Evidence map›Paper›PMID 23880820›Full record

Trial reportBritish journal of cancer2013

A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer.

A H Ko, M A Tempero, Y-S Shan, W-C Su, Y-L Lin, E Dito, A Ong, Y-W Wang, C G Yeh, L-T Chen

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 75 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 2 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.

NCT04923529 phase2completednot on this mapstarted 2021, after this paper: background citation

Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

TypeinterventionalSponsorThe University of Hong KongRan2021 to 2024Enrolled28ConditionsPancreas CancerArmsTAS 102
NCT05927857 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase Ib/II Study of Ramucirumab (Cyramza®), Nal-IRI (ONIVYDE®) and Trifluridine/Tipiracil (Lonsurf®) in Second Line Metastatic Gastric Cancer (COOL Study).

TypeinterventionalSponsorNational Health Research Institutes, TaiwanRan2024 to 2028Enrolled45ConditionsMetastatic Gastric Adenocarcinoma, Second Line, ChemotherapyArmsnal-IRI /Experimental, Ramucirumab /Experimental, Trifluridine/Tipiracil /Experimental
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  4. Sotorasib inThe New England journal of medicine · 2023
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15 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

10 authors.

A H KoDivision of Hematology/Oncology, Comprehensive Cancer Center, University of California, San Francisco, 1600 Divisadero Street, San Francisco, CA 94115, USA. andrewko@medicine.ucsf.edu
M A Tempero
Y-S Shan
W-C Su
Y-L Lin
E Dito
A Ong
Y-W Wang
C G Yeh
L-T Chen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPEP02, also known as MM-398, is a novel nanoliposomal irinotecan that has improved pharmacokinetics and tumour bio-distribution of the free drug. This phase 2 study evaluated PEP02 monotherapy as second-line treatment for pancreatic cancer.

methodsPatients who had metastatic pancreatic adenocarcinoma, Karnofsky performance status ≥70, and had progressed following gemcitabine-based therapy were eligible. Intravenous injection of PEP02 120 mg m(-2) was given every 3 weeks. Simon 2-stage design was used. The primary objective was 3-month survival rate (OS(3-month)).

resultsA total of 40 patients were enrolled. The most common severe adverse events included neutropenia, abdominal pain, asthenia, and diarrhoea. Three patients (7.5%) achieved an objective response, with an additional 17 (42.5%) demonstrating stable disease for a minimum of two cycles. Ten (31.3%) of 32 patients with an elevated baseline CA19-9 had a >50% biomarker decline. The study met its primary end point with an OS(3-month) of 75%, with median progression-free survival and overall survival of 2.4 and 5.2 months, respectively.

conclusionPEP02 demonstrates moderate antitumour activity with a manageable side effect profile for metastatic, gemcitabine-refractory pancreatic cancer patients. Given the limited treatment options available to this patient population, a phase 3 trial of PEP02 (MM-398), referred to as NAPOLI-1, is currently underway.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsCamptothecinDisease-Free SurvivalDrug CombinationsFemaleHumansIrinotecanLiposomesMaleMiddle AgedPancreatic NeoplasmsSalvage TherapyAntineoplastic AgentsCamptothecinDrug CombinationsIrinotecanirinotecan sucrosofateLiposomesSucrose

Identifiers

PMID23880820
PMCPMC3749576

What OpenQuestion holds

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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.