title: Phase I trial of radiochemotherapy with bendamustine in patients with recurrent squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  After initial radiochemotherapy of head-and-neck cancers, therapeutic options are often limited for patients with progressive disease. Reirradiation, with or without chemotherapy, appears to be the most potential treatment option. The aim of this study was to determine the maximum tolerated dose of bendamustine in combination with reirradiation for these patients.
  
  
  METHODS
  13 patients with recurrent squamous cell carcinoma of the head-and-neck region after initial radiochemotherapy were treated. Reirradiation of the recurrent region under protection of the spinal cord consisted of 1.8 Gy given five times per week, up to 30.6 Gy. Simultaneous bendamustine was administered on days 1 and 2 at increasing dose levels (80, 100, and 120 mg/m(2) bendamustine). The regimen was administered every 4 weeks. A minimum of three patients were enrolled at each dose level.
  
  
  RESULTS
  The therapy was well tolerated. Patients received one to six cycles of bendamustine (median: three). Hematologic toxicities observed were leukocytopenia, thrombocytopenia, or anemia. At dose level II (100 mg/m(2) bendamustine), grade 3/4 hematologic toxicity was seen in one patient so that this level was filled up to six patients. There was no grade 3/4 toxicity seen in the other twelve patients. The most frequent nonhematologic toxicities (grade 1 or 2) were infections (in most cases C-reactive protein elevations without other clinical signs of infection) and nausea.
  
  
  CONCLUSIONS
  The reapplication of radiochemotherapy with bendamustine is well tolerated. The recommended dose for phase II studies was established at dose level III (bendamustine 120 mg/m(2)).
authors.affiliation: Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Ulm, Germany. dirk.bottke@uniklinik-ulm.de
authors.forename: Dirk
authors.initials: D
authors.lastname: Bottke
authors.forename: Kathrin
authors.initials: K
authors.lastname: Bathe
authors.forename: Thomas
authors.initials: T
authors.lastname: Wiegel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hinkelbein
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000532:radiotherapy*; D009588:Nitrogen Mustard Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010039:Otorhinolaryngologic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride