Capecitabine in advanced gastric cancer

Expert Opinion on Pharmacotherapy

Volumn 8, Issue 16, 2007, Pages 2851-2861

  Okines, Alicia ^a   Chau, Ian ^a   Cunningham, David ^a  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

Author keywords

5 fluorouracil; Anthracycline; Capecitabine; Cisplatin; Docetaxel; Epirubicin; Gastric carcinoma; Hand foot syndrome; Irinotecan; Oxaliplatin; Paclitaxel

Indexed keywords

ANTHRACYCLINE; CAPECITABINE; CARBOPLATIN; CISPLATIN; DIHYDROPYRIMIDINE DEHYDROGENASE; DNA TOPOISOMERASE INHIBITOR; DOCETAXEL; EPIRUBICIN; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; MITOMYCIN C; OXALIPLATIN; PLATINUM COMPLEX; TAXANE DERIVATIVE; UFT; UFT PLUS MITOMYCIN C; UNCLASSIFIED DRUG; WARFARIN; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE; PRODRUG;

ABDOMINAL PAIN; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTINUOUS INFUSION; DEHYDRATION; DIARRHEA; DRUG ABSORPTION; DRUG BINDING; DRUG DEGRADATION; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INHIBITION; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; LETHARGY; LEUKOPENIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; RECOMMENDED DRUG DOSE; RISK REDUCTION; STOMACH CANCER; STOMATITIS; SURVIVAL RATE; THROMBOCYTOPENIA; VERTIGO; VOMITING; DRUG APPROVAL; REVIEW; STOMACH TUMOR;

ANTIMETABOLITES, ANTINEOPLASTIC; CLINICAL TRIALS; DEOXYCYTIDINE; DRUG APPROVAL; FLUOROURACIL; HUMANS; PRODRUGS; STOMACH NEOPLASMS;

EID: 36049018882     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.8.16.2851     Document Type: Article

References (62)

