Severe weight loss and dehydration during RT for head and neck cancer is common. Prophylactic feeding gastrostomy tubes significantly reduce the incidence of severe weight loss and hospitalization for dehydration during RT when placed before onset of RT. Patients at risk for severe weight loss include those with severe pretreatment weight loss, tumors of the nasopharynx and base of tongue, or treatment with chemoradiation.

Although all three DeltaNp63 isoforms are present in HNSCC, DeltaNp63alpha protein is the predominant isoform expressed in these malignancies. DeltaNp63alpha is also overexpressed in tumors compared with matched normal tissue specimens and is underexpressed in the pro-apoptotic condition of lichen planus. These findings suggest that DeltaNp63alpha plays an anti-differentiation and anti-apoptotic role in the mucosal epithelium of the head and neck, possibly playing a pivotal role in the formation of HNSCC. Currently, DeltaNp63alpha is an attractive target for mechanistic study aimed at therapeutic intervention.

The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.

BackgroundTopical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid‐eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.MethodsA randomized, sham‐controlled, double‐blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in‐office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co‐primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review.ResultsPatients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant‐related serious adverse event (epistaxis).ConclusionSignificant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.