Poor Concordance Between Cancer Antigen-125 and RECIST Assessment for Progression in Patients With Platinum-Sensitive Relapsed Ovarian Cancer on Maintenance Therapy With a Poly(ADP-ribose) Polymerase Inhibitor
PURPOSE: Cancer antigen-125 (CA-125) is recommended by treatment guidelines and widely used to diagnose ovarian cancer recurrence. The value of CA-125 as a surrogate for disease progression (PD) and its concordance with radiologic progression are unclear, particularly for women with platinum-sensitive relapsed ovarian cancer (PSROC) who have responded to chemotherapy and treated with maintenance poly(ADP-ribose) polymerase inhibitor (PARPi).
METHODS: In this pooled analysis of four randomized trials of maintenance PARPi or placebo (Study 19, SOLO2, ARIEL3, and NOVA), we extracted data on CA-125 PD as defined by Gynecologic Cancer InterGroup criteria and RECIST v1.1. We evaluated the concordance between CA-125 and RECIST PD and reported on the negative predictive value (NPV) and positive predictive value (PPV).
RESULTS: Of 1,262 participants (n = 818 PARPi, n = 444 placebo), 403 (32%) had CA-125 PD, and of these, 366 had concordant RECIST PD (PPV, 91% [95% CI, 88 to 93]). However, of 859 (68%) without CA-125 PD, 382 also did not have RECIST PD (NPV, 44% [95% CI, 41 to 48]). Within the treatment arms, PPV remained high (PARPi, 91% [95% CI, 86 to 94]; placebo, 91% [95% CI, 86 to 95]) but NPV was lower on placebo (PARPi, 53% [95% CI, 49 to 57]; placebo, 25% [95% CI, 20 to 31]). Of 477 with RECIST-only PD, most (95%) had a normal CA-125 at the start of maintenance therapy and the majority (n = 304, 64%) had CA-125 that remained within normal range. Solid organ recurrence without peritoneal disease was more common in those with RECIST-only PD than in those with CA-125 and RECIST PD (36% v 24%; P < .001).
CONCLUSION: In patients with PSROC treated with maintenance PARPi, almost half with RECIST PD did not have CA-125 PD, challenging current guidelines. Periodic computed tomography imaging should be considered as part of surveillance, particularly in those with a normal CA-125 at the start of maintenance therapy and on treatment.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
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| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 42(2024), 11 vom: 10. Apr., Seite 1301-1310 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tjokrowidjaja, Angelina [VerfasserIn] |
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| Links: |
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| Themen: |
Antineoplastic Agents |
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| Anmerkungen: |
Date Completed 08.04.2024 Date Revised 08.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1200/JCO.23.01182 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367059096 |
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| 100 | 1 | |a Tjokrowidjaja, Angelina |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Poor Concordance Between Cancer Antigen-125 and RECIST Assessment for Progression in Patients With Platinum-Sensitive Relapsed Ovarian Cancer on Maintenance Therapy With a Poly(ADP-ribose) Polymerase Inhibitor |
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| 500 | |a Date Revised 08.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: Cancer antigen-125 (CA-125) is recommended by treatment guidelines and widely used to diagnose ovarian cancer recurrence. The value of CA-125 as a surrogate for disease progression (PD) and its concordance with radiologic progression are unclear, particularly for women with platinum-sensitive relapsed ovarian cancer (PSROC) who have responded to chemotherapy and treated with maintenance poly(ADP-ribose) polymerase inhibitor (PARPi) | ||
| 520 | |a METHODS: In this pooled analysis of four randomized trials of maintenance PARPi or placebo (Study 19, SOLO2, ARIEL3, and NOVA), we extracted data on CA-125 PD as defined by Gynecologic Cancer InterGroup criteria and RECIST v1.1. We evaluated the concordance between CA-125 and RECIST PD and reported on the negative predictive value (NPV) and positive predictive value (PPV) | ||
| 520 | |a RESULTS: Of 1,262 participants (n = 818 PARPi, n = 444 placebo), 403 (32%) had CA-125 PD, and of these, 366 had concordant RECIST PD (PPV, 91% [95% CI, 88 to 93]). However, of 859 (68%) without CA-125 PD, 382 also did not have RECIST PD (NPV, 44% [95% CI, 41 to 48]). Within the treatment arms, PPV remained high (PARPi, 91% [95% CI, 86 to 94]; placebo, 91% [95% CI, 86 to 95]) but NPV was lower on placebo (PARPi, 53% [95% CI, 49 to 57]; placebo, 25% [95% CI, 20 to 31]). Of 477 with RECIST-only PD, most (95%) had a normal CA-125 at the start of maintenance therapy and the majority (n = 304, 64%) had CA-125 that remained within normal range. Solid organ recurrence without peritoneal disease was more common in those with RECIST-only PD than in those with CA-125 and RECIST PD (36% v 24%; P < .001) | ||
| 520 | |a CONCLUSION: In patients with PSROC treated with maintenance PARPi, almost half with RECIST PD did not have CA-125 PD, challenging current guidelines. Periodic computed tomography imaging should be considered as part of surveillance, particularly in those with a normal CA-125 at the start of maintenance therapy and on treatment | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Poly(ADP-ribose) Polymerase Inhibitors |2 NLM | |
| 650 | 7 | |a CA-125 Antigen |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 700 | 1 | |a Friedlander, M L |e verfasserin |4 aut | |
| 700 | 1 | |a Ledermann, Jonathan A |e verfasserin |4 aut | |
| 700 | 1 | |a Coleman, Robert L |e verfasserin |4 aut | |
| 700 | 1 | |a Mirza, Mansoor R |e verfasserin |4 aut | |
| 700 | 1 | |a Matulonis, Ursula A |e verfasserin |4 aut | |
| 700 | 1 | |a Pujade-Lauraine, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Lord, Sarah J |e verfasserin |4 aut | |
| 700 | 1 | |a Scott, Clare L |e verfasserin |4 aut | |
| 700 | 1 | |a Goble, Sandra |e verfasserin |4 aut | |
| 700 | 1 | |a York, Whitney |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Chee K |e verfasserin |4 aut | |
| 700 | 0 | |a Gynecologic Cancer Intergroup Meta-Analysis Committee |e verfasserin |4 aut | |
| 700 | 1 | |a Khoon Lee, Chee |e investigator |4 oth | |
| 700 | 1 | |a You, Benoit |e investigator |4 oth | |
| 700 | 1 | |a Paoletti, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Glasspool, Ros |e investigator |4 oth | |
| 700 | 1 | |a Friedlander, Michael |e investigator |4 oth | |
| 700 | 1 | |a Scott, Clare |e investigator |4 oth | |
| 700 | 1 | |a Mirza, Monsoor |e investigator |4 oth | |
| 700 | 1 | |a Pujade Lauraine, Eric |e investigator |4 oth | |
| 700 | 1 | |a Ledermann, Jonathan |e investigator |4 oth | |
| 700 | 1 | |a Antill, Yoland |e investigator |4 oth | |
| 700 | 1 | |a Mileshkin, Linda |e investigator |4 oth | |
| 700 | 1 | |a Ethier, Josee-Lyne |e investigator |4 oth | |
| 700 | 1 | |a Bookman, Michael |e investigator |4 oth | |
| 700 | 1 | |a Gourley, Charlie |e investigator |4 oth | |
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