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G. Xia
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-052 - Phase I Study and Pharmacokinetics of Paclitaxel Micelles for Injection in Chinese Patients with Advanced-Stage Malignancies (ID 3898)
14:30 - 14:30 | Author(s): G. Xia
- Abstract
Background:
Paclitaxel micelle for injection is a Cremophor-free, nanoscale, polymer micelles loaded paclitaxel formulation. The absence of Cremophor EL may permit Paclitaxel Micelle to be administered without the premedications used for the prevention of hypersensitivity reactions. The objective of this Phase I trial were to determine the toxic effects, maximum tolerated dose (MTD), Dose-limiting toxicity (DLT), pharmacokinetics(PKs) profile and recommended phase II dose of Paclitaxel Micelle.
Methods:
Dose escalation of paclitaxel micelle for injection followed the standard “3+3” rule, and started at does level 175 mg/m2. Eligible patients were treated with paclitaxel micelle given as a 3 h intravenous infusion on day 1 once every 3 weeks. Blood samples were collected to determine the PKs of paclitaxel micelle.
Results:
18 patients with advanced malignancies were enrolled and treated, including non-small cell lung cancer (NSCLC) 17 patients and breast cancer 1 patients. The dose of paclitaxel micelle for injection ranged from 175 mg/m2 (dose level 1) to 435 mg/m2 (dose level 5). All patients were evaluable for toxicity and antitumor response. The most common toxic reactions of paclitaxel micelles include neutropenia, peripheral nerve numbness and muscle pain, no acute hypersensitivity reactions were observed. DLT included grade 4 neutropenia, which occurred in 1 of 6 patients treated at 300 mg/m2 (level 3) and all of 3 patients at 435 mg/m2 (level 5), and grade 3 peripheral nerve numbness in 1 patient at 435 mg/m2 (level 5). The MTD was thus determined to be 390mg/m2 (level 4). Partial response was observed in 6 of 18 patients (33.3%), 3 of whom had prior exposure to paclitaxel chemotherapy. 9 patients (50%) had stable response and only 3 patients had disease progression. 18 patients completed 99 cycles of paclitaxel micelle chemotherapy (2~19 cycles), and now one patient at 390 mg/m2 (level 4) has been completed 19 cycles of chemotherapy and is still in treatment. The median PFS was 9.1months (95% CI,4.70-18.43). The paclitaxel Cmax and area under the curveinf values increased with escalating doses, which revealed paclitaxel micelles has linear PKs.
Conclusion:
In this study, Paclitaxel Micelles was administered safely without premedication for preventing hypersensitivity reactions and showed higher paclitaxel MTD without additional toxicity, which are more advantageous than conventional paclitaxel formulation in clinic treatment. Therefore, the recommended dose for the phase II study is 300 mg/m2.
