Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study.

PURPOSE: Pembrolizumab is a humanized monoclonal antibody that blocks interaction between programmed death receptor-1 (PD-1) and its ligands (PD-L1, PD-L2). Although pembrolizumab is approved for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), its role in the management of locally advanced (LA) disease is not defined. We report a phase IB study evaluating the safety and efficacy of adding pembrolizumab to cisplatin-based chemoradiotherapy in patients with LA HNSCC. PATIENTS AND METHODS: Eligible patients included those with oral cavity (excluding lip), oropharyngeal, hypopharyngeal, or laryngeal stage III to IVB HNSCC (according to American Joint Committee on Cancer, 7th edition, staging system) eligible for cisplatin-based, standard-dose (70 Gy) chemoradiotherapy. Pembrolizumab was administered concurrently with and after chemoradiotherapy with weekly cisplatin. Safety was the primary end point and was determined by incidence of chemoradiotherapy adverse events (AEs) and immune-related AEs (irAEs). Efficacy was defined as complete response (CR) rate on end-of-treatment (EOT) imaging or with pathologic confirmation at 100 days postradiotherapy completion. Key secondary end points included overall (OS) and progression-free survival (PFS). RESULTS: The study accrued 59 patients (human papillomavirus [HPV] positive, n = 34; HPV negative, n = 25) from November 2015 to October 2018. Five patients (8.8%) required discontinuation of pembrolizumab because of irAEs, all of which occurred during concurrent chemoradiotherapy; 98.3% of patients completed the full planned treatment dose (70 Gy) of radiotherapy without any delays ≥ 5 days; 88.1% of patients completed the goal cisplatin dose of ≥ 200 mg/m2. EOT CR rates were 85.3% and 78.3% for those with HPV-positive and -negative HNSCC, respectively. CONCLUSION: Pembrolizumab in combination with weekly cisplatin-based chemoradiotherapy is safe and does not impair delivery of curative radiotherapy or chemotherapy in HNSCC. Early efficacy data support further investigation of this approach.

Pathologic characteristics of exophytic renal masses.

OBJECTIVE: Pathologic grade is an important prognostic factor for renal-cell carcinoma (RCC). The objective of this study was to determine if there is any association of radiologic characteristics with pathologic grade and type of small renal tumors. PATIENTS AND METHODS: We retrospectively reviewed the records of 500 patients who underwent extirpative renal surgery. Fifty-one patients met the inclusion criteria of solitary RCC <6 cm and adequate radiologic imaging available for review. The axial images with the largest area of tumor growing into the kidney were evaluated by a single radiologist to determine the percent of tumor that was exophytic. RESULTS: Nine patients had tumors that were >67% exophytic, and 42 patients had tumors <67% exophytic. There is a statistically significant difference in the mean Fuhrman grade for these 2 groups (1.78 v 2.25, P < 0.01). The distribution of histologic subtype was as follows: 34 patients with clear cell, 15 with papillary, and one each with chromophobe and unclassified tumors. Papillary RCC comprised 78% (7 of 9) of tumors that were >67% exophytic and 15% (3 of 20) that were <33% exophytic. The relative risk of a >67% exophytic tumor being papillary v nonpapillary is 4.1. CONCLUSIONS: Exophytic renal tumors are more likely to be of lower pathologic grade and of the papillary RCC subtype when compared with endophytic renal tumors. A larger prospective study is required to confirm these findings and determine the implications. This information may be useful when small tumors are being considered for watchful waiting or ablative therapies.

Appendicitis due to tongue stud ingestion: a case study and review of management plans.

Among the causes of appendicitis, foreign body obstruction of the appendiceal lumen is one of the rarest. In the majority of cases, swallowed foreign bodies pass through the alimentary system without causing any significant disease manifestation. Of those items that are swallowed, rigid and/or sharp ones, such as needles, have the greatest potential to enter the appendiceal lumen and cause an inflammatory reaction with or without perforation. In this case report, appendectomy was performed in a patient who was symptomatic after swallowing a sharp foreign body.