Evidence map›Paper›PMID 27765756›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Safety and efficacy of nivolumab and standard chemotherapy drug combination in patients with advanced non-small-cell lung cancer: a four arms phase Ib study.

S Kanda, K Goto, H Shiraishi, E Kubo, A Tanaka, H Utsumi, K Sunami, S Kitazono, H Mizugaki, H Horinouchi and 5 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
7.7field-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

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Effectiveness of PD1/PD-L1 combined with anti-angiogenic drugs in patients with advanced nonsmall cell lung cancer: A systematic review and meta-analysis.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2024
    Review
  10. Peripheral CD4Frontiers in immunology · 2024
    Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. On the use of historical estimates.Statistical papers (Berlin, Germany) · 2023
    Article
  16. Review
  17. Review
  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

15 authors at 2 institutions in 2 countries.

S KandaDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo skanda@ncc.go.jp.
K GotoDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H ShiraishiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
E KuboDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
A TanakaDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H UtsumiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
K SunamiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
S KitazonoDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H MizugakiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H HorinouchiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
Y FujiwaraDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H NokiharaDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
N YamamotoDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
H HozumiONO Pharmaceutical Co. Ltd, Osaka, Japan.
T TamuraDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
National Cancer Center · USOno Pharmaceutical (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe human IgG4 monoclonal antibody nivolumab targets programmed cell death-1 (PD-1) and promotes antitumor response by blocking the interaction of PD-1 with its ligands. This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND

methodsPatients who had stage IIIB without indication for definitive radiotherapy, stage IV, or recurrent NSCLC were eligible. Regimens were nivolumab 10 mg/kg + gemcitabine/cisplatin (arm A), pemetrexed/cisplatin (arm B), paclitaxel/carboplatin/bevacizumab (arm C), or docetaxel (arm D). Regimens A, B, and D were repeated every 3 weeks for up to four cycles and regimen C was repeated for up to six cycles; nivolumab alone (arm A), with pemetrexed (arm B), bevacizumab (arm C), or docetaxel (arm D) was continued every 3 weeks as maintenance therapy until disease progression or unacceptable toxicity. Dose-limiting toxicity (DLT) was evaluated during the first treatment cycle.

resultsAs of March 2014, six patients were enrolled in each arm. The combination of nivolumab 10 mg/kg and chemotherapy was well tolerated. DLT was observed in only one patient in arm A (alanine aminotransferase increased). Select adverse events (those with a potential immunologic cause) of any grade were observed in six, four, six, and five patients in arms A, B, C, and D, respectively. Three, three, six, and one patient achieved partial response while median progression-free survival was 6.28, 9.63 months, not reached, and 3.15 months in arms A, B, C, and D, respectively.

conclusionsCombination of nivolumab 10 mg/kg and chemotherapy showed an acceptable toxicity profile and encouraging antitumor activity in patients with advanced NSCLC. CLINICAL TRIALS NUMBER: Japanese Pharmaceutical Information Center Clinical Trials Information (JapicCTI)-132071.

Indexed as

AdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCisplatinDeoxycytidineDisease-Free SurvivalDocetaxelFemaleGemcitabineHumansMaleMiddle AgedAntibodies, MonoclonalBevacizumabCarboplatinCisplatinDeoxycytidineDocetaxelGemcitabineNivolumabPaclitaxelPemetrexedTaxoidschemotherapycombinationnivolumabnon-small-cell lung cancer

Identifiers

PMID27765756
PMCPMC5178141
OpenAlexW2537295025

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.