Health-Related Quality of Life After Pancreatectomy: Results From a Randomized Controlled Trial

Abstract

Background A recent prospective randomized trial demonstrated that prophylactic pasireotide reduces the incidence of pancreatic complications (PC) following resection. In this secondary analysis, we aimed to describe quality of life (QoL) before and after resection, characterize the impact of PC on QoL, and assess whether pasireotide improves QoL. Methods We conducted a randomized, double-blind, placebo-controlled trial of preoperative pasireotide in patients undergoing pancreatectomy. Participants completed the EORTC C30 and PAN26 modules preoperatively and on postoperative days 14 and 60. Scores were compared using t-tests. Percent of patients with clinically important worsening (a decline ≥0.5 times the baseline standard deviation) was reported. Results Eighty-seven percent of patients (260/300) completed all questionnaires. No major differences were observed between the pasireotide and placebo groups, therefore the data was pooled for further analyses. A significant worsening of function at 14D was detected on all PAN26 and C30 function scales except hepatic and emotional functioning (EF), and all C30 symptom scales. More than 75% of patients experienced clinically important worsening of fatigue, pain and role functioning. Most effects persisted at 60D. 60D EF was significantly better than baseline (p=0.03). PC were associated with worse outcomes on most function scales. Conclusions During the 14D following resection, patients can be expected to have a significant decline in QoL. Many symptoms abate by 60D, and EF improves. PC were associated with impaired QoL on several domains. Although pasireotide effectively reduced PC, its effect did not appear to translate to improved QoL in this sample of 300 patients.

Impact of pancreatectomy on long‐term patient‐reported symptoms and quality of life in recurrence‐free survivors of pancreatic and periampullary neoplasms

“…For example, Heerkens et al found that health-related QOL decreased considerably immediately after pancreatectomy for malignancy, but near full recovery occurred 3-6 months postoperatively [9]. Similarly, Eaton et al utilized data from the prospective randomized controlled trial of prophylactic pasireotide to show that while significant declines in QOL occurred immediately postoperatively, most symptoms abated and emotional function improved by 60 days after pancreatectomy [5].…”

Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications

“…Previous studies have shown that in the period 1-3 months after major pancreatic operations, there is an obvious decrease in QoL. [3][4][5][6] It takes 3-6 months for QoL to fully recover after surgery. 3,[5][6][7] Literature has reported negative effects of complications on QoL in oesophageal and (colo)rectal cancer.…”

“…[15][16][17] Previous studies evaluating the difference in QoL between patients with and without complications demonstrate conflicting results. 4,6,[18][19][20] Some studies suggest there are no significant differences in postoperative QoL between patients with or without complications, 6,20 while others show that complications tend to negatively affect postoperative QoL. 4,18,19 Most patients in these studies were part of large randomized clinical trials.…”

“…4,6,[18][19][20] Some studies suggest there are no significant differences in postoperative QoL between patients with or without complications, 6,20 while others show that complications tend to negatively affect postoperative QoL. 4,18,19 Most patients in these studies were part of large randomized clinical trials. In contrast, this study used an unselected patient group to analyse postoperative QoL.…”

Population-based study of the prevalence and management of self-reported high pain scores in patients with non-resected pancreatic adenocarcinoma

“…Patient‐reported outcome measures (PROMs) have become a growing focus in oncology. RCTs demonstrated improvements in patient engagement, outcome and satisfaction with use of PROMs, which led to their routine use in clinical practice.…”