https://orcid.org/0000-0001-5743-0149
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Abstract
The patients harboring EGFR-mutated non-small-cell lung cancer, treated with EGFR tyrosine kinase inhibitor will lead to longer survival than those having non-small-cell lung cancer (NSCLC) patient who do not harbor EGFR mutations. This ongoing clinical trial is to investigate the secondary chemoprevention effect of osimertinib from CNS with platinum doublets chemotherapy in patients who had progressive disease outside of CNS lesions. The aim of this randomized, phase II trial is to evaluate platinum and pemetrexed chemotherapy followed by pemetrexed maintenance with or without continuation of osimertinib for secondary CNS prevention in patients with brain metastatic NSCLC with EGFR mutation, with other than CNS lesions, but no progressive disease in the CNS lesion after osimertinib. The primary end point is to assess progression-free survival by investigator assessment. The key secondary end points are overall survival, response rate, time to CNS controlling, time to whole-brain irradiation and safety.Clinical trial registration: Japan Registry of Clinical Trials (jRCT), Japan (jRCTs071200029)
Plain language summary
The authors are conducting a clinical trial aimed at improving treatment for individuals diagnosed with non-small-cell lung cancer, a specific type of lung cancer. In some cases, this cancer can spread to the brain. This study focuses on patients whose cancer is stable in the brain but progressing in other parts of the body. The study is comparing two different treatment approaches. One involves a combination of two drugs, platinum and pemetrexed, while the other combines these drugs with a third one called osimertinib. The main objective is to determine if continuing osimertinib treatment benefits these patients. The authors are evaluating the time it takes for the cancer to start growing again, known as progression-free survival, to identify the most effective treatment. Progression-free survival represents the duration that patients live without their disease worsening. This study, the EPONA study, will provide valuable insights into optimizing the treatment of this type of cancer.
Tweetable abstract
This randomized, phase II study is evaluating chemotherapy +/- the continuation of osimertinib for EGFR-mutant non-small-cell lung cancer patients bearing CNS metastasis and having systemic progressive disease outside of brain metastasis.
Author contributions
All the authors listed in the manuscript have sufficiently contributed to the project to be included as authors, and all those who are qualified as authors are listed in the author byline. The first draft of the manuscript was written by Y Okuma. All the co-authors have read the final version of the manuscript and have agreed to its submission.
Acknowledgments
The authors appreciate data management and other support staff of the Clinical Research Support Center (CReS) Kyushu. The authors also thank Shuji Nakamura, Yutaka Fujiwara and Yoshitaka Zenke as members of the Data and Safety Monitoring Committee. It is supported by the National and Cancer Research Development Fund (26-A-22) and is chaired by Haruhiko Fukuda and Nobuyuki Yamamoto. The authors would like to thank Editage (www.editage.com) for English language editing.
Financial & competing interests disclosure
The study was provided monetary support by AstraZeneca as a collaborative intergroup trial, of which the leading group is TORG. The cooperative groups include National Health Organization, Central Japan Lung Study Group (CJLCG), Okayama Lung Cancer Study Group (OLCSG) and Lung Oncology Group in Kyushu (LoGiK). Also, the trial framework is supported by Yamamoto-Fukuda. Y Okuma has received consulting or advisory fee from AstraZenec; grants from AstraZeneca, AbbVie, Merck Sharp & Dohme, Chugai and Ono Pharmaceutical; and honoraria from AstraZeneca, Ono Pharmaceutical, Nippon Boehringer-Ingelheim, Chugai, Eli Lilly, Eisai, Taiho Pharmaceutical and Takeda. S Nomura has received grants from AstraZeneca and Amgen and honoraria from AstraZeneca, Chugai and Kyowa Hakko. K Ninomiya has received honoraria from AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Chugai, Kyowa Kirin, Lilly Japan, MSD, Nippon Kayaku, Novartis Pharma, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical and Takeda Pharmaceutical. H Gyotoku has no conflict of interest. S Murakami has received honoraria from AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Chugai, Eli Lilly, Merck BioPharma, MSD, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, Takeda Pharmaceutical and grants from Chugai, Daiichi Sankyo, Janssen Pharmaceutical, MSD, Ono Pharmaceutical and Sanofi. Y Kogure has received honoraria from AstraZeneca, Lilly Japan, Chugai, MSD, Boehringer-Ingelheim and Ono Pharmaceutical and grants from MSD. D Harada has received honoraria from Takeda Pharmaceutical, Boehringer-Ingelheim, Taiho Pharmaceutical, AstraZeneca, Chugai, Eli Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Towa Pharmaceutical, Kyowa Hakko Kirin and MSD. K Okishio has received honoraria from AstraZeneca, Bristol Myers Squibb and Chugai. K Okishio has received speaker’s bureau fee from Bristol-Myers Squibb K.K., AstraZeneca K.K., Chugai Pharmaceutical, Nippon Kayaku and Takeda Pharmaceutical. H Okamoto has received grants from Bristol Myers Squibb, Chugai, Taiho Pharmaceutical, Astellas, Eli Lilly, Merck BioPharma, AstraZeneca, MSD, Boehringer-Ingelheim, Novartis and Chugai. Y Goto has received consulting or advisory fee from Eli Lilly, Chugai, Taiho Pharmaceutical, Boehringer-Ingelheim, Pfizer, Novartis, AstraZeneca, Glaxo Smith Kline, MSD, Guardant Health, Daiichi Sankyo, Kyorin, Chugai, Illumina, Thermo Fisher Scientific and Johnson & Johnson and speaker’s bureau fee from AstraZeneca, Eli Lilly, Chugai, Taiho Pharmaceutical, Boehringer-Ingelheim, Ono Pharmaceutical, Bristol Myers Squibb, Pfizer, MSD, Shionogi Pharma, Novartis, Merck and Johnson & Johnson. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.