PMID- 20724140
OWN - NLM
STAT- MEDLINE
DCOM- 20110119
LR  - 20151119
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 46
IP  - 15
DP  - 2010 Oct
TI  - Time until definitive quality of life score deterioration as a means of 
      longitudinal analysis for treatment trials in patients with metastatic pancreatic 
      adenocarcinoma.
PG  - 2753-62
LID - 10.1016/j.ejca.2010.07.023 [doi]
AB  - BACKGROUND: The Federation Francophone de Cancerologie Digestive phase III trial 
      in patients with metastatic pancreatic adenocarcinoma comparing 5FU, folinic acid 
      and cisplatin combination followed by gemcitabine (Arm A) versus the opposite 
      sequence (Arm B) failed to demonstrate a benefit in overall survival. To 
      longitudinally compare the quality of life (QoL) we explored different 
      definitions of time until definitive deterioration (TUDD) of QoL scores according 
      to minimal clinically important difference (MCID) cut-offs. METHODS: QoL was 
      evaluated using the EORTC QLQ-C30 every 8 weeks until death. The following scores 
      were analysed: global health, emotional functioning, physical functioning, 
      fatigue and pain. TUDD was defined as the time interval between randomisation and 
      the first occurrence of a decrease in QLQ-C30 score >/=5 points without any further 
      improvement in QoL score >/=5 points or any further available QoL data. Analyses 
      were repeated using a 10 point MCID and/or including death as event. RESULTS: 
      From 08/2003 to 05/2006, 102 patients in Arm A and 100 in Arm B were included. 
      Using a 5 and a 10 point MCID, TUDD curves of the 5 scores did not differ 
      according to treatment arm., The median TUDD of global health was 5.2 months 
      (4.3-6.2) in Arm A and 6.1 months (5.1-8.5) in Arm B (log-rank p=0.50) including 
      death as an event for a 5 point MCID. Multivariate Cox model showed that tumour 
      localisation and progression were independently associated with TUDD (p<0.05). 
      CONCLUSIONS: The strategy of chemotherapy did not influence the deterioration of 
      QoL. The TUDD approach seems to provide meaningful clinical results that are 
      adapted to metastatic pancreatic adenocarcinoma trials.
CI  - Copyright (c) 2010 Elsevier Ltd. All rights reserved.
FAU - Bonnetain, Franck
AU  - Bonnetain F
AD  - Biostatistic and Epidemiological Unit (EA 4184) and Clinical Research Platform 
      Qualite de vie et Cancer, Centre Georges Francois Leclerc Cancer Care Center, 
      Dijon, France. fbonnetain@cgfl.fr
FAU - Dahan, Laetitia
AU  - Dahan L
FAU - Maillard, Emilie
AU  - Maillard E
FAU - Ychou, Marc
AU  - Ychou M
FAU - Mitry, Emmanuel
AU  - Mitry E
FAU - Hammel, Pascal
AU  - Hammel P
FAU - Legoux, Jean-Louis
AU  - Legoux JL
FAU - Rougier, Philippe
AU  - Rougier P
FAU - Bedenne, Laurent
AU  - Bedenne L
FAU - Seitz, Jean-Francois
AU  - Seitz JF
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20100817
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
SB  - IM
MH  - Adenocarcinoma/drug therapy/mortality/*psychology
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Emotions
MH  - Fatigue/etiology
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Longitudinal Studies
MH  - Male
MH  - Neoplasm Metastasis
MH  - Pain/etiology
MH  - Pancreatic Neoplasms/drug therapy/mortality/*psychology
MH  - *Quality of Life
MH  - Surveys and Questionnaires
MH  - Time Factors
EDAT- 2010/08/21 06:00
MHDA- 2011/01/20 06:00
CRDT- 2010/08/21 06:00
PHST- 2010/06/10 00:00 [received]
PHST- 2010/07/15 00:00 [revised]
PHST- 2010/07/15 00:00 [accepted]
PHST- 2010/08/21 06:00 [entrez]
PHST- 2010/08/21 06:00 [pubmed]
PHST- 2011/01/20 06:00 [medline]
AID - S0959-8049(10)00701-X [pii]
AID - 10.1016/j.ejca.2010.07.023 [doi]
PST - ppublish
SO  - Eur J Cancer. 2010 Oct;46(15):2753-62. doi: 10.1016/j.ejca.2010.07.023. Epub 2010 
      Aug 17.