K Lindemann1, G Kristensen2, M R Mirza3, L Davies4, F Hilpert5, I Romero6, A Ayhan7, A Burges8, M J Rubio9, F Raspagliesi10, M Huizing11, G-J Creemers12, M Lykka13, C K Lee4, V Gebski4, E Pujade-Lauraine14. 1. NSGO and Department of Gynecological Cancer, The Norwegian Radium Hospital, Oslo University Hospital, Oslo stinalindemann@hotmail.com. 2. NSGO and Department of Gynecological Cancer and Institute for Cancer Genetics and Informatics, The Norwegian Radium Hospital, Oslo University Hospital and Institute for Clinical Medicine, Oslo University, Oslo, Norway. 3. NSGO and Department of Oncology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark. 4. NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia. 5. AGO and Oncological Center, Hospital Jerusalem, Hamburg, Germany. 6. GEICO and Valencia Institute of Oncology, Valencia, Spain. 7. GINECO and Baskent University, Ankara, Turkey. 8. AGO and Department of Gynecology and Obstetrics, Hospital of University of Munich, Campus Großhadern, Munich, Germany. 9. GEICO and University Hospital Queen Sofía, Córdoba, Spain. 10. MITO and National Tumour Institute of Milan, Milan, Italy. 11. BGOG and Antwerp University Hospital, Edegem, Belgium. 12. DGOG and Catharina Hospital, Eindhoven, The Netherlands. 13. HECOG and University of Athens, Athens, Greece. 14. GINECO and Paris Descartes University, AP-HP Central Paris University Hospitals, Paris, France.
Abstract
BACKGROUND: Data on CA-125 as a predictor of disease progression (PD) in ovarian cancer come predominantly from patients with platinum-sensitive disease receiving chemotherapy alone. We assessed concordance between CA-125-defined and RECIST-defined PD using data from the Gynecologic Cancer InterGroup (GCIG) randomized phase III AURELIA trial in platinum-resistant ovarian cancer (PROC). PATIENTS AND METHODS: Patients with PROC were randomized to receive single-agent chemotherapy with or without bevacizumab. PD by CA-125 was defined according to GCIG criteria (except that confirmatory CA-125 measurement was not required). This exploratory analysis included patients with RECIST PD and a CA-125 reading ≤28 days before and ≤21 days after RECIST-defined PD. RESULTS: Of 218 eligible patients, only 94 (43%, 95% confidence interval 36% to 50%) had concordant RECIST and CA-125 PD status (42% in the chemotherapy-alone arm; 45% in the bevacizumab combination arm, P = 0.6). There was no evidence of CA-125-defined PD in the remaining 124 patients despite PD according to imaging. There were no significant differences in baseline characteristics between patients with PD defined by both RECIST and CA-125 and those with RECIST-only PD. CA-125 was even less sensitive in detecting PD in patients with early (<8 weeks after randomization) compared with later RECIST-defined PD (69% versus 53%, respectively, not meeting CA-125 criteria; P = 0.053). There was no significant difference in survival after PD in patients with concordant PD by RECIST and CA-125 versus those with PD only by RECIST. We validated our findings in an independent study population of PROC. CONCLUSIONS: In this platinum-resistant population, PD was typically detected earlier by imaging than by CA-125, irrespective of bevacizumab treatment. Disease status by CA-125 at the time of PD was not prognostic for overall survival. Regular radiologic assessment as well as symptom benefit assessment should be considered during PROC follow-up.
RCT Entities:
BACKGROUND: Data on CA-125 as a predictor of disease progression (PD) in ovarian cancer come predominantly from patients with platinum-sensitive disease receiving chemotherapy alone. We assessed concordance between CA-125-defined and RECIST-defined PD using data from the Gynecologic Cancer InterGroup (GCIG) randomized phase III AURELIA trial in platinum-resistant ovarian cancer (PROC). PATIENTS AND METHODS: Patients with PROC were randomized to receive single-agent chemotherapy with or without bevacizumab. PD by CA-125 was defined according to GCIG criteria (except that confirmatory CA-125 measurement was not required). This exploratory analysis included patients with RECIST PD and a CA-125 reading ≤28 days before and ≤21 days after RECIST-defined PD. RESULTS: Of 218 eligible patients, only 94 (43%, 95% confidence interval 36% to 50%) had concordant RECIST and CA-125PD status (42% in the chemotherapy-alone arm; 45% in the bevacizumab combination arm, P = 0.6). There was no evidence of CA-125-defined PD in the remaining 124 patients despite PD according to imaging. There were no significant differences in baseline characteristics between patients with PD defined by both RECIST and CA-125 and those with RECIST-only PD. CA-125 was even less sensitive in detecting PD in patients with early (<8 weeks after randomization) compared with later RECIST-defined PD (69% versus 53%, respectively, not meeting CA-125 criteria; P = 0.053). There was no significant difference in survival after PD in patients with concordant PD by RECIST and CA-125 versus those with PD only by RECIST. We validated our findings in an independent study population of PROC. CONCLUSIONS: In this platinum-resistant population, PD was typically detected earlier by imaging than by CA-125, irrespective of bevacizumab treatment. Disease status by CA-125 at the time of PD was not prognostic for overall survival. Regular radiologic assessment as well as symptom benefit assessment should be considered during PROC follow-up.
Authors: Julia L Boland; Qin Zhou; Alexia E Iasonos; Roisin E O'Cearbhaill; Jason Konner; Margaret Callahan; Claire Friedman; Carol Aghajanian; Paul Sabbatini; Dmitriy Zamarin; Karen A Cadoo Journal: Gynecol Oncol Date: 2020-06-02 Impact factor: 5.482
Authors: Florian Heitz; Sotirios Lakis; Philipp Harter; Sebastian Heikaus; Jalid Sehouli; Jatin Talwar; Roopika Menon; Beyhan Ataseven; Miriam Bertrand; Stephanie Schneider; Erika Mariotti; Mareike Bommert; Judith N Müller; Sonia Prader; Frauke Leenders; Alexandra Hengsbach; Christian Gloeckner; Elena Ioana Braicu; Lukas C Heukamp; Andreas du Bois; Johannes M Heuckmann Journal: PLoS One Date: 2022-02-07 Impact factor: 3.240