Evidence map›Paper›PMID 37723846›Full record

Trial reportCancer medicine2023

The efficacy and safety of chemo-free therapy in epidermal growth factor receptor tyrosine kinase inhibitor-resistant advanced non-small cell lung cancer: A single-arm, phase II study.

Shuyang Zhang, Lu Yang, Yaning Yang, Guangjian Yang, Haiyan Xu, Xueliang Niu, Yan Wang

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 18% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. 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

7 authors at 5 institutions in 2 countries.

Shuyang ZhangCancer Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Lu YangDepartment of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing, China.ORCID 0000-0002-4286-9586
Yaning YangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Guangjian YangDepartment of Respiratory Medicine, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Haiyan XuDepartment of Comprehensive Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xueliang NiuDepartment of Medical Affairs, Shanghai Junshi Biosciences Co., Ltd., Shanghai, China.
Yan WangDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0000-0002-1743-6383
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBeijing Tongren Hospital · CNBioscience Research · USPeking University · CNShandong Tumor Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe purpose of this study was to explore the efficacy and safety of toripalimab combined with anlotinib in patients with advanced non-small cell lung cancer (NSCLC) who acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). MATERIALS AND

methodsPatients who developed resistance after using first- or second-generation EGFR-TKIs as their first-line regimen without EGFR T790M mutation or had disease progression after being treated with third-generation EGFR-TKIs as first- or second-line therapy were enrolled. All patients received toripalimab (240 mg/day on Day 1, intravenously) combined with anlotinib (12 mg/day, Days 1-14, orally) once every 3 weeks. Treatment continued until disease progression, or if toxicity was intolerable. The primary endpoint was the objective response rate (ORR) assessed by the investigator. The secondary endpoint was the progression-free survival (PFS).

resultsIn total, 19 patients were enrolled between May 2020 and October 2021.The ORR was 0%, and a median PFS was 2.1 months (95% CI 0.251-3.949). Grade ≥3 treatment-related adverse events (AEs) occurred in 11% patients. Common adverse events included hypothyroidism (12/19), fatigue (9/19), and hypertension (8/19). Patients in stable disease (SD) group had lower abundance of EGFR mutation allele frequency (AF) before enrollment than those in progressive disease (PD) group (p = 0.031). Patients without detectable EGFR mutation (EGFR-) had longer PFS compared to the ones with EGFR mutations (p = 0.059). Patients with high levels of soluble programmed cell death ligand 1 (PD-L1) at baseline also tended to have longer PFS (p = 0.160).

conclusionToripalimab combined with anlotinib was tolerable in EGFR-TKI-resistant advanced NSCLC patients not previously treated with chemotherapy. Patients without detectable EGFR mutation and high soluble PD-L1 levels may benefit from this chemotherapy-free treatment.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsB7-H1 AntigenDisease ProgressionErbB ReceptorsHumansMutationProtein Kinase InhibitorsTyrosine Kinase InhibitorsB7-H1 AntigenErbB ReceptorsProtein Kinase InhibitorsTyrosine Kinase Inhibitorsantiangiogenic agentschemo-free therapyEGFR gene mutationimmune checkpoint inhibitorsnon-small cell lung cancer

Identifiers

PMID37723846
PMCPMC10587943
OpenAlexW4386843270

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.