Evidence map›Paper›PMID 26061330›Full record

Trial reportMedicine2015

S-1 and Cisplatin With or Without Nimotuzumab for Patients With Untreated Unresectable or Metastatic Gastric Cancer: A Randomized, Open-Label Phase 2 Trial.

Feng Du, Zhaoxu Zheng, SuSheng Shi, Zhichao Jiang, Tao Qu, Xinhua Yuan, Yongkun Sun, Yan Song, Lin Yang, Jiuda Zhao and 2 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 3% 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

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Nimotuzumab Combined with Chemotherapy is a Promising Treatment for Locally Advanced and Metastatic Esophageal Cancer.Medical science monitor : international medical journal of experimental and clinical research · 2017
    Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Helicobacter pylori and gastric cancer: a lysosomal protease perspective.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2022
    Review
  9. Targeted therapies for gastroesophageal cancers.Annals of translational medicine · 2020
    Review
  10. Review
  11. Targeting EGFR in Esophagogastric Cancer.Frontiers in oncology · 2020
    Review
  12. Review
  13. Precision medicine in gastric cancer.World journal of gastrointestinal oncology · 2019
    Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. 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

12 authors at 1 institution in 1 country.

Feng DuFrom the Department of Medical Oncology (FD, ZJ, YS, YS, LY, JZ, JW, YC); The Department of Abdominal Surgical Oncology (ZZ, XY); and Department of Pathology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China (SSS).
Zhaoxu Zheng
SuSheng Shi
Zhichao Jiang
Tao Qu
Xinhua Yuan
Yongkun Sun
Yan Song
Lin Yang
Jiuda Zhao
Jinwan Wang
Yihebali Chi
Chinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This open-label, randomized phase II trial was performed to compare the efficacy and safety of nimotuzumab plus S-1 and cisplatin (NCS) versus S-1 and cisplatin (CS) alone in patients with untreated unresectable or metastatic gastric cancer in the first-line setting. Eligible participants were randomly assigned (1:1) to receive either NCS or CS. The treatment consisted of 3-week cycles of twice-daily S-1 40 mg/m² (on days 1-14) and intravenous cisplatin 30 mg/m² (on days 1, 2), with or without weekly nimotuzumab (200 mg/m²). The primary endpoint was objective response rate (ORR). The second endpoint included progression-free survival (PFS), overall survival (OS), safety and association between efficacy and tumor epidermal growth factor receptor (EGFR) expression. Between October, 2009, and February, 2012, we enrolled 62 patients in Cancer Hospital Chinese Academy of Medical Sciences (CAMS). The ORR for 31 patients allocated NCS was 54.8% compared with 58.1% for 31 patients who were allocated to receive CS alone (P = 0.798). Median PFS for patients in CS arm was significantly improved than that in NCS arm [7.2 months vs. 4.8 months HR = 2.136 (95% CI 1.193-3.826), P = 0.011]. There was also a trend toward better overall survival for patients in CS arm compared with NCS arm [14.3 months vs. 10.2 months; HR = 1.776 (95% CI 0.972-3.246), P = 0.062]. In the EGFR 2+/3+ subgroup, adding nimotuzumab also failed to show additional benefit than chemotherapy alone. Both groups were well tolerated. Less than 10% of patients in both arms developed grade 3/4 toxicity. Combination of nimotuzumab and S-1-cisplatin provided no additional benefit than chemotherapy alone in the first-line treatment of unresectable or metastatic gastric cancer.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic AgentsCisplatinDisease-Free SurvivalDrug CombinationsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedOxonic AcidProspective StudiesStomach NeoplasmsAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic AgentsCisplatinDrug CombinationsnimotuzumabOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID26061330
PMCPMC4616475
OpenAlexW2257030427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.