A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction

Annals of Oncology

Volumn 21, Issue 1, 2009, Pages 71-77

  Moehler, M ^a   Kanzler, S ^a   Geissler, M ^b   Raedle, J ^c   Ebert, M P ^d   Daum, S ^e   Flieger, D ^f   Seufferlein, T ^g   Galle, P R ^a   Hoehler, T ^h  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b UNIVERSITY OF FREIBURG   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

^d TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f KLINIKUM ASCHAFFENBURG   (Germany)

^g UNIVERSITY HOSPITAL ULM   (Germany)

^h PROSPER HOSPITAL   (Germany)

Author keywords

Capecitabine; Cisplatin; Elderly patients; Gastric cancer; Irinotecan

Indexed keywords

CAPECITABINE; CISPLATIN; IRINOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PAIN; CANCER SURVIVAL; CHOLINERGIC SYNDROME; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDUCED DISEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; GASTROESOPHAGEAL CANCER; HAND FOOT SYNDROME; HEARING IMPAIRMENT; HUMAN; INFECTION; LEUKOCYTE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH ADENOCARCINOMA; STOMACH CANCER; STOMATITIS; THROMBOCYTE; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

EID: 77949326012     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp269     Document Type: Article

References (39)

1. Lambert R, Guilloux A, Oshima A et al. Incidence and mortality from stomach cancer in Japan, Slovenia and the USA. Int J Cancer 2002; 97: 811-818.
2. Parkin DM, Wheland SL, Ferlay J et al. Cancer Incidence in Five Continents, Vol. VIII. Lyon, France: IARC 2002.
3. Jemal A, Murray T, Ward E et al. Cancer statistics, 2005. CA Cancer J Clin 2005; 55: 10-30.
4. Wagner AD, Grothe W, Haerting J et al. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 2006; 24: 2903-2909.
5. Cunningham D, Oliveira J. Gastric cancer: ESMO clinical recommendations for iagnosis, treatment and follow-up. Ann Oncol 2008; 19 (Suppl 2): ii23-ii24.
6. 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: 2580-2585.
7. Lorenzen S, Hentrich M, Haberl C et al. Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial. Ann Oncol 2007; 18: 1673-1679.
8. Roth AD, Fazio N, Stupp R et al. Docetaxel, cisplatin, and fluorouracil; docetaxe and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 2007; 25: 3217-3223.
9. 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: 3205-3209.
10. Chun H, Puccio C, Olson T et al. Cisplatin plus concurrent continuous infusion (CI) of 5-fluorouracil (5-FU) and paclitaxel: active regimen for adenocarcinoma of the stomach and gastroesophageal junction (GEJ). Proc Am Soc Clin Oncol 2000; 19 (Suppl): (Abstr 1058).
11. Cassidy J, Twelves C, Van Cutsem E et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 2002; 13: 566-575.
12. Van Cutsem E, Twelves C, Cassidy J et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001; 19: 4097-4106.
13. Okines A, Chau I, Cunningham D. Capecitabine in gastric cancer. Drugs Today (Barc) 2008; 44: 629-640.
14. 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: 893-1898.
15. Kang YK, Kang WK, Shin DB et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer a randomised phase III noninferiority trial. Ann Oncol 2009; 20: 666-673.
16. Cunningham D, Starling N, Rao S et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008; 358: 36-46.
17. Twelves C, Gollins S, Grieve R, Samuel L. A randomised cross-over tria comparing patient preference for oral capecitabine and 5-fluorouracil/leucovorinregimens in patients with advanced colorectal cancer. Ann Oncol 2006; 17: 239-245.
18. Enzinger PC, Kulke MH, Clark JW et al. A phase II trial of irinotecan in patients with previously untreated advanced esophageal and gastric adenocarcinoma. Dig Dis Sci 2005; 50: 2218-2223.
19. Kohne CH, Catane R, Klein B et al. Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial. Br J Cancer 2003; 89: 997-1001.
20. Futatsuki K, Wakui A, Nakao I et al. Late phase II study of irinotecan hydrochloride (CPT-11) in advanced gastric cancer. CPT-11 Gastrointestinal Cancer Study Group. Gan To Kagaku Ryoho 1994; 21: 1033-1038.
21. Rea DW, Nortier JW, Ten Bokkel Huinink WW et al. A phase I/II and pharmacokinetic study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol 2005; 16: 1123-1132.
22. Koopman M, Antonini NF, Douma J et al. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet 2007; 370: 135-142.
23. Moehler M, Eimermacher A, Siebler J et al. Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer. Br J Cancer 2005; 92: 2122-2128
24. Pozzo C, Barone C, Szanto J et al. Irinotecan in combination with 5-fluorouraci and folinic acid or with cisplatin in patients with advanced gastric or esophagealgastric junction adenocarcinoma: results of a randomized phase II study. Ann Oncol 2004; 15: 1773-1781.
25. Dank M, Zaluski J, Barone C et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol 2008; 19: 1450-1457
26. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, Nationa Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
27. Trotti A, Byhardt R, Stetz J et al. Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys 2000; 47: 13-47.
28. Bauer P, Kohne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50: 1029-1041.
29. Bouche O, Raoul JL, Bonnetain F et al. Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study-FFCD 9803. J Clin Oncol 2004; 22: 4319-4328.
30. Pozzo C, Barone C. Is there an optimal chemotherapy regimen for the treatmen of advanced gastric cancer that will provide a platform for the introduction of new biological agents? Oncologist 2008; 13: 794-806.
31. 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: 1996-2004.
32. 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: 261-267
33. Tetzlaff ED, Correa AM, Baker J et al. The impact on survival of thromboembolic phenomena occurring before and during protocol chemotherapy in patients with advanced gastroesophageal adenocarcinoma. Cancer 2007; 109: 1989-1995.
34. Rothenberg ML, Meropol NJ, Poplin EA et al. Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel. J Clin Oncol 2001; 19: 3801-3807.
35. Park SH, Nam E, Park J et al. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol 2008; 19: 729-733.
36. 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 2008; 26: 1435-1442.
37. Fuchs CS, Marshall J, Mitchell E et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol 2007; 25: 4779-4786.
38. Kohne CH, De Greve J, Hartmann JT et al. Irinotecan combined with infusional 5- fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015. Ann Oncol 2008; 19: 920-926.
39. Punt CJ, Koopman M. Capecitabine and irinotecan as first-line treatment of advanced colorectal cancer. J Clin Oncol 2008; 26: 1907-1908; author reply 1908-1909.