Japan Society of Clinical Oncology provisional clinical opinion for the diagnosis and use of immunotherapy in patients with deficient DNA mismatch repair tumors, cooperated by Japanese Society of Medical Oncology, First Edition

Saori Mishima, Hiroya Taniguchi, Kiwamu Akagi, Eishi Baba, Yutaka Fujiwara, Akira Hirasawa, Masafumi Ikeda, Osamu Maeda, Kei Muro, Hiroshi Nishihara, Hiroyki Nishiyama, Tadao Takano, Katsuya Tsuchihara, Yasushi Yatabe, Yasuhiro Kodera, Takayuki Yoshino

Research output: Contribution to journalArticle

Abstract

Background: Novel therapeutic agents have improved survival outcomes in patients with advanced solid tumors. In parallel, the development of predictive biomarkers to identify patients who are likely to benefit from a certain treatment has also contributed to the improvement of survival. Recently, clinical trials have reported the efficacy of immune checkpoint inhibitors in the treatment of mismatch repair-deficient (dMMR) advanced solid tumors. In Japan, a PD-1 inhibitor for dMMR advanced solid tumors, regardless of the primary tumor site, has been approved. However, there are some issues related to administering immune checkpoint inhibitors in the clinical practice setting, making it necessary to develop the guidelines. Methods: Clinical questions (CQs) regarding medical care were formulated for patients with dMMR advanced solid tumors, and evidence to the CQs was collected by manual search to prepare recommendations. Then, the committee members voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other factors. Results: The current guideline, which we consider a provisional clinical opinion at this point, describes the 11 requirements to be considered in terms of patients for whom dMMR testing is recommended, the timing and methods of dMMR testing, and clinical care systems required to perform dMMR testing properly and to administer immune checkpoint inhibitors safely. Conclusion: This provisional clinical opinion proposes the requirements for performing dMMR testing properly to select patients who are likely to benefit from immune checkpoint inhibitors and administering them safely.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusPublished - 2019 Jan 1

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DNA Repair-Deficiency Disorders
DNA Mismatch Repair
Medical Oncology
Immunotherapy
Japan
Neoplasms
Guidelines
Committee Membership
Survival
Therapeutics
Biomarkers
Clinical Trials

Keywords

  • dMMR
  • Mismatch repair-deficient advanced solid tumor
  • MSI-H
  • PD-1/PD-L1 inhibitor
  • Provisional clinical opinion

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

Cite this

Japan Society of Clinical Oncology provisional clinical opinion for the diagnosis and use of immunotherapy in patients with deficient DNA mismatch repair tumors, cooperated by Japanese Society of Medical Oncology, First Edition. / Mishima, Saori; Taniguchi, Hiroya; Akagi, Kiwamu; Baba, Eishi; Fujiwara, Yutaka; Hirasawa, Akira; Ikeda, Masafumi; Maeda, Osamu; Muro, Kei; Nishihara, Hiroshi; Nishiyama, Hiroyki; Takano, Tadao; Tsuchihara, Katsuya; Yatabe, Yasushi; Kodera, Yasuhiro; Yoshino, Takayuki.

In: International Journal of Clinical Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Mishima, Saori ; Taniguchi, Hiroya ; Akagi, Kiwamu ; Baba, Eishi ; Fujiwara, Yutaka ; Hirasawa, Akira ; Ikeda, Masafumi ; Maeda, Osamu ; Muro, Kei ; Nishihara, Hiroshi ; Nishiyama, Hiroyki ; Takano, Tadao ; Tsuchihara, Katsuya ; Yatabe, Yasushi ; Kodera, Yasuhiro ; Yoshino, Takayuki. / Japan Society of Clinical Oncology provisional clinical opinion for the diagnosis and use of immunotherapy in patients with deficient DNA mismatch repair tumors, cooperated by Japanese Society of Medical Oncology, First Edition. In: International Journal of Clinical Oncology. 2019.
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abstract = "Background: Novel therapeutic agents have improved survival outcomes in patients with advanced solid tumors. In parallel, the development of predictive biomarkers to identify patients who are likely to benefit from a certain treatment has also contributed to the improvement of survival. Recently, clinical trials have reported the efficacy of immune checkpoint inhibitors in the treatment of mismatch repair-deficient (dMMR) advanced solid tumors. In Japan, a PD-1 inhibitor for dMMR advanced solid tumors, regardless of the primary tumor site, has been approved. However, there are some issues related to administering immune checkpoint inhibitors in the clinical practice setting, making it necessary to develop the guidelines. Methods: Clinical questions (CQs) regarding medical care were formulated for patients with dMMR advanced solid tumors, and evidence to the CQs was collected by manual search to prepare recommendations. Then, the committee members voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other factors. Results: The current guideline, which we consider a provisional clinical opinion at this point, describes the 11 requirements to be considered in terms of patients for whom dMMR testing is recommended, the timing and methods of dMMR testing, and clinical care systems required to perform dMMR testing properly and to administer immune checkpoint inhibitors safely. Conclusion: This provisional clinical opinion proposes the requirements for performing dMMR testing properly to select patients who are likely to benefit from immune checkpoint inhibitors and administering them safely.",
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AU - Taniguchi, Hiroya

AU - Akagi, Kiwamu

AU - Baba, Eishi

AU - Fujiwara, Yutaka

AU - Hirasawa, Akira

AU - Ikeda, Masafumi

AU - Maeda, Osamu

AU - Muro, Kei

AU - Nishihara, Hiroshi

AU - Nishiyama, Hiroyki

AU - Takano, Tadao

AU - Tsuchihara, Katsuya

AU - Yatabe, Yasushi

AU - Kodera, Yasuhiro

AU - Yoshino, Takayuki

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N2 - Background: Novel therapeutic agents have improved survival outcomes in patients with advanced solid tumors. In parallel, the development of predictive biomarkers to identify patients who are likely to benefit from a certain treatment has also contributed to the improvement of survival. Recently, clinical trials have reported the efficacy of immune checkpoint inhibitors in the treatment of mismatch repair-deficient (dMMR) advanced solid tumors. In Japan, a PD-1 inhibitor for dMMR advanced solid tumors, regardless of the primary tumor site, has been approved. However, there are some issues related to administering immune checkpoint inhibitors in the clinical practice setting, making it necessary to develop the guidelines. Methods: Clinical questions (CQs) regarding medical care were formulated for patients with dMMR advanced solid tumors, and evidence to the CQs was collected by manual search to prepare recommendations. Then, the committee members voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other factors. Results: The current guideline, which we consider a provisional clinical opinion at this point, describes the 11 requirements to be considered in terms of patients for whom dMMR testing is recommended, the timing and methods of dMMR testing, and clinical care systems required to perform dMMR testing properly and to administer immune checkpoint inhibitors safely. Conclusion: This provisional clinical opinion proposes the requirements for performing dMMR testing properly to select patients who are likely to benefit from immune checkpoint inhibitors and administering them safely.

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