Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: Randomized study of an asian gynecologic oncology group

Chyong Huey Lai, Elizabeth Vallikad, Hao Lin, Lan Yan Yang, Shih Ming Jung, Hsueh Erh Liu, Yu Che Ou, Hung Hsueh Chou, Cheng Tao Lin, Huei Jean Huang, Kuan Gen Huang, Jiantai Qiu, Yao Ching Hung, Tzu I. Wu, Wei Yang Chang, Kien Thiam Tan, Chiao Yun Lin, Angel Chao, Chee Jen Chang

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2 引文 斯高帕斯(Scopus)

摘要

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.

原文英語
文章編號e5
期刊Journal of Gynecologic Oncology
31
發行號1
DOIs
出版狀態已發佈 - 一月 2020

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

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