Evidence map›Paper›PMID 30191365›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2019

Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis.

David F McDermott, Ruchit Shah, Komal Gupte-Singh, Javier Sabater, Linlin Luo, Marc Botteman, Sumati Rao, Meredith M Regan, Michael Atkins

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04830267 (A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT04830267 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

TypeinterventionalSponsorChongqing University Cancer HospitalRan2021 to 2026Enrolled39ConditionsNasopharyngeal CarcinomaArmsCamrelizumab, Stereotactic body radiotherapy
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
  4. Trial
  5. Article
  6. Treatment of Advanced Metastatic Melanoma.Dermatology practical & conceptual · 2021
    Review
  7. Review
  8. Review
  9. 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

9 authors.

David F McDermottBeth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Harvard Medical School, Boston, MA, USA. dmcdermo@bidmc.harvard.edu.
Ruchit ShahPharmerit International, Bethesda, MD, USA.
Komal Gupte-SinghBristol-Myers Squibb, Princeton, NJ, USA.
Javier SabaterBristol-Myers Squibb, Princeton, NJ, USA.
Linlin LuoPharmerit International, Bethesda, MD, USA.
Marc BottemanPharmerit International, Bethesda, MD, USA.
Sumati RaoBristol-Myers Squibb, Princeton, NJ, USA.
Meredith M ReganDana-Farber Cancer Institute, Boston, MA, USA.
Michael AtkinsLombardi Cancer Center, Georgetown University, Washington, DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo compare the quality-adjusted survival of nivolumab plus ipilimumab combination and nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma based on a minimum 36-month follow-up from the CheckMate 067 trial.

methodsOverall survival was partitioned into time without symptoms of progression or toxicity (TWiST), time with treatment-related grade ≥ 3 adverse events after randomization but before progression (TOX), and time from progression until end of follow-up or death (REL). Mean quality-adjusted TWiST (Q-TWiST) was calculated by multiplying the mean time spent in each health state by a utility of 1.0 for TWiST and 0.5 for TOX and REL. Sensitivity analyses included varying utilities of TOX and REL; Q-TWiST gains at different follow-up times were calculated using EQ-5D-3L utilities from the trial. Relative Q-TWiST gain of ≥ 10% was considered clinically important.

resultsCompared with ipilimumab-treated patients, those who received nivolumab + ipilimumab combination had significantly longer TWiST and TOX but shorter REL; nivolumab-treated patients had significantly longer TWiST, shorter REL, and shorter but statistically nonsignificant TOX. Mean Q-TWiST was highest for nivolumab + ipilimumab (23.5 months; 95% CI 21.9-25.2), followed by nivolumab (21.8 months; 95% CI 20.2-23.4) and ipilimumab (15.3 months; 95% CI 13.9-16.6). Relative Q-TWiST gains were favorable and clinically important for nivolumab + ipilimumab combination (+ 36.81%) and nivolumab alone (+ 29.18%) versus ipilimumab alone. Relative gains increased with follow-up from 3 to 40 months for all comparisons. These gains remained consistent in magnitude and direction in the different sensitivity analyses.

conclusionsNivolumab + ipilimumab combination and nivolumab alone resulted in a statistically significant and clinically important improvement in quality-adjusted survival compared with ipilimumab alone.

Indexed as

Antineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDisease ProgressionFemaleHumansIpilimumabMaleMelanomaNivolumabQuality of LifeSurvival AnalysisAntineoplastic Agents, ImmunologicalIpilimumabNivolumabAdvanced melanomaIpilimumabNivolumabQ-TWiSTQuality-adjusted survival

Identifiers

PMID30191365

What OpenQuestion holds

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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.