PMID- 34463869 OWN - NLM STAT- MEDLINE DCOM- 20211112 LR - 20221207 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 26 IP - 12 DP - 2021 Dec TI - Phase III study of adjuvant gemcitabine compared with adjuvant uracil-tegafur in patients with completely resected pathological stage IB-IIIA non-small cell lung cancer (WJTOG0101). PG - 2216-2223 LID - 10.1007/s10147-021-02012-9 [doi] AB - BACKGROUND: Adjuvant oral uracil-tegafur (UFT) has led to significantly longer postoperative survival among patients with non-small-cell lung cancer (NSCLC). Gemcitabine (GEM) monotherapy is also reportedly effective for NSCLC and has minor adverse events (AEs). This study compared the efficacy of GEM- versus UFT-based adjuvant regimens in patients with completely resected pathological stage (p-stage) IB-IIIA NSCLC. PATIENTS AND METHODS: Patients with completely resected p-stage IB-IIIA NSCLC were randomly assigned to GEM or UFT. The primary endpoint was overall survival (OS); secondary endpoints were disease-free survival (DFS), and AEs. RESULTS: We assigned 305 patients to the GEM group and 303 to the UFT group. Baseline factors were balanced between the arms. Of the 608 patients, 293 (48.1%) had p-stage IB disease, 195 (32.0%) had p-stage II disease and 121 (19.9%) had p-stage IIIA disease. AEs were generally mild in both groups, and only one death occurred, in the GEM group. After a median follow-up of 6.8 years, the two groups did not significantly differ in survival: 5 year OS rates were GEM: 70.0%, UFT: 68.8% (hazard ratio 0.948; 95% confidence interval 0.73-1.23; P = 0.69). CONCLUSION: Although GEM-based adjuvant therapy for patients with completely resected stage IB-IIIA NSCLC was associated with acceptable toxicity, it did not provide longer OS than did UFT. CI - (c) 2021. Japan Society of Clinical Oncology. FAU - Yamaguchi, Masafumi AU - Yamaguchi M AD - Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan. FAU - Tada, Hirohito AU - Tada H AUID- ORCID: 0000-0002-8972-6136 AD - Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan. htada@asahi.email.ne.jp. FAU - Mitsudomi, Tetsuya AU - Mitsudomi T AD - Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan. FAU - Seto, Takashi AU - Seto T AD - Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan. FAU - Yokoi, Kohei AU - Yokoi K AD - Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan. FAU - Katakami, Nobuyuki AU - Katakami N AD - Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan. FAU - Nakagawa, Kazuhiko AU - Nakagawa K AD - Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan. FAU - Oda, Makoto AU - Oda M AD - Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan. FAU - Ohta, Mitsunori AU - Ohta M AD - Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan. FAU - Sawa, Toshiyuki AU - Sawa T AD - Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan. FAU - Yamashita, Motohiro AU - Yamashita M AD - Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan. FAU - Iked, Norihiko AU - Iked N AD - Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan. FAU - Saka, Hideo AU - Saka H AD - Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan. FAU - Higashiyama, Masahiko AU - Higashiyama M AD - Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan. FAU - Nomori, Hiroaki AU - Nomori H AD - Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan. FAU - Semba, Hiroshi AU - Semba H AD - Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan. FAU - Negoro, Shunichi AU - Negoro S AD - Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan. FAU - Chiba, Yasutaka AU - Chiba Y AD - Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan. FAU - Shimokawa, Mototsugu AU - Shimokawa M AD - Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan. FAU - Fukuoka, Masahiro AU - Fukuoka M AD - Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan. FAU - Nakanishi, Yoichi AU - Nakanishi Y AD - Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan. CN - West Japan Thoracic Oncology Group (WJTOG) LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20210831 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0W860991D6 (Deoxycytidine) RN - 1548R74NSZ (Tegafur) RN - 56HH86ZVCT (Uracil) RN - 0 (Gemcitabine) SB - IM MH - *Carcinoma, Non-Small-Cell Lung/drug therapy/surgery MH - Chemotherapy, Adjuvant MH - Deoxycytidine/analogs & derivatives MH - Humans MH - *Lung Neoplasms/drug therapy/surgery MH - Tegafur MH - Uracil/therapeutic use MH - Gemcitabine OTO - NOTNLM OT - Adjuvant chemotherapy OT - Gemcitabine OT - NSCLC OT - Uracil-tegafur EDAT- 2021/09/01 06:00 MHDA- 2021/11/16 06:00 CRDT- 2021/08/31 13:17 PHST- 2021/04/26 00:00 [received] PHST- 2021/08/19 00:00 [accepted] PHST- 2021/09/01 06:00 [pubmed] PHST- 2021/11/16 06:00 [medline] PHST- 2021/08/31 13:17 [entrez] AID - 10.1007/s10147-021-02012-9 [pii] AID - 10.1007/s10147-021-02012-9 [doi] PST - ppublish SO - Int J Clin Oncol. 2021 Dec;26(12):2216-2223. doi: 10.1007/s10147-021-02012-9. Epub 2021 Aug 31.