title: Gemcitabine in the treatment of advanced head and neck cancer.
abstract: OBJECTIVE
  Several new chemotherapy agents show varying degrees of activity in head and neck cancer. One of them is gemcitabine, which is a new nucleoside analogue with an innovative cytostatic mode of action. Gemcitabine has demonstrated a broad spectrum anti-tumoural effect and a favourable toxicity profile. These attributes prompted us to introduce gemcitabine into the treatment of head-and-neck tumours.
  
  
  METHODS
  Ten heavily pre-treated patients with recurrent and incurable squamous-cell carcinoma of the head and neck (SCCHN) were treated with Gem. The initial cycle consisted of six administrations of the drug (1250 mg/m2 once weekly intravenously over 30 min) followed by a week without cytotoxic treatment. All following cycles were composed of two infusions once weekly (d1, 8), followed by a week of rest.
  
  
  RESULTS
  Toxic effects, length of survival and tumour response was assessable in eight patients owing to one suicide and loss of one patient for follow-up. One complete remission, two partial remissions and three 'no change' situations (stable disease) were observed, yielding a response rate of 37.5%. Median survival was 8 months (range 3-12). The incidence of haematological toxicity was low, with grade 3-4 neutropenia in less than 10%. Flu-like symptoms were reported by one-third of patients.
  
  
  CONCLUSIONS
  In this small phase-II study, gemcitabine demonstrated a high anti-tumoural activity in SCCHN, with a favourable toxicity profile. Gemcitabine seems to be a promising new drug without severe burden even for patients who are refractory to other cytostatic drugs. Within recent years, the activity and tolerability of gemcitabine was documented in several phase I and phase II trials, especially in combination with cisplatin, and paclitaxel resp, carboplatin/paclitaxel, cisplatin/ifosfamide, and 5-fluorouracil/paclitaxel. The results of these trials will be outlined in the discussion.
authors.affiliation: Clinic and Policlinic for Oral and Maxillofacial Surgery, Plastic Surgery, Germany. jan-dirk.raguse@charite.de
authors.forename: J D
authors.initials: JD
authors.lastname: Raguse
authors.forename: H J
authors.initials: HJ
authors.lastname: Gath
authors.forename: J
authors.initials: J
authors.lastname: Bier
authors.forename: H
authors.initials: H
authors.lastname: Riess
authors.forename: H
authors.initials: H
authors.lastname: Oettle
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D011878:Radiotherapy; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine