Multicenter phase II study of capecitabine plus oxaliplatin as a first-line therapy in Chinese patients with advanced gastric cancer

Anti-Cancer Drugs

Volumn 19, Issue 8, 2008, Pages 825-831

  Liu, Chaoying ^a   Sun, Qing ^a   Hang, Xiaosheng ^b   Zhong, Baoliang ^c   Wang, Daoyuan ^d  

^a NANJING MEDICAL UNIVERSITY   (China)

^b MEDICAL COLLEGE OF SOOCHOW UNIVERSITY   (China)

^c PEKING UNIVERSITY HEALTH SCIENCE CENTER   (China)

^d SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

Author keywords

Advanced gastric cancer; Capecitabine; Oxaliplatin

Indexed keywords

CAPECITABINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; PLATINUM COMPLEX;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CHINESE; CLINICAL TRIAL; CONSTIPATION; CREATININE BLOOD LEVEL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HEMATOLOGIC DISEASE; HUMAN; HYPERBILIRUBINEMIA; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; CHINA; DOSE RESPONSE; ESOPHAGUS TUMOR; MIDDLE AGED; PATHOLOGY; STOMACH TUMOR; SURVIVAL; TREATMENT OUTCOME;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHINA; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; ESOPHAGEAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 53749093792     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/CAD.0b013e32830c457e     Document Type: Article

References (46)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007; 57:43-66.
2. Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M. Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer 1993; 72:37-41.
3. Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with nonresectable gastric cancer. Br J Cancer 1995; 71:587-591.
4. Schipper DL, Wagener DJ. Chemotherapy of gastric cancer. Anti-cancer Drugs 1996; 7:137-149.
5. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 1997; 8:163-168.
6. Chang HM, Jung KH, Kim TY, Kim WS, Yang HK, Lee KU, et al. A phase III randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil and mitomycin C versus 5-fluorouracil alone in curatively resected gastric cancer. Ann Oncol 2002; 13:1779-1785.
7. Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, et al. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol 2000;18:2648-2657.
8. Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, et al. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002 ; 38:349-358.
9. Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 2001; 19:2282-2292.
10. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15:110-115.
11. Bollag W, Hartmann HR. Tumor inhibitory effects of a new fluorouracil derivative: 5′-deoxy-5-fluorouridine. Eur J Cancer 1980; 16:427-432.
12. Hartmann HR, Bollag W. 5′-deoxy-5-fluoruridine, a new antineoplastic pyrimidine antimetabolite. Schweiz Med Wochenschr 1980; 110: 1078-1080.
13. Ishikawa T, Sekiguchi F, Fukase Y, Sawada N, Ishitsuka H. Positive correlation between the efficacy of capecitabine and doxifluridine and the ratio of thymidine phosphorylase to dihydropyrimidine dehydrogenase activities in tumors in human cancer xenografts. Cancer Res 1998; 58: 685-690.
14. Ishikawa T, Utoh M, Sawada N, Nishida M, Fukase Y, Sekiguchi F, et al. Tumor selective delivery of 5-fluorouracil by capecitabine, a new oral fluoropyrimidine carbamate, in human cancer xenografts. Biochem Pharmacol 1998; 55:1091-1097.
15. Ishitsuka H. Capecitabine: preclinical pharmacology studies. Invest New Drugs 2000; 18:343-354.
16. Cao S, Lu K, Ishitsuka H, Rustum YM. Antitumor efficacy of capecitabine against fluorouracil-sensitive and -resistant tumors. Proc Am Soc Clin Oncol 1997;16:(abstract 795).
17. Hong YS, Song SY, Lee SI, Chung HC, Choi SH, Noh SH, et al. A phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. Ann Oncol 2004; 15:1344-1347.
18. Kim TW, Kang YK, Ahn JH, Chang HM, Yook JH, Oh ST, et al. Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol 2002; 13:1893-1898.
19. Kang YK, Kim TW, Chang HM, Ryu MH, Yook JH, Oh ST, et al. A phase I/II trial of docetaxel, capecitabine, and cisplatin as a first line chemotherapy for advanced gastric cancer. Proc Am Soc Clin Oncol 2004; 22: (abstract 4066).
20. Park YH, Ryoo BY, Choi SJ, Kim HT. A phase II study of capecitabine and docetaxel combination chemotherapy in patients with advanced gastric cancer. Br J Cancer 2004; 90:1329-1333.
21. Park YH, Kim BS, Ryoo BY, Yang SH. A phase II study of capecitabine plus 3-weekly oxaliplatin as first-line therapy for patients with advanced gastric cancer. Br J Cancer 2006; 94:959-963.
22. Woynarowsk JM, Faivre S, Herzig MC, Woynarowski JM, Faivre S, Herzig M, et al. Oxaliplatin-induced damage of cellular DNA. Mol Pharmacol 2000; 58:920-927.
23. Schmidt W, Chaney SG. Role of carrier ligand in platinum resistance of human carcinoma cell lines. Cancer Res 1993; 53:799-808.
24. Mamenta EL, Poma EE, Kaufmann WK, Delmastro DA, Grady HL, Chaney SG. Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines. Cancer Res 1994; 54:3500-3505.
25. Extra JM, Espie M, Calvo F, Ferme C, Mignot L, Marty M. Phase I study of oxaliplatin in patients with advanced cancer. Cancer Chemother Pharmacol 1990; 25:299-303.
26. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004; 22:23-30.
27. André T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, et al. Multicenter International Study of Oxaliplatin/5- Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004; 350:2343-2351.
28. Becouarn Y, Agostini C, TruZandier WK, Boulanger V. Oxaliplatin: available data in non-colorectal gastrointestinal malignancies. Crit Rev Oncol Hematol 2001; 40:265-272.
29. Cassidy J, Tabernero J, Twelves C, Brunet R, Butts C, Conroy T, et al. XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. J Clin Oncol 2004; 22: 2084-2091.
30. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10:1-10.
31. Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and metaanalysis based on aggregate data. J Clin Oncol 2006; 24:2903-2909.
32. Jin M, Shen L, Hu B, Yu J, Wen Z, Su Y, et al. Capecitabine (X) combined with fractionated cisplatin (C) as first-line therapy in Chinese patients with advanced gastric carcinoma. J Clin Oncol 2006; 23:321s (abstract 4053).
33. Park YH, Lee JL, Ryoo BY, Ryu MH, Yang SH, Kim BS, et al. Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother Pharmacol 2008; 61:623-629.
34. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. Randomized phase III trial of capecitabine/cisplatin (XP) vs. continuous infusion of 5-FU/ cisplatin (FP) as first-line therapy in patients with advanced gastric cancer: efficacy and safety results. J Clin Oncol 2006; 24:18S (LBA4018).
35. Qian J, Qin SK, Mei JF, Chen YX, Shao ZJ, He ZM. Oxaliplatin plus capecitabine as a second line chemotherapy for patients with advanced gastric cancer. Chin J Oncol 2004; 26:746-748.
36. Koizumi W, Saigenji K, Ujiie S, Terashima M, Sakata Y, Taguchi T. Clinical Study Group of Capecitabine. A pilot phase II study of capecitabine in advanced or recurrent gastric cancer. Oncology 2003; 64:232-236.
37. Sakamoto J, Chin K, Kondo K, Kojima H, Terashima M, Yamamura Y, et al. Clinical Study Group of Capecitabine. Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer. Anticancer Drugs 2006; 17:231-236.
38. Jatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, et al. North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol 2006;17:29-34.
39. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351:337-345.
40. Tol J, Koopman M, Rodenburg CJ, Cats A, Creemers GJ, Schrama JG, et al. A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity. Ann Oncol 2008;19:734-738.
41. Doi T, Koizumi W, Siena S, Cascinu S, Ohtsu A, Michael M, et al. Efficacy, tolerability and pharmacokinetics of gefitinib (ZD 1839) in pretreated patients with metastatic gastric cancer. Proc Am Soc Clin Oncol 2003; 22:258 (abstract 1036).
42. Adelstein DJ, Rybicki LA, Carrol M, Rice TW, Meckhail T. Phase II trial of gefitinib for recurrent or metastatic esophageal or gastroesphageal junction (GEJ) cancer. Proc Gastrointest Am Soc Clin Oncol Symp 2005; 85:A5.
43. Dragovich T, McCoy S, Urba SG, Zanner KS, Fenoglio-Preiser CM, Blanke CD, Abbruzzese JL. SWOG 0127 phase II trial of erlotinib in GEJ and gastric adenocarcinoma. Proc Gastrointest Am Soc Clin Oncol Symp 2005; 107:A49.
44. Pinto C, Fabio F Di, Siena S, Cascinu S, Rojas Llimpe FL, Ceccarelli C, et al. Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol 2007;18:510-517.
45. Cunningham D, Rao S, Starling N, Iveson T, Nicolson M, Coxon F, et al. NCRI Upper GI Study Group. Randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer: the REAL 2 trial. J Clin Oncol 2006; 24:18S (LBA4017).
46. Al-Batran S, Hartmann J, Probst S, Hofheinz R, Stoehlmacher J, Schmalenberg H, et al. A randomized phase III trial in patients with advanced adenocarcinoma of the stomach receiving first-line chemotherapy with fluorouracil, leucovorin and oxaliplatin (FLO) versus fluorouracil, leucovorin and cisplatin (FLP). J Clin Oncol 2006; 24:18S (LBA4016).