title: Hedgehog pathway inhibitor in combination with radiation therapy for basal cell carcinomas of the head and neck : First clinical experience with vismodegib for locally advanced disease.
abstract: BACKGROUND
  Definitive radiotherapy and vismodegib, an oral inhibitor of the hedgehog pathway, are both established treatment options for locally advanced basal cell carcinomas (BCC). Both have shown good results in local tumor control; however, the effects concerning advanced tumors are often not of a lasting nature and to date no systematic data about the combination of the two modalities are available.
  
  
  METHODS
  We retrospectively analyzed four patients who received vismodegib and radiotherapy in combination. Radiation doses varied between 50.4 Gy and 66.0 Gy. Three patients had recurrent BCC. One patient had locoregional lymph node involvement. Vismodegib was taken once a day (150 mg) during the entire time of irradiation and beyond upon instructions of the attending dermatologist.
  
  
  RESULTS
  In three cases a persistent complete response was observed, in one case the tumor remained stable for approximately 6 months until further tumor progression was documented. The combined therapy was well tolerated in all cases. No exceptional side effects pointing at a drug-radiation interaction were observed.
  
  
  CONCLUSIONS
  The combination of vismodegib and radiation seems feasible and the initial results are promising. In our cohort, there was no increase in unexpected side effects. Further research is needed to evaluate the significance of this combined therapy.
authors.affiliation: Department of Radiation Oncology, University Hospital Johann Wolfgang Goethe University, Theodor Stern Kai 7, 60590, Frankfurt, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Schulze
authors.affiliation: Department of Dermatology, University Hospital Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Meissner
authors.affiliation: Department of Craniofacial and Plastic Surgery, University Hospital Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: Shahram
authors.initials: S
authors.lastname: Ghanaati
authors.affiliation: Department of Diagnostic and Interventional Radiology, University Hospital Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: Iris
authors.initials: I
authors.lastname: Burck
authors.affiliation: Department of Radiation Oncology, University Hospital Johann Wolfgang Goethe University, Theodor Stern Kai 7, 60590, Frankfurt, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Rödel
authors.affiliation: Department of Radiation Oncology, University Hospital Johann Wolfgang Goethe University, Theodor Stern Kai 7, 60590, Frankfurt, Germany. panagiotis.balermpas@kgu.de.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Balermpas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D011725:Pyridines / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D000813:Anilides; C538724:HhAntag691; D011725:Pyridines
keywords: Basal cell carcinoma; Combination therapy; Hedgehog pathway; Radiation; Vismodegib