1.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
Journal of Gynecologic Oncology 2020;31(1):e5-
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.
2.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
Journal of Gynecologic Oncology 2020;31(1):5-