Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: A multicenter phase II trial of the Southern Italy Cooperative Oncology Group

Cancer Chemotherapy and Pharmacology

Volumn 64, Issue 5, 2009, Pages 893-899

  Comella, Pasquale ^a   Lorusso, Vito ^b,d   Maiorino, Luigi ^c   Casaretti, Rossana ^a   Cannone, Michele ^d   Massidda, Bruno ^e   Putzu, Carlo ^f   Leo, Silvana ^d   Roselli, Mario ^g   Mancarella, Sergio ^d   Palmeri, Sergio ^h   Greco, Ettore ^d   Vessia, Giacomo ^d   Sandomenico, Claudia ^a   Franco, Luca ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b NATIONAL CANCER INSTITUTE GIOVANNI PAOLO II   (Italy)

^c San Gennaro Hospital   (Italy)

^d City Hospital   (Italy)

^e UNIVERSITY OF CAGLIARI   (Italy)

^f UNIVERSITY OF SASSARI   (Italy)

^g UNIVERSITY OF ROME TOR VERGATA   (Italy)

^h UNIVERSITY OF PALERMO   (Italy)

Author keywords

Fluorouracil; Gastric cancer; Irinotecan; Oxaliplatin; Triplet regimen

Indexed keywords

CAPECITABINE; CISPLATIN; DOCETAXEL; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; ITALY; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTOXICITY; NEUROPATHY; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTIDOTES; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOOD CELL COUNT; CAMPTOTHECIN; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIERS ESTIMATE; LEUCOVORIN; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TOMOGRAPHY, X-RAY COMPUTED;

EID: 69049094922     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-0938-4     Document Type: Article

References (37)

