Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE).
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Agents
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Carcinoma, Transitional Cell
/ drug therapy
Docetaxel
/ administration & dosage
Double-Blind Method
Female
Humans
Male
Middle Aged
Neoplasm Staging
Quality of Life
Urologic Neoplasms
/ drug therapy
Ramucirumab
Antiangiogenesis
Bladder cancer
Neoplasm metastatsis
Patient-reported outcomes
Quality of life
Ramucirumab
Urinary bladder neoplasm
Urothelial carcinoma
Journal
BMC urology
ISSN: 1471-2490
Titre abrégé: BMC Urol
Pays: England
ID NLM: 100968571
Informations de publication
Date de publication:
07 Nov 2020
07 Nov 2020
Historique:
received:
13
07
2020
accepted:
26
10
2020
entrez:
8
11
2020
pubmed:
9
11
2020
medline:
4
6
2021
Statut:
epublish
Résumé
To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). RANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit. Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment. NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.
Sections du résumé
BACKGROUND
BACKGROUND
To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC).
METHODS
METHODS
RANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m
RESULTS
RESULTS
Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit.
CONCLUSIONS
CONCLUSIONS
Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment.
CLINICAL TRAIL REGISTRATION
BACKGROUND
NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.
Identifiants
pubmed: 33160359
doi: 10.1186/s12894-020-00752-w
pii: 10.1186/s12894-020-00752-w
pmc: PMC7648381
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents
0
Docetaxel
15H5577CQD
Banques de données
ClinicalTrials.gov
['NCT02426125']
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
181Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Références
Med Decis Making. 2016 Aug;36(6):714-25
pubmed: 26957566
BMC Palliat Care. 2019 Apr 5;18(1):34
pubmed: 30953485
Eur J Cancer. 2019 Jan;107:115-123
pubmed: 30557792
Lancet. 2018 Feb 24;391(10122):748-757
pubmed: 29268948
Expert Opin Emerg Drugs. 2017 Jun;22(2):149-164
pubmed: 28556678
J Clin Oncol. 2018 Jun 1;36(16):1579-1587
pubmed: 29590008
Expert Opin Investig Drugs. 2015;24(7):913-27
pubmed: 26098435
Clin Cancer Res. 2020 Jun 1;26(11):2506-2514
pubmed: 32127394
Urol Oncol. 2017 Jul;35(7):465-472
pubmed: 28366271
J Clin Oncol. 2000 Jun;18(12):2395-405
pubmed: 10856099
Curr Oncol. 2011 Jan;18(1):e25-34
pubmed: 21331269
JAMA. 2017 Jul 11;318(2):197-198
pubmed: 28586821
Drugs. 2014 Jun;74(9):1047-58
pubmed: 24916147
J Clin Oncol. 1998 Jan;16(1):139-44
pubmed: 9440735
Eur J Cancer. 2009 Jan;45(2):228-47
pubmed: 19097774
J Patient Rep Outcomes. 2018 Jun 13;2:27
pubmed: 29951640
Tohoku J Exp Med. 1998 Jul;185(3):173-84
pubmed: 9823778
Health Econ. 2018 Jan;27(1):7-22
pubmed: 28833869
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
N Engl J Med. 2019 Jul 25;381(4):338-348
pubmed: 31340094
Lancet Oncol. 2018 Nov;19(11):e588-e653
pubmed: 30344075
Ther Adv Med Oncol. 2013 Nov;5(6):318-23
pubmed: 24179486
J Clin Oncol. 2016 Feb 20;34(6):557-65
pubmed: 26644527
Lancet. 2017 Nov 18;390(10109):2266-2277
pubmed: 28916371
BMJ Open. 2018 Dec 6;8(12):e022711
pubmed: 30530472
Health Qual Life Outcomes. 2019 Jan 22;17(1):20
pubmed: 30670040
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
J Urol. 2006 Apr;175(4):1245-52
pubmed: 16515971
Lancet Oncol. 2020 Jan;21(1):105-120
pubmed: 31753727
J Biol Chem. 2003 Oct 31;278(44):43496-507
pubmed: 12917408
Health Qual Life Outcomes. 2006 Oct 11;4:79
pubmed: 17034633
BJU Int. 2018 Nov;122(5):760-773
pubmed: 29726085
J Clin Oncol. 2019 Oct 10;37(29):2592-2600
pubmed: 31356140