Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

J Ovarian Res. 2021 Jan 11;14(1):12. doi: 10.1186/s13048-020-00736-2.

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.

Keywords: CA125; Partially platinum-sensitive relapse; Pegylated liposomal doxorubicin; Platinum-refractory relapse; Platinum-resistant relapse.

Publication types

  • Multicenter Study

MeSH terms

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

Substances

  • liposomal doxorubicin
  • Polyethylene Glycols
  • Doxorubicin