Evidence map›Paper›PMID 34921023›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

A Randomized Phase II Study Comparing Nivolumab with Carboplatin-Pemetrexed for EGFR-Mutated NSCLC with Resistance to EGFR Tyrosine Kinase Inhibitors (WJOG8515L).

Hidetoshi Hayashi, Shunichi Sugawara, Yasushi Fukuda, Daichi Fujimoto, Satoru Miura, Keiichi Ota, Yuichi Ozawa, Satoshi Hara, Junko Tanizaki, Koichi Azuma and 10 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 8 pooled it
7.6field-weighted citation impact, top 2% 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

52 citing papers in PubMed, 8 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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  18. The Activity of EGFR CAR NK and CAR T Cells against EGFR Inhibitor-Resistant NSCLC and Drug-Tolerant Persister Cells.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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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

20 authors at 15 institutions in 1 country.

Hidetoshi HayashiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.ORCID 0000-0001-8787-5587
Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Aoba-ku, Sendai, Miyagi, Japan.ORCID 0000-0002-3427-4558
Yasushi FukudaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
Daichi FujimotoDepartment of Respiratory Medicine, Kobe City Medical Center General Hospital, Chuo-ku, Kobe, Hyogo, Japan.
Satoru MiuraDepartment of Internal Medicine, Niigata Cancer Center Hospital, Chuo-ku, Niigata, Niigata, Japan.ORCID 0000-0001-7868-6661
Keiichi OtaResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Higashi-ku, Fukuoka, Japan.
Yuichi OzawaThird Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.ORCID 0000-0003-3798-3488
Satoshi HaraDepartment of Respiratory Medicine, Itami City Hospital, Itami, Hyogo, Japan.
Junko TanizakiDepartment of Medical Oncology, Kishiwada City Hospital, Kishiwada, Osaka, Japan.ORCID 0000-0002-6727-9435
Koichi AzumaDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
Shota OmoriDivision of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan.ORCID 0000-0003-1407-9779
Motoko TachiharaDivision of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Chuo-ku, Kobe, Hyogo, Japan.ORCID 0000-0002-4598-220X
Kazumi NishinoDepartment of Thoracic Oncology, Osaka International Cancer Institute, Chuo-ku, Osaka, Japan.ORCID 0000-0003-2000-7472
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Kita-ku, Okayama, Japan.ORCID 0000-0002-0394-7377
Yasutaka ChibaClinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, Japan.
Koji HarataniDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.ORCID 0000-0002-1767-6854
Kazuko SakaiDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.
Kazuto NishioDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.ORCID 0000-0002-8275-0846
Nobuyuki YamamotoThird Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.ORCID 0000-0002-7342-0853
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan.ORCID 0000-0003-1284-9776
Kindai University Hospital · JPKindai University · JPWakayama Medical University · JPItami City Hospital · JPKishiwada City Hospital · JPKobe City Medical Center General Hospital · JPKobe University · JPKurashiki Central Hospital · JPKurume University · JPKyushu University · JPNiigata Cancer Center Hospital · JPOkayama Red Cross General Hospital · JPOsaka International Cancer Institute · JPSendai Kousei Hospital · JPShizuoka Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlthough the efficacy of programmed cell death-1 (PD-1) blockade is generally poor for non-small cell lung cancer (NSCLC) with activating mutations of the epidermal growth factor receptor (EGFR) gene, EGFR tyrosine kinase inhibitors (TKIs) may improve the tumor immune microenvironment. We performed a randomized study to assess whether nivolumab improves outcome compared with chemotherapy in such patients previously treated with EGFR-TKIs. PATIENTS AND

methodsPatients with EGFR-mutated NSCLC who acquired EGFR-TKI resistance not due to a secondary T790M mutation of EGFR were randomized 1:1 to nivolumab (n = 52) or carboplatin-pemetrexed (n = 50). The primary endpoint was progression-free survival (PFS).

resultsMedian PFS and 1-year PFS probability were 1.7 months and 9.6% for nivolumab versus 5.6 months and 14.0% for carboplatin-pemetrexed [log-rank P < 001; hazard ratio (HR) of 1.92, with a 60% confidence interval (CI) of 1.61-2.29]. Overall survival was 20.7 and 19.9 months [HR, 0.88 (95% CI, 0.53-1.47)], and response rate was 9.6% and 36.0% for nivolumab and carboplatin-pemetrexed, respectively. No subgroup including patients with a high tumor mutation burden showed a substantially longer PFS with nivolumab than with carboplatin-pemetrexed. The T-cell-inflamed gene expression profile score (0.11 vs. -0.17, P = 0.036) and expression of genes related to cytotoxic T lymphocytes or their recruitment were higher in tumors that showed a benefit from nivolumab.

conclusionsNivolumab did not confer a longer PFS compared with carboplatin-pemetrexed in the study patients. Gene expression profiling identified some cases with a favorable tumor immune microenvironment that was associated with nivolumab efficacy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsNivolumabCarboplatinErbB ReceptorsHumansMutationPemetrexedProtein Kinase InhibitorsTumor MicroenvironmentCarboplatinEGFR protein, humanErbB ReceptorsNivolumabPemetrexedProtein Kinase Inhibitors

Identifiers

PMID34921023
PMCPMC9397372
OpenAlexW4200417352

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.