Evidence map›Paper›PMID 35544539›Full record

Trial reportPloS one2022

Phase II trial of nafamostat mesilate/gemcitabin/S-1 for unresectable pancreatic cancer.

Tadashi Uwagawa, Taro Sakamoto, Takeshi Gocho, Hiroaki Shiba, Shinji Onda, Jungo Yasuda, Yoshihiro Shirai, Ryoga Hamura, Kenei Furukawa, Katsuhiko Yanaga and 1 more

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

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

11 authors at 1 institution in 1 country.

Tadashi UwagawaDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.ORCID 0000-0002-7194-8427
Taro SakamotoDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Takeshi GochoDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Hiroaki ShibaDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Shinji OndaDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Jungo YasudaDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Yoshihiro ShiraiDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Ryoga HamuraDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Kenei FurukawaDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Katsuhiko YanagaDepartment of Surgery, Fukuoka Sanno Hospital, Fukuoka, Japan.ORCID 0000-0001-8918-4720
Toru IkegamiDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Jikei University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the efficacy of combination chemotherapy with nafamostat mesilate, gemcitabine and S-1 for unresectable pancreatic cancer patients. MATERIALS AND

methodsThe study was conducted as a single-arm, single center, institutional review board-approved phase II trial. Patients received nafamosntat mesilate (4.8 mg/kg continuous transregional arterial infusion) with gemcitabine (1000 mg/m2 transvenous) on days 1 and15, and with oral S-1 [(80 mg/day (BSA<1.25 m2), 100 mg/day (1.25 ≤ BSA<1.5 m2), or 120 mg/day (BSA ≥1.5 m2)] on days 1-14 or, days 1-7 and 15-21. This regimen was repeated at 28-day intervals.

resultsForty-seven evaluable patients (Male/Female: 31/16, Age (median): 66 (range 35-78) yrs, Stage III/IV 10/37.) were candidates in this study. Two patients in stage III (20%) could undergo conversion surgery. Twenty-four patients (51%) underwent subsequent treatment (1st line/ 2nd line / 4th line, 13/ 10/ 1, FOLFIRINOX: 12, GEM/nab-PTX: 18, TAS-118: 3, chemoradiation with S-1: 2, GEM/Erlotinib: 1, nal-IRI: 1, surgery: 2). Median PFS and OS were 9.7 (95% CI, 8.9-14.7 mo) and 14.2 months (99% CI, 13.3-23.9 mo), respectively. Median PFS in stage IV patients was 9.2 months (95% CI, 8.4-12.0 mo). Median OS in patients without subsequent treatment was 10.8 months (95% CI, 9.1-13.8 mo). Median OS in patients with subsequent treatment was 19.3 months (95% CI, 18.9-31.9 mo). Grade 4 treatment-related hematological toxicities were encountered in 7 patients. Two patients developed grade 3 allergic reaction after 6 cycles or later. No febrile neutropenia has been observed.

conclusionNAM/GEM/S-1 therapy is safe and could be promising option for unresectable pancreatic cancer, especially for stage IV cancer.

Indexed as

Pancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBenzamidinesDeoxycytidineFemaleGemcitabineGuanidinesHumansMaleTreatment OutcomeBenzamidinesDeoxycytidineGemcitabineGuanidinesnafamostat

Identifiers

PMID35544539
PMCPMC9094514
OpenAlexW4280501297

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.