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Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer
- Source :
- Journal of Ovarian Research, Journal of Ovarian Research, Vol 14, Iss 1, Pp 1-13 (2021)
- Publication Year :
- 2020
-
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.
- Subjects :
- 0301 basic medicine
Oncology
Adult
medicine.medical_specialty
Peritoneal cancer
endocrine system diseases
Adolescent
Platinum-refractory relapse
medicine.medical_treatment
Population
Carcinoma, Ovarian Epithelial
lcsh:Gynecology and obstetrics
Pegylated Liposomal Doxorubicin
Polyethylene Glycols
03 medical and health sciences
Young Adult
CA125
0302 clinical medicine
Internal medicine
Pegylated liposomal doxorubicin
medicine
Humans
Epithelial ovarian cancer
In patient
education
lcsh:RG1-991
Aged
Aged, 80 and over
education.field_of_study
Chemotherapy
business.industry
Research
Obstetrics and Gynecology
Middle Aged
female genital diseases and pregnancy complications
Clinical trial
030104 developmental biology
Partially platinum-sensitive relapse
Doxorubicin
Platinum-resistant relapse
030220 oncology & carcinogenesis
Female
business
Subjects
Details
- ISSN :
- 17572215
- Volume :
- 14
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of ovarian research
- Accession number :
- edsair.doi.dedup.....0e1d7944bf8be93b8191612f2370a62f