Evidence map›Paper›PMID 27339809›Full record

Trial reportInvestigational new drugs2016

Intravenous and intraperitoneal paclitaxel with S-1 for treatment of refractory pancreatic cancer with malignant ascites.

Naminatsu Takahara, Hiroyuki Isayama, Yousuke Nakai, Hironori Ishigami, Sohei Satoi, Suguru Mizuno, Hirofumi Kogure, Saburo Matsubara, Natsuyo Yamamoto, Hironori Yamaguchi and 4 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 16% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  7. The complex role of IL-10 in malignant ascites: a review.Cancer immunology, immunotherapy : CII · 2024
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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

14 authors at 4 institutions in 1 country.

Naminatsu TakaharaDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Hiroyuki IsayamaDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. isayama-tky@umin.ac.jp.
Yousuke NakaiDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Hironori IshigamiDepartment of Chemotherapy, The University of Tokyo, Tokyo, Japan.
Sohei SatoiDepartment of Surgery, Kansai Medical University, Osaka, Japan.
Suguru MizunoDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Hirofumi KogureDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Saburo MatsubaraDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Natsuyo YamamotoDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Hironori YamaguchiDepartment of Surgery, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.
Minoru TadaDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Joji KitayamaDepartment of Surgery, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.
Toshiaki WatanabeDepartment of Surgical Oncology, The University of Tokyo, Tokyo, Japan.
Kazuhiko KoikeDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
The University of Tokyo · JPJichi Medical University · JPJapan Society of Chemotherapy · JPKansai Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledObjectives The aim of this study was to evaluate the safety and efficacy of intravenous and intraperitoneal paclitaxel (PTX) combined with S-1 for treatment of gemcitabine-refractory pancreatic cancer with malignant ascites. Methods After the feasibility of this regimen was first confirmed in an interim analysis in 10 patients, a total of 35 patients were enrolled between April 2011 and December 2014. PTX was administered intravenously (50 mg/m(2)) and intraperitoneally (20 mg/m(2)) on days 1 and 8, and 80 mg/m(2) S-1 was administered on days 1-14 every 3 weeks. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), the objective tumor response, efficacy against malignant ascites, and safety. Result In all 35 patients, the median OS and PFS were 4.8 (95 % confidence interval [CI], 2.1-5.3) months and 2.8 (95 % CI, 0.9-4.1) months, respectively. The 26 patients who were evaluable for efficacy achieved a response rate of 8 % and a disease control rate of 69 %. Malignant ascites had disappeared or decreased in 18 (69 %) patients, including complete resolution in 4 (15 %), and a negative change in cytological status was achieved in 8 (31 %) patients. The major grade 3/4 adverse events included neutropenia (34 %), anemia (31 %), nausea (9 %), and catheter-related infections (6 %). Conclusion Combination chemotherapy consisting of intravenous and intraperitoneal PTX with S-1 showed acceptable toxicity and favorable efficacy in pancreatic cancer patients with malignant ascites. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000005306).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsOxonic AcidPaclitaxelTegafurAdenocarcinomaAdministration, IntravenousAdultAgedAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicAscitesDeoxycytidineDisease-Free SurvivalDrug CombinationsDrug Resistance, NeoplasmFemaleAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicDeoxycytidineDrug CombinationsGemcitabineOxonic AcidPaclitaxelS 1 (combination)TegafurIntraperitoneal chemotherapyMalignant ascitesPaclitaxelPancreatic cancerPeritoneal metastasisS-1

Identifiers

PMID27339809
OpenAlexW2475170675

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.