Evidence map›Paper›PMID 28470558›Full record

Trial reportInvestigational new drugs2017

Phase II study of lanreotide autogel in Japanese patients with unresectable or metastatic well-differentiated neuroendocrine tumors.

Tetsuhide Ito, Yoshitaka Honma, Susumu Hijioka, Atsushi Kudo, Akira Fukutomi, Akira Nozaki, Yasutoshi Kimura, Fuyuhiko Motoi, Hiroyuki Isayama, Izumi Komoto and 3 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Investigational new drugs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–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.

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

17 citing papers in PubMed.

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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

13 authors.

Tetsuhide ItoDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Science, Kyushu University, Maidashi 3-1-1, Fukuoka Higashi-ku, Fukuoka, Japan. itopapa@med.kyushu-u.ac.jp.
Yoshitaka HonmaGastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
Susumu HijiokaDepartment of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
Atsushi KudoDepartment of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Akira FukutomiGastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Akira NozakiDepartment of Medical Oncology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Yasutoshi KimuraDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University Hospital, Sapporo, Japan.
Fuyuhiko MotoiDepartment of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan.
Hiroyuki IsayamaGastroenterology, The University of Tokyo Hospital, Tokyo, Japan.
Izumi KomotoDepartment of Surgery, Kansai Electric Power Hospital, Osaka, Japan.
Seiichi HisamatsuPharmaceutical Research & Development Division, Teijin Pharma Limited, Tokyo, Japan.
Akihiro NakajimaPharmaceutical Research & Development Division, Teijin Pharma Limited, Tokyo, Japan.
Akira ShimatsuClinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Lanreotide is a long-acting somatostatin analog with demonstrated efficacy against enteropancreatic neuroendocrine tumor (NET) in the phase III (CLARINET) study. Materials and Methods In this single-arm study, Japanese patients with grade (G) 1/G2 NET received lanreotide (120 mg/4 weeks) for 48 weeks. Those who completed the study were enrolled in a long-term extension study. The primary endpoint was the clinical benefit rate (CBR) defined as a complete response, partial response (PR), or stable disease (SD) over 24-weeks. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and pharmacokinetics. Results Thirty-two patients were recruited at 10 sites. The full analysis set (FAS) comprised 28 patients. Primary tumors were located in pancreas (12 patients), foregut (non-pancreas, lung; 1), midgut (2), hindgut (8), and unknown (5). Four patients had gastrinoma of the functional NET, and 3 had multiple endocrine neoplasia type 1. In the FAS, 39.3% had progressive disease at baseline. The CBR at 24 weeks was 64.3% (95% confidence interval; CI: 44.1-81.4), and median PFS was 36.3 weeks (95% CI: 24.1-53.1). PR was confirmed in 1 patient at 60 weeks during the extension study (ORR: 3.6%). Frequent adverse events related to lanreotide included injection site induration (28.1%), faeces pale (18.8%), flatulence (12.5%), and diabetes mellitus (12.5%). Conclusions The efficacy and safety of lanreotide in this study indicated its usefulness as a treatment option for Japanese NET patients.

trial registrationJapicCTI-132,375, JapicCTI-142,698.

Indexed as

AgedAntineoplastic AgentsAsian PeopleDisease-Free SurvivalFemaleGastrointestinal NeoplasmsGelsHumansKaplan-Meier EstimateMaleMiddle AgedNeuroendocrine TumorsPancreatic NeoplasmsPeptides, CyclicSomatostatinTreatment OutcomeAntineoplastic AgentsGelslanreotidePeptides, CyclicSomatostatinJapaneseLanreotideNeuroendocrine tumorPhase IISomatostatin analog

Identifiers

PMID28470558
PMCPMC5502055

What OpenQuestion holds

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Registered trials

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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.