Neoadjuvant Osimertinib for Resectable EGFR -Mutated Non–Small Cell Lung Cancer

作者：Jianxing He, Jianxing He, Masahiro Tsuboi, Masahiro Tsuboi, Walter Weder, Ke-Neng Chen, Maximilian J. Hochmair, Jin‐Yuan Shih, Sung Yong Lee, Kang‐Yun Lee, Nguyen Viet Nhung, Somcharoen Saeteng, Lunxu Liu, Ligang Xing, Nguyen Hoang Gia, Shuji Murakami, Yongtao Han, Maria Paz Saavedra, Seong Hoon Yoon, Carlos Henrique Andrade Teixeira, Carles Escriu, Alex Martínez‐Martí, Collin M. Blakely, Yasushi Yatabe, Sanja Dacic, Yuri Rukazenkov, Xiangning Huang, Anupriya Dayal, Jamie E. Chaft, Jamie E. Chaft, for the NeoADAURA Investigators, Gudrun Absenger, Maximilian J. Hochmair, Clarissa Baldotto, Georgia Fiuza Alencar Araripe, Jose Miziara, Jose Fernando Moura, Carlos H.A. Teixeira, Nataliya Chilingirova, Rossitza Krasteva, Велко Минчев, Marc de Perrot, Jonathan Spicer, Marcelo Garrido, Maria Paz Saavedra, Kaican Cai, Chao Cheng, Ke-Neng Chen, Qixun Chen, Chao Cheng, Duan Hongbing, Wentao Fang, Yongtao Han, Jianxing He, Jianxing He, Gaofeng Li, Shanqing Li, Quan Lin, Lunxu Liu, Buhai Wang, Jingdi Wang, Qun Wang, Runxiang Yang, Bentong Yu, Nan Wu, Ligang Xing, Runxiang Yang, Bentong Yu, Wei Zhang, Jun Zhao, Ming Zhou, S. Galland-Girodet, Frank Griesinger, Justyna Rawluk, Wolfgang Schütte, Prabhat Malik, Bhavesh Poladia, Jair Bar, Elizabeth Dudnik, D. Cortinovis, Domenico Galetta, Silvia Novello, Sabrina Rossi, Norihiko Ikeda, Toshi Menju, Shuji Murakami, Morihito Okada, Jiro Okami, Akira Ono, Miyako Satouchi, Shunichi Sugawara, Hidemi Suzuki, Kazuya Takamochi, Hiroshi Tanaka, Masahiro Tsuboi, Masahiro Tsuboi, Yasuhiro Tsutani, Noriko Yanagitani, Yasushi Yatabe, Oscar Arrieta Rodriguez, Froylán López-López, Jerónimo Rodríguez Cid, Ana Fernandez, Jarosław Kołb-Sielecki, Jusang Kim, Sung Yong Lee, Seung Hyeun Lee, P. K. Yаblonskiy, Seung Soo Yoo, Seong Hoon Yoon, Tatiana Kleimenteva, Guzel Mukhametshina, Petr Yablonskiy, M. Dómine Gómez, Alex Martinez-Marti, Mariano Provencio Pulla, Ulrich Richter, Walter Weder, Gee Chen Chang, Chao-Hsun Chen, Yuh-Min Chen, Han-Pin Kuo, Kang-Yun Lee, Jin-Yuan Shih, Touch Ativitavas, Manoch Buranachokphaisan, Jarin Chindaprasirt, Hataiwan Ratanabunjerdkul, Somcharoen Saeteng, Piyada Sitthideatphaiboon, Mustafa Dikilitas, M. Şendur, Shobhit Baijal, Carles Escriu, Arya Amini, Ian Anderson, Collin M. Blakley, Adam Bograd, Jamie E. Chaft, Jamie E. Chaft, Sanja Dacic, D. Finley, Jonathan Goldman, Erminia Massarelli, Julia Rotow, Catherine Shu, Alexander Spira, Hien P. Nguyen, Nguyen Hoang Gia, Nguyen Viet Nhung, Mai Thi Chi Tran, Dat T. Vo, Vinh Vu · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco-25-00883 · 被引用次数：80 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Lung Cancer Research Studies

PURPOSE Adjuvant osimertinib is the standard of care for patients with resected epidermal growth factor receptor ( EGFR )–mutated non–small cell lung cancer (NSCLC). Neoadjuvant treatment could improve surgical and long-term outcomes. METHODS In this randomized, controlled, phase III study, patients with resectable, EGFR -mutated, stage II-IIIB NSCLC were randomly assigned (1:1:1) to receive neoadjuvant osimertinib (80 mg orally once daily for ≥9 weeks) plus platinum-based chemotherapy (once every 3 weeks for three cycles), osimertinib monotherapy (for ≥9 weeks), or placebo plus platinum-based chemotherapy (control), followed by surgical resection. Adjuvant osimertinib was offered to eligible patients after completion of surgery. The primary end point was major pathologic response (MPR) by blinded central pathology review. Event-free survival (EFS) was a secondary end point. RESULTS Overall, 358 patients were randomly assigned to receive osimertinib plus chemotherapy (121 patients), osimertinib monotherapy (117 patients), or placebo plus chemotherapy (120 patients). Osimertinib plus chemotherapy (MPR rate 26%) and osimertinib monotherapy (25%) demonstrated statistically significant improvement in the MPR rate versus placebo plus chemotherapy (2%), with corresponding odds ratios of 19.82 (95.002% CI, 4.60 to 85.33; P < .0001) and 19.28 (99.9% CI, 1.71 to 217.39; P < .0001), respectively. With 15% data maturity, the EFS rates at 12 months were 93%, 95%, and 83% with osime...