作者
Keiju Aokage,Kenji Suzuki,Hisashi Saji,Masashi Wakabayashi,Tomoko Kataoka,Yuta Sekino,Haruhiko Fukuda,Makoto Endo,Aritoshi Hattori,Takahiro Mimae,Tomohiro Miyoshi,Mitsuhiro Isaka,Hiroshige Yoshioka,Ryu Nakajima,Kazuo Nakagawa,Jiro Okami,Hiroyuki Ito,Hiroaki Kuroda,Masahiro Tsuboi,Norihito Okumura,Makoto Takahama,Yasuhisa Ohde,Tadashi Aoki,Yasuhiro Tsutani,Minoru Okada,Shun‐ichi Watanabe,Yukinori Sakao,Sakae Okumura,Toshihiko Iwamoto,Ichiro Yoshino,Atsushi Fujita,Minoru Okada,Masahiro Yoshimura,Yuji Asato,Kenji Suzuki,Haruhiko Nakayama,Isao Matsumoto,Tetsuya Mitsudomi,Takashi Marutsuka,Makoto Suzuki,Norihito Okumura,Haruhiko Kondo,Hiroshi Date,Takeshi Nagayasu,Kohei Yokoi,Shun‐ichi Watanabe,Masahiro Tsuboi,Akira Matsumura,Yoshihisa Yamashita,Kiyoshi Ishikawa,Motohiro Yamashita,Yasuki Saito,Mitsuhiro Takenoyama,Katsuo Yoshiya,Kenji Sugio,Shinichiro Miyoshi,Makoto Takahama,Yoshihisa Kadota,Masahiko Higashiyama,Meinoshin Okumura,Hirohiko Akiyama,Atsushi Iwasaki,Yasuhisa Ohde,Hiroki Nakamura,Haruhisa Matsuguma,Takashi Kondo,Norihiko Ikeda,Hirotoshi Horio,Tôru Satô,Takuya Nagashima,Akira Yoshizu,Hiromi Katsuki,Hiroaki Kuroda,Mingyon Mun,Kohei Tajima,Wataru Nishio,Moriyuki Kiyoshima,Hiroyuki Ito,Yasuhiro Tsutani,Masashi Kobayashi,Masaki Anraku,Toyofumi Yoshikawa,Hyungeun Yoon,Takashi Mimura,Tsutomu Kawabata,Toru Hasumi,Tatsuro Okamoto,Tadashi Aoki,Shinichi Toyooka,Jiro Okami,Yasushi Shintani,Tomomi Hirata,Hisashi Saji,Yoshinori Okada,Makoto Endo,Tetsukan Woo,Mai Daido
摘要
Although segmentectomy is a widely used surgical procedure, lobectomy is the standard procedure for resectable non-small-cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of segmentectomy for NSCLC up to 3 cm in size, including ground-glass opacity (GGO) and predominant GGO.A multicentre, single-arm, confirmatory phase 3 trial was conducted across 42 institutions (hospitals, university hospitals, and cancer centres) in Japan. Segmentectomy with hilar, interlobar, and intrapulmonary lymph node dissection was performed as protocol surgery for patients with a tumour diameter of up to 3 cm, including GGO and dominant GGO. Eligible patients were those aged 20-79 years with an Eastern Cooperative Oncology Group performance score of 0 or 1 and clinical stage IA tumour confirmed by thin-sliced CT. The primary endpoint was 5-year relapse-free survival (RFS). This study is registered with the University Hospital Medical Information Network Clinical Trials (UMIN000011819), and is ongoing.A total of 396 patients were registered from Sept 20, 2013, to Nov 13, 2015, of whom 357 underwent segmentectomy. At a median follow-up of 5·4 years (IQR 5·0-6·0), the 5-year RFS was 98·0% (95% CI 95·9-99·1). This finding exceeded the 87% of the pre-set threshold 5-year RFS and the primary endpoint was met. Grade 3 or 4 early postoperative complications occurred in seven patients (2%), but no grade 5 treatment-related deaths occurred.Segmentectomy should be considered as part of standard treatment for patients with predominantly GGO NSCLC with a tumour size of 3 cm or less in diameter, including GGO even if it exceeds 2 cm.National Cancer Centre Research and Development Fund and Japan Agency for Medical Research and Development.