Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.

INTRODUCTION: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the United States. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system. METHODS: This post-marketing surveillance in Korea included patients in line with approved indications, i.e. patients with early or metastatic breast cancer or metastatic gastric cancer. Safety outcomes were adverse events and adverse drug reactions. Effectiveness outcomes were tumor response and event-free survival. RESULTS: 424 patients were evaluated: 366 patients (86%) with early breast cancer, 53 patients (13%) with metastatic breast cancer, and 5 patients (1%) with metastatic gastric cancer. Among patients with breast cancer, adverse events (mostly mild) and adverse drug reactions were reported by 158 (37.7%) and 57 (13.6%) patients, respectively. Most patients with an AE (141, 75.9%) had no change in treatment schedule. Treatment was temporarily suspended in 14 (8.2%) patients with an AE and completely discontinued in 7 (3.7%). Among patients with early and metastatic breast cancer who were evaluated for efficacy, objective response rates were 82.7% and 38.3%, respectively. Pathological complete response was 64.6% in patients with early breast cancer. DISCUSSION/CONCLUSION: Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab.

A disposable microfluidic device with a reusable magnetophoretic functional substrate for isolation of circulating tumor cells.

We describe an assembly-disposable microfluidic device based on a silicone-coated release polymer thin film. It consists of a disposable polymeric superstrate and a reusable functional substrate and they are assembled simply using vacuum pressure. The disposable polymeric superstrate is manufactured by bonding a silicone-coated release polymer thin film and a microstructured polydimethylsiloxane (PDMS) replica, containing only a simple structured microchannel. The reusable functional substrate generates an intricate energy field that can penetrate the micrometer-thick polymer film into the microchannel and control microfluids. This is the first report to introduce a silicone-coated release polyethylene terephthalate (PET) thin film as a bonding layer on a microstructured PDMS replica. The bonding strength was ∼600 kPa, which is the strongest among bonding methods of PDMS and PET polymer. Additionally, accelerated tests for bond stability and leakage demonstrated that the silicone-coated release PET film can form a very robust bond with PDMS. To demonstrate the usefulness of the proposed assembly-disposable microfluidic device, a lateral magnetophoretic microseparator was developed in an assembly-disposable microfluidic device format and was evaluated for isolating circulating tumor cells (CTCs) from patients with breast cancer.

Circulating tumor cell microseparator based on lateral magnetophoresis and immunomagnetic nanobeads.

This paper presents a circulating tumor cell (CTC) microseparator for isolation of CTCs from human peripheral blood using immunomagnetic nanobeads with bound antiepithelial cell adhesive molecule (EpCAM) antibodies that specifically bind to epithelial cancer cells. The isolation is performed through lateral magnetophoresis, which is induced by high-gradient magnetic separation technology, involving a ferromagnetic wire array inlaid in the bottom substrate of a microchannel. Experimental results showed that the CTC microseparator isolates about 90% of spiked CTCs in human peripheral blood at a flow rate of up to 5 mL/h and purifies to approximately 97%. The overall isolation procedure was completed within 15 min for 200 µL of peripheral blood. CTCs from peripheral blood of patients with breast and lung cancers were isolated with the CTC microseparator, and the results were compared with those of healthy donors. Using a fluorescence-based viability assay, the viability of CTCs isolated from peripheral blood of patients with cancer was observed. In addition, the usefulness of the CTC microseparator for subsequent genetic assay was confirmed by reverse-transcriptase polymerase chain reaction (RT-PCR) amplification of cancer-specific genes using CTCs isolated from patients with cancer.