1. WAGNER AD, GROTHE W, HAERTING J, KLEBER G, GROTHEY A, FLEIG WE: Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J. Clin. Oncol. (2006) 24(18):2903-2909.
2. KIM NK, PARK YS, HEO DS et al.: A Phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer (1993) 71(12):3813-3818.
3. 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. (2003) 21(1):54-59.
4. VANHOEFER U, ROUGIER P, WILKE H 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(14):2648-2657.
5. LUTZ MP, WILKE H, WAGENER DJ et al.: Weekly infusional high-dose fluorouracil (HD-FU), HD-FU plus folinic acid (HD-FU/FA), or HD-FU/FA plus biweekly cisplatin in advanced gastric cancer: randomized Phase II trial 40953 of the European organisation for research and treatment of cancer gastrointestinal group and the arbeitsgemeinschaft internistische onkologie. J. Clin. Oncol. (2007) 25(18):2580-2585.
6. WEBB A, CUNNINGHAM D, SCARFFE JH et al.: Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin. Oncol. (1997) 15(1):261-267.
7. ROSS P, NICOLSON M, CUNNINGHAM D et al.: Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J. Clin. Oncol. (2002) 20(8):1996-2004.
8. CUNNINGHAM D, RAO S, STARLING N et al.: Randomised multicentre Phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric (OG) cancer: the REAL 2 trial. J. Clin. Oncol. (2006) 24(18 Suppl.).Abstr. LBA4017.
9. AL BATRAN S, HARTMANN JT, PROBST S et al.: Final results of 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). Eur. J. Cancer (2007) 5(4):3502.
10. BOKU N, YAMAMOTO S, SHIRAO K et al.: Randomized Phase III study of 5-fluorouracil (5-FU) alone versus combination of irinotecan and cisplatin (CP) versus S-1 alone in advanced gastric cancer (JCOG9912). J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. LBA4513.
11. DANK M, ZALUSKI J, BARONE C et al.: Randomized Phase III trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in Ist-line advanced gastric cancer patients. J. CLin. Oncol. (2005) 23(16 Suppl.):Abstr. 4003.
12. KANG Y. KANG WK, SHIN DB et al.: Capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III trial. Eur. J. Cancer (2007) 5(4):3501.
13. NARAHARA H, KOIZUMI W. HARA T et al.: Randomized Phase III study of S-1 alone versus S-1 + cisplatin in the treatment for advanced gastric cancer (The SPIRITS trial) SPIRITS: S-1 plus cisplatin vs S-1 in RCT in the treatment for stomach cancer. J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. 4514.
14. 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. (2006) 24(31):4991-4997.
15. AJANI JA, MOISEYENKO VM, TJULANDIN S et al.: Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a Phase III trial for advanced gastric or gastroesophageal adenocarcinoma: the V-325 study group. J. Clin. Oncol. (2007) 25(22):3210-3216.
16. AJANI JA, MOISEYENKO VM, TJULANDIN S et al.: Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a Phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: the V-325 study group. J. Clin. Oncol. (2007) 25(22):3205-3209.
17. TAKIUCHI H, AJANI JA. Uracil-tegafur in gastric carcinoma: a comprehensive review. J. Clin. Oncol. (1998) 16(8):2877-2885.
18. KIM YH, CHEONG SK LEE JD, PARK JS, SHIN SW, KIM JS: Phase II trial of oral UFT and leucovorin in advanced gastric carcinoma. Am. J. Clin. Oncol. (1996) 19(2):212-216.
19. KOIZUMI W, KURIHARA M, NAKANO S, HASEGAWA K: Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 cooperative gastric cancer study group. Oncology (2000) 58(3):191-197.
20. SAKATA Y, OHTSU A, HORIKOSHI N, SUGIMACHI K, MITACHI Y, TAGUCHI T: Late Phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur. J. Cancer (1998) 34(11):1715-1720.
21. SUGIMACHI K, MAEHARA Y, HORIKOSHI N et al: An early Phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. The S-1 gastrointestinal cancer study group. Oncology (1999) 57(3):202-210.
22. SCHOFFSKI P: The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drugs (2004) 15(2):85-106.
23. CHIN K, IISHI H, IMAMURA H et al.: Irinotecan plus S-1 (IRIS) versus S-1 alone as first fine treatment for advanced gastric cancer preliminary results of a randomized Phase III study (GC0301/TOP-002). J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. 4525.
24. HIRATA K, HORIKOSHI N, AIBA K et al.: Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin. Cancer Res. (1999) 5(8):2000-2005.
25. MILANO G, FERRERO JM, FRANCOIS E: Comparative pharmacology of oral fluoropyrimidines: a focus on pharmacokinetics, pharmacodynamics and pharmacomodulation. Br. J. Cancer (2004) 91(4):613-617.
26. MIWA M, URA M, NISHIDA M et al.: Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur. J. Cancer (1998) 34(8):1274-1281.
27. ISHITSUKA H: Capecitabine: preclinical pharmacology studies. Invest. N. Drugs (2000) 18(4):343-354.
28. NISHINA T, HYODO I, MIYAIKE J, INABA T, SUZUKI S, SHIRATORI Y: The ratio of thymidine phosphorylase to dihydropyrimidine dehydrogenase in tumour tissues of patients with metastatic gastric cancer is predictive of the clinical response to 5′-deoxy-5-fluorouridine. Eur. J. Cancer (2004) 40(10):1566-1571.
29. CASSIDY J, DIRIX L, BISSETT D et al.: A Phase I study of capecitabine in combination with oral leucovorin in patients with intractable solid tumors. Clin. Cancer Res. (1998) 4(11):2755-2761.
30. JUDSON IR, BEALE PJ, TRIGO JM et al.: A human capecitabine excretion balance and pharmacokinetic study after administration of a single oral dose of 14C-labelled drug. Invest. New Drugs (1999) 17(1):49-56.
31. REIGNER B, VERWEIJ J, DIRIX L et al.: Effect of food on the pharmacokinetics of capecitabine and its metabolites following oral administration in cancer patients. Clin. Cancer Res. (1998) 4(4):941-948.
