Details

Autor(en) / Beteiligte

• Tjokrowidjaja, Angelina
• Friedlander, M.L.
• Ledermann, Jonathan A.
• Coleman, Robert L.
• Mirza, Mansoor R.
• Matulonis, Ursula A.
• Pujade-Lauraine, Eric
• Lord, Sarah J.
• Scott, Clare L.
• Goble, Sandra
• York, Whitney
• Lee, Chee K.
• Khoon Lee, Chee
• You, Benoit
• Paoletti, Xavier
• Glasspool, Ros
• Friedlander, Michael
• Scott, Clare
• Mirza, Monsoor
• Pujade Lauraine, Eric
• Ledermann, Jonathan
• Antill, Yoland
• Mileshkin, Linda
• Ethier, Josee-Lyne
• Bookman, Michael
• Gourley, Charlie

Titel

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

Ist Teil von

• Journal of clinical oncology, 2024-04, Vol.42 (11), p.1301-1310

Erscheinungsjahr

2024

Beschreibungen/Notizen

• 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. In women with PSROC on maintenance PARPi, approximately one in two with RECIST PD did not have CA-125 PD.