Evidence map›Paper›PMID 35333492›Full record

Trial reportCancer journal (Sudbury, Mass.)

Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer.

Shun Lu, Yan Yu, Gisoo Barnes, Xiusong Qiu, Yuanyuan Bao, Boxiong Tang

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer journal (Sudbury, Mass.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03663205 (A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT03663205 phase3completednot on this map

A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer

TypeinterventionalSponsorBeiGeneRan2018 to 2023Enrolled334ConditionsNon-Small Cell Lung CancerArmsTislelizumab, Cisplatin, Carboplatin, Pemetrexed
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. 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

6 authors at 2 institutions in 1 country.

Shun LuFrom the Shanghai Chest Hospital, Jiao Tong University, Shanghai.
Yan YuAffiliated Tumor Hospital of Harbin Medical University, Harbin, China.
Gisoo BarnesBeiGene, San Mateo, CA.
Xiusong QiuBeiGene (Shanghai) Co, Beijing, China.
Yuanyuan BaoBeiGene (Shanghai) Co, Beijing, China.
Boxiong TangBeiGene, San Mateo, CA.
Harbin Medical University · CNShanghai Chest Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study assessed the effects of tislelizumab, a programmed cell death protein 1 inhibitor, in combination with chemotherapy versus chemotherapy alone as first-line treatment on health-related quality of life (HRQoL) in patients with advanced nonsquamous non-small cell lung cancer (nSQ-NSCLC).

methodsPatients in this randomized, open-label, multicenter phase III study RATIONALE 304 (NCT03663205) with histologically confirmed stage IIIB/IV nSQ-NSCLC were randomized 2:1 to tislelizumab plus platinum-pemetrexed (arm T + PP) or platinum-pemetrexed alone (arm PP). Health-related QoL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer. Key patient-reported outcome endpoints include mean score change from baseline at weeks 12 (during chemotherapy) and 18 (following chemotherapy) in the 30-item Quality of Life Questionnaire Core's global health status/quality of life (GHS/QoL) and time to deterioration in GHS/QoL.

resultsThree hundred thirty-two patients received at least 1 dose of study drug and completed at least 1 HRQoL assessment. Global health status/QoL score improved in arm T + PP at week 18 (between-group least square mean difference, 5.7; 95% confidence interval [CI], 1.0-10.5; P = 0.018). Patients in arm T + PP experienced greater reduction in coughing (-5.9; 95% CI, -11.6 to -0.1; P = 0.044), dyspnea (-3.8; 95% CI, -7.8 to 0.1; P = 0.059), chest pain (-6.2; 95% CI, -10.8 to -1.6; P = 0.008), and peripheral neuropathy (-2.6; 95% CI, -5.5 to 0.2; P = 0.066). Median time to deterioration in GHS/QoL was not achieved for either arm. DISCUSSION: The addition of tislelizumab to platinum-based chemotherapy was associated with improvements in nSQ-NSCLC patients' HRQoL as well as the important disease-specific symptoms of coughing, chest pain, and dyspnea.ClinicalTrials.gov Identifier: NCT03663205.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansQuality of LifeAntibodies, Monoclonal, Humanizedtislelizumab

Identifiers

PMID35333492
PMCPMC8974185
OpenAlexW4220820715

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.