title: Comparison of four cisplatin-based radiochemotherapy regimens for nonmetastatic stage III/IV squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  To compare the outcomes of four cisplatin-based radiochemotherapy regimens in 311 patients with Stage III/IV squamous cell carcinoma of the head and neck.
  
  
  METHODS
  Concurrent chemotherapy consisted of three courses of cisplatin 100 mg/m(2) on Day 1 (Group A, n = 74), two courses of cisplatin 20 mg/m(2) on Days 1-5 plus 5-fluorouracil 1,000 mg/m(2) on Days 1-5 (Group B, n = 49), two courses of cisplatin 20 mg/m(2) on Days 1-5 plus 5-fluorouracil 600 mg/m(2) on Days 1-5 (Group C, n = 102), or two courses of cisplatin 20 mg/m(2) on Days 1-5 (Group D, n = 86). The groups were retrospectively compared for toxicity and outcomes, and 11 additional factors were evaluated for outcomes.
  
  
  RESULTS
  No significant difference was observed among the groups regarding radiation-related acute oral mucositis and radiation-related late toxicities. Acute Grade 3 skin toxicity was significantly more frequent in Group B than in the patients of the other three groups (p = .013). The chemotherapy-related Grade 3 nausea/vomiting rate was 24% for Group A, 8% for Group B, 9% for Group C, and 6% for Group D (p = .003). The corresponding Grade 3 nephrotoxicity rates were 8%, 1%, 2%, and 1% (p = .019). The corresponding Grade 3-4 hematologic toxicity rates were 35%, 41%, 19%, and 21% (p = .027). Chemotherapy could be completed in 50%, 59%, 74%, and 83% of the Group A, B, C, and D patients, respectively (p = .002). Toxicity-related radiotherapy breaks occurred in 39%, 43%, 21%, and 15% of Groups A, B, C, and D, respectively (p = .005). The 3-year locoregional control rate was 67%, 72%, 60%, and 59% for Groups A, B, C, and D, respectively (p = .48). The corresponding 3-year metastasis-free survival rates were 67%, 74%, 63%, and 79% (p = .31), and the corresponding 3-year survival rates were 60%, 63%, 50%, and 71% (p = .056). On multivariate analysis, Karnofsky performance status, histologic grade, T/N category, preradiotherapy hemoglobin level, completion of chemotherapy, and radiotherapy breaks were associated with the outcome.
  
  
  CONCLUSIONS
  The four compared radiochemotherapy regimens were not significantly different regarding treatment outcomes. Two courses of cisplatin 20 mg/m(2) on Days 1-5 were better tolerated than the other three regimens.
authors.affiliation: Department of Radiation Oncology, University of Lubeck, Lubeck, Germany. Rades.Dirk@gmx.net
authors.forename: Dirk
authors.initials: D
authors.lastname: Rades
authors.forename: Stefanie
authors.initials: S
authors.lastname: Kronemann
authors.forename: Thekla
authors.initials: T
authors.lastname: Meyners
authors.forename: Guenther
authors.initials: G
authors.lastname: Bohlen
authors.forename: Silke
authors.initials: S
authors.lastname: Tribius
authors.forename: Nadja
authors.initials: N
authors.lastname: Kazic
authors.forename: Ursula
authors.initials: U
authors.lastname: Schroeder
authors.forename: Samer G
authors.initials: SG
authors.lastname: Hakim
authors.forename: Steven E
authors.initials: SE
authors.lastname: Schild
authors.forename: Juergen
authors.initials: J
authors.lastname: Dunst
mesh_terms: D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D010610:Pharyngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D011832:Radiation Injuries / Q000150:complications; D011855:Radiodermatitis / Q000209:etiology; D013280:Stomatitis / Q000209:etiology; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D002945:Cisplatin; D005472:Fluorouracil