Quality of Life in Patients with Locally Advanced Pancreatic Cancer During Stereotactic Radiotherapy Combined with Heat-Killed Mycobacterium Obuense Vaccination.

Abstract

Background: New treatment options for patients with locally advanced pancreatic cancer (LAPC) have proven to be safe but, in addition, may have an effect on the patient's quality of life. Objectives: To evaluate the effect of stereotactic body radiotherapy (SBRT) combined with intradermal heat-killed mycobacterium obuense (IMM-101) vaccination on health-related quality of life (HRQoL), pain, and sleep, in patients with LAPC. Design: Prospective cohort study. Setting/Participants: In total, 42 Dutch patients with LAPC were included after completion of at least four cycles of (m) leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX). Measurements: Quality of life was assessed with the EORTC QLQ-C30. Patients completed the Richard Campbell Sleep Questionnaire (RCSQ) for five consecutive nights and wore simultaneously a GENEActiv tri-axial accelerometer, which registered sleep duration and sleep efficiency. The Numeric Rating Scale was used to assess pain intensity during treatment. Data were collected at the baseline visit [i.e., at inclusion in the study after (m)FOLFIRINOX treatment] and at week 8 (i.e., 6 weeks after start date of SBRT and after four IMM-101 vaccinations). Results: Univariable linear mixed model analysis revealed significant improvement for EORTC QLQ-C30 items "cognitive functioning" and "emotional functioning." Outcomes on RCSQ subscales and "RCSQ total score" did not significantly change. In the multivariable model, with "Global HRQoL scale" and "RCSQ total score" as outcomes, we did not find a significant change during treatment. Conclusion: In this prospective cohort study, we found that SBRT combined with IMM-101, in patients with LAPC, is well tolerated and does not negatively affect HRQoL, sleep quality, and pain.