Alginate-coated Silicone Implants with Anti-solvent Crystallized Paclitaxel to Prevent Breast Cancer Recurrence and Reduce Fibrosis

Abstract

Breast cancer patients undergoing mastectomy receive silicone implant-based breast reconstruction to mitigate the psychological distress of breast loss, typically in conjunction with adjuvant therapy. However, significant problems remain, such as systemic toxicity from chemotherapy and fibrosis that causes capsular contracture. Here, we report the development of a silicone implant coated with an alginate gel containing anti-solvent crystallized paclitaxel (acPTX). By anti-solvent crystallization, the compact formulation of acPTX ensures slow release for long-term breast cancer recurrence prevention. The mixture of acPTX and the biodegradable alginate gel, which reduces fibrosis, is uniformly coated onto the silicone implant using 3D printed implant-specific molds based on the shape obtained from 3D scanning. In a breast cancer recurrence mouse model, silicone implants coated with acPTX gel show a long-term preventive effect compared to gel-coated implants with commercially available PTX. Furthermore, animal studies using C57BL/6 mice show that alginate gel-coated implants significantly reduced capsule thickness, collagen density, and the number of fibrosis-related cells around the implant compared to silicone implants. The developed acPTX gel-coated implant presents a promising approach for breast reconstruction in mastectomized breast cancer patients. It provides a novel platform for developing implants with long-term drug release properties.