Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study
Abstract Introduction Niraparib was approved for first-line (1L) maintenance (1LM) treatment of patients with advanced epithelial ovarian cancer (EOC) following the PRIMA/ENGOT-OV26/GOG-3012 (PRIMA) trial. PRIMA was restricted to patients at higher risk of progression (excluded stage III EOC with no...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2025-01-01
|
| Series: | Oncology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s40487-024-00318-y |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850030084974444544 |
|---|---|
| author | Dana M. Chase Maya Hanna Jonathan T. Lim Tirza Areli Calderón Boyle Mark Guinter Madeline Richey Khilna Patel Jeanne M. Schilder Jean A. Hurteau Amanda K. Golembesky |
| author_facet | Dana M. Chase Maya Hanna Jonathan T. Lim Tirza Areli Calderón Boyle Mark Guinter Madeline Richey Khilna Patel Jeanne M. Schilder Jean A. Hurteau Amanda K. Golembesky |
| author_sort | Dana M. Chase |
| collection | DOAJ |
| description | Abstract Introduction Niraparib was approved for first-line (1L) maintenance (1LM) treatment of patients with advanced epithelial ovarian cancer (EOC) following the PRIMA/ENGOT-OV26/GOG-3012 (PRIMA) trial. PRIMA was restricted to patients at higher risk of progression (excluded stage III EOC with no visible residual disease [NVRD] after primary cytoreductive surgery [PCS]). This retrospective study evaluated the potential impact of excluding stage III EOC with NVRD from PRIMA by assessing real-world treatment outcomes following 1LM niraparib monotherapy in this patient population. Methods Data from a US-nationwide electronic health record-derived deidentified database comprised adult patients diagnosed with stage III/IV EOC who received 1L platinum-based chemotherapy and initiated niraparib 1LM monotherapy (01Jan2017–28Feb2023). Patients were classified as PRIMA-like (EOC with higher-risk prognostic factors for disease progression) or stage III disease with NVRD after PCS. Real-world time to next treatment (rwTTNT) and progression-free survival (rwPFS), assessed from the end date of 1L platinum-based chemotherapy, were measured via Kaplan–Meier methods. Results Among 453 patients who received niraparib 1LM (PRIMA-like cohort, n = 390; stage III NVRD cohort, n = 63), median follow-up from index was 14.9 (interquartile range [IQR], 7.3–25.1) and 18.4 (IQR, 9.3–29.1) months in the PRIMA-like and stage III NVRD cohorts, respectively. Median rwTTNT was significantly longer in the stage III NVRD cohort (22.5 [95% confidence interval (CI), 17.3–not reached] months) than in the PRIMA-like cohort (11.7 [95% CI, 10.8–12.9] months; P < 0.001). Median rwPFS in the stage III NVRD cohort (25.2 [95% CI, 12.6–not reached] months) was more than double that in the PRIMA-like cohort (10.1 [95% CI, 9.1–11.9] months; P < 0.001). Conclusions In the stage III NVRD cohort, rwTTNT and rwPFS were significantly longer than in the PRIMA-like cohort, consistent with clinical expectation. Results suggest niraparib clinical benefit may have been underestimated in PRIMA because of the exclusion of patients with stage III EOC with NVRD after PCS. |
| format | Article |
| id | doaj-art-326b6380ea1f410aabfcd207103001ec |
| institution | DOAJ |
| issn | 2366-1070 2366-1089 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Oncology and Therapy |
| spelling | doaj-art-326b6380ea1f410aabfcd207103001ec2025-08-20T02:59:19ZengAdis, Springer HealthcareOncology and Therapy2366-10702366-10892025-01-0113125326210.1007/s40487-024-00318-yNiraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World StudyDana M. Chase0Maya Hanna1Jonathan T. Lim2Tirza Areli Calderón Boyle3Mark Guinter4Madeline Richey5Khilna Patel6Jeanne M. Schilder7Jean A. Hurteau8Amanda K. Golembesky9David Geffen School of Medicine at UCLAGSKGSKGSKFlatiron HealthFlatiron HealthFlatiron HealthGSKGSKGSKAbstract Introduction Niraparib was approved for first-line (1L) maintenance (1LM) treatment of patients with advanced epithelial ovarian cancer (EOC) following the PRIMA/ENGOT-OV26/GOG-3012 (PRIMA) trial. PRIMA was restricted to patients at higher risk of progression (excluded stage III EOC with no visible residual disease [NVRD] after primary cytoreductive surgery [PCS]). This retrospective study evaluated the potential impact of excluding stage III EOC with NVRD from PRIMA by assessing real-world treatment outcomes following 1LM niraparib monotherapy in this patient population. Methods Data from a US-nationwide electronic health record-derived deidentified database comprised adult patients diagnosed with stage III/IV EOC who received 1L platinum-based chemotherapy and initiated niraparib 1LM monotherapy (01Jan2017–28Feb2023). Patients were classified as PRIMA-like (EOC with higher-risk prognostic factors for disease progression) or stage III disease with NVRD after PCS. Real-world time to next treatment (rwTTNT) and progression-free survival (rwPFS), assessed from the end date of 1L platinum-based chemotherapy, were measured via Kaplan–Meier methods. Results Among 453 patients who received niraparib 1LM (PRIMA-like cohort, n = 390; stage III NVRD cohort, n = 63), median follow-up from index was 14.9 (interquartile range [IQR], 7.3–25.1) and 18.4 (IQR, 9.3–29.1) months in the PRIMA-like and stage III NVRD cohorts, respectively. Median rwTTNT was significantly longer in the stage III NVRD cohort (22.5 [95% confidence interval (CI), 17.3–not reached] months) than in the PRIMA-like cohort (11.7 [95% CI, 10.8–12.9] months; P < 0.001). Median rwPFS in the stage III NVRD cohort (25.2 [95% CI, 12.6–not reached] months) was more than double that in the PRIMA-like cohort (10.1 [95% CI, 9.1–11.9] months; P < 0.001). Conclusions In the stage III NVRD cohort, rwTTNT and rwPFS were significantly longer than in the PRIMA-like cohort, consistent with clinical expectation. Results suggest niraparib clinical benefit may have been underestimated in PRIMA because of the exclusion of patients with stage III EOC with NVRD after PCS.https://doi.org/10.1007/s40487-024-00318-yElectronic health recordsFirst-line maintenance therapyNiraparibOvarian cancerReal-worldTime to next treatment |
| spellingShingle | Dana M. Chase Maya Hanna Jonathan T. Lim Tirza Areli Calderón Boyle Mark Guinter Madeline Richey Khilna Patel Jeanne M. Schilder Jean A. Hurteau Amanda K. Golembesky Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study Oncology and Therapy Electronic health records First-line maintenance therapy Niraparib Ovarian cancer Real-world Time to next treatment |
| title | Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study |
| title_full | Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study |
| title_fullStr | Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study |
| title_full_unstemmed | Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study |
| title_short | Niraparib as First-Line Maintenance Therapy in Patients with Stage III Ovarian Cancer and No Visible Residual Disease: AR1ZE Real-World Study |
| title_sort | niraparib as first line maintenance therapy in patients with stage iii ovarian cancer and no visible residual disease ar1ze real world study |
| topic | Electronic health records First-line maintenance therapy Niraparib Ovarian cancer Real-world Time to next treatment |
| url | https://doi.org/10.1007/s40487-024-00318-y |
| work_keys_str_mv | AT danamchase niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT mayahanna niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT jonathantlim niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT tirzaarelicalderonboyle niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT markguinter niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT madelinerichey niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT khilnapatel niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT jeannemschilder niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT jeanahurteau niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy AT amandakgolembesky niraparibasfirstlinemaintenancetherapyinpatientswithstageiiiovariancancerandnovisibleresidualdiseasear1zerealworldstudy |