Evidence map›Paper›PMID 21484249›Full record

Trial reportInvestigational new drugs2012

Results of a phase II trial of S-1 as first-line treatment of metastatic pancreatic cancer (CESAR-study group).

Beate Schultheis, Dirk Strumberg, Lothar Bergmann, Ullrich Graeven, Axel-Rainer Hanauske, Rainer Lipp, Jochen Schuette, K Saito, Paul Scigalla, Max E Scheulen

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

8 citing papers in PubMed, 14 citations in OpenAlex.

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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

10 authors at 7 institutions in 2 countries.

Beate SchultheisDepartment of Haematology and Medical Oncology, University of Bochum (Marienhospital Herne), Herne, Germany. beate.schultheis@marienhospital-herne.de
Dirk Strumberg
Lothar Bergmann
Ullrich Graeven
Axel-Rainer Hanauske
Rainer Lipp
Jochen Schuette
K Saito
Paul Scigalla
Max E Scheulen
Taiho Oncology (United States) · USAsklepios Klinik St. Georg · DEEssen University Hospital · DEGoethe University Frankfurt · DEKliniken Maria Hilf · DEMarien Hospital Düsseldorf · DEUniversitätsklinik Marien Hospital Herne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeS-1, an oral fluoropyrimidine derivative, has previously demonstrated anticancer efficacy in pancreatic cancer (PC), predominantly in Asian populations. This study evaluated the antitumor effect and safety of S-1 in Caucasian patients with metastatic PC.

methodsChemotherapy-naïve patients received S-1 orally at 30 mg/m(2) twice daily (BID) for 2 weeks, repeated every 3 weeks. Primary endpoint was ORR. Secondary endpoints included PFS, OS and safety assessment. The trial had a Simon's two-stage design with 22 patients evaluable for efficacy in stage 1 and an additional 18 patients in stage 2, if ≥3/22 patients had a confirmed response at the first stage.

resultsThree out of 27 patients showed PR, however, detection of asymptomatic brain metastases in one of them prevented this study from proceeding to stage 2. The median PFS and OS for all patients was 3.5 and 9.1 months, respectively. The median duration of disease control for patients with SD or PR (n = 17) was 4.3 months. S-1 was well tolerated; fatigue was the most frequent grade 3/4 adverse event.

conclusionsEfficacy data of PFS and OS are at least comparable to gemcitabine, the current standard of care. S-1 is active in Caucasian patients with metastatic PC.

Indexed as

AdultAgedAged, 80 and overAntimetabolites, AntineoplasticBone NeoplasmsDrug CombinationsFemaleHumansLiver NeoplasmsLung NeoplasmsLymph NodesMaleMiddle AgedOxonic AcidPancreatic NeoplasmsTegafurAntimetabolites, AntineoplasticDrug CombinationsOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID21484249
OpenAlexW2050339021

What OpenQuestion holds

Textmetadata
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.