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: OBJECTIVE
  To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: Pablo E
authors.initials: PE
authors.lastname: Serrano
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Herman
authors.affiliation: Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
authors.forename: Kent A
authors.initials: KA
authors.lastname: Griffith
authors.affiliation: Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
authors.forename: Mark M
authors.initials: MM
authors.lastname: Zalupski
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Kim
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio.
authors.forename: Tanios S
authors.initials: TS
authors.lastname: Bekaii-Saab
authors.affiliation: Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
authors.forename: Edgar
authors.initials: E
authors.lastname: Ben-Josef
authors.affiliation: Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Dawson
authors.affiliation: Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
authors.forename: Jolie
authors.initials: J
authors.lastname: Ringash
authors.affiliation: 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.
authors.forename: Alice C
authors.initials: AC
authors.lastname: Wei
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010180:Pancreatectomy; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000628:therapy*; D010349:Patient Compliance / Q000706:statistics & numerical data; D011446:Prospective Studies; D011788:Quality of Life; D020266:Radiotherapy, Conformal; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine
references.citation: J Natl Cancer Inst. 1992 Jul 1;84(13):1023-6
references.pmid: 1608053
references.citation: J Clin Oncol. 1998 Jan;16(1):139-44
references.pmid: 9440735
references.citation: CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29
references.pmid: 14974761
references.citation: Surg Oncol Clin N Am. 2004 Oct;13(4):639-61, ix
references.pmid: 15350939
references.citation: N Engl J Med. 2011 May 12;364(19):1817-25
references.pmid: 21561347
references.citation: Cancer. 2013 Aug 1;119(15):2692-700
references.pmid: 23720019
references.citation: Cancer. 2010 Feb 15;116(4):830-6
references.pmid: 20029974
references.citation: Ann Oncol. 1996 Aug;7(6):593-600
references.pmid: 8879373
references.citation: J Clin Epidemiol. 1997 Apr;50(4):441-50
references.pmid: 9179103
references.citation: J Clin Oncol. 1993 Mar;11(3):570-9
references.pmid: 8445433
references.citation: J Clin Oncol. 2007 Jun 20;25(18):2567-72
references.pmid: 17577035
references.citation: J Clin Oncol. 2008 May 20;26(15):2526-31
references.pmid: 18487569
references.citation: Am J Clin Oncol. 1982 Dec;5(6):649-55
references.pmid: 7165009
references.citation: J Clin Oncol. 2013 Jan 1;31(1):23-9
references.pmid: 23213101
references.citation: Ann Surg Oncol. 2013 Aug;20(8):2787-95
references.pmid: 23435609
references.citation: Stat Med. 1998 Mar 15-Apr 15;17(5-7):603-12
references.pmid: 9549809
references.citation: Ann Surg Oncol. 2006 Feb;13(2):150-8
references.pmid: 16418882
references.citation: J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
references.pmid: 8433390
references.citation: J Clin Oncol. 2002 May 1;20(9):2229-39
references.pmid: 11980994
references.citation: J Am Coll Surg. 2008 May;206(5):833-46; discussion 846-8
references.pmid: 18471707
references.citation: Eur J Cancer. 1999 Jun;35(6):939-41
references.pmid: 10533475
references.citation: Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):157-62
references.pmid: 22543205
references.citation: Cancer. 2007 Jul 1;110(1):196-202
references.pmid: 17546575
references.citation: JAMA. 2008 Mar 5;299(9):1019-26
references.pmid: 18319412
references.citation: JAMA. 2007 Jan 17;297(3):267-77
references.pmid: 17227978
references.citation: Psychooncology. 1999 May-Jun;8(3):260-3
references.pmid: 10390738
references.citation: J Clin Oncol. 2008 Aug 1;26(22):3695-701
references.pmid: 18669454
references.citation: J Clin Oncol. 2008 Jul 20;26(21):3503-10
references.pmid: 18640931
references.citation: Surgery. 1999 Jul;126(1):1-4
references.pmid: 10418584