TY - JOUR
T1 - Discordance between GCIG CA-125 progression and RECIST progression in the CALYPSO trial of patients with platinum-sensitive recurrent ovarian cancer
AU - Zebic, Danka Sinikovic
AU - Tjokrowidjaja, Angelina
AU - Francis, Katherine Elizabeth
AU - Friedlander, Michael
AU - Gebski, Val
AU - Lortholary, Alain
AU - Joly, Florence
AU - Hasenburg, Annette
AU - Mirza, Mansoor
AU - Denison, Ursula
AU - Cecere, Sabrina Chiara
AU - Ferrero, Annamaria
AU - Pujade-Lauraine, Eric
AU - Lee, Chee Khoon
N1 - © 2023. Crown.
PY - 2024/2
Y1 - 2024/2
N2 - BACKGROUND: CA-125 alone is widely used to diagnose progressive disease (PD) in platinum-sensitive recurrent ovarian cancer (PSROC) on chemotherapy. However, there are increasing concerns regarding its accuracy. We assessed concordance between progression defined by CA-125 and RECIST using data from the CALYPSO trial.METHODS: We computed concordance rates for PD by CA-125 and RECIST to determine the positive (PPV) and negative predictive values (NPV).RESULTS: Of 769 (79%) evaluable participants, 387 had CA-125 PD, where only 276 had concordant RECIST PD (PPV 71%, 95% CI 67-76%). For 382 without CA-125 PD, 255 had RECIST PD but 127 did not (NPV 33%, 95% CI 29-38). There were significant differences in NPV according to baseline CA-125 (≤100 vs >100: 42% vs 25%, P < 0.001); non-measurable vs measurable disease (51% vs 26%, P < 0.001); and platinum-free-interval (>12 vs 6-12 months: 41% vs 14%, P < 0.001). We observed falling CA-125 levels in 78% of patients with RECIST PD and CA-125 non-PD.CONCLUSION: Approximately 2 in 3 women with PSROC have RECIST PD but not CA-125 PD by GCIG criteria. Monitoring CA-125 levels alone is not reliable for detecting PD. Further research is required to investigate the survival impact of local therapy in radiological detected early asymptomatic PD.
AB - BACKGROUND: CA-125 alone is widely used to diagnose progressive disease (PD) in platinum-sensitive recurrent ovarian cancer (PSROC) on chemotherapy. However, there are increasing concerns regarding its accuracy. We assessed concordance between progression defined by CA-125 and RECIST using data from the CALYPSO trial.METHODS: We computed concordance rates for PD by CA-125 and RECIST to determine the positive (PPV) and negative predictive values (NPV).RESULTS: Of 769 (79%) evaluable participants, 387 had CA-125 PD, where only 276 had concordant RECIST PD (PPV 71%, 95% CI 67-76%). For 382 without CA-125 PD, 255 had RECIST PD but 127 did not (NPV 33%, 95% CI 29-38). There were significant differences in NPV according to baseline CA-125 (≤100 vs >100: 42% vs 25%, P < 0.001); non-measurable vs measurable disease (51% vs 26%, P < 0.001); and platinum-free-interval (>12 vs 6-12 months: 41% vs 14%, P < 0.001). We observed falling CA-125 levels in 78% of patients with RECIST PD and CA-125 non-PD.CONCLUSION: Approximately 2 in 3 women with PSROC have RECIST PD but not CA-125 PD by GCIG criteria. Monitoring CA-125 levels alone is not reliable for detecting PD. Further research is required to investigate the survival impact of local therapy in radiological detected early asymptomatic PD.
KW - Carcinoma, Ovarian Epithelial
KW - Female
KW - Humans
KW - Neonicotinoids
KW - Neoplasm Recurrence, Local/drug therapy
KW - Ovarian Neoplasms/diagnostic imaging
KW - Response Evaluation Criteria in Solid Tumors
KW - Thiazines
UR - http://www.scopus.com/inward/record.url?scp=85179695438&partnerID=8YFLogxK
U2 - 10.1038/s41416-023-02528-z
DO - 10.1038/s41416-023-02528-z
M3 - Journal article
C2 - 38097739
SN - 0007-0920
VL - 130
SP - 425
EP - 433
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 3
ER -