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
Copyright © 2020 Elsevier Ltd. All rights reserved..
BACKGROUND: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:139 |
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| Enthalten in: |
European journal of cancer (Oxford, England : 1990) - 139(2020) vom: 01. Nov., Seite 59-67 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tjokrowidjaja, Angelina [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 22.02.2021 Date Revised 22.02.2021 published: Print-Electronic ClinicalTrials.gov: NCT01874353 Citation Status MEDLINE |
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| doi: |
10.1016/j.ejca.2020.08.021 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM315479795 |
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| 100 | 1 | |a Tjokrowidjaja, Angelina |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 22.02.2021 | ||
| 500 | |a Date Revised 22.02.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01874353 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Elsevier Ltd. All rights reserved. | ||
| 520 | |a BACKGROUND: 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 | ||
| 520 | |a METHODS: 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) | ||
| 520 | |a RESULTS: 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 | ||
| 520 | |a CONCLUSIONS: 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a BRCA mutation | |
| 650 | 4 | |a CA-125 | |
| 650 | 4 | |a CT | |
| 650 | 4 | |a Olaparib | |
| 650 | 4 | |a Ovarian cancer | |
| 650 | 4 | |a Poly(ADP-Ribose) polymerase inhibitors | |
| 650 | 4 | |a Response evaluation criteria in solid tumours | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a Biomarkers, Tumor |2 NLM | |
| 650 | 7 | |a CA-125 Antigen |2 NLM | |
| 650 | 7 | |a Fanconi Anemia Complementation Group Proteins |2 NLM | |
| 650 | 7 | |a Organoplatinum Compounds |2 NLM | |
| 650 | 7 | |a Phthalazines |2 NLM | |
| 650 | 7 | |a Piperazines |2 NLM | |
| 650 | 7 | |a Poly(ADP-ribose) Polymerase Inhibitors |2 NLM | |
| 650 | 7 | |a olaparib |2 NLM | |
| 650 | 7 | |a WOH1JD9AR8 |2 NLM | |
| 700 | 1 | |a Lee, Chee K |e verfasserin |4 aut | |
| 700 | 1 | |a Friedlander, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Gebski, Val |e verfasserin |4 aut | |
| 700 | 1 | |a Gladieff, Laurence |e verfasserin |4 aut | |
| 700 | 1 | |a Ledermann, Jonathan |e verfasserin |4 aut | |
| 700 | 1 | |a Penson, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Oza, Amit |e verfasserin |4 aut | |
| 700 | 1 | |a Korach, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Huzarski, Tomasz |e verfasserin |4 aut | |
| 700 | 1 | |a Manso, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Pisano, Carmela |e verfasserin |4 aut | |
| 700 | 1 | |a Asher, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Lord, Sarah J |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Se Ik |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Jung-Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Colombo, Nicoletta |e verfasserin |4 aut | |
| 700 | 1 | |a Park-Simon, Tjoung-Won |e verfasserin |4 aut | |
| 700 | 1 | |a Fujiwara, Keiichi |e verfasserin |4 aut | |
| 700 | 1 | |a Sonke, Gabe |e verfasserin |4 aut | |
| 700 | 1 | |a Vergote, Ignace |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae-Weon |e verfasserin |4 aut | |
| 700 | 1 | |a Pujade-Lauraine, Eric |e verfasserin |4 aut | |
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