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Clinical Trial
. 2023 Jun;11(6):540-549.
doi: 10.1016/S2213-2600(23)00041-3. Epub 2023 Mar 6.

Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial

Keiju Aokage  1 , Kenji Suzuki  2 , Hisashi Saji  3 , Masashi Wakabayashi  4 , Tomoko Kataoka  4 , Yuta Sekino  4 , Haruhiko Fukuda  4 , Makoto Endo  5 , Aritoshi Hattori  2 , Takahiro Mimae  6 , Tomohiro Miyoshi  7 , Mitsuhiro Isaka  8 , Hiroshige Yoshioka  9 , Ryu Nakajima  10 , Kazuo Nakagawa  11 , Jiro Okami  12 , Hiroyuki Ito  13 , Hiroaki Kuroda  14 , Masahiro Tsuboi  7 , Norihito Okumura  15 , Makoto Takahama  10 , Yasuhisa Ohde  8 , Tadashi Aoki  16 , Yasuhiro Tsutani  17 , Morihito Okada  6 , Shun-Ichi Watanabe  11 ; Japan Clinical Oncology Group
Collaborators, Affiliations
Clinical Trial

Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial

Keiju Aokage et al. Lancet Respir Med. 2023 Jun.

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: National Cancer Centre Research and Development Fund and Japan Agency for Medical Research and Development.

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Conflict of interest statement

Declaration of interests KA, AH, HI, TK, HK, TMiy, RN, YO, MO, JO, YT, and SW report research funding from the National Cancer Center Research and Development Fund by the National Cancer Center and Practical Research for Innovative Cancer Control Fund by Japan Agency for Medical Research and Development. HF reports lecture fees from Chugai Pharmaceuticals, outside of the submitted work. MW reports honoraria from Nihon Medi-Physics outside of the submitted work. MTs reports research funding from Boehringer-Ingelheim Japan and commissioned research for clinical trials from MSD, Astrazeneca, Ono Pharmaceutical, Bristol-Myers Squibb, Eli Lilly Japan, Novartis, and BMG; lecture fees from Johnson & Johnson Japan, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Bristol-Myers Squibb, Teijin Pharma, Taiho Pharma, Medtronic Japan, ONO Pharmaceutical, Daiichi-Sankyo, and Novartis, outside of the submitted work; is on the advisory board of AstraZeneca, Chugai Pharmaceutical, MSD, Novartis, and Eli Lilly, outside of the submitted work; and also is on the committee of Japan Lung Cancer Society and Japanese Association of Chest Surgery, Cancer Net Japan, Japanese Organization for Research, and Treatment of Cancer, outside of the submitted work. TMim reports research funding from the Japan Society for the Promotion of Science KAKENHI (grant number 20K09177) by the Japan Society for Promotion of Science, outside of the submitted work. All other authors declare no competing interests.

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