Health-Related Quality of Life After Pancreatectomy: Results From a Randomized Controlled Trial.
BACKGROUND: A recent prospective randomized trial demonstrated that prophylactic pasireotide reduces the incidence of pancreatic complications (PC) after resection. This secondary analysis aimed to describe quality of life (QoL) before and after resection, to characterize the impact of PC on QoL, and to assess whether pasireotide improves QoL. METHODS: A randomized, double-blind, placebo-controlled trial of preoperative pasireotide in patients undergoing pancreatectomy was conducted. Participants completed the European Organization for Research and Treatment of Cancer (EORTC) C30 and PAN26 modules preoperatively and on postoperative days 14 and 60. Scores were compared using t tests. The percentage of patients with clinically important worsening (a decline ≥0.5 times the baseline standard deviation) was reported. RESULTS: All questionnaires were completed by 87 % (260/300) of the patients. No major differences were observed between the pasireotide and placebo groups. Therefore, the data were pooled for further analyses. A significant worsening of function at 14 days was detected on all the PAN26 and C30 function scales except hepatic and emotional functioning (EF), and on all the C30 symptom scales. More than 75 % of the patients experienced clinically important worsening of fatigue, pain, and role functioning. Most effects persisted at 60 days, with the 60-day EF significantly better than at baseline (p = 0.03). PC were associated with worse outcomes on most function scales. CONCLUSIONS: During the 14 days after resection, patients can be expected to have a significant decline in QoL. Many symptoms abate by 60 days, and EF improves. PC were associated with impaired QoL in several domains. Although pasireotide effectively reduced PC, its effect did not appear to translate to improved QoL in this sample of 300 patients.
Eaton, AA; Gonen, M; Karanicolas, P; Jarnagin, WR; D'Angelica, MI; DeMatteo, R; Kingham, TP; Allen, PJ
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