title: Paclitaxel by three-hour infusion and carboplatin in advanced carcinoma of nasopharynx and other sites of the head and neck. A phase II study conducted by the Hellenic Cooperative Oncology Group.
abstract: BACKGROUND
  Paclitaxel has been demonstrated to have significant activity in recurrent or metastatic head and neck cancer (HNC). In addition, the combination of paclitaxel and cisplatin is active in untreated patients with inoperable HNC. Substitution of carboplatin for cisplatin allows the treatment to be delivered on an outpatient basis.
  
  
  OBJECTIVE
  To evaluate the activity and toxicity of the combination of paclitaxel by three-hour infusion and carboplatin as first-line chemotherapy in patients with recurrent or metastatic HNC.
  
  
  METHODS
  From March 1994 until August 1996, 49 patients with recurrent or metastatic HNC were treated with paclitaxel (200 mg/m2, by three-hour infusion) followed by carboplatin at an AUC of 7 mg.min/ml, every four weeks. G-CSF was administered prophylactically on days 2 to 12 of each cycle. There were 41 men and 8 women with a median age of 57 years (range 23-73). The majority of the patients were symptomatic and they had recurrent disease locoregionally. Fourteen patients had nasopharyngeal cancer (NPC) and 35 had squamous cell cancers of other areas of the head and neck region (non-NPC).
  
  
  RESULTS
  At the completion of treatment, two patients with NPC demonstrated complete and six partial responses for an overall response rate of 57% (95% CI 29%-82%). Among patients with non-NPC, the response rate was 23% (95% CI 9%-37%). After a median follow up period of 15 months, the median time to progression was 4.3 months in the non-NPC group and 16.5 months in the NPC group. At the time of the analysis, median survival had not been reached in NPC while it was 7.3 months in non-NPC patients. Grade 3-4 toxicities included anemia (2%) and leukopenia, thrombocytopenia, stomatitis, nausea/vomiting and diarrhea (4% each).
  
  
  CONCLUSIONS
  The combination of paclitaxel and carboplatin appears to be well tolerated but only moderately active in patients with advanced non-NPC of the head and neck region. However, its activity appears promising in NPC and deserves further investigation.
authors.affiliation: AHEPA Hospital, Aristotle University of Thessaloniki, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
authors.forename: D
authors.initials: D
authors.lastname: Skarlos
authors.forename: A
authors.initials: A
authors.lastname: Athanassiades
authors.forename: A
authors.initials: A
authors.lastname: Kalogera-Fountzila
authors.forename: E
authors.initials: E
authors.lastname: Samantas
authors.forename: C
authors.initials: C
authors.lastname: Bacoyiannis
authors.forename: A
authors.initials: A
authors.lastname: Nicolaou
authors.forename: N
authors.initials: N
authors.lastname: Dombros
authors.forename: E
authors.initials: E
authors.lastname: Briasoulis
authors.forename: M
authors.initials: M
authors.lastname: Dinopoulou
authors.forename: G
authors.initials: G
authors.lastname: Stathopoulos
authors.forename: N
authors.initials: N
authors.lastname: Pavlidis
authors.forename: P
authors.initials: P
authors.lastname: Kosmidis
authors.forename: J
authors.initials: J
authors.lastname: Daniilidis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D016190:Carboplatin; D017239:Paclitaxel