1. SS Wohrer M Radere M Hejna 2004 Palliative chemotherapy for advanced gastric cancer Ann Oncol 15 1585 1595
2. E Van Cutsem C Van de Velde A Roth et al. 2008 Expert opinion on management of gastric and gastro-oesophageal junction adenocarcinoma on behalf of the European Organisation for Research and Treatment of Cancer (EORTC)-Gastrointestinal Cancer Group Eur J Cancer 44 182 194
3. AD Wagner W Grothe J Haerting et al. 2006 Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data J Clin Oncol 24 2903 2909
4. C Cunningham LM Jost G Purkalne J Oliveira 2005 ESMO minimum clinical recommendations for diagnosis, treatment and follow-up of gastric cancer Ann Oncol 16 22 23
5. A Webb D Cunningham JH Scarffe et al. 1997 Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer J Clin Oncol 15 261 267
6. D Cunningham N Starling S Rao et al. 2008 Capecitabine and oxaliplatin for advanced esophagogastric cancer N Engl J Med 358 36 46
7. E Van Cutsem VM Moiseyenko S Tjulandin et al. 2006 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
8. CH Köhne R Catane B Klein et al. 2003 Irinotecan is active in chemonaive patients with metastatic gastric cancer phase II multicentric trial Br J Cancer 89 997 1001
9. FS Farhat 2007 A general review of the role of irinotecan (CPT11) in the treatment of gastric cancer Med Oncol 24 137 146
10. M Moehler U Haas J Siebler et al. 2003 Weekly treatment with irinotecan, folinic acid and infusional 5-fluorouracil (IFL) in patients with advanced gastric cancer Anticancer Drugs 14 645 650
11. L Assersohn G Brown D Cunningham et al. 2004 Phase II study of irinotecan and 5-fluorouracil/leucovorin in patients with primary refractory or relapsed advanced oesophageal and gastric carcinoma Ann Oncol 15 64 69
12. O Bouché JL Raoul F Bonnetain et al. 2004 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 22 4319 4328
13. ST Kim WK Kang JH Kang et al. 2005 Salvage chemotherapy with irinotecan, 5-fluorouracil and leucovorin for taxane- and cisplatin-refractory, metastatic gastric cancer Br J Cancer 23 1850 1854
14. M Dank J Zaluski C Barone et al. 2008 Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to Cisplatin combined with 5-fluorouracil in chemotherapy naïve patients with advanced adenocarcinoma of the stomach or esophagogastric junction Ann Oncol 19 1450 1457
15. C Louvet T André JM Tigaud et al. 2002 Phase II study of oxaliplatin, fluorouracil, and folinic acid in locally advanced or metastatic gastric cancer patients J Clin Oncol 20 4543 4548
16. SE Al-Batran A Atmaca S Hegewisch-Becker et al. 2004 Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer J Clin Oncol 22 658 663
17. Y Chao KH Yeh CJ Chang et al. 2004 Phase II study of weekly oxaliplatin and 24-h infusion of high-dose 5-fluorouracil and folinic acid in the treatment of advanced gastric cancer Br J Cancer 91 453 458
18. F De Vita M Orditura E Matano et al. 2005 A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients Br J Cancer 92 1644 1649
19. F Lordick S Lorenzen J Stollfuss et al. 2005 Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer Br J Cancer 93 190 194
20. DY Kim JH Kim SH Lee et al. 2003 Phase II study of oxaliplatin, 5-fluorouracil and leucovorin in previously platinum-treated patients with advanced gastric cancer Ann Oncol 14 383 387
21. S-E Al-Batran JT Hartmann S Probst et al. 2008 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
22. C Placencia M Taron A Abad R Rosell 2000 Synergism of oxaliplatin (OXA) with either 5-fluorouracil (5FU) or topoisomerase I inhibitor in sensitive and 5FU-resistant colorectal cancer cell lines is independent of DNA-mismatch repair and p53 status Proc Am Soc Clin Oncol 19 204a (Abstr 793)
23. J-L Fischel M-C Etienne P Formento G Milano 1998 Search for the optimal schedule for the oxaliplatin/5-fluorouracil association modulated or not by folinic acid: preclinical data Clin Cancer Res 4 2529 2535
24. R Tanaka H Ariyama B Qin et al. 2005 Synergistic interaction between oxaliplatin and SN-38 in human gastric cancer cell lines in vitro Oncol Rep 14 683 688
25. J Souglakos K Syrigos A Potamianou et al. 2004 Combination of irinotecan (CPT-11) plus oxaliplatin (L-OHP) as first-line treatment in locally advanced or metastatic gastric cancer: a multicentre phase II trial Ann Oncol 15 1204 1209
26. E Wöll T Kühr W Eisterer 2008 Biweekly oxaliplatin and irinotecan chemotherapy in advanced gastric cancer. a first-line multicenter phase II trial of the Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT) Anticancer Res 28 2901 2905
27. P Comella R Casaretti V De Rosa et al. 2002 Oxaliplatin plus irinotecan and leucovorin-modulated 5-fluorouracil triplet regimen every other week: a dose-finding study in patients with advanced gastrointestinal malignancies Ann Oncol 13 1874 1881
28. P Comella B Massidda S Palmeri et al. 2006 Biweekly oxaliplatin plus irinotecan and folinic acid-modulated 5-fluorouracil: a phase II study in pretreated patients with metastatic colorectal cancer Anticancer Drugs 7 985 992
29. AB Miller B Hoogstraten M Staquet A Winkler 1981 Reporting results of cancer treatment Cancer 47 207 214
30. F Lévi JL Misset S Brienza et al. 1992 A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using ambulatory multichannel programmable pump. High antitumor effectiveness against metastatic colorectal cancer Cancer 69 893 900
31. R Simon 1989 Optimal two stage design for phase II clinical trials Control Clin Trials 10 1 10
32. ES Kaplan P Meier 1958 Non parametric estimation for incomplete observations J Am Stat Assoc 53 557 580
33. I Chau AR Norman D Cunningham JS Waters J Oates PJ Ross 2004 Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer-pooled analysis from three multicenter, randomized, controlled trials using individual patient data J Clin Oncol 22 2395 2403
34. J Lee WK Kang JM Kwon et al. 2007 Phase II trial of irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin in patients with untreated metastatic gastric adenocarcinoma Ann Oncol 18 88 92
35. E Bajetta L Celio E Ferrario et al. 2007 Capecitabine plus oxaliplatin and irinotecan regimen every other week: a phase I/II study in first-line treatment of metastatic colorectal cancer Ann Oncol 18 1810 1816
36. Fornaro L, Masi G, Bursi S (2008) A dose finding and pharmacokinetic study of capecitabine in combination with oxaliplatin and irinotecan in metastatic colorectal cancer. Cancer Chemother Pharmacol, Oct 7. (Epub ahead of print)
37. Maroun JA, Jonker D, Cripps C, Goel R, Lister D, Chiritescu J (2007) Encouraging results from a phase I study of capecitabine, oxaliplatin and irinotecan as first-line therapy in patients with metastatic colorectal cancer (MCRC). J Clin Oncol, 2006 ASCO Annual Meeting Proceedings, Part I, vol 25, No. 18S (June 20 Supplement), 4086