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Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):270-7. doi: 10.1016/j.ijrobp.2014.05.053. Epub 2014 Aug 4.

Quality of life in a prospective, multicenter phase 2 trial of neoadjuvant full-dose gemcitabine, oxaliplatin, and radiation in patients with resectable or borderline resectable pancreatic adenocarcinoma.

Author information

1
Department of Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
2
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
3
Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
4
Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
5
Division of Medical Oncology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio.
6
Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada.
7
Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
8
Department of Surgery, University Health Network, University of Toronto, Toronto, ON, Canada; Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. Electronic address: alice.wei@uhn.ca.

Abstract

PURPOSE:

To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma.

METHODS AND MATERIALS:

Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores were compared with baseline. A change >10% was considered a minimal clinically important difference.

RESULTS:

Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (-8, P=.02). This was in parallel with deterioration in physical functioning (-14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (-13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit.

CONCLUSIONS:

The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical resection, most domains returned back to baseline levels by 6 months.

PMID:
25104069
PMCID:
PMC4751588
DOI:
10.1016/j.ijrobp.2014.05.053
[Indexed for MEDLINE]
Free PMC Article
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