Background To determine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of a single cycle of RM-1929 photoimmunotherapy, an anti-EGFR antibody cetuximab conjugated with a light-activatable dye (IRDye®700DX), in Japanese patients with recurrent head and neck squamous cell carcinoma (rHNSCC). Methods Patients received a single fixed dose (640 mg/m2) of RM-1929 and a fixed light treatment dose (50 J/cm2 for superficial illumination; 100 J/cm fiber diffuser length for interstitial illumination). Safety, tumor response (modified RECIST v1.1 by central radiology review), pharmacokinetics, and immunogenicity were evaluated. Results Three Japanese patients were enrolled who had failed ≥ 3 prior lines of therapy including radiation, chemotherapy, cetuximab, and immunotherapy. Target lesions were: submental lesion; right superficial cervical node lesion and oropharynx lesion; and external auditory canal lesion. All patients experienced ≥ 1 treatment-emergent adverse event (TEAE), but none were considered dose-limiting. TEAEs were mild to moderate in severity except for one grade 3 application-site pain, which was transient, resolved without sequelae within 24 h, and did not affect study treatment administration. Thirteen of 17 TEAEs reported were possibly or probably related to study treatment. Three patient reports of application-site pain and localized edema were deemed probably related to study treatment. Objective response was observed in two patients (both partial responses). The third patient had disease progression. RM-1929 concentrations and pharmacokinetic parameters were similar in all patients. No patients tested positive for anti-drug antibodies. Conclusions RM-1929 photoimmunotherapy showed a manageable safety profile in rHNSCC. Tumor response in these heavily pre-treated patients was clinically meaningful and warrants further investigation. Clinical trial registration The trial was registered with the Japanese registry of clinical trials as jRCT2031200133.

Laryngeal papillomatosis has a high rate of recurrence after surgery. Narrow band imaging (NBI) is a novel optical enhancement technology used for the diagnosis. This is the first report to date to indicate the availability of the combination of laryngomicro surgery and videoendoscopic surgery for laryngeal papillomatosis using NBI technology. The patients were a 34-year-old man and a 30-year-old man. Both patients underwent surgery in another hospital. However, due to recurrence, they were subsequently referred to the authors' department for further evaluation. The presence of papillomas was confirmed by NBI, and the papillomas were removed using an XPS Micro Debrider and a CO2 laser. Using the NBI system, the border between the normal mucosa and the papillomas could be clearly identified, allowing precise resection. Further treatment on the lesions has been carried out several times to date using NBI. The lesions have now been eradicated without further recurrence.

Objectives: Although our group has had mostly successful results with clinical application of a tracheal prosthesis, delayed epithelial regeneration remains a problem. In our previous studies using rats, it was demonstrated that tracheal fibroblasts accelerated proliferation and differentiation of the tracheal epithelium in vitro and in vivo. The purpose of this study was to evaluate the effects of fibroblasts on epithelial regeneration in larger tracheal defects in rabbits. Methods: We developed a bioengineered scaffold, the luminal surface of which was coated with fibroblasts. This scaffold was implanted into tracheal defects in 12 rabbits (bioengineered group), and scaffolds without fibroblasts were implanted in 12 rabbits (control group). The regenerated epithelium was histologically examined by light microscopy, scanning electron microscopy, and immunohistochemical studies. Results: In the bioengineered group, a stratified squamous epithelium was observed on the surface 7 days after transplantation. However, in the control group, the scaffolds were exposed. Fourteen days after implantation, a columnar ciliated epithelium was observed in the bioengineered group. The average thickness of the regenerated epithelium in the bioengineered group was significantly greater than that in the control group. Conclusions: This study indicated that fibroblasts had a stimulatory effect that hastened regeneration of the epithelium in large tracheal defects.

No abstract

This study indicated that fibroblasts had a stimulatory effect that hastened regeneration of the epithelium in large tracheal defects.