Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer Journal Article


Authors: Rao, A. D.; Sugar, E. A.; Chang, D. T.; Goodman, K. A.; Hacker-Prietz, A.; Rosati, L. M.; Columbo, L.; O'Reilly, E.; Fisher, G. A.; Zheng, L.; Pai, J. S.; Griffith, M. E.; Laheru, D. A.; Iacobuzio-Donahue, C. A.; Wolfgang, C. L.; Koong, A.; Herman, J. M.
Article Title: Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer
Abstract: Purpose 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 and materials 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. © 2016 American Society for Radiation Oncology
Journal Title: Practical Radiation Oncology
Volume: 6
Issue: 6
ISSN: 1879-8519
Publisher: Elsevier Inc.  
Date Published: 2016-11-01
Start Page: 417
End Page: 424
Language: English
DOI: 10.1016/j.prro.2016.05.005
PROVIDER: scopus
PUBMED: 27552809
PMCID: PMC5572652
DOI/URL:
Notes: Article -- Export Date: 6 December 2016 -- Source: Scopus
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  1. Karyn A Goodman
    257 Goodman
  2. Eileen O'Reilly
    780 O'Reilly