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- Title
Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group.
- Authors
Chyong-Huey Lai; Vallikad, Elizabeth; 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; Chao, Angel; Chee-Jen Chang
- 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 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.
- Subjects
OVARIAN cancer; GYNECOLOGIC oncology; DOXORUBICIN; ASIAN studies; CANCER remission; PROGRESSION-free survival; TARGETED drug delivery; OVARIAN function tests
- Publication
Journal of Gynecologic Oncology, 2020, Vol 31, Issue 1, p1
- ISSN
2005-0380
- Publication type
Article
- DOI
10.3802/jgo.2020.31.e5