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Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study

Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hyp...

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Autores principales: Jain, Minish M., Gupte, Smita U., Patil, Shekhar G., Pathak, Anand B., Deshmukh, Chetan D., Bhatt, Niraj, Haritha, Chiramana, Govind Babu, K., Bondarde, Shailesh A., Digumarti, Raghunadharao, Bajpai, Jyoti, Kumar, Ravi, Bakshi, Ashish V., Bhattacharya, Gouri Sankar, Patil, Poonam, Subramanian, Sundaram, Vaid, Ashok K., Desai, Chirag J., Khopade, Ajay, Chimote, Geetanjali, Bapsy, Poonamalle P., Bhowmik, Shravanti
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4788678/
https://www.ncbi.nlm.nih.gov/pubmed/26941199
http://dx.doi.org/10.1007/s10549-016-3736-9
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author Jain, Minish M.
Gupte, Smita U.
Patil, Shekhar G.
Pathak, Anand B.
Deshmukh, Chetan D.
Bhatt, Niraj
Haritha, Chiramana
Govind Babu, K.
Bondarde, Shailesh A.
Digumarti, Raghunadharao
Bajpai, Jyoti
Kumar, Ravi
Bakshi, Ashish V.
Bhattacharya, Gouri Sankar
Patil, Poonam
Subramanian, Sundaram
Vaid, Ashok K.
Desai, Chirag J.
Khopade, Ajay
Chimote, Geetanjali
Bapsy, Poonamalle P.
Bhowmik, Shravanti
author_facet Jain, Minish M.
Gupte, Smita U.
Patil, Shekhar G.
Pathak, Anand B.
Deshmukh, Chetan D.
Bhatt, Niraj
Haritha, Chiramana
Govind Babu, K.
Bondarde, Shailesh A.
Digumarti, Raghunadharao
Bajpai, Jyoti
Kumar, Ravi
Bakshi, Ashish V.
Bhattacharya, Gouri Sankar
Patil, Poonam
Subramanian, Sundaram
Vaid, Ashok K.
Desai, Chirag J.
Khopade, Ajay
Chimote, Geetanjali
Bapsy, Poonamalle P.
Bhowmik, Shravanti
author_sort Jain, Minish M.
collection PubMed
description Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m(2) [n = 64] and 295 mg/m(2) [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m(2) every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m(2) every 3 weeks was effective and well tolerated and showed similar tolerability compared with nab-paclitaxel 260 mg/m(2) every 3 weeks. Statistically, significant differences were not observed in the PICN and nab-paclitaxel treatment arms for radiologist-assessed ORR or median PFS. The novel paclitaxel formulation, PICN, offers apart from efficacy, potential safety advantage of decreased use of corticosteroid pretreatment and the absence of the risk of transmission of blood product-borne disease.
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spelling pubmed-47886782016-04-09 Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study Jain, Minish M. Gupte, Smita U. Patil, Shekhar G. Pathak, Anand B. Deshmukh, Chetan D. Bhatt, Niraj Haritha, Chiramana Govind Babu, K. Bondarde, Shailesh A. Digumarti, Raghunadharao Bajpai, Jyoti Kumar, Ravi Bakshi, Ashish V. Bhattacharya, Gouri Sankar Patil, Poonam Subramanian, Sundaram Vaid, Ashok K. Desai, Chirag J. Khopade, Ajay Chimote, Geetanjali Bapsy, Poonamalle P. Bhowmik, Shravanti Breast Cancer Res Treat Clinical Trial Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m(2) [n = 64] and 295 mg/m(2) [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m(2) every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m(2) every 3 weeks was effective and well tolerated and showed similar tolerability compared with nab-paclitaxel 260 mg/m(2) every 3 weeks. Statistically, significant differences were not observed in the PICN and nab-paclitaxel treatment arms for radiologist-assessed ORR or median PFS. The novel paclitaxel formulation, PICN, offers apart from efficacy, potential safety advantage of decreased use of corticosteroid pretreatment and the absence of the risk of transmission of blood product-borne disease. Springer US 2016-03-03 2016 /pmc/articles/PMC4788678/ /pubmed/26941199 http://dx.doi.org/10.1007/s10549-016-3736-9 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Clinical Trial
Jain, Minish M.
Gupte, Smita U.
Patil, Shekhar G.
Pathak, Anand B.
Deshmukh, Chetan D.
Bhatt, Niraj
Haritha, Chiramana
Govind Babu, K.
Bondarde, Shailesh A.
Digumarti, Raghunadharao
Bajpai, Jyoti
Kumar, Ravi
Bakshi, Ashish V.
Bhattacharya, Gouri Sankar
Patil, Poonam
Subramanian, Sundaram
Vaid, Ashok K.
Desai, Chirag J.
Khopade, Ajay
Chimote, Geetanjali
Bapsy, Poonamalle P.
Bhowmik, Shravanti
Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title_full Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title_fullStr Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title_full_unstemmed Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title_short Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study
title_sort paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase ii/iii study
topic Clinical Trial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4788678/
https://www.ncbi.nlm.nih.gov/pubmed/26941199
http://dx.doi.org/10.1007/s10549-016-3736-9
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