Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of PLD in treating of in patients who experience epithelial ovarian, fallopian tubal, and peritoneal cancer progression within 12 months after the first-line platinum-based therapy.

METHODS:

This was an open-label, single-arm and multicenter clinical trial. The ORR was the interim primary objective, and the DCR, AEs and QOL were the secondary objectives. The impact of factors on efficacy outcomes, the change trend of CA125 and the artificial platinum-free interval were exploratory endpoints.

RESULTS:

Totally, 115 patients were enrolled in this study and included in the ITT population. Moreover, 101 patients were included in the safety population. The median follow-up time was 4 months (IQR 2-6). In the ITT population, the confirmed ORR was 37.4% (95% CI, 28.4-46.4%), and the DCR was 65.2% (95% CI, 56.4-74.1%). The previous response status to platinum-based chemotherapy and baseline CA125 levels were significantly correlated with the ORR. The ORR was significantly higher in patients with a CA125 decrease after the first cycle than in the patients with a CA125 increase. The most common grade 3 or higher AE was hand-foot syndrome (3 [3.0%] of 101 patients). No statistically significant differences existed between the baseline and the postbaseline questionnaires.

CONCLUSIONS:

For patients who experience platinum-resistant and platinum-refractory relapse, the use of PLD may be acceptable because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a low CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for satisfactory efficacy.

• Authors: Zhen Yuan, Ying Zhang, Dongyan Cao, Keng Shen, Qingshui Li, Guonan Zhang, Xiaohua Wu, Manhua Cui, Ying Yue, Wenjun Cheng, Li Wang, Pengpeng Qu, Guangshi Tao, Jianqing Hou, Lixin Sun, Yuanguang Meng, Guiling Li, Changzhong Li, Huirong Shi, Yaqing Chen
• Journal: Journal of ovarian research (J Ovarian Res) Vol. 14 Issue 1 Pg. 12 (Jan 11 2021) ISSN: 1757-2215 [Electronic] England
• PMID: 33423683 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• liposomal doxorubicin
• Polyethylene Glycols
• Doxorubicin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Carcinoma, Ovarian Epithelial (drug therapy)
• Doxorubicin (analogs & derivatives, pharmacology, therapeutic use)
• Female
• Humans
• Middle Aged
• Polyethylene Glycols (pharmacology, therapeutic use)
• Young Adult