title: High-dose superselective intra-arterial cisplatin and concomitant radiation (RADPLAT) for advanced head and neck cancer.
abstract: BACKGROUND
  The purpose of this study was to study the effect of intensive targeted chemoradiation in a group of patients with head and neck cancer with stage IV inoperable disease.
  
  
  METHODS
  We examined 79 patients with inoperable stage IV head and neck cancer receiving intra-arterial infusion of high-dose cisplatin (150 mg/m(2)) on days 2, 9, 16, and 23 concomitant with delivery of external beam radiotherapy (total dose, 70 Gy; 2 Gy, 35 fractions; 1 fraction/day for 7 weeks). Sodium thiosulfate was administered intravenously to provide effective cisplatin neutralization.
  
  
  RESULTS
  Four patients were not assessable. Complete local tumor response was achieved in 72 patients (91%) and a partial response in three patients. The complete response rate of neck node metastases was 90%. The 1- and 2-year locoregional control rates were 82% and 69%, respectively. The median overall survival time was 2.2 years, with a 3-year overall survival probability of 43%. Acute toxicities were as follows: grade III/IV hematologic toxicity (22%/16%), grade III/IV nephrotoxicity (0%), grade III mucositis (43%), grade III skin reactions (24%), grade III toxicity of the upper gastrointestinal tract (57%), grade III nausea (20%), and grade III subjective hearing loss (10%). Grade V toxicity (treatment-related deaths) was 3.8%. Six (18%) of 33 patients with complete remission needed tube feeding 2 years after treatment without intercurrent salvage surgery.
  
  
  CONCLUSIONS
  Supradose superselective intra-arterial cisplatin and concomitant radiation is an effective organ-preserving therapy in an unfavorable group of patients. Our series confirms encouraging results reported previously. This regimen is justified in unresectable patients despite the substantial toxicity.
authors.affiliation: Department of Head and Neck Oncology, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. a.balm@nki.nl
authors.forename: Alfons J M
authors.initials: AJ
authors.lastname: Balm
authors.forename: Coen R N
authors.initials: CR
authors.lastname: Rasch
authors.forename: Jan H
authors.initials: JH
authors.lastname: Schornagel
authors.forename: Frans J M
authors.initials: FJ
authors.lastname: Hilgers
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Keus
authors.forename: Leo
authors.initials: L
authors.lastname: Schultze-Kool
authors.forename: Annemieke H
authors.initials: AH
authors.lastname: Ackerstaff
authors.forename: Wim
authors.initials: W
authors.lastname: Busschers
authors.forename: I Bing
authors.initials: IB
authors.lastname: Tan
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D034381:Hearing Loss / Q000139:chemically induced; D006333:Heart Failure / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007261:Infusions, Intra-Arterial; D002546:Ischemic Attack, Transient / Q000139:chemically induced; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects; D009325:Nausea / Q000139:chemically induced; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012871:Skin Diseases / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin