Evidence map›Paper›PMID 20628385›Full record

Trial reportBritish journal of cancer2010

Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan.

T Okusaka, K Nakachi, A Fukutomi, N Mizuno, S Ohkawa, A Funakoshi, M Nagino, S Kondo, S Nagaoka, J Funai and 5 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 372 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
372citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

NCT03524508 phase2completednot on this mapstarted 2018, after this paper: background citation

Randomized Phase II Trial of Fluorouracil and Folinic Acid With or Without Liposomal Irinotecan (ONIVYDE) for Patients With Metastatic Biliary Tract Cancer Which Progressed Following Gemcitabine Plus Cisplatin

TypeinterventionalSponsorChanghoon YooRan2018 to 2021Enrolled178ConditionsMetastatic Biliary Tract CancerArmsOnivyde, 5-FU/LV
NCT03982680 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma

TypeinterventionalSponsorJiangmen Central HospitalRan2019 to 2021Enrolled30ConditionsAdvanced CholangiocarcinomaArmsToripalimab, Gemcitabine, 5- fluorine pyrimidine
NCT04059562 phase2completednot on this mapstarted 2021, after this paper: background citation

Efficacy and Safety of Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma

TypeinterventionalSponsorHeinrich-Heine University, DuesseldorfRan2021 to 2024Enrolled28ConditionsCholangiocarcinomaArmsCombination of Lonsurf® and Irinotecan
3 · Its place in the literature

Who cites it

372 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
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  7. SEOM clinical guidelines for pancreatic and biliary tract cancer (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Guideline
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  17. Prospective Randomized Controlled Trial Comparing Adjuvant Chemotherapy vs. No Chemotherapy for Patients with Carcinoma of Gallbladder Undergoing Curative Resection.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2022
    Trial
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312 more citing papers are in PubMed but not listed here.

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.

T OkusakaHepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. tokusaka@ncc.go.jp
K Nakachi
A Fukutomi
N Mizuno
S Ohkawa
A Funakoshi
M Nagino
S Kondo
S Nagaoka
J Funai
M Koshiji
Y Nambu
J Furuse
M Miyazaki
Y Nimura

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA British randomised study of gemcitabine plus cisplatin (GC) combination showed promising results in biliary tract cancer (BTC) patients. In our study, we evaluated the efficacy and safety of this combination compared with gemcitabine alone (G) in Japanese BTC patients.

methodsOverall, 84 advanced BTC patients were randomised to either cisplatin 25 mg m(-2) plus gemcitabine 1000 mg m(-2) on days 1, 8 of a 21-day cycle (GC-arm), or single-agent gemcitabine 1000 mg m(-2) on days 1, 8 and 15 of a 28-day cycle (G-arm). Treatments were repeated for at least 12 weeks until disease progression or unacceptable toxicity occurred, up to a maximum of 48 weeks.

resultsA total of 83 patients were included in the analysis. For the GC and G-arms, respectively, the 1-year survival rate was 39.0 vs 31.0%, median survival time 11.2 vs 7.7 months, median progression-free survival time 5.8 vs 3.7 months and overall response rate 19.5 vs 11.9%. The most common grade 3 or 4 toxicities (GC-arm/G-arm) were neutropenia (56.1%/38.1%), thrombocytopenia (39.0%/7.1%), leukopenia (29.3%/19.0%), haemoglobin decrease (36.6%/16.7%) and gamma-GTP increase (29.3%/35.7%).

conclusionsGemcitabine plus cisplatin combination therapy was found to be effective and well tolerated, suggesting that it could also be a standard regimen for Japanese patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCisplatinDeoxycytidineFemaleGemcitabineHumansJapanMaleMiddle AgedTreatment OutcomeAntineoplastic AgentsCisplatinDeoxycytidineGemcitabine

Identifiers

PMID20628385
PMCPMC2939781

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.