Abstract
ObjectiveTo 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.MethodsThis 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.ResultsTotally, 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.ConclusionsFor 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.
Highlights
In 2018, it was estimated that 22,240 new diagnoses of ovarian cancer occurred in the United States [1]
Half of all first relapses occur within 12 months after ending first-line therapy, and one-quarter of all relapses occur within 6 months [4], which is defined as platinumrefractory or platinum-resistant relapse
Twenty-one patients (18.3%) discontinued pegylated liposomal doxorubicin (PLD) because of progressive disease (PD), and 19 patients (16.5%) received other anticancer therapies based on the decision of the investigator, 16 patients of whom (84.2%) received platinum-based chemotherapy
Summary
In 2018, it was estimated that 22,240 new diagnoses of ovarian cancer occurred in the United States [1]. More than 70% of patients present with advanced disease [2]. 80% of patients with advanced ovarian cancer will experience tumor progression or relapse [3]. Half of all first relapses occur within 12 months after ending first-line therapy, and one-quarter of all relapses occur within 6 months [4], which is defined as platinumrefractory or platinum-resistant relapse. The current management and treatment options for platinumresistant and platinum-refractory recurrent ovarian cancer are limited [5]. A retrospective study described the real-world treatment patterns in these patients from January 2010 to June 2014 in the United States, the United Kingdom, and Canada and found that the most common initial therapy was pegylated liposomal doxorubicin (PLD) monotherapy [6]
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