A randomized, open-label, phase II study of anti-NaPi2b antibody-drug conjugate (ADC) lifastuzumab (Lifa) vedotin (DNIB0600A) compared to pegylated liposomal doxorubicin (PLD) in patients (pts) with platinum-resistant ovarian cancer (PROC).

et al. 2020

Preprint

Abstract Objective To evaluate the efficacy and safety of PLD in treating of in patients with epithelial ovarian, 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. ORR was the interim primary objective and DCR, AEs and QOL were the secondary objectives. The impact of factors on the 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. Moreover, 101 patients were included in the safety analysis. The median follow-up time was 4 months (IQR 2–6). In ITT, 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 statistically correlated with the ORR. The ORR was significantly higher in the 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 with platinum-resistant and platinum refractory relapse, the use of PLD may be a favorite choice because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a lower CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for a better efficacy.

Section: Discussionsupporting

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

et al. 2020

Preprint

“…In this preliminary analysis, though the total sample size was 67 (less than 78), 20 patients had achieved an objective response. Therefore, PLD could be considered a success and the response rate in the platinum-resistant and-refractory group was 29.9%, which is consistent with previous studies that reported response rates of 15% [16], 23.1% [25], 26% [26] or 40.4% [6]. Moreover, the response rate of PLD was similar to that of other single agents: topotecan, 17% [27]-20.5% [28]; gemcitabine, 9.2% [29]-29% [30]; oral etoposide, 26.8% [31]; docetaxel, 22.4% [32] and weekly paclitaxel,13.2% [28]-25% [33].…”

Section: Discussionsupporting

confidence: 88%

Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

et al. 2020

Preprint

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.

Section: Discussionsupporting

confidence: 88%

Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

et al. 2020

Preprint

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.