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KMID : 1137020200310010005
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Journal of Gynecologic Oncology
2020 Volume.31 No. 1 p.5 ~ p.5
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Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
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Lai Chyong-Huey
Vallikad Elizabeth
Lin Hao
Yang Lan-Yan
Jung Shih-Ming
Liu Hsueh-Erh
Ou Yu-Che
Chou Hung-Hsueh
Lin Cheng-Tao
Huang Huei-Jean
Huang Kuan-Gen
Qiu Jiantai
Hung Yao-Ching
Wu Tzu-I
Chang Wei-Yang
Tan Kien-Thiam
Lin Chiao-Yun
Chao Angel
Chang Chee-Jen
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Abstract
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Objectives: An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer.
Methods: Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis.
Results: Enrollment was slow, accrual was closed when 7+ years had passed. With a median follow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19?0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCA/non-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11?1.18; p=0.091).
Conclusions: Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.
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KEYWORD
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Maintenance Chemotherapy, Advanced Ovarian Cancer, Genes, BRCA1 and BRCA2, Homologous Recombination Deficiency, Liposomal Doxorubicin
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