Phase I/II trial of gemcitabine plus oral TS-1 in elderly patients with advanced non-small cell lung cancer: Thoracic oncology research group study 0502

Lung Cancer

Volumn 69, Issue 2, 2010, Pages 213-217

  Seto, Takashi ^a   Yamanaka, Takeharu ^a   Wasada, Izumi ^b   Seki, Nobuhiko ^c   Okamoto, Hiroaki ^d   Ogura, Takashi ^e   Shibuya, Masahiko ^f   Takiguchi, Yuichi ^g   Shinkai, Tetsu ^h   Masuda, Noriyuki ⁱ   Ichinose, Yukito ^a   Eguchi, Kenji ^c   Watanabe, Koshiro ^d  

^a NATIONAL KYUSHU CANCER CENTER   (Japan)

^b TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d YOKOHAMA MUNICIPAL CITIZEN'S HOSPITAL   (Japan)

^e Kanagawa Prefectural Cardiovascular and Respiratory Diseases Center Hospital   (Japan)

^f TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^g CHIBA UNIVERSITY   (Japan)

^h NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

ⁱ KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Advanced non small cell lung cancer; Elderly patients; Gemcitabine; TS 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; GEMCITABINE; TS 1; UNCLASSIFIED DRUG;

ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; COUGHING; DIARRHEA; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FEVER; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; LEUKOCYTE; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL; OVERALL SURVIVAL; PAIN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SKIN ALLERGY; SKIN TOXICITY; STOMATITIS; SURVIVAL TIME; THROMBOCYTE; THROMBOCYTOPENIA; UREA NITROGEN BLOOD LEVEL; VOMITING;

ADMINISTRATION, ORAL; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; DEOXYCYTIDINE; DISEASE PROGRESSION; FOLLOW-UP STUDIES; HUMANS; INFECTION; LUNG NEOPLASMS; MAXIMUM TOLERATED DOSE; NEOPLASM STAGING; SILICATES; SURVIVAL ANALYSIS; TITANIUM;

EID: 77954130953     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2009.10.017     Document Type: Article

References (20)

1. Gridelli C., Shepherd F.A. Chemotherapy for elderly patients with non-small cell lung cancer: a review of the evidence. Chest 2005, 128:947-957.
2. The Elderly Lung Cancer Vinorelbine Italian Study Group. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 1999, 91:66-72.
3. Gridelli C., Perrone F., Gallo C., Cigolari S., Rossi A., Piantedosi F., et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 2003, 95:362-372.
4. Kudoh S., Takeda K., Nakagawa K., Takada M., Katakami N., Matsui K., et al. Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). J Clin Oncol 2006, 24:3657-3663.
5. Yamada Y., Toko T., Miyauchi S., Unemi N. Effect of UFT on immune responses in mice. Jpn J Cancer Chemother 1980, 7:2134-2140.
6. Schulz L., Schalhorn A., Wilmanns W., Heinemann V. Synergistic interaction of gemcitabine and 5-fluorouracil in colon cancer cells. Proc Am Soc Clin Oncol 1998, 17:251a. (abstr #965).
7. Cascinu S., Silva R.R., Barni S., Labianca R., Frontini L., Piazza E., et al. A combination of gemcitabine and 5-fluorouracil in advanced pancreatic cancer, a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD). Br J Cancer 1999, 80:1595-1598.
8. Madajewicz S., Hentschel P., Burns P., Caruso R., Fiore J., Fried M., et al. Phase I chemotherapy study of biochemical modulation of folinic acid and fluorouracil by gemcitabine in patients with solid tumor malignancies. J Clin Oncol 2000, 18:3553-3557.
9. Ichinose Y., Seto T., Semba H., Itoh K., Inoue Y., Tanaka F., et al. UFT plus gemcitabine combination chemotherapy in patients with advanced non-small-cell lung cancer: a multi-institutional phase II trial. Br J Cancer 2005, 93:770-773.
10. Seto T., Yoh K., Asoh H., Yamamoto H., Semba H., Ichinose Y. A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer. Br J Cancer 2002, 86:1701-1704.
11. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drugs 2004, 15:85-106.
12. Kawahara M., Furuse K., Segawa Y., Yoshimori K., Matsui K., Kudoh S., 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.
13. Brookmeyer R., Crowley J. A confidence interval for the median survival time. Biometrics 1982, 38:29-41.
14. Lilenbaum R.C., Herndon J.E., List M.A., Desch C., Watson D.M., Miller A.A., et al. Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B (study 9730). J Clin Oncol 2005, 23:190-196.
15. Sederholm C., Hillerdal G., Lamberg K., Kolbeck K., Dufmats M., Westberg R., et al. Phase III trial of gemcitabine plus carboplatin versus single-agent gemcitabine in the treatment of locally advanced or metastatic non-small-cell lung cancer: the Swedish Lung Cancer Study Group. J Clin Oncol 2005, 23:8380-8388.
16. Pressacco J., Mitrovski B., Erlichman C., Hedley D.W. Effects of thymidylate synthase inhibition on thymidine kinase activity and nucleoside transporter expression. Cancer Res 1995, 55:1505-1508.
17. Pressacco J., Wiley J.S., Jamieson G.P., Erlichman C., Hedley D.W. Modulation of the equilibrative nucleoside transporter by inhibitors of DNA synthesis. Br J Cancer 1995, 72:939-942.
18. Mackey J.R., Mani R.S., Selner M., Mowles D., Young J.D., Belt J.A., et al. Functional nucleoside transporters are required for gemcitabine influx and manifestation of toxicity in cancer cell lines. Cancer Res 1998, 58:4349-4357.
19. Correale P., Cerretani D., Marsili S., Pozzessere D., Petrioli R., Messinese S., et al. Gemcitabine increases systemic 5-fluorouracil exposure in advanced cancer patients. Eur J Cancer 2003, 39:1547-1551.
20. Rauchwerger D.R., Firby P.S., Hedley D.W., Moore M.J. Equilibrative-sensitive nucleoside transporter and its role in gemcitabine sensitivity. Cancer Res 2000, 60:6075-6079.