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

Pablo E. Serrano, Joseph M. Herman, Kent A. Griffith, Mark M. Zalupski, Edward Kim, Tanios S. Bekaii-Saab, Edgar Ben-Josef, Laura A. Dawson, Jolie Ringash, Alice C. Wei

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)270-277
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume90
Issue number2
DOIs
StatePublished - Oct 1 2014
Externally publishedYes

Fingerprint

oxaliplatin
gemcitabine
therapy
Adenocarcinoma
Quality of Life
Radiation
Neoadjuvant Therapy
dosage
radiation
cancer
surgery
polyacrylonitrile
deterioration
health
Neoplasms
cycles
pain
Therapeutics
Patient Compliance
Pancreatic Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research
  • Medicine(all)

Cite this

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. / Serrano, Pablo E.; Herman, Joseph M.; Griffith, Kent A.; Zalupski, Mark M.; Kim, Edward; Bekaii-Saab, Tanios S.; Ben-Josef, Edgar; Dawson, Laura A.; Ringash, Jolie; Wei, Alice C.

In: International Journal of Radiation Oncology Biology Physics, Vol. 90, No. 2, 01.10.2014, p. 270-277.

Research output: Contribution to journalArticle

Serrano, Pablo E. ; Herman, Joseph M. ; Griffith, Kent A. ; Zalupski, Mark M. ; Kim, Edward ; Bekaii-Saab, Tanios S. ; Ben-Josef, Edgar ; Dawson, Laura A. ; Ringash, Jolie ; Wei, Alice C. / 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. In: International Journal of Radiation Oncology Biology Physics. 2014 ; Vol. 90, No. 2. pp. 270-277.
@article{d325aff3630a415ea676bbe57ef7d62f,
title = "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",
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.",
author = "Serrano, {Pablo E.} and Herman, {Joseph M.} and Griffith, {Kent A.} and Zalupski, {Mark M.} and Edward Kim and Bekaii-Saab, {Tanios S.} and Edgar Ben-Josef and Dawson, {Laura A.} and Jolie Ringash and Wei, {Alice C.}",
year = "2014",
month = "10",
day = "1",
doi = "10.1016/j.ijrobp.2014.05.053",
language = "English (US)",
volume = "90",
pages = "270--277",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - 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

AU - Serrano, Pablo E.

AU - Herman, Joseph M.

AU - Griffith, Kent A.

AU - Zalupski, Mark M.

AU - Kim, Edward

AU - Bekaii-Saab, Tanios S.

AU - Ben-Josef, Edgar

AU - Dawson, Laura A.

AU - Ringash, Jolie

AU - Wei, Alice C.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84908260165&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908260165&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2014.05.053

DO - 10.1016/j.ijrobp.2014.05.053

M3 - Article

VL - 90

SP - 270

EP - 277

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 2

ER -