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

Tjokrowidjaja, A; Friedlander, ML; Ledermann, JA; Coleman, RL; Mirza, MR; Matulonis, UA; Pujade-Lauraine, E; Lord, SJ; Scott, CL; Goble, S; York, W; Lee, CK

Author(s): Tjokrowidjaja, A; Friedlander, ML; Ledermann, JA; Coleman, RL; Mirza, MR; Matulonis, UA; Pujade-Lauraine, E; Lord, SJ; Scott, CL; Goble, S; York, W; Lee, CK;
Details: Publication Year 2024-04-10,Volume 42,Issue #11,Page 1301-1310
Journal Title: Journal of Clinical Oncology
Abstract: 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.
Publisher: ASCO
Keywords: Humans; Female; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use; CA-125 Antigen/therapeutic use; Response Evaluation Criteria in Solid Tumors; Neoplasm Recurrence, Local/drug therapy; *Antineoplastic Agents/therapeutic use; *Ovarian Neoplasms/diagnostic imaging/drug therapy; Carcinoma, Ovarian Epithelial/drug therapy
Research Division(s): Cancer Biology And Stem Cells
PubMed ID: 38215359
Publisher's Version: https://doi.org/10.1200/jco.23.01182
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-04-18 09:15:20

Last Modified: 2024-04-18 09:24:54