Abstract
Purpose To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) in patients with metastatic castration-resistant prostate cancer (mCRPC). Materials and Methods In this multicenter, retrospective study, we analyzed the medical charts of mCRPC patients, who were treated with NDLS administered as 2-weekly (50 mg/m2) or 3-weekly regimens (75 mg/m2). The study endpoints were prostate-specific antigen (PSA) response (>50% PSA decline from baseline), PSA progression (PSA increase from baseline beyond 12 weeks: ≥25% and ≥2 ng/mL), median PSA decline, and time-to-treatment failure (TTF). Overall survival (OS) and safety were also evaluated. Results Data of 24 patients with mCRPC were analyzed in this study. NDLS was administered as a 2-weekly regimen in 37.5% (9/24; all first-line) patients and as a 3-weekly regimen in 62.5% patients (15/24; first-line: 20% (3/15), second-line: 80% (12/15)). Overall, PSA response was reported in 66.7% (16/24) patients. The PSA response was 77.8% (7/9 patients) in the 2-weekly group and 60% (9/15 patients) in the 3-weekly group. The median decline in PSA was 96.31% in the 2-weekly group and 83.29% in the 3-weekly group; the median TTF was 6.7 and 6.5 months in the 2 weekly group and 3-weekly group, respectively. The median OS was 14.6 months (follow-up: 5.5–25.8 months) in the 2-weekly group whereas it was not reached in the 3-weekly group (follow-up: 7.9–15.6 months). The most common hematological AEs were anemia, lymphopenia, thrombocytopenia, and neutropenia whereas nausea, weakness, constipation, vomiting, and diarrhea were the most common (≥10%) nonhematological AEs. Overall, NDLS treatment was well tolerated without any new safety concerns. Conclusions Nanosomal docetaxel lipid suspension (2-weekly or 3-weekly) was effective and well tolerated in patients with metastatic castration-resistant prostate cancer.
Highlights
Prostate cancer is the second most common malignancy in men globally (1,276,106 new cases; 7.1% of all cancer cases) with the seventh highest cancer-related mortality (358,989 deaths, 3.8% of all cases) as per GLOBOCAN 2018 data [1]
Here, a multicenter, retrospective experience evaluating the efficacy and safety of Nanosomal docetaxel lipid suspension (NDLS) in the treatment of metastatic castration-resistant prostate cancer (mCRPC)
NDLS was administered as 50 mg/m2 in 2-weekly or 75 mg/m2 in 3-weekly cycles as a 1-hour infusion
Summary
Prostate cancer is the second most common malignancy in men globally (1,276,106 new cases; 7.1% of all cancer cases) with the seventh highest cancer-related mortality (358,989 deaths, 3.8% of all cases) as per GLOBOCAN 2018 data [1]. Androgen-deprivation therapy (ADT), which includes bilateral orchiectomy or medical castration with gonadotropin-releasing hormone analogues, has been the cornerstone for the management of advanced prostate cancer, which can provide palliation of symptoms and improves patient survival [2]. Despite initial favorable response with ADT, the disease progresses to castration-resistant prostate cancer (CRPC) in almost all patients [3]. Docetaxel was the first systemic agent to show survival advantage in mCRPC patients based on the pivotal Phase III TAX327 [4] and SWOG9916 [6] studies, and is considered as the standard first-line chemotherapy regimen [7]. Docetaxel has demonstrated effectiveness and tolerability as second-line chemotherapy in the management of mCRPC [8]. Docetaxel is generally administered at 75 mg/m2 dose as 3weekly cycles, but due to its tolerability and toxicity issues, weekly [9] and 2-weekly [10] regimens have been evaluated in CRPC, which have shown tolerability advantages over the 3-weekly dosing schedule
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