32. BUDMAN DR, MEROPOL NJ, REIGNER B et al.: Preliminary studies of a novel oral fluoropyrimidine carbamate: capecitabine. J. Clin. Oncol. (1998) 16(5):1795-1802.
33. MACKEAN M, PLANTING A, TWELVES C et al.: Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J. Clin. Oncol. (1998) 16(9):2977-2985.
34. EVANS TR, PENTHEROUDAKIS G, PAUL J et al.: A Phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric: adenocarcinoma. Ann. Oncol. (2002) 13(9:1469-1478.
35. TSAI JY, IANNITTI D, BERKENBLIT A et al.: Phase I study of docetaxel, capecitabine, and carboplatin in metastatic esophagogastric cancer. Am. J. Clin. Oncol. (2005) 28(4):329-333.
36. BURGE ME, SMITH D, TOPHAM C et al.: A Phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma. Br. J. Cancer (2006) 94(9):1281-1286.
37. DUPONT J, JENSEN HA, JENSEN BV, PFEIFFER P: Phase I study of short-time oxaliplatin, capecitabine and epirubicin (EXE) as first line therapy in patients with non-resectable gastric cancer. Acta Oncol. (2007) 46(3):330-335.
38. HONG YS, SONG SY, LEE SI et al.: A Phase II trial of capecitabine in previously untreated patients with advanced and/or metastatic gastric cancer. Ann. Oncol. (2004) 15(9):1344-1347.
39. SAKAMOTO J, CHIN K, KONDO K et al.: Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer. Anticancer Drugs (2006) 17(2):231-236.
40. KOIZUMI W, SAIGENJI K, UJIIE S, TERASHIMA M, SAKATA Y, TAGUCHI T: A pilot Phase II study of capecitabine in advanced or recurrent gastric cancer. Oncology (2003) 64(3):232-236.
41. BAEK JH, KIM JG, JEON SB et al.: Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer. Br. J. Cancer (2006) 94(10):1407-1411.
42. KIM TW, KANG YK, AHN JH et al.: Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann. Oncol. (2002) 13(12):1893-1898.
43. PARK YH, LEE JL, RYOO BY et al.: Capecitabine in combination with oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother. Pharmacol. (2007).
44. PARK SH, LEE WK, CHUNG M et al.: Paclitaxel versus docetaxel for advanced gastric cancer: a randomized Phase II trial in combination with infusional 5-fluorouracil. Anticancer Drug (2006) 17(2):225-229.
45. INOKUCHI M, YAMASHITA T, YAMADA H et al.: Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer. Br. J. Cancer (2006) 94(8):1130-1135.
46. YOSHIDA Y, NINOMIYA M, TAKAKURA N et al.: Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin. Cancer Res. (2006) 12(11 Part 1):3402-3407.
47. THUSS-PATIENCE PC, KRETZSCHMAR A, REPP M et al.: Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized Phase II study. J. Clin. Oncol. (2005) 23(3):494-501.
48. CHUN JH, KIM HK, LEE JS et al.: Weekly docetaxel in combination with capecitabine in patients with metastatic gastric cancer. Am. J. Clin. Oncol. (2005) 28(2):188-194.
49. LEE JJ, KIM SY, CHUNG HC et al.: A multi-center Phase II study of S-1 plus paclitaxel as first-line therapy in patients with advanced or relapsed gastric cancer. J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. 4634.
50. KANG HJ, KIM TW, CHANG HM et al.: A Phase II study of paclitaxel and capecitabine combination chemotherapy in patients with advanced gastric cancer as a first-fine therapy. J. Clin. Oncol. (2004) 22(14 Suppl.):Abstr. 4051.
51. AL BATRAN SE, STOHLMACHER J, PROBST S et al.: Fluorouracil, leucovorin and oxaliplatin (FLO) versus fluorouracil, leucovorin and cisplatin (FLP) as a first line therapy for patients with advanced gastric cancer; first interim analysis of a randomised multicenter Phase II study. J. Clin. Oncol. (2005) 23(16 Suppl.):Abstr. 4015.
52. 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 (2007) 109(1):33-40.
53. KANG Y, LEE J, MIN Y et al: A randomized multi-center Phase II trial of capecitabine (X) versus S-1 (S) as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. 4546.
54. CHO EK, LEE WK, IM SA et al.: A Phase II study of epirubicin, cisplatin and capecitabine combination chemotherapy in patients with metastatic or advanced gastric cancer. Oncology (2005) 68(4-6):333-340.
55. KANG YK, KIM TW, CHANG HM et al: A Phase I/II trial of docetaxel, capecitabine, and cisplatin as a first line chemotherapy for advanced gastric cancer. J. Clin. Oncol. (2004) 22(14 Suppl.):Abstr. 4066.
56. LEON-CHONG J, LORDICK F, KANG YK et al: HER2 positivity in advanced gastric cancer is comparable to breast cancer. J. Clin. Oncol. (2007) 25(18 Suppl.):Abstr. 15057.
57. CAMIDGE R, REIGNER B, CASSIDY J et al.: Significant effect of capecitabine on the pharmacokinetics and pharmacodynamics of warfarin in patients with cancer. J. Clin. Oncol. (2005) 23(21):4719-4725.
58. POOLE C, GARDINER J, TWELVES C et al.: Effect of renal impairment on the pharmacokinetics and tolerability of capecitabine (Xeloda) in cancer patients. Cancer Chemother. Pharmacol. (2002) 49(3):225-234.
59. TWELVES C, GOLLINS S, GRIEVE R, SAMUEL L: A randomised cross-over trial comparing patient preference for oral capecitabine and 5-fluorouraci/ leucovorin regimens in patients with advanced colorectal cancer. Ann. Oncol. (2006) 17(2):239-245.
60. PFEIFFER P, MORTENSEN JP, BJERREGAARD B et al.: Patient preference for oral or intravenous chemotherapy. a randomised cross-over trial comparing capecitabine and nordic fluorouracil/leucovorin in patients with colorectal cancer. Eur. J. Cancer (2006) 42(16):2738-2743.
61. BORNER MM, SCHOFFSKI P, DE WIT R 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(3):349-358.
62. 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(7):1329-1333.