title: A prospective feasibility study of respiratory-gated proton beam therapy for liver tumors.
abstract: OBJECTIVE
  To evaluate the feasibility of a respiratory-gated proton beam therapy for liver tumors.
  
  
  METHODS
  Fifteen patients were enrolled in a prospective institutional review board-approved protocol. Eligibility criteria included Childs-Pugh A/B cirrhosis, unresectable biopsy- proven hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or metastatic disease (solid tumors only), 1-3 lesions, and tumor size of ≤6 cm. Patients received 15 fractions to a total dose of 45-75 GyE [gray equivalent] using respiratory-gated proton beam therapy. Gating was performed with an external respiratory position monitoring based system.
  
  
  RESULTS
  Of the 15 patients enrolled in this clinical trial, 11 had HCC, 3 had ICC, and 1 had metastasis from another primary. Ten patients had a single lesion, 3 patients had 2 lesions, and 2 patients had 3 lesions. Toxicities were grade 3 bilirubinemia-2, grade 3 gastrointestinal bleed-1, and grade 5 stomach perforation-1. One patient had a marginal recurrence, 3 had hepatic recurrences elsewhere in the liver, and 2 had extrahepatic recurrence. With a median follow-up for survivors of 69 months, 1-, 2-, and 3-year overall survivals are 53%, 40%, and 33%, respectively. Progression-free survivals are 40%, 33%, and 27% at 1, 2, and 3 years, respectively.
  
  
  CONCLUSIONS
  Respiratory-gated proton beam therapy for liver tumors is feasible. Phase 2 studies for primary liver tumors and metastatic tumors are underway.
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: tshong1@partners.org.
authors.forename: Theodore S
authors.initials: TS
authors.lastname: Hong
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: DeLaney
authors.affiliation: Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
authors.forename: Harvey J
authors.initials: HJ
authors.lastname: Mamon
authors.affiliation: Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Willett
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Beow Y
authors.initials: BY
authors.lastname: Yeap
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Niemierko
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: John A
authors.initials: JA
authors.lastname: Wolfgang
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Hsiao-Ming
authors.initials: HM
authors.lastname: Lu
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Judith
authors.initials: J
authors.lastname: Adams
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Weyman
authors.affiliation: Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Arellano
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Blaszkowsky
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Jill N
authors.initials: JN
authors.lastname: Allen
authors.affiliation: Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Kenneth K
authors.initials: KK
authors.lastname: Tanabe
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: David P
authors.initials: DP
authors.lastname: Ryan
authors.affiliation: Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Andrew X
authors.initials: AX
authors.lastname: Zhu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D018281:Cholangiocarcinoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D061766:Proton Therapy; D011879:Radiotherapy Dosage; D012119:Respiration; D015996:Survival Rate; D011522:Protons
chemical_list: D011522:Protons