Literature DB >> 25104069

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 Serrano1, Joseph M Herman2, Kent A Griffith3, Mark M Zalupski3, Edward J Kim4, Tanios S Bekaii-Saab5, Edgar Ben-Josef4, Laura A Dawson6, Jolie Ringash7, Alice C Wei8.   

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.
Copyright © 2014 Elsevier Inc. All rights reserved.

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Year:  2014        PMID: 25104069      PMCID: PMC4751588          DOI: 10.1016/j.ijrobp.2014.05.053

Source DB:  PubMed          Journal:  Int J Radiat Oncol Biol Phys        ISSN: 0360-3016            Impact factor:   7.038


  29 in total

1.  Collecting quality of life data in EORTC clinical trials--what happens in practice?

Authors:  T Young; J Maher
Journal:  Psychooncology       Date:  1999 May-Jun       Impact factor: 3.894

2.  Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial.

Authors:  Helmut Oettle; Stefan Post; Peter Neuhaus; Klaus Gellert; Jan Langrehr; Karsten Ridwelski; Harald Schramm; Joerg Fahlke; Carl Zuelke; Christof Burkart; Klaus Gutberlet; Erika Kettner; Harald Schmalenberg; Karin Weigang-Koehler; Wolf-Otto Bechstein; Marco Niedergethmann; Ingo Schmidt-Wolf; Lars Roll; Bernd Doerken; Hanno Riess
Journal:  JAMA       Date:  2007-01-17       Impact factor: 56.272

3.  A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma.

Authors:  Mark S Talamonti; William Small; Mary F Mulcahy; Jeffrey D Wayne; Vikram Attaluri; Lisa M Colletti; Mark M Zalupski; John P Hoffman; Gary M Freedman; Timothy J Kinsella; Philip A Philip; Cornelius J McGinn
Journal:  Ann Surg Oncol       Date:  2006-01-19       Impact factor: 5.344

4.  Gemcitabine, cisplatin, and radiotherapy for patients with locally advanced pancreatic adenocarcinoma: results of the North Central Cancer Treatment Group Phase II Study N9942.

Authors:  Michael G Haddock; Revathi Swaminathan; Nathan R Foster; Mark D Hauge; James A Martenson; John K Camoriano; Philip J Stella; Richard C Tenglin; Paul L Schaefer; Dennis F Moore; Steven R Alberts
Journal:  J Clin Oncol       Date:  2007-06-20       Impact factor: 44.544

5.  Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001.

Authors:  Jürg Bernhard; Daniel Dietrich; Werner Scheithauer; Daniela Gerber; György Bodoky; Thomas Ruhstaller; Bengt Glimelius; Emilio Bajetta; Johannes Schüller; Piercarlo Saletti; Jean Bauer; Arie Figer; Bernhard C Pestalozzi; Claus-Henning Köhne; Walter Mingrone; Salomon M Stemmer; Karin Tàmas; Gabriela V Kornek; Dieter Koeberle; Richard Herrmann
Journal:  J Clin Oncol       Date:  2008-08-01       Impact factor: 44.544

6.  Borderline resectable pancreatic cancer: the importance of this emerging stage of disease.

Authors:  Matthew H G Katz; Peter W T Pisters; Douglas B Evans; Charlotte C Sun; Jeffrey E Lee; Jason B Fleming; J Nicolas Vauthey; Eddie K Abdalla; Christopher H Crane; Robert A Wolff; Gauri R Varadhachary; Rosa F Hwang
Journal:  J Am Coll Surg       Date:  2008-03-17       Impact factor: 6.113

7.  Prospective phase II trial of neoadjuvant chemotherapy with gemcitabine and cisplatin for resectable adenocarcinoma of the pancreatic head.

Authors:  Stefan Heinrich; Bernhard C Pestalozzi; Markus Schäfer; Achim Weber; Peter Bauerfeind; Alexander Knuth; Pierre-Alain Clavien
Journal:  J Clin Oncol       Date:  2008-05-20       Impact factor: 44.544

8.  Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial.

Authors:  William F Regine; Kathryn A Winter; Ross A Abrams; Howard Safran; John P Hoffman; Andre Konski; Al B Benson; John S Macdonald; Mahesh R Kudrimoti; Mitchel L Fromm; Michael G Haddock; Paul Schaefer; Christopher G Willett; Tyvin A Rich
Journal:  JAMA       Date:  2008-03-05       Impact factor: 56.272

9.  Analysis of fluorouracil-based adjuvant chemotherapy and radiation after pancreaticoduodenectomy for ductal adenocarcinoma of the pancreas: results of a large, prospectively collected database at the Johns Hopkins Hospital.

