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.

Figure 1

Changes in European Organization for Research and Treatment of Cancer QoL core cancer QLQ-C30 (A) and QLQ-PAN26 (B) quality of life scores between baseline (BL) and 1FUP for individuals completing baseline and 1FUP evaluations (N = 38). Shaded boxes highlight changes that were considered clinically significant. 1FUP, first follow-up.

Figure 2

Changes in European Organization for Research and Treatment of Cancer QoL core cancer QLQ-C30 (A) and QLQ-PAN26 (B) QoL scores between baseline (BL) and 1FUP for individuals completing baseline, 1FUP, and 2FUP QoL evaluations (N = 22). Shaded boxes highlight changes that were considered clinically significant. 1FUP, first follow-up; 2FUP, second follow-up; QoL, quality of life.

Figure 3

Changes in European Organization for Research and Treatment of Cancer QoL core cancer QLQ-C30 (A) and QLQ-PAN26 (B) QoL scores between baseline and 2FUP for individuals completing baseline and 2FUP QoL evaluations (N = 22). Shaded boxes highlight changes that were considered clinically significant. 1FUP, first follow-up; 2FUP, second follow-up; QoL, quality of life.