Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors

Yoichi Naito; Saori Mishima; Kiwamu Akagi; Naomi Hayashi; Akira Hirasawa; Tomoro Hishiki; Ataru Igarashi; Masafumi Ikeda; Shigenori Kadowaki; Hiroaki Kajiyama; Motohiro Kato; Hirotsugu Kenmotsu; Yasuhiro Kodera; Keigo Komine; Takafumi Koyama; Osamu Maeda; Mitsuru Miyachi; Hiroshi Nishihara; Hiroyuki Nishiyama; Shouichi Ohga; Wataru Okamoto; Eiji Oki; Shigeru Ono; Masashi Sanada; Ikuo Sekine; Tadao Takano; Kayoko Tao; Keita Terashima; Katsuya Tsuchihara; Yasushi Yatabe; Takayuki Yoshino; Eishi Baba

doi:10.1007/s10147-023-02345-7

Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors

Int J Clin Oncol. 2023 Jul;28(7):827-840. doi: 10.1007/s10147-023-02345-7. Epub 2023 May 22.

Authors

Yoichi Naito¹, Saori Mishima¹, Kiwamu Akagi², Naomi Hayashi³, Akira Hirasawa⁴, Tomoro Hishiki⁵, Ataru Igarashi⁶, Masafumi Ikeda¹, Shigenori Kadowaki⁷, Hiroaki Kajiyama⁸, Motohiro Kato⁹, Hirotsugu Kenmotsu¹⁰, Yasuhiro Kodera¹¹, Keigo Komine¹², Takafumi Koyama¹³, Osamu Maeda¹¹, Mitsuru Miyachi¹⁴, Hiroshi Nishihara¹⁵, Hiroyuki Nishiyama¹⁶, Shouichi Ohga¹⁷, Wataru Okamoto¹⁸, Eiji Oki¹⁷, Shigeru Ono¹⁹, Masashi Sanada²⁰, Ikuo Sekine¹⁶, Tadao Takano¹², Kayoko Tao¹³, Keita Terashima²¹, Katsuya Tsuchihara¹, Yasushi Yatabe¹³, Takayuki Yoshino¹, Eishi Baba²²

Affiliations

¹ National Cancer Center Hospital East, Kashiwa, Japan.
² Saitama Cancer Center, Saitama, Japan.
³ The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
⁴ Okayama University, Okayama, Japan.
⁵ Chiba University, Chiba, Japan.
⁶ Yokohama City University School of Medicine, Yokohama, Japan.
⁷ Aichi Cancer Center, Aichi, Japan.
⁸ Nagoya University, Aichi, Japan.
⁹ The University of Tokyo, Tokyo, Japan.
¹⁰ Shizuoka Cancer Center, Shizuoka, Japan.
¹¹ Nagoya University Hospital, Aichi, Japan.
¹² Tohoku University, Miyagi, Japan.
¹³ National Cancer Center Hospital, Tokyo, Japan.
¹⁴ Kyoto Prefectural University of Medicine, Kyoto, Japan.
¹⁵ Keio University, Tokyo, Japan.
¹⁶ Tsukuba University, Ibaraki, Japan.
¹⁷ Kyushu University, Fukuoka, Japan.
¹⁸ Hiroshima University Hospital, Hiroshima, Japan.
¹⁹ Jichi Medical University, Tochigi, Japan.
²⁰ National Hospital Organization Nagoya Medical Center, Aichi, Japan.
²¹ National Center for Child Health and Development, Tokyo, Japan.
²² Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. baba.eishi.889@m.kyushu-u.ac.jp.

Abstract

Background: Clinical trials have reported the efficacy of tropomyosin receptor kinase (TRK) inhibitors against neurotrophic receptor tyrosine kinase (NTRK) fusion gene-positive advanced solid tumors. The accumulated evidence of tumor-agnostic agent has made since TRK inhibitors were approved and used in clinical practice. Therefore, we have revised the 'Japan Society of Clinical Oncology (JSCO)/Japanese Society of Medical Oncology (JSMO)-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors, cooperated by the Japanese Society of Pediatric Hematology/Oncology (JSPHO)'.

Methods: Clinical questions regarding medical care were formulated for patients with NTRK fusion-positive advanced solid tumors. Relevant publications were searched by PubMed and Cochrane Database. Critical publications and conference reports were added manually. Systematic reviews were performed for each clinical question for the purpose of developing clinical recommendations. The committee members identified by JSCO, JSMO, and JSPHO voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other related factors. Thereafter, a peer review by experts nominated from JSCO, JSMO, and JSPHO, and the public comments among all societies' members was done.

Results: The current guideline describes 3 clinical questions and 14 recommendations for whom, when, and how NTRK fusion should be tested, and what is recommended for patients with NTRK fusion-positive advanced solid tumors.

Conclusion: The committee proposed 14 recommendations for performing NTRK testing properly to select patients who are likely to benefit from TRK inhibitors.

Keywords: Advanced solid tumor; Clinical practice guideline; Neurotrophic receptor tyrosine kinase (NTRK) fusion; Tropomyosin receptor kinase (TRK) inhibitor; Tumor-agnostic treatment.

Publication types

Practice Guideline

MeSH terms

Adult
Child
East Asian People
Gene Fusion
Humans
Japan
Neoplasms* / drug therapy
Neoplasms* / genetics
Neoplasms* / pathology
Protein Kinase Inhibitors / pharmacology
Protein Kinase Inhibitors / therapeutic use
Receptor Protein-Tyrosine Kinases* / genetics
Tropomyosin* / therapeutic use

Substances

Protein Kinase Inhibitors
Receptor Protein-Tyrosine Kinases
Tropomyosin
NTRK1 protein, human