Abstract
1115 Background: Nanoparticle paclitaxel (NP), DO/NDR/02 is a cremophor-free polymer based formulation of paclitaxel, developed to alleviate the toxicities associated with cremophor component of conventional paclitaxel (CP). Methods: This phase II (N = 194), open label, randomized, three-arm study was conducted in anthracycline failed advanced recurrent/metastatic breast cancer patients. Estrogen/progesterone receptor positive patients were excluded. Sixty-four patients received CP as a 3-hour intravenous (i.v.) infusion at 175 mg/m2 along with standard premedication, 64 patients received a one-hour i.v. infusion of NP at 300 mg/m2 (NP-300) and 66 patients received 220 mg/m2 (NP-220), without premedication. Treatment was administered at three-week intervals for 6 cycles. Efficacy was assessed using Response Evaluation Criteria in Solid Tumours (RECIST) and adverse events were graded as per National Cancer Institute Common Terminology Criteria (NCICTC) version 3. Results: Demographic data revealed that the disease burden with respect to the number of metastatic sites, presence of liver metastasis and raised tumour marker (CA 15.3) levels was higher in the NP-300 arm as compared to NP-220 and CP-175 arms. Other demographic characteristics were comparable in the three arms. Efficacy analysis revealed 40% objective response rate (ORR) each with NP-300 and NP-220, while CP had an ORR of 32.3%. Stable disease was 32.7% and 29.0% for NP-300 and NP-220, respectively; and 27.3% for CP. Progressive disease for NP-300 was 27.3% and NP-220 was 32.7% compared to 38.7% with CP. Hypersensitivity was not observed with NP inspite of absence of premedication. Incidence of neutropenia was 56.3% and 39.4% with NP-300 and NP-220, respectively; and 50% with CP. Grade 4 neutropenia was 21.8%, 12.1% and 14% with NP-300, NP-220 and CP, respectively. There was no grade 4 neuropathy. Grade 3 sensory neuropathy was observed in 12.5% and 1.5% patients with NP-300 and NP-220, respectively and 6.3% with CP. Conclusions: Nanoparticle paclitaxel (DO/NDR/02) can be safely administered as one-hour i.v. infusion without any premedication. Although, this study was not designed as powered study, but the novel formulation has shown improved efficacy and safety. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Dabur Research Foundation Dabur Research Foundation Dabur Research Foundation
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