title: A phase II study of submandibular gland transfer prior to radiation for prevention of radiation-induced xerostomia in head-and-neck cancer (RTOG 0244).
abstract: OBJECTIVE
  We report the results of a phase II study to determine the reproducibility of a submandibular salivary gland transfer (SGT) surgical technique for prevention of radiation (XRT)-induced xerostomia in a multi-institutional setting and to assess severity of xerostomia.
  
  
  METHODS
  Eligible patients had surgery for primary, neck dissection, and SGT, followed by XRT, during which the transferred salivary gland was shielded. Intensity modulated radiation therapy, amifostine, and pilocarpine were not allowed, but postoperative chemotherapy was allowed. Each operation was reviewed by 2 reviewers and radiation by 1 reviewer. If 13 or more (of 43) were "not per protocol," then the technique would be considered not reproducible as per study design. The secondary endpoint was the rate of acute xerostomia, grade 2 or higher, and a rate of ≤ 51% was acceptable.
  
  
  RESULTS
  Forty-four of the total 49 patients were analyzable: male (81.8%), oropharynx (63.6%), stage IV (61.4%), median age 56.5 years. SGT was "per protocol" or within acceptable variation in 34 patients (77.3%) and XRT in 79.5%. Nine patients (20.9%) developed grade 2 acute xerostomia; 2 had grade 0-1 xerostomia (4.7%) but started on amifostine/pilocarpine. Treatment for these 11 patients (25.6%) was considered a failure for the xerostomia endpoint. Thirteen patients died; median follow-up for 31 surviving patients was 2.9 years. Two-year overall and disease-free survival rates were 76.4% and 71.7%, respectively.
  
  
  CONCLUSIONS
  The technique of submandibular SGT is reproducible in a multicenter setting. Seventy-four percent of patients were prevented from XRT-induced acute xerostomia.
authors.affiliation: University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada. jha@albertahealthservices.ca
authors.forename: Naresh
authors.initials: N
authors.lastname: Jha
authors.forename: Jonathan
authors.initials: J
authors.lastname: Harris
authors.forename: Hadi
authors.initials: H
authors.lastname: Seikaly
authors.forename: John R
authors.initials: JR
authors.lastname: Jacobs
authors.forename: A J B
authors.initials: AJ
authors.lastname: McEwan
authors.forename: K Thomas
authors.initials: KT
authors.lastname: Robbins
authors.forename: John
authors.initials: J
authors.lastname: Grecula
authors.forename: Anand K
authors.initials: AK
authors.lastname: Sharma
authors.forename: K Kian
authors.initials: KK
authors.lastname: Ang
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011832:Radiation Injuries; D011859:Radiography; D012008:Recurrence; D015203:Reproducibility of Results; D013363:Submandibular Gland / Q000000981:diagnostic imaging / Q000601:surgery*; D014987:Xerostomia / Q000145:classification / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D000970:Antineoplastic Agents