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)
| Autor: | Yoichi Nakanishi, Yasutaka Chiba, Masahiro Fukuoka, Makoto Oda, Kohei Yokoi, Hiroshi Semba, Hiroaki Nomori, Takashi Seto, Shunichi Negoro, Nobuyuki Katakami, Mitsunori Ohta, Mototsugu Shimokawa, Masafumi Yamaguchi, Toshiyuki Sawa, Masahiko Higashiyama, Kazuhiko Nakagawa, Motohiro Yamashita, Tetsuya Mitsudomi, Norihiko Iked, Hirohito Tada, Hideo Saka |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Lung Neoplasms endocrine system diseases medicine.medical_treatment Deoxycytidine Gastroenterology Carcinoma Non-Small-Cell Lung Internal medicine medicine Clinical endpoint Adjuvant therapy Humans Stage (cooking) Uracil Adverse effect Lung cancer Tegafur business.industry Hazard ratio Hematology General Medicine medicine.disease Gemcitabine Oncology Chemotherapy Adjuvant Surgery business Adjuvant medicine.drug |
| Zdroj: | International Journal of Clinical Oncology. 26:2216-2223 |
| ISSN: | 1437-7772 1341-9625 |
| DOI: | 10.1007/s10147-021-02012-9 |
| Popis: | 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 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. 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). 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. |
| Databáze: | OpenAIRE |
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