Evidence map›Paper›PMID 32697335›Full record

Trial reportCancer2020

A quality-adjusted survival time without symptoms or toxicities analysis of glasdegib plus low-dose cytarabine versus low-dose cytarabine as initial therapy for acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy.

Caitlyn T Solem, Timothy J Bell, Youngmin Kwon, Joseph C Cappelleri, Courtney Johnson, Helen Bhattacharyya, Caroline J Hoang, Jorge E Cortes

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
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

8 authors at 3 institutions in 1 country.

Caitlyn T SolemPharmerit - an OPEN Health Company, Bethesda.ORCID 0000-0002-4914-8052
Timothy J BellPfizer, Inc, New York, New York.
Youngmin KwonPharmerit - an OPEN Health Company, Bethesda.
Joseph C CappelleriPfizer, Inc, New York, New York.
Courtney JohnsonPharmerit - an OPEN Health Company, Bethesda.
Helen BhattacharyyaPfizer, Inc, New York, New York.
Caroline J HoangPfizer, Inc, New York, New York.
Jorge E CortesPharmerit - an OPEN Health Company, Bethesda.
Pfizer (United States) · USPharmerit (United States) · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NIH HHS P30 CA016672PfizerUniversity of Texas MD Anderson Cancer Center
6 · The paper itself

Abstract

backgroundIn a randomized study, glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC) significantly prolonged survival in comparison with LDAC in patients with acute myeloid leukemia (AML). A quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) approach was used to evaluate comparative quality-adjusted survival.

methodsOverall survival was partitioned into the following: time with any treatment-emergent grade 3 or higher adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL). Q-TWiST was calculated by multiplying the restricted mean time in each state by respective utilities and then summing up the utility-adjusted time.

resultsAt 20 months of follow-up, the survival probabilities for the glasdegib-LDAC arm and the LDAC arm were 28.2% and 7.9%, respectively. Glasdegib-LDAC patients (n = 78), in comparison with LDAC patients (n = 38), had significantly longer mean TWiST (+3.4 months; 95% confidence interval [CI], 1.8-5.2 months) and TOX (+0.8 months; 95% CI, 0.1-1.6 months) and longer but nonsignificant REL (+0.3 months; 95% CI, -1.9 to 2.3 months). Q-TWiST was 4.0 months (95% CI, 2.1-5.8 months) longer with glasdegib plus LDAC, and this translated into a 75% relative improvement in quality-adjusted survival with respect to LDAC. Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.

conclusionsThese results suggest that most of the survival benefit from glasdegib plus LDAC versus LDAC alone is TWiST, and this represents added time in relatively "good" health. These results support the clinical value of glasdegib plus LDAC as initial therapy for AML in patients for whom intensive chemotherapy is not an option.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCytarabineFemaleHumansLeukemia, Myeloid, AcuteMalePhenylurea CompoundsSurvival AnalysisBenzimidazolesCytarabineglasdegibPhenylurea Compoundsacute myeloid leukemiaglasdegiblow-dose cytarabinequality-adjusted survivalquality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST)quality of life

Identifiers

PMID32697335
PMCPMC7540307
OpenAlexW3044819267

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.