Gynecologic oncology · 2026
Comparing niraparib versus platinum-taxane doublet chemotherapy as neoadjuvant treatment in patients with newly diagnosed homologous recombination-deficient stage III/IV ovarian cancer: Findings from cohort C of the OPAL phase 2 trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Westin Shannon N, Belotte Jimmy, Felicetti Brunella, Aghera Vishvajit, YoussefAgha Ahmed, Bakirtzi Evi, Ortiz Ana Godoy, García Arantzazu Barquín, Provencher Diane, Vázquez Raúl Márquez, Cortijo Lucia González, Zeng Xing, Silasi Dan-Arin, Bradford Leslie S, Musa Fernanda B, Chan John K, Liu Joyce F, Rojas-Espaillat Luis
Аннотация
BACKGROUND: Despite therapeutic improvements in advanced ovarian cancer (aOC), prognosis remains poor for patients with residual disease after cytoreductive surgery. Reported here are results from cohort C of the phase 1b/2 OPAL study of a neoadjuvant poly(ADP-ribose) polymerase (PARP) inhibitor for aOC.
METHODS: Eligible adults with newly diagnosed stage III/IV homologous recombination-deficient (HRd) aOC and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 were randomized 1:1 to receive neoadjuvant platinum-taxane chemotherapy (platinum-taxane) or niraparib. During the prescreening period, patients received 1 run-in cycle of carboplatin-paclitaxel. After neoadjuvant therapy, patients with an unconfirmed complete/partial response (CR/PR) or stable disease per RECIST could undergo interval debulking surgery (IDS), followed by adjuvant platinum-taxane-based chemotherapy. After adjuvant therapy, patients without progression received niraparib-based maintenance treatment. Primary endpoint was pre-IDS unconfirmed investigator-assessed overall response rate (ORR) per RECIST. Secondary endpoints included safety.
RESULTS: Of 36 patients randomized, 19 received niraparib and 17, platinum-taxane. Baseline demographics and characteristics were similar between arms. Overall, the pre-IDS unconfirmed ORR was 31.6% (CR/PR, 0/31.6%) with niraparib and 70.6% (CR/PR, 0/70.6%) with platinum-taxane. The pre-IDS unconfirmed ORR (80% CI) difference was -39.0% (-56.8% to -17.7%), favoring platinum-taxane. The trial was closed early for futility. Grade ≥3 adverse-event rates during the neoadjuvant period were 42% and 59% in the niraparib and platinum-taxane arms, respectively. No fatal serious adverse events occurred.
CONCLUSIONS: In newly diagnosed HRd aOC, neoadjuvant niraparib did not improve ORR versus standard platinum-based chemotherapy, and the trial was discontinued. The safety profile was consistent with those of previous PARP inhibitor studies.
METHODS: Eligible adults with newly diagnosed stage III/IV homologous recombination-deficient (HRd) aOC and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 were randomized 1:1 to receive neoadjuvant platinum-taxane chemotherapy (platinum-taxane) or niraparib. During the prescreening period, patients received 1 run-in cycle of carboplatin-paclitaxel. After neoadjuvant therapy, patients with an unconfirmed complete/partial response (CR/PR) or stable disease per RECIST could undergo interval debulking surgery (IDS), followed by adjuvant platinum-taxane-based chemotherapy. After adjuvant therapy, patients without progression received niraparib-based maintenance treatment. Primary endpoint was pre-IDS unconfirmed investigator-assessed overall response rate (ORR) per RECIST. Secondary endpoints included safety.
RESULTS: Of 36 patients randomized, 19 received niraparib and 17, platinum-taxane. Baseline demographics and characteristics were similar between arms. Overall, the pre-IDS unconfirmed ORR was 31.6% (CR/PR, 0/31.6%) with niraparib and 70.6% (CR/PR, 0/70.6%) with platinum-taxane. The pre-IDS unconfirmed ORR (80% CI) difference was -39.0% (-56.8% to -17.7%), favoring platinum-taxane. The trial was closed early for futility. Grade ≥3 adverse-event rates during the neoadjuvant period were 42% and 59% in the niraparib and platinum-taxane arms, respectively. No fatal serious adverse events occurred.
CONCLUSIONS: In newly diagnosed HRd aOC, neoadjuvant niraparib did not improve ORR versus standard platinum-based chemotherapy, and the trial was discontinued. The safety profile was consistent with those of previous PARP inhibitor studies.