A phase I/II study of altered fractionated IMRT alone for intermediate T-stage oropharyngeal carcinoma.
OBJECTIVE
To prospectively assess the feasibility and efficacy of an accelerated and hyperfractionated intensity- modulated radiation therapy (IMRT) schedule for intermediate T-stage oropharyngeal cancer.


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%.


CONCLUSIONS
While the routine clinical use of this exploratory schedule is discouraged, it may represent the basis for future developments.
Gunn
G Brandon
GB
Department of Radiation Oncology, University of Texas Medical Branch, Galveston, TX 77030, USA. gbgunn@mdanderson.org
Endres
Eugene J
EJ
Parker
Brent
B
Sormani
Maria Pia
MP
Sanguineti
Giuseppe
G
D005240:Feasibility Studies; D005774:Gastrostomy; D006801:Humans; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods*; D012867:Skin / Q000473:pathology / Q000528:radiation effects; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
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