Evidence map›Paper›PMID 33160359›Full record

Trial reportBMC urology2020

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).

Andrea Necchi, Hiroyuki Nishiyama, Nobuaki Matsubara, Jae-Lyun Lee, Daniel P Petrylak, Ronald de Wit, Alexandra Drakaki, Astra M Liepa, Huzhang Mao, Katherine Bell-McGuinn and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02426125 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02426125 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2022Enrolled530ConditionsUrothelial CarcinomaArmsRamucirumab, Docetaxel, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 6 countries.

Andrea NecchiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, 20133, Milan, Italy. andrea.necchi@istitutotumori.mi.it.
Hiroyuki NishiyamaUniversity of Tsukuba, Tsukuba, Japan.
Nobuaki MatsubaraNational Cancer Center Hospital East, Chiba, Japan.
Jae-Lyun LeeAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Daniel P PetrylakYale University, New Haven, CT, USA.
Ronald de WitErasmus MC Cancer Institute, Rotterdam, Netherlands.
Alexandra DrakakiUniversity of California Los Angeles, Los Angeles, CA, USA.
Astra M LiepaEli Lilly and Company, Indianapolis, IN, USA.
Huzhang MaoEli Lilly and Company, Indianapolis, IN, USA.
Katherine Bell-McGuinnEli Lilly and Company, Indianapolis, IN, USA.
Thomas PowlesBarts Cancer Institute, London, UK.
Eli Lilly (United States) · USBarts Health NHS Trust · GBErasmus MC Cancer Institute · NLFondazione IRCCS Istituto Nazionale dei Tumori · ITNational Cancer Center Hospital East · JPUniversity of California, Los Angeles · USUniversity of Tsukuba · JPUniversity of Ulsan · KRYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundTo evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC).

methodsRANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m

resultsOf 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.

conclusionsRamucirumab 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: NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellDocetaxelDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasm StagingRamucirumabAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDocetaxelRamucirumabAntiangiogenesisBladder cancerNeoplasm metastatsisPatient-reported outcomesQuality of lifeRamucirumabUrinary bladder neoplasmUrothelial carcinoma

Identifiers

PMID33160359
PMCPMC7648381
OpenAlexW3095323841

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.