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)

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...

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Detalles Bibliográficos
Autores principales: Wakuda, Kazushige, Yamaguchi, Hiroyuki, Kenmotsu, Hirotsugu, Fukuda, Minoru, Ito, Kentaro, Tsuchiya-Kawano, Yuko, Tanaka, Kentaro, Harada, Taishi, Nakatani, Yuki, Miura, Satoru, Yokoyama, Toshihide, Nakamura, Tomomi, Izumi, Miiru, Nakamura, Atsushi, Ikeda, Satoshi, Takayama, Koichi, Yoshimura, Kenichi, Nakagawa, Kazuhiko, Yamamoto, Nobuyuki, Sugio, Kenji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10689268/
https://www.ncbi.nlm.nih.gov/pubmed/38046380
http://dx.doi.org/10.1016/j.jtocrr.2023.100587
Descripción
Sumario: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.

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