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Patient-centered outcomes in the POLO study of active maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer.
Kindler, Hedy L; Yoo, Hyun Kyoo; Hettle, Robert; Cui, Karen Y; Joo, Seongjung; Locker, Gershon Y; Golan, Talia.
Afiliación
  • Kindler HL; Section of Hematology/Oncology, University of Chicago, Chicago, Illinois, USA.
  • Yoo HK; Health Economics and Payer Evidence, AstraZeneca, Cambridge, UK.
  • Hettle R; Health Economics and Payer Evidence, AstraZeneca, Cambridge, UK.
  • Cui KY; Late Development Oncology, AstraZeneca, Gaithersburg, Maryland, USA.
  • Joo S; Center for Observational and Real-World Evidence, Oncology, Merck & Co, Inc, Rahway, New Jersey, USA.
  • Locker GY; Late Development Oncology, AstraZeneca, Gaithersburg, Maryland, USA.
  • Golan T; Institute of Oncology, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel.
Cancer ; 129(9): 1411-1418, 2023 05 01.
Article en En | MEDLINE | ID: mdl-36811344
BACKGROUND: The phase 3 POLO study demonstrated a significant progression-free survival (PFS) benefit and preserved health-related quality of life (HRQOL) for active maintenance treatment with olaparib vs placebo in patients with metastatic pancreatic cancer and a germline BRCA mutation. Here, we present a post hoc analysis of the patient-centered outcomes: time without significant symptoms of disease progression or toxicity (TWiST) and quality-adjusted TWiST (Q-TWiST). METHODS: Patients were randomized 3:2 to maintenance olaparib (300 mg tablets twice daily) or placebo. Overall survival time was divided into TWiST, toxicity (TOX; time before disease progression with significant symptoms of toxicity), and relapse (REL; time after disease progression until death or censoring). Q-TWiST was the sum of TWiST, TOX, and REL, each weighted by HRQOL utility scores during the relevant health-state period. A base-case and three sensitivity analyses were performed using differing definitions of TOX. RESULTS: In total, 154 patients were randomized (olaparib, n = 92; placebo, n = 62). TWiST was significantly longer for olaparib than placebo in the base-case analysis (14.6 vs 7.1 months; 95% CI, 2.9-12.0; p = .001) and all sensitivity analyses. No statistically significant benefit for Q-TWiST was observed in the base-case analysis (18.4 vs 15.9 months; 95% CI, -1.1 to 6.1; p = .171) or the sensitivity analyses. CONCLUSION: These results support the previous findings that maintenance olaparib significantly improves PFS relative to placebo without compromising HRQOL and demonstrate that the clinically meaningful benefits of olaparib persist even when symptoms of toxicity are considered.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias Pancreáticas Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans Idioma: En Revista: Cancer Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias Pancreáticas Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans Idioma: En Revista: Cancer Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos