Annals of Surgical Oncology

, Volume 23, Issue 7, pp 2137–2145 | Cite as

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

  • Anne A. Eaton
  • Mithat Gonen
  • Paul Karanicolas
  • William R. Jarnagin
  • Michael I. D’Angelica
  • Ronald DeMatteo
  • T. Peter Kingham
  • Peter J. Allen
Healthcare Policy and Outcomes

Abstract

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.

Keywords

Pasireotide Memorial Sloan Kettering Cancer Center Digestive Symptom Baseline Standard Deviation Pancreatic Complication 

Notes

Acknowledgments

This work was supported in part by Cancer Center core grant P30 CA008748. The core grant provides funding to institutional cores such as Biostatistics, which was used in this study. The research was funded by Novartis.

Disclosure

Dr Peter J. Allen has worked in a consulting/advisory role for Sanofi and received research funding from Novartis.

Supplementary material

10434_2015_5077_MOESM1_ESM.docx (1 kb)
Supplementary material 1 (DOCX 1 kb)

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Copyright information

© Society of Surgical Oncology 2016

Authors and Affiliations

  • Anne A. Eaton
    • 1
  • Mithat Gonen
    • 1
  • Paul Karanicolas
    • 2
  • William R. Jarnagin
    • 3
  • Michael I. D’Angelica
    • 3
  • Ronald DeMatteo
    • 3
  • T. Peter Kingham
    • 3
  • Peter J. Allen
    • 3
  1. 1.Department of Epidemiology and BiostatisticsMemorial Sloan Kettering Cancer CenterNew YorkUSA
  2. 2.Odette Cancer Research ProgramSunnybrook Health Sciences CenterTorontoCanada
  3. 3.Hepatopancreatobiliary Service, Department of SurgeryMemorial Sloan Kettering Cancer CenterNew YorkUSA

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