A phase I/II study of altered fractionated IMRT alone for intermediate T-stage oropharyngeal carcinoma

Strahlenther Onkol. 2010 Sep;186(9):489-95. doi: 10.1007/s00066-010-2093-6. Epub 2010 Aug 30.

Abstract

Background and purpose: To prospectively assess the feasibility and efficacy of an accelerated and hyperfractionated intensity- modulated radiation therapy (IMRT) schedule for intermediate T-stage oropharyngeal cancer.

Patients and methods: Patients with T3 or unfavorable T2 oropharyngeal squamous cell carcinoma were eligible; a three-dose level simultaneous integrated boost IMRT strategy was used, delivering 78, 69, and 60 Gy to gross disease, high-risk and low-risk target areas, respectively, in 60 twice daily fractions over 6 weeks. No sequential/concomitant systemic treatment or up-front radical surgery was allowed. Median follow-up is 41.7 months (range: 3.5-80.8 months).

Results: 25 patients were treated from 11/2002 to 11/2005. 92% of the individual fractions were delivered as scheduled. Grade 3 mucosal and skin toxicity was 100% and 72%, respectively, none of which persisted beyond 12 weeks; a percutaneous endoscopic gastrostomy tube was temporarily placed in 60% of patients. The estimated locoregional progression-free, distant metastases-free, and overall survival rates at 3 years were 86.3% ± 7.4%, 76.4% ± 9.6%, and 70.0% ± 9.6%, respectively. At the same time interval, the actuarial prevalence of grade 3+ CTCAE v3.0 toxicity was 26.1%.

Conclusion: While the routine clinical use of this exploratory schedule is discouraged, it may represent the basis for future developments.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Feasibility Studies
  • Gastrostomy
  • Humans
  • Neoplasm Staging
  • Oropharyngeal Neoplasms / mortality
  • Oropharyngeal Neoplasms / pathology
  • Oropharyngeal Neoplasms / radiotherapy*
  • Radiotherapy, Intensity-Modulated / adverse effects*
  • Radiotherapy, Intensity-Modulated / methods*
  • Skin / pathology
  • Skin / radiation effects
  • Survival Rate
  • Time Factors
  • Treatment Outcome