A randomized phase II study of a combination of docetaxel and s-1 versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy: Results of Okayama Lung Cancer Study Group (OLCSG) trial 0503

Journal of Thoracic Oncology

Volumn 5, Issue 9, 2010, Pages 1430-1434

  Segawa, Yoshihiko ^a,b   Kiura, Katsuyuki ^c   Hotta, Katsuyuki ^c   Takigawa, Nagio ^c   Tabata, Masahiro ^c   Matsuo, Keitaro ^d   Yoshioka, Hiroshige ^e   Hayashi, Hidetoshi ^e   Kawai, Haruyuki ^f   Aoe, Keisuke ^a   Maeda, Tadashi ^a   Ueoka, Hiroshi ^a   Tanimoto, Mitsune ^c  

^a NATIONAL SANYO HOSPITAL   (Japan)

^b NATIONAL HOSPITAL ORGANIZATION   (Japan)

^c OKAYAMA UNIVERSITY MEDICAL SCHOOL   (Japan)

^d AICHI CANCER CENTER HOSPITAL   (Japan)

^e KURASHIKI CENTRAL HOSPITAL   (Japan)

^f OKAYAMA SAISEIKAI GENERAL HOSPITAL   (Japan)

Author keywords

Docetaxel; Non small cell lung cancer; S 1; Second line chemotherapy

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; CISPLATIN; DOCETAXEL;

ADULT; AGED; ANEMIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER RELAPSE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LEUKOPENIA; LIVER DYSFUNCTION; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL;

EID: 77956262817     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3181e3248e     Document Type: Article

References (25)

1. Pfister DG, Johnson DH, Azzoli CG, et al. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004;22:330-353.
2. Hotta K, Matsuo K, Ueoka H, et al. Meta-analysis of randomized clinical trials comparing cisplatin to carboplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol 2004;22:3852-3859.
3. Hotta K, Matsuo K. Long-standing debate on cisplatin-versus carbo-platin-based chemotherapy in the treatment of advanced non-small-cell lung cancer. J Thorac Oncol 2007;2:96.
4. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000;18:2095-2103.
5. Shepherd FA, Pereira J, Ciuleanu TE, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-132.
6. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetacel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-1597.
7. Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008;372:1809-1818.
8. Shirasaka T, Shimamoto Y, Fukushima M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 1993;53:4004-4009.
9. Kawahara M, Furuse K, Segawa Y, et al. Phase II study of S-1, a novel oral fluorouracil, in advanced non-small-cell lung cancer. Br J Cancer 2001;85:939-943.
10. Takeda Y, Yoshizaki Y, Nonaka Y, et al. Docetaxel alone or orally combined with 5-fluorouracil and its derivatives: effects on mouse mammary tumor cell line MM2 in vitro and in vivo. Anticancer Drugs 2001;12:691-698.
11. Wada Y, Yoshida K, Suzuki T, et al. Synergistic effects of docetaxel and S-1 by modulating the expression of metabolic enzymes of 5-fluorou-racil in human gastric cancer cell lines. Int J Cancer 2006;119:783-791.
12. Suto A, Kubota T, Fukushima M, et al. Antitumor effect of combination of S-1 and docetaxel on the human breast cancer xenograft transplanted into SCID mice. Oncol Rep 2006;15:1517-1522.
13. Han JY, Lee DH, Kim HY, et al. A phase II study of a weekly docetaxel plus capecitabine for patients with advanced nonsmall cell lung carcinoma. Cancer 2003;98:1918-1924.
14. Kindwall-Keller T, Otterson GA, Young G, et al. Phase II evaluation of docetaxel-modulated capecitabine in previously treated patients with non-small cell lung cancer. Clin Cancer Res 2005;11:1870-1876.
15. O'Shaughnessy A, Miles D, Vukelja S, et al. Superior survival with capecitab-ine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002;20:2812-2823.
16. Yoshida K, Hirabayashi N, Takiyama W, et al. Phase I study of combination therapy with S-1 and docetaxel (TXT) for advanced or recurrent gastric cancer. Anticancer Res 2004;24:1843-1851.
17. Common Terminal Criteria for Adverse Events v3.0 [Japan Clinical Oncology Group Web site]. Available at: http://www.jcog.jp/doctor/tool/ctcae.html. Accessed February 13, 2010.
18. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216.
19. Maruyama R, Nishiwaki Y, Tamura T, et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 2008;26:4244-4252.
20. Kunitoh H, Watanabe K, Ohnoshi T, et al. Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: a Japanese cooperative study. J Clin Oncol 1996;14:1649-1655.
21. Atagi S, Kawahara M, Kusunoki Y, et al. Phase I/II study of docetaxel and S-1 in patients with previously treated non-small cell lung cancer. J Thorac Oncol 2008;3:1012-1017.
22. Suehisa H, Toyooka S, Hotta K, et al. Epidermal growth factor receptor mutation status and adjuvant chemotherapy with uracil-tegafur for ade-nocarcinoma of the lung. J Clin Oncol 2007;25:3952-3957.
23. Di Maio, Chiodini P, Georgoulias V, et al. Meta-analysis of single-agent chemotherapy compared with combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2009; 27:1836-1843.
24. Yanagihara K, Yoshimura K, Niimi M, et al. Phase II study of S-1 and docetaxel for previously treated patients with locally advanced or metastatic non-small cell lung cancer [published online ahead of print January 13, 2010]. Cancer Chemother Pharmacol doi: 10.1007/s00280-009-1239-7.
25. Takeda K, Negoro S, Tamura T, et al. Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol 2009;20:835-841.