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A multicenter phase II randomized study of Cremophor‐free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline
Author(s) -
Ranade Anantbhushan A,
Bapsy Poonamalle P,
Nag Shona,
Raghunadharao Digumarti,
Raina Vinod,
Advani Suresh H,
Patil Shekhar,
Maru Anish,
Gangadharan Vadavattath Padmanabhan,
Goswami Chanchal,
Sekhon Jagdev Singh,
Sambasivaiah Kuraparthy,
Parikh Purvish,
Bakshi Ashish,
Mohapatra Ranjan
Publication year - 2013
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12035
Subject(s) - paclitaxel , premedication , medicine , metastatic breast cancer , breast cancer , neutropenia , taxane , chemotherapy , lung cancer , anthracycline , randomized controlled trial , pharmacology , urology , cancer , oncology , surgery
Aims Paclitaxel is extensively used in the treatment of advanced carcinomas of the breast, ovary and non‐small cell lung cancer. In clinical use it is formulated in the non‐ionic surfactant polyethoxylated castor oil (Cremophor) and dehydrated alcohol to enhance drug solubility. Cremophor adds to toxic effects of paclitaxel by producing or contributing to the well‐described hypersensitivity reactions that commonly occur during its infusion, affecting a large number of patients. This randomized trial was conducted to evaluate efficacy and safety of novel nanoparticle‐based paclitaxel in the treatment of patients with advanced breast cancer. Method Patients were randomized to receive either nanoparticle paclitaxel ( NP) 300 mg/m 2 , ( NP 300) or NP 220 mg/m 2 or Cremophor paclitaxel 175 mg/m 2 ( CP 175). NP was administered as a 1‐h infusion without premedication and CP as a 3‐h infusion with premedication every 3 weeks. Results In total, 194 patients who had been administered at least one dose were included for safety analysis and 170 patients who completed at least two cycles of therapy were analyzed for efficacy. NP showed an overall response rate (complete response + partial response) of 40% in the NP 220 and NP 300 arms as compared to 31% in the CP arm. The incidence of neutropenia (all grades) was lowest in the NP 220 arm (39.4%) compared to the NP 300 (55%) and CP arm (50%). Conclusion NP is well tolerated and can be safely administered without any premedication in comparison to conventional paclitaxel, which requires the use of premedication before administration. NP demonstrates promising efficacy with a favorable safety profile.