PMID- 30545995
OWN - NLM
STAT- MEDLINE
DCOM- 20191028
LR  - 20191028
IS  - 1540-1413 (Electronic)
IS  - 1540-1405 (Linking)
VI  - 16
IP  - 12
DP  - 2018 Dec
TI  - Impact of Patient- and Clinician-Reported Cumulative Toxicity on Quality of Life 
      in Patients With Metastatic Castration-Naive Prostate Cancer.
PG  - 1481-1488
LID - 10.6004/jnccn.2018.7069 [doi]
AB  - Background: Current toxicity evaluation is primarily focused on high-grade 
      adverse events (AEs) reported by clinicians. However, the cumulative effect of 
      multiple lower-grade AEs may also impact patients' quality of life (QoL). 
      Further, patient-reported toxicity may be more representative of patients' 
      treatment experiences. This study aimed to determine whether cumulative toxicity 
      comprising all-grade AEs is more associated with QoL than cumulative toxicity 
      comprising high-grade AEs only, and whether patient-reported cumulative toxicity 
      is more associated with QoL than clinician-reported cumulative toxicity. Methods: 
      Patients with metastatic castration-naive prostate cancer participating in the 
      phase III GETUG-AFU 15 trial completed questionnaires on AEs (at 3 and 6 months) 
      and QoL (at baseline and 3 and 6 months). Clinicians reported AEs during clinical 
      visits. Cumulative toxicity scores were calculated for clinicians and patients in 
      3 ways: total number of high-grade AEs, total number of all-grade AEs, and total 
      number of all AEs multiplied by their grade (severity score). Relationships 
      between cumulative toxicity scores and QoL were studied using longitudinal 
      regression analyses; unstandardized (B) and standardized regression coefficients 
      (beta) are reported. Results: Of 385 patients, 184 with complete QoL and toxicity 
      data were included. Clinician-reported all-grade AEs (B, -2.2; 95% CI, -3.3 to 
      -1.1; P<.01) and severity score (B, -1.4; 95% CI, -2.2 to -0.7; P<.01) were 
      associated with deteriorated physical QoL, whereas the total number of high-grade 
      AEs was not. All patient-reported scores were significantly (P<.01 for all) 
      associated with deteriorated physical and global QoL. Standardized regression 
      coefficients indicated that patient-reported toxicity scores were more associated 
      with QoL outcomes than clinician-reported scores, with the strongest association 
      found for the all-grade AEs and severity cumulative toxicity scores. Conclusions: 
      Patient- and clinician-based cumulative toxicity scores comprising all-grade AEs 
      better reflect impact on patient QoL than toxicity scores comprising high-grade 
      AEs only. To assess the effect of toxicity on QoL, patient-reported cumulative 
      toxicity scores are preferred.
CI  - Copyright (c) 2018 by the National Comprehensive Cancer Network.
FAU - Schuurhuizen, Claudia S E W
AU  - Schuurhuizen CSEW
FAU - Marino, Patricia
AU  - Marino P
FAU - Braamse, Annemarie M J
AU  - Braamse AMJ
FAU - Buffart, Laurien M
AU  - Buffart LM
FAU - Joly, Florence
AU  - Joly F
FAU - Fizazi, Karim
AU  - Fizazi K
FAU - Habibian, Muriel
AU  - Habibian M
FAU - Boher, Jean-Marie
AU  - Boher JM
FAU - Soulie, Michel
AU  - Soulie M
FAU - Oudard, Stephane
AU  - Oudard S
FAU - Konings, Inge R H M
AU  - Konings IRHM
FAU - Verheul, Henk M W
AU  - Verheul HMW
FAU - Dekker, Joost
AU  - Dekker J
FAU - Gravis, Gwenaelle
AU  - Gravis G
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Natl Compr Canc Netw
JT  - Journal of the National Comprehensive Cancer Network : JNCCN
JID - 101162515
RN  - 0 (Androgen Antagonists)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0F65R8P09N (Goserelin)
RN  - 15H5577CQD (Docetaxel)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Androgen Antagonists/adverse effects
MH  - Antineoplastic Agents, Hormonal/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects
MH  - Docetaxel/adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*complications/diagnosis
MH  - Goserelin/adverse effects
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - *Patient Reported Outcome Measures
MH  - Progression-Free Survival
MH  - Prospective Studies
MH  - Prostatic Neoplasms/*drug therapy/mortality/pathology
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Time Factors
EDAT- 2018/12/14 06:00
MHDA- 2019/10/29 06:00
CRDT- 2018/12/15 06:00
PHST- 2018/02/21 00:00 [received]
PHST- 2018/08/03 00:00 [accepted]
PHST- 2018/12/15 06:00 [entrez]
PHST- 2018/12/14 06:00 [pubmed]
PHST- 2019/10/29 06:00 [medline]
AID - 10.6004/jnccn.2018.7069 [doi]
PST - ppublish
SO  - J Natl Compr Canc Netw. 2018 Dec;16(12):1481-1488. doi: 10.6004/jnccn.2018.7069.