Authors:  Joseph M Herman; Michael J Swartz; Charles C Hsu; Jordan Winter; Timothy M Pawlik; Elizabeth Sugar; Ray Robinson; Daniel A Laheru; Elizabeth Jaffee; Ralph H Hruban; Kurtis A Campbell; Christopher L Wolfgang; Fariba Asrari; Ross Donehower; Manuel Hidalgo; Luis A Diaz; Charles Yeo; John L Cameron; Richard D Schulick; Ross Abrams
Journal:  J Clin Oncol       Date:  2008-07-20       Impact factor: 44.544

10.  Interpreting clinically significant changes in patient-reported outcomes.

Authors:  Jolie Ringash; Brian O'Sullivan; Andrea Bezjak; Donald A Redelmeier
Journal:  Cancer       Date:  2007-07-01       Impact factor: 6.860

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  12 in total

1.  Correlation of clinical stage and performance status with quality of life in patients seen in a pancreas multidisciplinary clinic.

Authors:  Shalini Moningi; Amanda J Walker; Charles C Hsu; Jennifer Barsky Reese; Jing-Ya Wang; Katherine Y Fan; Lauren M Rosati; Daniel A Laheru; Matthew J Weiss; Christopher L Wolfgang; Timothy M Pawlik; Joseph M Herman
Journal:  J Oncol Pract       Date:  2015-01-06       Impact factor: 3.840

2.  Patient experience and quality of life during neoadjuvant therapy for pancreatic cancer: a systematic review and study protocol.

Authors:  Jordan M Cloyd; Sarah Hyman; Tanya Huwig; Christina Monsour; Heena Santry; Celia Wills; Allan Tsung; John F P Bridges
Journal:  Support Care Cancer       Date:  2020-10-08       Impact factor: 3.603

3.  Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer.

Authors:  Avani D Rao; Elizabeth A Sugar; Daniel T Chang; Karyn A Goodman; Amy Hacker-Prietz; Lauren M Rosati; Laurie Columbo; Eileen O'Reilly; George A Fisher; Lei Zheng; Jonathan S Pai; Mary E Griffith; Daniel A Laheru; Christine A Iacobuzio-Donahue; Christopher L Wolfgang; Albert Koong; Joseph M Herman
Journal:  Pract Radiat Oncol       Date:  2016-05-25

4.  A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma.

Authors:  Harish Lavu; Harry B Lengel; Naomi M Sell; Joseph A Baiocco; Eugene P Kennedy; Theresa P Yeo; Sherry A Burrell; Jordan M Winter; Sarah Hegarty; Benjamin E Leiby; Charles J Yeo
Journal:  J Am Coll Surg       Date:  2014-12-17       Impact factor: 6.113

5.  Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment.

Authors:  Joseph M Herman; Helen Kitchen; Arnold Degboe; Natalie V J Aldhouse; Andrew Trigg; Mary Hodgin; Amol Narang; Colin D Johnson
Journal:  Qual Life Res       Date:  2019-07-04       Impact factor: 4.147

6.  Impact on health-related quality of life deterioration-free survival of a first-line therapy combining nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial.

Authors:  Emilie Charton; Jean-Baptiste Bachet; Pascal Hammel; Jérôme Desramé; Benoist Chibaudel; Romain Cohen; Philippe Debourdeau; Jérome Dauba; Thierry Lecomte; Jean-François Seitz; Christophe Tournigand; Thomas Aparicio; Véronique Guerin-Meyer; Julien Taieb; Julien Volet; Christophe Louvet; Amélie Anota; Franck Bonnetain
Journal:  Cancer Med       Date:  2019-07-17       Impact factor: 4.452

7.  Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib.

Authors:  P Hammel; H L Kindler; M Reni; E Van Cutsem; T Macarulla; M J Hall; J O Park; D Hochhauser; D Arnold; D-Y Oh; A Reinacher-Schick; G Tortora; H Algül; E M O'Reilly; D McGuinness; K Y Cui; S Joo; H K Yoo; N Patel; T Golan
Journal:  Ann Oncol       Date:  2019-12-01       Impact factor: 32.976

8.  Comparison of chemotherapy effects on mechanical sensitivity and food-maintained operant responding in male and female rats.

Authors:  Luke P Legakis; Clare M Diester; Edward A Townsend; Ladan Karim-Nejad; Sidney Stevens Negus
Journal:  Behav Pharmacol       Date:  2020-08       Impact factor: 2.277

9.  Landscape of Health-Related Quality of Life in Patients With Early-Stage Pancreatic Cancer Receiving Adjuvant or Neoadjuvant Chemotherapy: A Systematic Literature Review.

Authors:  Teresa Macarulla; Andrew E Hendifar; Chung-Pin Li; Michele Reni; Hanno Riess; Margaret A Tempero; Amylou C Dueck; Marc F Botteman; Chinmay G Deshpande; Eleanor J Lucas; Do-Youn Oh
Journal:  Pancreas       Date:  2020-03       Impact factor: 3.243

10.  Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer.

Authors:  Christopher N Hurt; Somnath Mukherjee; John Bridgewater; Stephen Falk; Tom Crosby; Alec McDonald; George Joseph; John Staffurth; Ross A Abrams; Jane M Blazeby; Sarah Bridges; Peter Dutton; Gareth Griffiths; Tim Maughan; Colin Johnson
Journal:  Int J Radiat Oncol Biol Phys       Date:  2015-08-24       Impact factor: 7.038

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