title: A randomized phase III trial of oral S-1 plus cisplatin versus docetaxel plus cisplatin in Japanese patients with advanced non-small-cell lung cancer: TCOG0701 CATS trial.
abstract: BACKGROUND
  Platinum-based two-drug combination chemotherapy has been standard of care for patients with advanced nonsmall-cell lung cancer (NSCLC). The primary aim was to compare overall survival (OS) of patients with advanced NSCLC between the two chemotherapy regimens. Secondary end points included progression-free survival (PFS), response, safety, and quality of life (QoL).
  
  
  METHODS
  Patients with previously untreated stage IIIB or IV NSCLC, an Eastern Cooperative Oncology Group performance status of 0-1 and adequate organ function were randomized to receive either oral S-1 80 mg/m(2)/day on days 1-21 plus cisplatin 60 mg/m(2) on day 8 every 4-5 weeks, or docetaxel 60 mg/m(2) on day 1 plus cisplatin 80 mg/m(2) on day 1 every 3-4 weeks, both up to six cycles.
  
  
  RESULTS
  A total of 608 patients from 66 sites in Japan were randomized to S-1 plus cisplatin (n = 303) or docetaxel plus cisplatin (n = 305). OS for oral S-1 plus cisplatin was noninferior to docetaxel plus cisplatin [median survival, 16.1 versus 17.1 months, respectively; hazard ratio = 1.013; 96.4% confidence interval (CI) 0.837-1.227]. Significantly higher febrile neutropenia (7.4% versus 1.0%), grade 3/4 neutropenia (73.4% versus 22.9%), grade 3/4 infection (14.5% versus 5.3%), and grade 1/2 alopecia (59.3% versus 12.3%) were observed in the docetaxel plus cisplatin than in the S-1 plus cisplatin. There were no differences found in PFS or response between the two arms. QoL data investigated by EORTC QLQ-C30 and LC-13 favored the S-1 plus cisplatin.
  
  
  CONCLUSIONS
  Oral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC.
  
  
  BACKGROUND
  UMIN000000608.
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo.
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.affiliation: Department of Thoracic Oncology, Saitama Cancer Center, Kita-adachi-gun.
authors.forename: H
authors.initials: H
authors.lastname: Sakai
authors.affiliation: Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe.
authors.forename: N
authors.initials: N
authors.lastname: Katakami
authors.affiliation: Department of Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo.
authors.forename: M
authors.initials: M
authors.lastname: Nishio
authors.affiliation: Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai.
authors.forename: A
authors.initials: A
authors.lastname: Inoue
authors.affiliation: Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Hodogaya-ku.
authors.forename: H
authors.initials: H
authors.lastname: Okamoto
authors.affiliation: Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo.
authors.forename: H
authors.initials: H
authors.lastname: Isobe
authors.affiliation: Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo.
authors.forename: H
authors.initials: H
authors.lastname: Kunitoh
authors.affiliation: Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba.
authors.forename: Y
authors.initials: Y
authors.lastname: Takiguchi
authors.affiliation: Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama.
authors.forename: K
authors.initials: K
authors.lastname: Kobayashi
authors.affiliation: Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki.
authors.forename: Y
authors.initials: Y
authors.lastname: Nakamura
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: H
authors.initials: H
authors.lastname: Ohmatsu
authors.affiliation: Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai.
authors.forename: S
authors.initials: S
authors.lastname: Sugawara
authors.affiliation: Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota.
authors.forename: K
authors.initials: K
authors.lastname: Minato
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Omura.
authors.forename: M
authors.initials: M
authors.lastname: Fukuda
authors.affiliation: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata.
authors.forename: A
authors.initials: A
authors.lastname: Yokoyama
authors.affiliation: Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), Kitasato University School of Pharmacy, Tokyo.
authors.forename: M
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), Kitasato University School of Pharmacy, Tokyo.
authors.forename: H
authors.initials: H
authors.lastname: Michimae
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo agemma@nms.ac.jp.
authors.forename: A
authors.initials: A
authors.lastname: Gemma
authors.affiliation: Double-Barred Cross Hospital Japan Anti-Tuberculosis Association, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Kudoh
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin
keywords: S-1; advanced nonsmall-cell lung cancer; cisplatin; docetaxel; randomized trial