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

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/m(2)) 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 2 FUP (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. (C) 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.