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),International Journal of Clinical Oncology

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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)
International Journal of Clinical Oncology ( IF 2.4 ) Pub Date : 2021-08-31 , DOI: 10.1007/s10147-021-02012-9
Masafumi Yamaguchi ₁ , Hirohito Tada ₂ , Tetsuya Mitsudomi ₃ , Takashi Seto ₁ , Kohei Yokoi ₄ , Nobuyuki Katakami ₅ , Kazuhiko Nakagawa ₆ , Makoto Oda ₇ , Mitsunori Ohta ₈ , Toshiyuki Sawa ₉ , Motohiro Yamashita ₁₀ , Norihiko Iked ₁₁ , Hideo Saka ₁₂ , Masahiko Higashiyama ₁₃ , Hiroaki Nomori ₁₄ , Hiroshi Semba ₁₅ , Shunichi Negoro ₁₆ , Yasutaka Chiba ₁₇ , Mototsugu Shimokawa ₁₈ , Masahiro Fukuoka ₆ , Yoichi Nakanishi ₁₉ ,

Affiliation

Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan.
Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan.
Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan.
Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan.
Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan.
Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan.
Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan.
Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan.
Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan.
Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan.
Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan.
Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan.
Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan.
Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan.
Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan.
Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan.
Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan.
Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan.

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.

中文翻译：

在完全切除的病理分期 IB-IIIA 非小细胞肺癌患者中，吉西他滨辅助治疗与尿嘧啶-替加氟辅助治疗的 III 期研究（WJTOG0101）

背景

辅助口服尿嘧啶替加氟 (UFT) 可显着延长非小细胞肺癌 (NSCLC) 患者的术后生存期。据报道，吉西他滨 (GEM) 单一疗法对 NSCLC 也有效，并且具有轻微的不良事件 (AE)。本研究比较了 GEM 与基于 UFT 的辅助方案在完全切除的病理分期（p 期）IB-IIIA NSCLC 患者中的疗效。

患者和方法

完全切除的 p 期 IB-IIIA NSCLC 患者被随机分配到 GEM 或 UFT。主要终点是总生存期（OS）；次要终点是无病生存期（DFS）和不良事件。

结果

我们将 305 名患者分配到 GEM 组，将 303 名患者分配到 UFT 组。各组之间的基线因素是平衡的。在 608 名患者中，293 名（48.1%）患有 p 期 IB 疾病，195 名（32.0%）患有 p 期 II 期疾病，121 名（19.9%）患有 p 期 IIIA 期疾病。两组的 AE 一般都很轻微，GEM 组仅发生 1 例死亡。中位随访 6.8 年后，两组的生存率没有显着差异：5 年 OS 率为 GEM：70.0%，UFT：68.8%（风险比 0.948；95% 置信区间 0.73-1.23；P = 0.69 ）。