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International Journal of Clinical Oncology

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01-10-2018 | Original Article

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)

Authors: Tomoro Hishiki, Kimikazu Matsumoto, Miki Ohira, Takehiko Kamijo, Hiroyuki Shichino, Tatsuo Kuroda, Akihiro Yoneda, Toshinori Soejima, Atsuko Nakazawa, Tetsuya Takimoto, Isao Yokota, Satoshi Teramukai, Hideto Takahashi, Takashi Fukushima, Takashi Kaneko, Junichi Hara, Michio Kaneko, Hitoshi Ikeda, Tatsuro Tajiri, Akira Nakagawara, For the Japan Childhood Cancer Group Neuroblastoma Committee (JNBSG)

Published in: International Journal of Clinical Oncology | Issue 5/2018

Abstract

Background

The 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.

Methods

JN-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.

Results

The 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.

Conclusions

The 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.

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Title: 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)
Authors: Tomoro Hishiki
Kimikazu Matsumoto
Miki Ohira
Takehiko Kamijo
Hiroyuki Shichino
Tatsuo Kuroda
Akihiro Yoneda
Toshinori Soejima
Atsuko Nakazawa
Tetsuya Takimoto
Isao Yokota
Satoshi Teramukai
Hideto Takahashi
Takashi Fukushima
Takashi Kaneko
Junichi Hara
Michio Kaneko
Hitoshi Ikeda
Tatsuro Tajiri
Akira Nakagawara
For the Japan Childhood Cancer Group Neuroblastoma Committee (JNBSG)
Publication date: 01-10-2018
Publisher: Springer Japan
Published in: International Journal of Clinical Oncology / Issue 5/2018
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-018-1281-8

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Abstract

Background

Methods

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Conclusions

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