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논문 기본 정보

자료유형
학술저널
저자정보
Keiichi Fujiwara (Saitama Medical University International Medical Center) Hiroyuki Fujiwara (Jichi Medical University) Hiroyuki Yoshida (Saitama Medical University International Medical Center) Toyomi Satoh (University of Tsukuba Hospital Ibaraki Japan) Kan Yonemori (National Cancer Center Hospital Tokyo Japan) Shoji Nagao (Hyogo Cancer Center) Takashi Matsumoto (Ehime University Graduate School of Medicine) Hiroaki Kobayashi (Kagoshima University Hospital Kagoshima Japan) Hughes Bourgeois (Centre Jean Bernard – Clinique Victor Hugo GINECO Le Mans France) Philipp Harter (Department of Gynecology and Gynecologic Oncology Ev. Kliniken Essen-Mitte Essen Germany) Anna Maria Mosconi (Ospedale Santa Maria della Misericordia Perugia Italy) Isabel Palacio Vazquez (Hospital Universitario Central de Asturias Oviedo Spain) Alexander Reinthaller (Medical University Vienna Vienna Austria) Tomoko Fujita (Astrazeneca Osaka Japan) Philip Rowe (AstraZeneca Cambridge UK) Eric Pujade-Lauraine (Medical Oncology Université Paris Descartes Paris France) Isabelle Ray-Coquard (Centre Léon BERARD and University Claude Bernard Lyon I GINECO Lyon France)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.32 No.5
발행연도
2021.9
수록면
1 - 11 (11page)
DOI
https://doi.org/10.3802/jgo.2021.32.e82

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초록· 키워드

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Objective: The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1. Methods: PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint). Results: Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11?1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16?2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab. Conclusion: Results in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02477644

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