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      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

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          Abstract

          Oral S-1 plus cisplatin is noninferior to docetaxel plus cisplatin in terms of overall survival with favorable QoL data. S-1 plus cisplatin is an option for the first-line treatment of patients with advanced NSCLC.

          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).

          Patients and 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.

          Conclusion

          Oral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC.

          Clinical trial number

          UMIN000000608.

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          Most cited references17

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          Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group.

          Rodryg Ramlau, V. Gorbounova, E Kaukel … (2003)
          To investigate whether docetaxel plus platinum regimens improve survival and affect quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC) compared with vinorelbine plus cisplatin as first-line chemotherapy. Patients (n = 1,218) with stage IIIB to IV NSCLC were randomly assigned to receive docetaxel 75 mg/m2 and cisplatin 75 mg/m2 every 3 weeks (DC); docetaxel 75 mg/m2 and carboplatin area under the curve of 6 mg/mL * min every 3 weeks (DCb); or vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2 every 4 weeks (VC). Patients treated with DC had a median survival of 11.3 v 10.1 months for VC-treated patients (P =.044; hazard ratio, 1.183 [97.2% confidence interval, 0.989 to 1.416]). The 2-year survival rate was 21% for DC-treated patients and 14% for VC-treated patients. Overall response rate was 31.6% for DC-treated patients v 24.5% for VC-treated patients (P =.029). Median survival (9.4 v 9.9 months [for VC]; P =.657; hazard ratio, 1.048 [97.2 confidence interval, 0.877 to 1.253]) and response (23.9%) with DCb were similar to those results for VC. Neutropenia, thrombocytopenia, infection, and febrile neutropenia were similar with all three regimens. Grade 3 to 4 anemia, nausea, and vomiting were more common (P <.01) with VC than with DC or DCb. Patients treated with either docetaxel regimen had consistently improved QoL compared with VC-treated patients, who experienced deterioration in QoL. DC resulted in a more favorable overall response and survival rate than VC. Both DC and DCb were better tolerated and provided patients with consistently improved QoL compared with VC. These findings demonstrate that a docetaxel plus platinum combination is an effective treatment option with a favorable therapeutic index for first-line treatment of advanced or metastatic NSCLC.
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            American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer.

            Christopher G Azzoli, Sherman Baker, Sarah Temin … (2009)
            The purpose of this article is to provide updated recommendations for the treatment of patients with stage IV non-small-cell lung cancer. A literature search identified relevant randomized trials published since 2002. The scope of the guideline was narrowed to chemotherapy and biologic therapy. An Update Committee reviewed the literature and made updated recommendations. One hundred sixty-two publications met the inclusion criteria. Recommendations were based on treatment strategies that improve overall survival. Treatments that improve only progression-free survival prompted scrutiny of toxicity and quality of life. For first-line therapy in patients with performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For patients with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with carboplatin-paclitaxel, except for patients with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy.
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              Antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats.

              T Takechi, M. Fukushima, N Unemi … (1996)
              The purpose of this study was to establish a nude rat orthotopic (organ-specific) human colorectal cancer model as an in vivo secondary screen for general evaluation of new anticancer agents against colorectal cancer and to evaluate practically the antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1), a new p.o. fluoropyrimidine, in comparison to 1 M tegafur-4 M uracil [(UFT) effective on colorectal tumor in clinical]. After implantation of KM12C, a human colorectal cancer cell line, into the subserosal layer of the colon as a single-cell suspension, extensive local tumor growth and invasion to both the mucosal and the serosal sides were observed in all rats. Metastatic foci were also formed in both lymph nodes and lungs following local tumor growth in all of them. Using this method, an equitoxic dose of S-1 (15 mg/kg/day) and UFT (30 mg/kg/day) was administered p.o. for 14 consecutive days from 7 days after tumor cell implantation. S-1 showed a higher tumor growth inhibition than UFT did [S-1, 57% (significantly different from the tumor weight of the untreated group at P 0.05)]. When both drugs were administered to nude rats bearing KM12C injected into the cecal wall for 28 consecutive days at equitoxic doses, the mean survival in the S-1 group was 16 days longer than that in the untreated group (P 0.05). After the administration of an equitoxic dose of both drugs, S-1 gave the higher levels than UFT in various pharmacokinetic parameters as follows: area under the curve 0-24 h of 5-fluorouracil in plasma (3.5-fold), area under the curve 0-24 h of 5-fluorouracil incorporated into RNA in the tumor (1.3-fold), and thymidylate synthase inhibition rate (percentage) in the tumor (about 20%). Collectively, these findings suggested that this orthotopic human colorectal tumor model in nude rats is useful to evaluate the clinical therapeutic efficacy of drugs or therapies for colorectal cancer, and that S-1 had a higher therapeutic effect on human colorectal tumor than UFT did.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Ann Oncol
                Journal ID (iso-abbrev): Ann. Oncol
                Journal ID (publisher-id): annonc
                Journal ID (hwp): annonc
                Title: Annals of Oncology
                Publisher: Oxford University Press
                ISSN (Print): 0923-7534
                ISSN (Electronic): 1569-8041
                Publication date (Print): July 2015
                Publication date (Electronic): 23 April 2015
                Publication date PMC-release: 23 April 2015
                Volume: 26
                Issue: 7
                Pages: 1401-1408
                Affiliations
                [1 ]Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School , Tokyo
                [2 ]Department of Thoracic Oncology, Saitama Cancer Center , Kita-adachi-gun
                [3 ]Division of Integrated Oncology, Institute of Biomedical Research and Innovation , Kobe
                [4 ]Department of Thoracic Medical Oncology, Cancer Institute Hospital of JFCR , Tokyo
                [5 ]Clinical Research, Innovation and Education Center, Tohoku University Hospital , Sendai
                [6 ]Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital , Hodogaya-ku
                [7 ]Department of Medical Oncology, KKR Sapporo Medical Center , Sapporo
                [8 ]Department of Medical Oncology, Japanese Red Cross Medical Center , Tokyo
                [9 ]Department of Medical Oncology, Graduate School of Medicine, Chiba University , Chiba
                [10 ]Department of Respiratory Medicine, Saitama Medical University International Medical Center , Saitama
                [11 ]Second Department of Internal Medicine, Nagasaki University School of Medicine , Nagasaki
                [12 ]Division of Thoracic Oncology, National Cancer Center Hospital East , Kashiwa
                [13 ]Department of Pulmonary Medicine, Sendai Kousei Hospital , Sendai
                [14 ]Department of Respiratory Medicine, Gunma Prefectural Cancer Center , Ota
                [15 ]Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center , Omura
                [16 ]Department of Internal Medicine, Niigata Cancer Center Hospital , Niigata
                [17 ]Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), Kitasato University School of Pharmacy , Tokyo
                [18 ]Double-Barred Cross Hospital Japan Anti-Tuberculosis Association , Tokyo, Japan
                Author notes
                [* ] Correspondence to: Dr Akihiko Gemma, Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan. Tel: +81-3-3822-2131; Fax: +81-3-3822-8575; E-mail: agemma@ 123456nms.ac.jp
                Article
                Publisher ID: mdv190
                DOI: 10.1093/annonc/mdv190
                PMC ID: 4478975
                PubMed ID: 25908605
                SO-VID: d0143a30-dcde-425f-90dd-72a4063e8fa8
                Copyright © © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 25 December 2014
                Date revision received : 5 March 2015
                Date revision received : 9 April 2015
                Date accepted : 13 April 2015
                Funding
                Funded by: TCOG
                Funded by: Taiho Pharmaceutical Co. Ltd
                Categories
                Subject: Original Articles
                Subject: Thoracic Tumors

                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: advanced nonsmall-cell lung cancer,s-1,cisplatin,docetaxel,randomized trial
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy
                Keywords: advanced nonsmall-cell lung cancer, s-1, cisplatin, docetaxel, randomized trial

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