Evidence map›Paper›PMID 38853265›Full record

Trial reportBMC medicine2024

Optimizing perioperative treatment for potentially resectable stage III squamous cell lung carcinoma: promising results of a condensed four-cycle regimen with tislelizumaband chemotherapy.

Jianzhen Shan, Zhen Liu, Songan Chen, Chengli Du, Bing Li, Lingxiang Ruan, Mei Kong, Lingjie Wang, Miaoyan Du, Shuo Shi and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC 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 NCT05024266 (Tislelizumab Combined With Albumin Paclitaxel + Carboplatin as Neoadjuvant Therapy for Patients With Stage IIIA-IIIB), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT05024266 phase2unknown statusnot on this map

Tislelizumab Combined With Albumin Paclitaxel + Carboplatin as Neoadjuvant Therapy for Patients With Stage IIIA-IIIB (N2) Lung Squamous Cell Carcinoma: A Single-arm, Single-center, Exploratory Phase II Clinical Study

TypeinterventionalSponsorFirst Affiliated Hospital of Zhejiang UniversityRan2021 to 2023Enrolled30ConditionsLung Squamous Cell Carcinoma, Neoadjuvant Therapy, ImmunotherapyArmsTislelizumab
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. 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

13 authors.

Jianzhen Shan *Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China. shanjz@zju.edu.cn.ORCID http://orcid.org/0000-0001-5308-7056
Zhen Liu *Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Songan ChenDepartment of Medicine, Burning Rock Biotech, Guangzhou, China.
Chengli DuDepartment of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Bing LiDepartment of Medicine, Burning Rock Biotech, Guangzhou, China.
Lingxiang RuanDepartment of Radiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Mei KongDepartment of Pathology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Lingjie WangDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Miaoyan DuDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Shuo ShiData Science Department, Burning Rock Biotech, Guangzhou, China.
Guoliang QiaoDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Tian TianDepartment of Medical Oncology, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China.
Zhengliang TuDepartment of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, Shangcheng District, China. drtuzhengliang@zju.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe standard care for resectable non-small cell lung cancer (NSCLC) involves perioperative therapy combining chemotherapy and immune checkpoint inhibitors, typically lasting 6 to 12 months. However, the optimal treatment strategies for potentially resectable squamous cell lung carcinoma (SCC) remain unclear. This Phase 2 trial aimed to assess the efficacy and safety of a condensed four-cycle perioperative treatment regimen with tislelizumab combined with chemotherapy in patients with potentially resectable stage III SCC.

methodsPatients with potentially resectable stage IIIA-IIIB (N2) SCC received intravenous tislelizumab, albumin-bound paclitaxel, and carboplatin for up to four cycles. The primary endpoints were major pathologic response (MPR) and incidence of treatment-related adverse events. Safety and potential biomarkers for efficacy prediction were also assessed.

resultsAmong 35 enrolled patients, 32 underwent surgery with R0 resection achieved in all cases. MPR was achieved in 24 patients and pathological complete response (pCR) in 14 patients. Radiographic objective response was observed in 31 patients. The 12-month and 24-month event-free survival rate was 85.7 and 61.0%, respectively. Four patients experienced grade 3 or 4 adverse events. Tumor tissue based next-generation sequencing revealed the potential associations between several biomarkers and pathological response, including tumor neoantigen burden score, 18-gene expression profile score, CD8 + T cells, M1/M2 macrophages ratio and interferon-gamma expression level. Besides, circulating tumor DNA (ctDNA) dynamics and concentration were also associated with pathological response and the presence of ctDNA at postoperative month 1 was a strong predictor for disease relapse. Furthermore, metagenomic sequencing in bronchoalveolar lavage fluid demonstrated Streptococcus was the most abundant genus in the pCR group.

conclusionsA condensed four-cycle perioperative treatment regimen of tislelizumab combined with chemotherapy demonstrated promising efficacy and manageable toxicities in potentially resectable stage III SCC. Specific biomarkers showed potential for predicting treatment efficacy and the mechanism of superior antitumor response of pCR patients was preliminarily and indirectly explored.

trial registrationClinicalTrials.gov, NCT05024266. Registered August 27, 2021.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsLung NeoplasmsAdultAgedCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleHumansMaleMiddle AgedNeoplasm StagingPaclitaxelPerioperative CareTreatment OutcomeAntibodies, Monoclonal, HumanizedCarboplatinPaclitaxeltislelizumabBiomarkersMajor pathologic responsePerioperative therapySquamous cell lung carcinomaTislelizumab

Identifiers

PMID38853265
PMCPMC11163755

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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.