title: Protecting the oral mucosa in patients with oral tongue squamous cell carcinoma treated postoperatively with intensity-modulated radiotherapy: a randomized study.
abstract: OBJECTIVE
  Is the severity of acute oral mucositis in patients who receive postoperative intensity-modulated radiotherapy (PO-IMRT) for oral tongue squamous cell carcinoma (SCC) reduced by sparing the oral mucosa outside of the planning target volume (PTV)?
  
  
  METHODS
  Prospective, randomized trial.
  
  
  METHODS
  Forty-eight patients with oral tongue SCC who received PO-IMRT at our institution were randomized to two groups: the oral-sparing (OR-SP) group and oral-unsparing (OR-USP) group. For the OR-SP group (n = 24), the oral mucosa outside of the PTV was spared. Furthermore, the mucosa including the bilateral cheeks, upper lip, and lower lip was defined as the united site and given <32 Gy. For the OR-USP group (n = 24), none of the oral mucosa was protected. The severity of clinical acute mucositis in each patient was assessed weekly during PO-IMRT until completely healed. Oral mucositis was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Dosimetry and therapeutic measures related to acute mucositis between the two groups were compared.
  
  
  RESULTS
  During PO-IMRT, no patient experienced grade 4+ acute mucositis in any oral site. Compared to the OR-USP group, there was less grade 2 and 3 mucositis in the united site of the OR-SP group (0% and 25% vs. 45.8% and 54.2%, respectively; P = .000). Also, the mean dose to the united site was significantly lower with OR-SP compared to OR-USP (41.8 ± 7.4 Gy vs. 58.8 ± 2.2 Gy; P = .000). The OR-SP group was associated with significant reductions in the use of analgesics (P = .043) and intravenous antibiotics (P = .039). No recurrences were detected in the vicinity of the spared oral mucosa (the united site) during a median follow-up time of 30 months.
  
  
  CONCLUSIONS
  OR-SP PO-IMRT for patients with oral tongue SCC resulted in a significant decrease in the severity of acute mucositis and improved quality of life. The sparing of the oral mucosa outside of the PTV is safe and does not compromise oncologic outcomes.
authors.affiliation: Division of Radiation Oncology, The Shanghai Ninth Peoples Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
authors.forename: Zhong-He
authors.initials: ZH
authors.lastname: Wang
authors.forename: Shi-Zhou
authors.initials: SZ
authors.lastname: Zhang
authors.forename: Zhi-Yuan
authors.initials: ZY
authors.lastname: Zhang
authors.forename: Chen-Ping
authors.initials: CP
authors.lastname: Zhang
authors.forename: Hai-Sheng
authors.initials: HS
authors.lastname: Hu
authors.forename: Wen-Yong
authors.initials: WY
authors.lastname: Tu
authors.forename: Jessica
authors.initials: J
authors.lastname: Kirwan
authors.forename: William M
authors.initials: WM
authors.lastname: Mendenhall
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000532:radiotherapy* / Q000601:surgery; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D019647:Oral Surgical Procedures / Q000379:methods*; D011446:Prospective Studies; D011832:Radiation Injuries / Q000453:epidemiology / Q000517:prevention & control*; D011835:Radiation Protection / Q000379:methods*; D018714:Radiotherapy, Adjuvant / Q000379:methods; D014062:Tongue Neoplasms / Q000175:diagnosis / Q000532:radiotherapy* / Q000601:surgery; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014987:Xerostomia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*