Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group
- Author:
Chyong-Huey LAI
1
;
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
Author Information
- Publication Type:Original Article
- From:Journal of Gynecologic Oncology 2020;31(1):e5-
- CountryRepublic of Korea
-
Abstract:
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 medianfollow-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 BRCAon-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.
