A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer
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 we...
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Wiley
2020-01-01
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| Series: | Prostate Cancer |
| Online Access: | http://dx.doi.org/10.1155/2020/4242989 |
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| author | Aseem Samar Srikant Tiwari Sundaram Subramanian Nisarg Joshi Jaykumar Sejpal Mujtaba A. Khan Imran Ahmad |
| author_facet | Aseem Samar Srikant Tiwari Sundaram Subramanian Nisarg Joshi Jaykumar Sejpal Mujtaba A. Khan Imran Ahmad |
| author_sort | Aseem Samar |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-31fadb8adb6e46e4b2fab1c908457ec4 |
| institution | Kabale University |
| issn | 2090-3111 2090-312X |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Prostate Cancer |
| spelling | doaj-art-31fadb8adb6e46e4b2fab1c908457ec42025-02-03T00:58:52ZengWileyProstate Cancer2090-31112090-312X2020-01-01202010.1155/2020/42429894242989A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate CancerAseem Samar0Srikant Tiwari1Sundaram Subramanian2Nisarg Joshi3Jaykumar Sejpal4Mujtaba A. Khan5Imran Ahmad6Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan 302017, IndiaJawaharlal Nehru Cancer Hospital & Research Centre, Bhopal, Madhya Pradesh 462001, IndiaVS Hospital, Madras Cancer Institute, Advanced Cancer Care, Chennai, Tamil Nadu 600031, IndiaMedical Affairs and Clinical Development, Intas Pharmaceuticals Ltd. Sola, Ahmedabad, Gujarat 380054, IndiaMedical Affairs and Clinical Development, Intas Pharmaceuticals Ltd. Sola, Ahmedabad, Gujarat 380054, IndiaMedical Affairs and Clinical Development, Intas Pharmaceuticals Ltd. Sola, Ahmedabad, Gujarat 380054, IndiaJina Pharmaceuticals Inc., Libertyville, Illinois 60048, USAPurpose. 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.http://dx.doi.org/10.1155/2020/4242989 |
| spellingShingle | Aseem Samar Srikant Tiwari Sundaram Subramanian Nisarg Joshi Jaykumar Sejpal Mujtaba A. Khan Imran Ahmad A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer Prostate Cancer |
| title | A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer |
| title_full | A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer |
| title_fullStr | A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer |
| title_full_unstemmed | A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer |
| title_short | A Multicentric, Retrospective Efficacy and Safety Study of Nanosomal Docetaxel Lipid Suspension in Metastatic Castration-Resistant Prostate Cancer |
| title_sort | multicentric retrospective efficacy and safety study of nanosomal docetaxel lipid suspension in metastatic castration resistant prostate cancer |
| url | http://dx.doi.org/10.1155/2020/4242989 |
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