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).

Carcinoma, Non-Small-Cell Lung / drug therapy Chemotherapy, Adjuvant Deoxycytidine / analogs & derivatives Humans Lung Neoplasms / drug therapy Tegafur Uracil / therapeutic use Gemcitabine
Adjuvant chemotherapy Gemcitabine NSCLC Uracil-tegafur

Journal

International journal of clinical oncology
ISSN: 1437-7772
Titre abrégé: Int J Clin Oncol
Pays: Japan
ID NLM: 9616295

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 26 04 2021
accepted: 19 08 2021
pubmed: 1 9 2021
medline: 16 11 2021
entrez: 31 8 2021
Statut: ppublish

Résumé

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.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

DOI: 10.1007/s10147-021-02012-9 PMID: 34463869
pubmed: 34463869
doi: 10.1007/s10147-021-02012-9
pii: 10.1007/s10147-021-02012-9
doi:

Substances chimiques

Deoxycytidine 0W860991D6
Tegafur 1548R74NSZ
Uracil 56HH86ZVCT
Gemcitabine 0

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

2216-2223

Informations de copyright

© 2021. Japan Society of Clinical Oncology.

Références

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Auteurs

Masafumi Yamaguchi (M)

Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan.

Hirohito Tada (H)

Department of Thoracic Surgery, Osaka City General Hospital, Osaka City, Osaka, Japan. htada@asahi.email.ne.jp.
ORCID: 0000-0002-8972-6136

Tetsuya Mitsudomi (T)

Department of Thoracic Surgery, Aichi Cancer Center, Nagoya City, Aichi, Japan.

Takashi Seto (T)

Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka City, Fukuoka, Japan.

Kohei Yokoi (K)

Department of Thoracic Surgery, Nagoya University School of Medicine, Nagoya City, Aichi, Japan.

Nobuyuki Katakami (N)

Division of Pulmonary Medicine, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan.

Kazuhiko Nakagawa (K)

Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan.

Makoto Oda (M)

Department of Thoracic Surgery, Kanazawa University School of Medicine, Kanazawa City, Ishikawa, Japan.

Mitsunori Ohta (M)

Department of Thoracic Surgery, Osaka Habikino Medical Center, Habikino City, Osaka, Japan.

Toshiyuki Sawa (T)

Department of Pulmonary Medicine, Gifu Municipal Hospital, Gifu City, Gifu, Japan.

Motohiro Yamashita (M)

Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan.

Norihiko Iked (N)

Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.

Hideo Saka (H)

Department of Pulmonary Medicine, National Hospital Organization Nagoya Hospital, Nagoya City, Aichi, Japan.

Masahiko Higashiyama (M)

Department of General Thoracic Surgery, Osaka International Cancer Institute, Osaka City, Osaka, Japan.

Hiroaki Nomori (H)

Department of Thoracic Surgery, School of Medicine, Kumamoto University, Kumamoto City, Kumamoto, Japan.

Hiroshi Semba (H)

Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto City, Kumamoto, Japan.

Shunichi Negoro (S)

Department of Medical Oncology, Hyogo Cancer Center, Akashi City, Hyogo, Japan.

Yasutaka Chiba (Y)

Division of Biostatistics, Clinical Research Center, Kinki University School of Medicine, Osakasayama CIty, Osaka, Japan.

Mototsugu Shimokawa (M)

Department of Biostatistics, Yamaguchi University School of Medicine, Yamaguchi City, Yamaguchi, Japan.

Masahiro Fukuoka (M)

Department of Medical Oncology, Kinki University School of Medicine, Osakasayama City, Osaka, Japan.

Yoichi Nakanishi (Y)

Research Institute for Diseases of the Chest, Kyushu University, Fukuoka City, Fukuoka, Japan.

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Classifications MeSH

questionsmedicales.fr › Maladies de l'appareil respiratoire › Tumeurs de l'appareil respiratoire › Tumeurs du poumon › Tumeurs des bronches › Carcinome bronchogénique › Carcinome pulmonaire non à petites cellules › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Traitement médicamenteux adjuvant › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Acides nucléiques, nucléotides et nucléosides › Nucléosides › Nucléosides pyrimidiques › Désoxycytidine › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Tumeurs de l'appareil respiratoire › Tumeurs du poumon › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyrimidines › Pyrimidinones › Uracile › Fluorouracil › Tégafur › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyrimidines › Pyrimidinones › Uracile › Phase III study of adjuvant gemcitabine...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyrimidines › Gemcitabine › Phase III study of adjuvant gemcitabine...