title: Concurrent chemoradiation in locally advanced head and neck cancers: a comparative study of weekly Paclitaxel versus Cisplatin-based regimen.
abstract: BACKGROUND
  Concurrent chemoradiotherapy is the standard of care for patients with unresectable locally advanced squamous cell carcinoma of head and neck (LASCCHN). The optimal chemotherapy agents and their dose schedules have yet to be defined. Cisplatin improves the anti-tumour efficacy of radiation therapy (RT) with 5-year loco-regional control rates between 35-70%. The last decade witnessed the introduction of new chemotherapeutic agents. Among these, taxane-based chemotherapies emerged as one of the most powerful compounds that might improve loco-regional control. The aim of this study was to compare the outcome and toxicity of weekly paclitaxel with weekly cisplatin-based concurrent chemoradiation in LA-SCCHN.
  
  
  METHODS
  Fifty two untreated patients with LA-SCCHN were enrolled in a chemoradiation feasibility study in the Oncology Department, Assuit University Hospital, between the time period from November 2006 to September 2008 of whom forty one patients were eligible for the study. The patients were randomized into 2 groups; group I (21 patients) who received paclitaxel 30mg/m2 I.V 1 hour infusion weekly and group II (20 patients) received Cisplatin 30mg/m2, I.V 2 hours infusion weekly, both during the course of radiation therapy. All patients received 66-70Gy concurrent radiation using a linear accelerator with 6mv photons, at the rate of 2Gy/day, 5 fractions/week, over a period of 6-7 weeks. Response was assessed according to WHO criteria and toxicity according to Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria and NCI-CTC version 2.
  
  
  RESULTS
  Complete response was achieved in 57.1% of patients in group I and 50% of patients in group II while partial response was achieved in 28.6% in group I and 25% in group II. Thus, the objective overall response was 85.7% in group I versus 75% in group II with no statistically significant difference (p=0.3). The median duration of follow-up was 15 months in group I (range 9- 28 months) while it was 16.5 months for group II (range7- 29 months). The median progression free survival (PFS) was 26 months for group I and 22 months for group II. The 1-year PFS was 80.7% and 64% for group I and group II while the 2-year PFS were 52.2 and 41.1% for group I and group II respectively with no statistically significant difference (p=0.5). The median survival was 27 and 25 months for group I and II respectively. The1-year overall survival (OS) was 80.7% and 64.6% for group I and II while the 2-year OS was 58.4 and 46% for group I and group II respectively with no statistically significant difference (p=0.41). Treatment toxicities including skin reactions, mucositis and dysphagia were comparable in both groups and tolerable.
  
  
  CONCLUSIONS
  The results of weekly paclitaxel schedule in the treatment of LA-SCCHN were comparable to those of weekly cisplatin schedule with no additional efficacy. So, concurrent chemoradiotherapy with weekly paclitaxel is feasible when contraindication to cisplatin exists as in cases of fear of hearing loss or renal disease.
  
  
  BACKGROUND
  Chemoradiation - Paclitaxel - Cisplatin - Locally advanced head and neck cancers.
authors.affiliation: The Departments of Oncology and Otolaryngology, Faculty of Medicine, Assuit University, Egypt.
authors.forename: Hoda H
authors.initials: HH
authors.lastname: Essa
authors.forename: Mohammed
authors.initials: M
authors.lastname: Azzam