Early decline in cancer antigen 125 as a surrogate for progression-free survival in recurrent ovarian cancer
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Early decline in cancer antigen 125 as a surrogate for progression-free survival in recurrent ovarian cancer. / Lee, Chee K; Friedlander, Michael; Brown, Chris; Gebski, Val J; Georgoulopoulos, Alexander; Vergote, Ignace; Pignata, Sandro; Donadello, Nicoletta; Schmalfeldt, Barbara; Delva, Rémy; Mirza, Mansoor Raza; Sauthier, Philippe; Pujade-Lauraine, Eric; Lord, Sarah J; Simes, R John.
In: JNCI-J NATL CANCER I, Vol. 103, No. 17, 07.09.2011, p. 1338-42.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Early decline in cancer antigen 125 as a surrogate for progression-free survival in recurrent ovarian cancer
AU - Lee, Chee K
AU - Friedlander, Michael
AU - Brown, Chris
AU - Gebski, Val J
AU - Georgoulopoulos, Alexander
AU - Vergote, Ignace
AU - Pignata, Sandro
AU - Donadello, Nicoletta
AU - Schmalfeldt, Barbara
AU - Delva, Rémy
AU - Mirza, Mansoor Raza
AU - Sauthier, Philippe
AU - Pujade-Lauraine, Eric
AU - Lord, Sarah J
AU - Simes, R John
PY - 2011/9/7
Y1 - 2011/9/7
N2 - We used data from 886 patients from the CAELYX in Platinum Sensitive Ovarian Patients (CALYPSO) trial, recruited between April 2005 and September 2007, to examine the role of early decline in cancer antigen 125 (CA125) and early tumor response as prognostic factors and surrogates for superiority of treatment with carboplatin-pegylated liposomal doxorubicin (CPLD) compared with carboplatin-paclitaxel (CP) in a landmark analysis. Progression-free survival (PFS) was estimated by Kaplan-Meier analyses. We used univariate and multivariable Cox proportional hazards analyses to assess early decline and early response as surrogates for CPLD treatment benefit compared with CP. All statistical tests were two-sided. Early decline (defined as rate of CA125 decrease of at least 50% per month) was associated with improved PFS (adjusted hazard ratio [HR] for progression = 0.81, 95% confidence interval [CI] = 0.67 to 0.97, P = .02) but early response (complete or partial responses) was not. CPLD was associated with improved PFS compared with CP (HR = 0.82, 95% CI = 0.69 to 0.96, P = .01). However, fewer CPLD patients had an early decline (161 [37.4%] vs 233 [51.2%], P < .001) or an early response (146 [33.9%] vs 176 [38.7%], P = .14) compared with CP patients. The PFS for CPLD patients did not change statistically significantly after adjustment for early decline (adjusted HR = 0.80, 95% CI = 0.68 to 0.94, P = .007). These findings are opposite to what would be expected if these markers were good surrogates for treatment benefit.
AB - We used data from 886 patients from the CAELYX in Platinum Sensitive Ovarian Patients (CALYPSO) trial, recruited between April 2005 and September 2007, to examine the role of early decline in cancer antigen 125 (CA125) and early tumor response as prognostic factors and surrogates for superiority of treatment with carboplatin-pegylated liposomal doxorubicin (CPLD) compared with carboplatin-paclitaxel (CP) in a landmark analysis. Progression-free survival (PFS) was estimated by Kaplan-Meier analyses. We used univariate and multivariable Cox proportional hazards analyses to assess early decline and early response as surrogates for CPLD treatment benefit compared with CP. All statistical tests were two-sided. Early decline (defined as rate of CA125 decrease of at least 50% per month) was associated with improved PFS (adjusted hazard ratio [HR] for progression = 0.81, 95% confidence interval [CI] = 0.67 to 0.97, P = .02) but early response (complete or partial responses) was not. CPLD was associated with improved PFS compared with CP (HR = 0.82, 95% CI = 0.69 to 0.96, P = .01). However, fewer CPLD patients had an early decline (161 [37.4%] vs 233 [51.2%], P < .001) or an early response (146 [33.9%] vs 176 [38.7%], P = .14) compared with CP patients. The PFS for CPLD patients did not change statistically significantly after adjustment for early decline (adjusted HR = 0.80, 95% CI = 0.68 to 0.94, P = .007). These findings are opposite to what would be expected if these markers were good surrogates for treatment benefit.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - CA-125 Antigen
KW - Carboplatin
KW - Confidence Intervals
KW - Disease-Free Survival
KW - Doxorubicin
KW - Female
KW - Humans
KW - Kaplan-Meier Estimate
KW - Middle Aged
KW - Multivariate Analysis
KW - Odds Ratio
KW - Ovarian Neoplasms
KW - Paclitaxel
KW - Polyethylene Glycols
KW - Predictive Value of Tests
KW - Prognosis
KW - Proportional Hazards Models
KW - Recurrence
KW - Reproducibility of Results
KW - Time Factors
KW - Tumor Markers, Biological
U2 - 10.1093/jnci/djr282
DO - 10.1093/jnci/djr282
M3 - SCORING: Journal article
C2 - 21840849
VL - 103
SP - 1338
EP - 1342
JO - JNCI-J NATL CANCER I
JF - JNCI-J NATL CANCER I
SN - 0027-8874
IS - 17
ER -