Evidence map›Paper›PMID 39021272›Full record

Trial reportCancer medicine2024

Quality of life and patient-reported toxicities in patients with advanced Merkel cell carcinoma treated with combined nivolumab and ipilimumab with or without stereotactic body radiation therapy.

Aasha I Hoogland, Andrew S Brohl, Brent J Small, Lauren Michael, Evan Wuthrick, Zeynep Eroglu, Dukagjin Blakaj, Claire Verschraegen, Nikhil I Khushalani, Heather S L Jim and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03071406 (A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT03071406 phase2active not recruitingnot on this map

A Phase 2, Randomized, Multi-institutional Study of Nivolumab and Ipilimumab Versus Nivolumab, Ipilimumab and Stereotactic Body Radiation Therapy for Metastatic Merkel Cell Carcinoma

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2017 to 2026Enrolled50ConditionsMerkel Cell Carcinoma, Skin CancerArmsNivolumab, Ipilimumab, Stereotactic Body Radiation Therapy (SBRT)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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.

Aasha I HooglandDepartment of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-8691-8132
Andrew S BrohlDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Brent J SmallSchool of Aging Studies, University of South Florida, Tampa, Florida, USA.
Lauren MichaelDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Evan WuthrickDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Zeynep ErogluDepartment of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Dukagjin BlakajDepartment of Radiation Oncology, Ohio State University, Columbus, Ohio, USA.
Claire VerschraegenDepartment of Cutaneous Oncology, Ohio State University, Columbus, Ohio, USA.
Nikhil I KhushalaniDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Heather S L JimDepartment of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0001-7353-3711
Sungjune KimDepartment of Radiation Oncology, Mayo Clinic, Jacksonville, Florida, USA.

Funding

Role of Sirt2 in T Cell Metabolism - ExtensionR37CA248298 · NCI · MAYO CLINIC JACKSONVILLE · PI Sungjune Kim · 2021 to 2026
$2.2M
Bristol Myers Squibb Rare Population Malignancy ProgramNCI NIH HHS R37 CA248298
6 · The paper itself

Abstract

backgroundMerkel cell carcinoma is a rare skin cancer associated with poor survival. Based on a previous Phase II trial of adults with advanced Merkel cell carcinoma by Kim and colleagues (2022), there is now a strong rationale for combination therapy (i.e., nivolumab and ipilimumab) to become a treatment option for patients with advanced Merkel cell carcinoma. The goal of this paper was to report on the secondary outcome of quality of life (QOL) among patients on this trial.

methodsPatients receiving combined nivolumab and ipilimumab, with or without stereotactic body radiation therapy (SBRT), completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 prior to starting treatment and every 2 weeks thereafter. Changes in QOL during treatment and post-treatment were evaluated using piecewise random-effects mixed models. Exploratory analyses compared changes in QOL between study arms. The original trial was registered with ClinicalTrials.gov (NCT03071406).

resultsStudy participants (n = 50) reported no changes in overall QOL (ps > 0.05), but emotional functioning improved during treatment (p = 0.01). Cognitive and social functioning worsened post-treatment (ps < 0.01). In general, patients treated with combination therapy only (n = 25) reported no change in QOL over time, whereas patients also treated with SBRT (n = 25) consistently demonstrated worsening QOL post-treatment.

conclusionQOL is generally preserved in patients treated with combination therapy, but the addition of SBRT may worsen QOL. Combined with clinical efficacy data published previously, results support the use of combination therapy with nivolumab and ipilimumab as a treatment option for patients with advanced Merkel cell carcinoma.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Merkel CellIpilimumabNivolumabQuality of LifeRadiosurgerySkin NeoplasmsAgedAged, 80 and overFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresIpilimumabNivolumabimmune checkpoint inhibitor therapyMerkel cell carcinomapatient‐reported outcomesquality of life

Identifiers

PMID39021272
PMCPMC11255021

What Socratic 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 Socratic graph.