title: Pilot trial of concomitant chemotherapy with paclitaxel and split-course radiotherapy for very advanced squamous cell carcinoma of head and neck.
abstract: OBJECTIVE
  The combination of chemotherapy and irradiation is considered the standard of care for the treatment of advanced squamous cell carcinoma of head and neck (SCCHN). Paclitaxel has shown a single-agent activity in SCCHN. Besides, this drug is a promising radiosensitizer for some human solid tumors. This is a phase II trial to evaluate the feasibility, efficacy, and toxicity of paclitaxel administered concurrently with split-course radiotherapy in advanced unresectable SCCHN. Methods and Materials Thirty-one patients with advanced SCCHN were enrolled in this trial. Radiotherapy consisted of 66 to 70 Gy delivered over 8 to 10 weeks to the primary tumor and lymphatic drainage, with a fractionation scheme of 1.8 to 2 Gy/field/d. After the initial five patients were treated, a 1-week treatment break was introduced. Paclitaxel was administered weekly in a 1-hour intravenous infusion at a projected dosage of 45 mg/m(2)/wk.
  
  
  RESULTS
  The complete and partial response rates, based on a 4-week postradiation evaluation were 43.3% and 40%, respectively, with an overall response rate of 83.3%. Median survival was 49.4 weeks, and 1-year survival was 48%. Freedom from local progression was 65.6% at 1 year. Thirty-six percent and 20% of the patients are alive and disease free at 1 and 2 years, respectively. Grade 3/4 of acute toxicity consisted mostly of mucositis, cutaneous reaction, and weight loss.
  
  
  CONCLUSIONS
  Paclitaxel concurrent with radiotherapy seems to be active in squamous cell carcinoma of the head and neck. In the regimen selected for this trial, toxicity was significant and led to a prolongation of treatment time.
authors.affiliation: Hospital do Câncer, A. C. Camargo, Department of Medical Oncology, Rua Professor Antônio Prudente, 211; 2 degrees andar São Paulo SP, Brazil CEP 01509-010.
authors.forename: Olavo
authors.initials: O
authors.lastname: Feher
authors.forename: Sandro J
authors.initials: SJ
authors.lastname: Martins
authors.forename: Candice A
authors.initials: CA
authors.lastname: Lima
authors.forename: João V
authors.initials: JV
authors.lastname: Salvajoli
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Simpson
authors.forename: Luiz P
authors.initials: LP
authors.lastname: Kowalski
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000532:radiotherapy / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage; D015996:Survival Rate
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel