Evidence map›Paper›PMID 29700636›Full record

Trial reportInternational journal of clinical oncology2018

Results of a phase II trial for high-risk neuroblastoma treatment protocol JN-H-07: a report from the Japan Childhood Cancer Group Neuroblastoma Committee (JNBSG).

Tomoro Hishiki, Kimikazu Matsumoto, Miki Ohira, Takehiko Kamijo, Hiroyuki Shichino, Tatsuo Kuroda, Akihiro Yoneda, Toshinori Soejima, Atsuko Nakazawa, Tetsuya Takimoto and 11 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 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.

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

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  20. Diagnostic Use of Post-therapyDiagnostics (Basel, Switzerland) · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Tomoro HishikiChildren's Cancer Center, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 157-8535, Japan. tomoro.hishiki@gmail.com.
Kimikazu MatsumotoChildren's Cancer Center, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo, 157-8535, Japan.
Miki OhiraResearch Institute for Clinical Oncology, Saitama Cancer Center, Saitama, Japan.
Takehiko KamijoResearch Institute for Clinical Oncology, Saitama Cancer Center, Saitama, Japan.
Hiroyuki ShichinoPediatrics, National Center for Global Health and Medicine, Tokyo, Japan.
Tatsuo KurodaPediatric Surgery, Keio University School of Medicine, Tokyo, Japan.
Akihiro YonedaPediatric Surgery, Osaka City General Hospital, Osaka, Japan.
Toshinori SoejimaKobe Proton Center, Kobe, Japan.
Atsuko NakazawaPathology, National Center for Child Health and Development, Tokyo, Japan.
Tetsuya TakimotoClinical Epidemiology Research Center for Pediatric Cancer, National Center for Child Health and Development, Tokyo, Japan.
Isao YokotaBiostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Satoshi TeramukaiBiostatistics, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Hideto TakahashiNational Institute of Public Health, Saitama, Japan.
Takashi FukushimaPediatrics, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Takashi KanekoHematology and Oncology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
Junichi HaraPediatric Hematology and Oncology, Osaka City General Hospital, Osaka, Japan.
Michio KanekoIbaraki Prefectural Association of Health Evaluation and Promotion, Mito, Japan.
Hitoshi IkedaPediatric Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
Tatsuro TajiriPediatric Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Akira NakagawaraSaga Medical Center KOSEIKAN Hospital, Saga, Japan.
Japan Childhood Cancer Group Neuroblastoma Committee (JNBSG)

Funding

Japan Agency for Medical Research and Development 16ck0106070h0003Japan Agency for Medical Research and Development 16ck0106130h0003
6 · The paper itself

Abstract

backgroundThe Japanese Children's Cancer Group (JCCG) Neuroblastoma Committee (JNBSG) conducted a phase II clinical trial for high-risk neuroblastoma treatment. We report the result of the protocol treatment and associated genomic aberration studies.

methodsJN-H-07 was a single-arm, late phase II trial for high-risk neuroblastoma treatment with open enrollment from June 2007 to February 2009. Eligible patients underwent five courses of induction chemotherapy followed by high-dose chemotherapy with hematopoietic stem cell rescue. Surgery for the primary tumor was scheduled after three or four courses of induction chemotherapy. Radiotherapy was administered to the primary tumor site and to any bone metastases present at the end of induction chemotherapy.

resultsThe estimated 3-year progression-free and overall survival rates of the 50 patients enrolled were 36.5 ± 7.0 and 69.5 ± 6.6%, respectively. High-dose chemotherapy caused severe toxicity including three treatment-related deaths. In response to this, the high-dose chemotherapy regimen was modified during the trial by infusing melphalan before administering carboplatin and etoposide. The modified high-dose chemotherapy regimen was less toxic. Univariate analysis revealed that patients younger than 547 days and patients whose tumor showed a whole chromosomal gains / losses pattern had a significantly poor prognosis. Notably, the progression-free survival of cases with MYCN amplification were not inferior to those without MYCN amplification.

conclusionsThe outcome of patients treated with the JN-H-07 protocol showed improvement over the results reported by previous studies conducted in Japan. Molecular and genetic profiling may enable a more precise stratification of the high-risk cohort.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinChildChild, PreschoolComparative Genomic HybridizationEtoposideFemaleHumansInduction ChemotherapyInfantJapanMaleMelphalanNeuroblastomaBiomarkers, TumorCarboplatinEtoposideMelphalanClinical trialGenomic signatureHigh-riskMultidisciplinary treatmentNeuroblastomaSurgery

Identifiers

PMID29700636

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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.