title: Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer.
abstract: OBJECTIVE
  We previously reported clinical outcomes and physician-reported toxicity of gemcitabine and hypofractionated stereotactic body radiation therapy (SBRT) in locally advanced pancreatic cancer (LAPC). Here we prospectively investigate the impact of gemcitabine and SBRT on patient-reported quality of life (QoL).
  
  
  METHODS
  Forty-nine LAPC patients received 33 Gy SBRT (6.6 Gy daily fractions) upfront or after ≤3 doses of gemcitabine (1000 mg/m2) followed by gemcitabine until progression. European Organization for Research and Treatment of Cancer QoL core cancer (QLQ-C30) and pancreatic cancer-specific (European Organization for Research and Treatment of Cancer QLQ-PAN26) questionnaires were administered to patients pre-SBRT and at 4 to 6 weeks (first follow-up [1FUP]) and 4 months (2FUP) post-SBRT. Changes in QoL scores were deemed clinically relevant if median changes were at least 5 points in magnitude.
  
  
  RESULTS
  Forty-three (88%) patients completed pre-SBRT questionnaires. Of these, 88% and 51% completed questionnaires at 1FUP and 2FUP, respectively. There was no change in global QoL from pre-SBRT to 1FUP (P = .17) or 2FUP (P > .99). Statistical and clinical improvements in pancreatic pain (P = .001) and body image (P = .007) were observed from pre-SBRT to 1FUP. Patients with 1FUP and 2FUP questionnaires reported statistically and clinically improved body image (P = .016) by 4 months. Although pancreatic pain initially demonstrated statistical and clinical improvement (P = .020), scores returned to enrollment levels by 2FUP (P = .486). A statistical and clinical decline in role functioning (P = .002) was observed in patients at 2FUP.
  
  
  CONCLUSIONS
  Global QoL scores are not reduced with gemcitabine and SBRT. In this exploratory analysis, patients experience clinically relevant short-term improvements in pancreatic cancer-specific symptoms. Previously demonstrated acceptable clinical outcomes combined with these favorable QoL data indicate that SBRT can be easily integrated with other systemic therapies and may be a potential standard of care option in patients with LAPC.
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Avani D
authors.initials: AD
authors.lastname: Rao
authors.affiliation: Department of Biostatistics and Epidemiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sugar
authors.affiliation: Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.
authors.forename: Daniel T
authors.initials: DT
authors.lastname: Chang
authors.affiliation: Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Karyn A
authors.initials: KA
authors.lastname: Goodman
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Amy
authors.initials: A
authors.lastname: Hacker-Prietz
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Rosati
authors.affiliation: Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.
authors.forename: Laurie
authors.initials: L
authors.lastname: Columbo
authors.affiliation: Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Eileen
authors.initials: E
authors.lastname: O'Reilly
authors.affiliation: Department of Medical Oncology, Stanford University School of Medicine, Stanford, California.
authors.forename: George A
authors.initials: GA
authors.lastname: Fisher
authors.affiliation: Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Lei
authors.initials: L
authors.lastname: Zheng
authors.affiliation: University of California at San Francisco School of Medicine, San Francisco, California.
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Pai
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Griffith
authors.affiliation: Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Laheru
authors.affiliation: Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Iacobuzio-Donahue
authors.affiliation: Department of Surgical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Wolfgang
authors.affiliation: Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.
authors.forename: Albert
authors.initials: A
authors.lastname: Koong
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: joe@jhmi.edu.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Herman
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000072716:Cancer Pain; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000628:therapy*; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D016634:Radiosurgery / Q000379:methods*; D011795:Surveys and Questionnaires; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine