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Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy

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Název: Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy
Autoři: Carmela Pisano, Laurence Gladieff, Eric Pujade-Lauraine, Ignace Vergote, Jae Weon Kim, Jacob Korach, Angelina Tjokrowidjaja, Keiichi Fujiwara, Tomasz Huzarski, Richard T. Penson, Tjoung Won Park-Simon, Chee Khoon Lee, Gabe S. Sonke, Nicoletta Colombo, Se Ik Kim, Rebecca Asher, Luis Manso, Val Gebski, Jung Yun Lee, Michael Friedlander, Jonathan A. Ledermann, Amit M. Oza, Sarah J. Lord
Přispěvatelé: Angelina Tjokrowidjaja, Chee K Lee, Michael Friedlander, Val Gebski, Laurence Gladieff, Jonathan Ledermann, Richard Penson, Amit Oza, Jacob Korach, Tomasz Huzarski, Luis Manso, Carmela Pisano, Rebecca Asher, Sarah J Lord, Se Ik Kim, Jung-Yun Lee, Nicoletta Colombo, Tjoung-Won Park-Simon, Keiichi Fujiwara, Gabe Sonke, Ignace Vergote, Jae-Weon Kim, Eric Pujade-Lauraine, Lee, Jung-Yun
Zdroj: European Journal of Cancer. 139:59-67
Informace o vydavateli: Elsevier BV, 2020.
Rok vydání: 2020
Témata: Piperazines / therapeutic use, Organoplatinum Compounds, Fanconi Anemia Complementation Group Proteins / genetics, BRCA mutation, CA-125, CT, Olaparib, Ovarian cancer, Poly(ADP-Ribose) polymerase inhibitors, Response evaluation criteria in solid tumours, Piperazines, Tumor / metabolism, 0302 clinical medicine, Germ-Line Mutation / genetics, Ovarian Neoplasms / genetics, Phthalazines / therapeutic use, Ovarian Neoplasms / drug therapy, Ovarian Neoplasms, Local / metabolism, Middle Aged, Fanconi Anemia Complementation Group Proteins, 3. Good health, Organoplatinum Compounds / therapeutic use, Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use, Disease Progression, Female, Antineoplastic Agents, Antineoplastic Agents / therapeutic use, Poly(ADP-ribose) Polymerase Inhibitors, Maintenance Chemotherapy, Local / drug therapy, 03 medical and health sciences, Biomarkers, Tumor, Humans, Germ-Line Mutation, Response Evaluation Criteria in Solid Tumors, Local / genetics, Local / pathology, CA-125 Antigen / metabolism, Ovarian Neoplasms / metabolism, Ovarian Neoplasms / pathology, Neoplasm Recurrence, CA-125 Antigen, Phthalazines, Maintenance Chemotherapy / methods, Neoplasm Recurrence, Local, Biomarkers
Popis: Limited evidence exists to support CA-125 as a valid surrogate biomarker for progression in patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy. We aimed to assess the concordance between CA-125 and Response Evaluation Criteria in Solid Tumours (RECIST) criteria for progression in patients with BRCA mutations on maintenance PARPi or placebo.We extracted data on progression as defined by Gynecologic Cancer InterGroup CA-125, investigator- and independent central-assessed RECIST from the SOLO2/ENGOT-ov21(NCT01874353) trial. We excluded those with progression other than by RECIST, progression on date of randomisation, and no repeat CA-125 beyond baseline. We evaluated the concordance between CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV).Of 295 randomised patients, 275 (184 olaparib, 91 placebo) were included. 171 patients had investigator-assessed RECIST progression. Of 80 patients with CA-125 progression, 77 had concordant RECIST progression (PPV 96%, 95% confidence interval 90-99%). Of 195 patients without CA-125 progression, 94 had RECIST progression (NPV 52%, 45-59%). Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]). Of 94 patients with RECIST but without CA-125 progression, 64 (68%) had CA-125 that remained within normal range. We observed similar findings using independent-assessed RECIST.Almost half the patients without CA-125 progression had RECIST progression, and most of these had CA-125 within the normal range. Regular computed tomography imaging should be considered as part of surveillance in patients treated with or without maintenance olaparib rather than relying on CA-125 alone.
Druh dokumentu: Article
Jazyk: English
ISSN: 0959-8049
DOI: 10.1016/j.ejca.2020.08.021
Přístupová URL adresa: https://discovery.ucl.ac.uk/10111354/3/Ledermann_Concordance%20between%20CA-125%20and%20RECIST%20progression%20in%20patients%20with%20germline%20BRCA-mutated%20platinum-sensitive%20relapsed%20ovarian%20cancer_AAM.pdf
https://pubmed.ncbi.nlm.nih.gov/32977221
https://europepmc.org/article/MED/32977221
https://www.sciencedirect.com/science/article/pii/S095980492030472X
https://pubmed.ncbi.nlm.nih.gov/32977221/
https://snucm.elsevierpure.com/en/publications/concordance-between-ca-125-and-recist-progression-in-patients-wit
https://www.ncbi.nlm.nih.gov/pubmed/32977221
https://moh-it.pure.elsevier.com/en/publications/concordance-between-ca-125-and-recist-progression-in-patients-wit-2
https://discovery-pp.ucl.ac.uk/id/eprint/10111354/
Rights: Elsevier TDM
CC BY NC ND
Přístupové číslo: edsair.doi.dedup.....fce0ebc682f22d2e3ea44062a7a1a93e
Databáze: OpenAIRE
Popis
Abstrakt:Limited evidence exists to support CA-125 as a valid surrogate biomarker for progression in patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy. We aimed to assess the concordance between CA-125 and Response Evaluation Criteria in Solid Tumours (RECIST) criteria for progression in patients with BRCA mutations on maintenance PARPi or placebo.We extracted data on progression as defined by Gynecologic Cancer InterGroup CA-125, investigator- and independent central-assessed RECIST from the SOLO2/ENGOT-ov21(NCT01874353) trial. We excluded those with progression other than by RECIST, progression on date of randomisation, and no repeat CA-125 beyond baseline. We evaluated the concordance between CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV).Of 295 randomised patients, 275 (184 olaparib, 91 placebo) were included. 171 patients had investigator-assessed RECIST progression. Of 80 patients with CA-125 progression, 77 had concordant RECIST progression (PPV 96%, 95% confidence interval 90-99%). Of 195 patients without CA-125 progression, 94 had RECIST progression (NPV 52%, 45-59%). Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]). Of 94 patients with RECIST but without CA-125 progression, 64 (68%) had CA-125 that remained within normal range. We observed similar findings using independent-assessed RECIST.Almost half the patients without CA-125 progression had RECIST progression, and most of these had CA-125 within the normal range. Regular computed tomography imaging should be considered as part of surveillance in patients treated with or without maintenance olaparib rather than relying on CA-125 alone.
ISSN:09598049
DOI:10.1016/j.ejca.2020.08.021