (OVA-301):
1) the concordance between CA-125 level vs. best overall response (OR)
and progression-free survival (PFS) determined by radiological
assessment 2) the impact of early CA-125 changes over the subsequent
radiological response, and 3) the prognostic value of CA-125 response
and CA-125 PFS to predict radiological response and PFS.
METHODS:
Assessment
of response in the entire randomized population was performed by the
Response Evaluation Criteria in Solid Tumors 1.0 (RECIST) and modified
Rustin criteria for CA-125 determination.
RESULTS:
Most
CA-125 decreases were observed in RECIST responders (82% of patients
treated with the combination and 74% in the PLD alone). CA-125
progression preceded RECIST progression in 35% of patients with a median
lead time of 8.4weeks. A high concordance rate between CA-125 PFS
status at 4months (PFS4) and CA-125 response as a predictor of PFS4
(87%) and radiological response (79%) was found in the combination, with
high positive predictive value for radiological PFS4 (92%) and high
negative predictive value for OR (90%). An early CA-125 decrease was
predictive for the ultimate response since it was found in a high rate
of RECIST responders.
CONCLUSION:
Radiological response
was preceded by a favorable predictive CA-125 decrease in a high
proportion of patients, suggesting that CA-125 evaluation may be an
appropriate tool for tumor assessment in patients with ovarian cancer.
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