Evidence map›Paper›PMID 24716542›Full record

Trial reportCancer science2014

Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer.

Yasutsuna Sasaki, Tomohiro Nishina, Hirofumi Yasui, Masahiro Goto, Kei Muro, Akihito Tsuji, Wasaburo Koizumi, Yasushi Toh, Takuo Hara, Yoshinori Miyata

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00661167 (Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.), which is not on this map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 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.

NCT00661167 phase2completednot on this map

Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.

TypeinterventionalSponsorTaiho Pharmaceutical Co., Ltd.Ran2008 to 2011Enrolled56ConditionsGastric CancerArmsABI-007
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 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 9 institutions in 1 country.

Yasutsuna SasakiDepartment of Medical Oncology, Saitama Medical University International Medical Center, Hidaka-shi, Japan; Division of Medical Oncology, Department of Medicine, Showa University Hospital, Tokyo, Japan.
Tomohiro Nishina
Hirofumi Yasui
Masahiro Goto
Kei Muro
Akihito Tsuji
Wasaburo Koizumi
Yasushi Toh
Takuo Hara
Yoshinori Miyata
Aichi Cancer Center · JPKitasato University · JPKouseiren Takaoka Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka Medical and Pharmaceutical University · JPSaku Central Hospital · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPShowa University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This multicenter phase II study first investigated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) when given every 3 weeks to patients with unresectable or recurrent gastric cancer who had received a prior round of fluoropyrimidine-containing chemotherapy. Patients with unresectable or recurrent gastric cancer who experienced progression despite fluoropyrimidine-containing treatment were studied. Nab-paclitaxel was given i.v. at 260 mg/m(2) on day 1 of each 21-day cycle without anti-allergic premedication until disease progression or study discontinuation. The primary endpoint was the overall response rate. The secondary endpoints were the disease control rate, progression-free survival, overall survival, and safety. From April 2008 to July 2010, 56 patients were enrolled, 55 patients received the study treatment, and 54 patients were evaluable for responses. According to an independent review committee, the overall response rate was 27.8% (15/54; 95% confidence interval [CI], 16.5-41.6) and the disease control rate was 59.3% (32/54; 95% CI, 45.0-72.4). One patient had a complete response. The median progression-free survival and overall survival were 2.9 months (95% CI, 2.4-3.6) and 9.2 months (95% CI, 6.9-11.4), respectively. The most common grade 3/4 toxicities were neutropenia (49.1%), leucopenia (20.0%), lymphopenia (10.9%), and peripheral sensory neuropathy (23.6%). There were no treatment-related deaths. Nab-paclitaxel, given every 3 weeks, showed promising activity against previously treated unresectable or recurrent gastric cancers, with well-tolerated toxicities. (Trial registration, ClinicalTrials.gov: NCT00661167).

Indexed as

AdultAgedAlbuminsAntineoplastic Agents, PhytogenicDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm Recurrence, LocalNeutropeniaPaclitaxelStomach NeoplasmsTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelGastric cancernab-paclitaxelphase IIsecond-line chemotherapytriweekly

Identifiers

PMID24716542
PMCPMC4317911
OpenAlexW2061480909

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.