A Phase 2 Single-Arm Study of Osimertinib for Radiotherapy-Naive Central Nervous System Metastasis NSCLC: Results for the First-Line Cohort of the OCEAN Study (LOGIK 1603/WJOG 9116L)

Kazushige Wakuda, MD; Hiroyuki Yamaguchi, MD, PhD; Hirotsugu Kenmotsu, MD, PhD; Minoru Fukuda, MD, PhD; Kentaro Ito, MD; Yuko Tsuchiya-Kawano, MD, PhD; Kentaro Tanaka, MD, PhD; Taishi Harada, MD, PhD; Yuki Nakatani, MD; Satoru Miura, MD; Toshihide Yokoyama, MD; Tomomi Nakamura, MD; Miiru Izumi, MD, PhD; Atsushi Nakamura, MD, PhD; Satoshi Ikeda, MD, PhD; Koichi Takayama, MD, PhD; Kenichi Yoshimura, PhD; Kazuhiko Nakagawa, MD, PhD; Nobuyuki Yamamoto, MD, PhD; Kenji Sugio, MD, PhD

JTO Clinical and Research Reports (Dec 2023)

A Phase 2 Single-Arm Study of Osimertinib for Radiotherapy-Naive Central Nervous System Metastasis NSCLC: Results for the First-Line Cohort of the OCEAN Study (LOGIK 1603/WJOG 9116L)

Kazushige Wakuda, MD,
Hiroyuki Yamaguchi, MD, PhD,
Hirotsugu Kenmotsu, MD, PhD,
Minoru Fukuda, MD, PhD,
Kentaro Ito, MD,
Yuko Tsuchiya-Kawano, MD, PhD,
Kentaro Tanaka, MD, PhD,
Taishi Harada, MD, PhD,
Yuki Nakatani, MD,
Satoru Miura, MD,
Toshihide Yokoyama, MD,
Tomomi Nakamura, MD,
Miiru Izumi, MD, PhD,
Atsushi Nakamura, MD, PhD,
Satoshi Ikeda, MD, PhD,
Koichi Takayama, MD, PhD,
Kenichi Yoshimura, PhD,
Kazuhiko Nakagawa, MD, PhD,
Nobuyuki Yamamoto, MD, PhD,
Kenji Sugio, MD, PhD

Affiliations

Kazushige Wakuda, MD: Division of Thoracic Oncology, Shizuoka Cancer Center Hospital, Shizuoka, Japan; Corresponding author. Address for correspondence: Kazushige Wakuda, MD, Division of Thoracic Oncology, Shizuoka Cancer Center Hospital, 1007 Shimonagakubo, Nagaizumi-cho, Suntou-gun, Shizuoka 411-8777, Japan.
Hiroyuki Yamaguchi, MD, PhD: Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Hirotsugu Kenmotsu, MD, PhD: Division of Thoracic Oncology, Shizuoka Cancer Center Hospital, Shizuoka, Japan
Minoru Fukuda, MD, PhD: Cancer Treatment Center, Nagasaki Prefecture Shimabara Hospital, Shimabara, Japan
Kentaro Ito, MD: Department of Respiratory Medicine, Matsusaka Municipal Hospital Respiratory Center, Mie, Japan
Yuko Tsuchiya-Kawano, MD, PhD: Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Fukuoka, Japan
Kentaro Tanaka, MD, PhD: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Taishi Harada, MD, PhD: Department of Respiratory Medicine, Japan Community Health Care Organization (JCHO) Kyushu Hospital, Fukuoka, Japan
Yuki Nakatani, MD: Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan
Satoru Miura, MD: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan
Toshihide Yokoyama, MD: Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan
Tomomi Nakamura, MD: Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan
Miiru Izumi, MD, PhD: Department of Respiratory Medicine, National Hospital Organization, Omuta National Hospital, Fukuoka, Japan
Atsushi Nakamura, MD, PhD: Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan
Satoshi Ikeda, MD, PhD: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan
Koichi Takayama, MD, PhD: Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
Kenichi Yoshimura, PhD: Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan
Kazuhiko Nakagawa, MD, PhD: Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan
Nobuyuki Yamamoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan
Kenji Sugio, MD, PhD: Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan

Journal volume & issue: Vol. 4, no. 12
p. 100587

Abstract

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Introduction: Osimertinib may be effective in treating central nervous system (CNS) metastasis, but its efficacy in treating radiation therapy (RT)-naive metastasis is unclear. The OCEAN study assessed the efficacy of osimertinib against RT-naive CNS metastasis in patients previously treated (T790M cohort) and untreated patients (first-line cohort) with EGFR mutation. Here, we report the results of the first-line cohort. Methods: Previously untreated patients with RT-naive CNS metastasis and EGFR mutation-positive NSCLC were treated with osimertinib. The brain metastasis response rate (BMRR), progression-free survival (PFS), and overall survival in the first-line cohort were secondary end points. Results: A total of 26 patients were enrolled in the study between September 2019 and July 2020. The median age was 72.0 years with 80.8% female. There were 20 patients who had multiple CNS metastases. BMRR assessed by PAREXEL criteria was 76.9% (90% confidence interval [CI]: 63.3%–90.5%), BMRR assessed by Response Evaluation Criteria in Solid Tumors was 76.9% (95% CI: 54.0%–99.8%), and median PFS of CNS metastasis was 22.0 months (95% CI: 9.7 mo–not reached). The overall response rate was 64.0% (95% CI: 45.2%–82.8%), median PFS was 11.5 months (95% CI: 6.9 mo–not reached), and median survival time was 23.7 months (95% CI: 16.5 mo–not reached). Paronychia and increased creatinine level were the most frequent nonhematological toxicities observed in 13 patients (50%). Grade three and higher adverse events were less than 10%, and there were no treatment-related deaths. Pneumonitis was observed in five patients (19.2%). Conclusions: These results suggest that osimertinib is effective in untreated patients with RT-naive asymptomatic CNS metastasis in a clinical practice first-line setting. Trial registration: UMIN identifier: UMIN000024218. jRCT identifier: jRCTs071180017.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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