Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: The FLAGS trial

Journal of Clinical Oncology

Volumn 28, Issue 9, 2010, Pages 1547-1553

  Ajani, Jaffer A ^a   Rodriguez, Wuilbert ^b   Bodoky, Gyorgy ^b   Moiseyenko, Vladimir ^c   Lichinitser, Mikhail ^d   Gorbunova, Vera ^e   Vynnychenko, Ihor ^f   Garin, August ^g   Lang, Istvan ^g   Falcon, Silvia ^g  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b SUMY STATE UNIVERSITY   (Ukraine)

^c HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS   (Peru)

^d NATIONAL INSTITUTE OF ONCOLOGY   (Hungary)

^e N N PETROV RESEARCH INSTITUTE OF ONCOLOGY   (Russian Federation)

^f N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^g NN Blokhin Cancer Research Centre ^*

Author keywords

[No Author keywords available]

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; CISPLATIN; FLUOROPYRIMIDINE; FLUOROURACIL; ANTINEOPLASTIC AGENT; OXONIC ACID; S 1 (COMBINATION); TEGAFUR;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ANOREXIA; ARTICLE; CANCER CHEMOTHERAPY; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FATALITY; DRUG INFUSION; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEMALE; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOPHOSPHATEMIA; KAPLAN MEIER METHOD; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH ADENOCARCINOMA; STOMATITIS; THROMBOCYTOPENIA; TREATMENT FAILURE; TREATMENT OUTCOME; VOMITING; WEIGHT REDUCTION; ADENOCARCINOMA; ADOLESCENT; AGED; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COMBINATION; ESOPHAGUS TUMOR; METASTASIS; MIDDLE AGED; STOMACH TUMOR; SURVIVAL;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DRUG COMBINATIONS; ESOPHAGEAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; OXONIC ACID; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TEGAFUR; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77951888102     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.25.4706     Document Type: Article

References (21)

1. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2006. CA Cancer J Clin 56:106-130, 2006
2. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
3. Boku N, Yamamoto S, Fukuda H, et al: Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: A randomised phase 3 study. Lancet Oncol 10:1063-1069, 2009
4. Al-Batran SE, Hartmann JT, Probst S, et al: Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: A study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 26: 1435-1442, 2008
5. Ohtsu A, Shimada Y, Shirao K, et al: Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol 21:54-59, 2003
6. Van Cutsem E, Moiseyenko VM, Tjulandin S, et al: Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: A report of the V325 Study group. J Clin Oncol 24:4991-4997, 2006 (Pubitemid 46631401)
7. Cunningham D, Starling N, Rao S, et al: Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358:36-46, 2008
8. Koizumi W, Narahara H, Hara T, et al: S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): A phase III trial. Lancet Oncol 9:215-221, 2008
9. Sakuramoto S, Sasako M, Yamaguchi T, et al: Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 357:1810-1820, 2007
10. Chap LI, Laux I, VanVugt A, et al: A phase I study of S-1 GI toxicity with and without oxonic acid (Oxo). J Clin Oncol 26:623s, 2008 (abstr 13539)
11. Saif MW, Rosen LS, Zhang J, et al: A phase I study evaluating the effect of CDHP as a component of S-1 on the pharmacokinetics (PK) of 5-fluorouracil (5-FU). J Clin Oncol 26:115s, 2008 (abstr 2514)
12. Ikeda K, Yoshisue K, Matsushima E, et al: Bioactivation of tegafur to 5-fluorouracil is catalyzed by cytochrome P-450 2A6 in human liver microsomes in vitro. Clin Cancer Res 6:4409-4415, 2000
13. Daigo S, Takahashi Y, Fujieda M, et al: A novel mutant allele of the CYP2A6 gene (CYP2A6*11) found in a cancer patient who showed poor metabolic phenotype towards tegafur. Pharmacogenetics 12:299-306, 2002 (Pubitemid 34620657)
14. Goh BC, Soo RA, Lim S, et al: Inter-ethnic variability of S-1 pharmacokinetics (PK) and correlation with CYP2A6 phenotyping. J Clin Oncol 26:113s, 2008 (abstr 2507)
15. Ajani JA, Faust J, Ikeda K, et al: Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 23:6957-6965, 2005
16. Lenz HJ, Lee FC, Haller DG, et al: Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study. Cancer 109:33-40, 2007 (Pubitemid 46120192)
17. Ajani JA, Lee FC, Singh DA, et al: Multicenter phase II trial of S-1 plus cisplatin in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol 24:663-667, 2006 (Pubitemid 46630431)
18. Gordon Lan KK, Demets DL: Discrete sequential boundaries for clinical trials. Biometrika 70:659-663, 1983
19. O'Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 35:549-556, 1979 (Pubitemid 10242750)
20. Haller DG, Cassidy J, Clarke SJ, et al: Potential regional differences for the tolerability profiles of fluoropyrimidines. J Clin Oncol 26:2118-2123, 2008
21. Meyerhardt JA, Mayer RJ: Systemic therapy for colorectal cancer. N Engl J Med 352:476-487, 2005