Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study)

British Journal of Cancer

Volumn 101, Issue 8, 2009, Pages 1261-1268

  Pinto, C ^a   Di Fabio, F ^a   Barone, C ^b   Siena, S ^c   Falcone, A ^d   Cascinu, S ^e   Rojas Llimpe, F L ^a   Stella, G ^f   Schinzari, G ^b   Artale, S ^c   Mutri, V ^a   Giaquinta, S ^a   Giannetta, L ^c   Bardelli, A ^f   Martoni, A A ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^c Falck Division   (Italy)

^d UNIVERSITY OF PISA   (Italy)

^e UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^f UNIVERSITY OF TURIN   (Italy)

Author keywords

Advanced gastric cancer; Cetuximab; Cisplatin docetaxel

Indexed keywords

ANTIHISTAMINIC AGENT; CAPECITABINE; CETUXIMAB; CISPLATIN; CORTICOSTEROID; DEXAMETHASONE; DOCETAXEL; EPIRUBICIN; ETOPOSIDE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; SEROTONIN 3 ANTAGONIST;

ACNE CONGLOBATA; ADD ON THERAPY; ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL EVALUATION; CLINICAL TRIAL; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; ESOPHAGEAL ADENOCARCINOMA; FEBRILE NEUTROPENIA; FEMALE; GASTRECTOMY; GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA; HISTOLOGY; HUMAN; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; HYPOACUSIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN TOXICITY; STOMACH ADENOCARCINOMA; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR LOCALIZATION;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; ESOPHAGEAL NEOPLASMS; ESOPHAGOGASTRIC JUNCTION; FEMALE; HUMANS; MALE; MIDDLE AGED; STOMACH NEOPLASMS; TAXOIDS;

EID: 70349937924     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605319     Document Type: Article

References (44)

1. Ajani JA, Fodor MB, Tjulandin SA, Moiseyenko VM, Chao Y, Cabral Filho S, Majlis A, Assadourian S, Van Cutsem E (2005) Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastro-esophageal adenocarcinoma. J Clin Oncol 23: 5660-5667
2. Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V, Vynnychenko I, Garin A, Lang I, Falcon S (2009) Multicenter phase III comparison of cisplatin/S-1 (CS) with cisplatin/5-FU (CF) as first-line therapy in patients with advanced gastric cancer (FLAGS). Proc ASCO GI, Abstract 8
3. Albanell J, Rojo F, Baselga J (2001) Pharmacodynamic studies with the epidermal growth factor receptor tyrosine kinase inhibitor ZD 1839. Semin Oncol 28(Suppl 16): 56-66
4. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P (2009) Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 10: 663-671
5. Bosetti C, Bertuccio P, Levi F, Lucchini F, Negri E, La Vecchia C (2008) Cancer mortality in the European Union, 1970-2003, with a joinpoint analysis. Ann Oncol 19: 631-640
6. Ciardiello F, Tortora G (2001) A novel approach in the treatment of cancer: targeting the epidermal growth factor receptor. Clin Cancer Res 7: 2958-2970
7. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351: 337-345 (Pubitemid 38944402)
8. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, coxon F, Middleton G, Daniel F, Oates J, Norman AR, Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358: 36-46
9. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Cisar L, Wang K, Bugat R (2008) 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 19(8): 1450-1457
10. Garcia M, Ward EM, Center MM (2007) Global Cancer Facts and Figures 2007 [online]. Accessed August 20, 2008. URL: www.cancer.gov
11. Han S, Park R, Lee K, Song H, Kim MA, Oh D, Im S, Kim W, Bang Y, Kim T (2008) Phase II study and biomarker analysis of cetuximab in combination with oxaliplatin, 5-fluorouracil, leucovorin as first-line treatment in patients with recurrent or metastatic gastric cancer. J Clin Oncol 26: 15S, Proc ASCO, Abstract 4549
12. Han SW, Oh DY, Im SA, Park SR, Lee KW, Song HS, Lee NS, Lee KH, Choi IS, Lee MH, Kim MA, Kim WH, Bang YJ, Kim TY (2009) Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer. Br J Cancer 100: 298-304
13. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ (2007) Cetuximab for the treatment of colorectal cancer. N Engl J Med 357: 2040-2048
14. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI (2009) Capecitabine/cisplatin vs 5-fluorouracil/ cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol 20: 666-673
15. kanzler S, Trarbach T, Seufferlein T, Kubicka S, Lordick F, Geissler M, Daum S, Galle P, Moehler MH, AIO Gastric group, Germany (2009) Cetuximab with irinotecan/folinic acid/5-FU as first-line treatment in advanced gastric cancer: A nonrandomized multicenter AIO phase II study. Preliminary results of a nonrandomised multi-centre AIO phase II study. J Clin Oncol 27: 15s, Proc ASCO, Abstract 4534
16. Kaplan EL, Meier P (1958) Non-parametric estimation from incomplete observation. J Am Stat Assoc 53: 457-481
17. Kelley JR, Duggan JM (2003) Gastric cancer epidemiology and risk factors. J Clin Epidemiol 56: 1-9
18. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M (2008) 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
19. Lordick F, Lorenzen S, Hegewisch-Becker S, Folprecht G, Wöll E, Decker T, Endlicher E, Röthling N, Fend F, Peschel C (2007) Cetuximab plus weekly oxaliplatin/5FU/FA (FUFOX) in 1st line metastatic gastric cancer. Final results from a multicenter phase II study of the AIO upper GI study group. J Clin Oncol 25: 18S, Proc ASCO, Abstract 4526
20. Lorenzen S, Hentrich M, Haberl C, Heinemann V, Schuster T, Seroneit T, Roethling N, Peschel C, Lordick F (2007) 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 18: 1673-1679
21. Malvezzi M, Bosetti C, Negri E, La Vecchia C, Decarli A (2008) Cancer Mortality in Italy, 1970-2002. Tumori 94: 640-657
22. Mendelsohn J (2002) Targeting the epidermal growth factor receptor for cancer therapy. J Clin Oncol 20: 1-13
23. Moutinho C, Mateus AR, Milanezi F, Carneiro F, Seruca R, Suriano G (2008) Epidermal growth factor receptor structural alterations in gastric cancer. BMC Cancer 8: 10
24. Nakata E, Hunter N, Mason K, Fan Z, Ang KK, Milas L (2004) C225 antiepidermal growth factor receptor antibody enhances the efficacy of docetaxel chemoradiotherapy. Int J Radiat Oncol Biol Phys 59: 1163-1173
25. National Cancer Institute (NCI) (2006) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, 9 August
26. Orditura M, Martinelli E, Galizia G, Carlomagno C, Aurilio G, Vecchione L, Lieto E, De Placido S, Catalano G, Ciardiello F, De Vita F (2006) Weekly docetaxel and capecitabine is not effective in the treatment of advanced gastric cancer: a phase II study. Ann Oncol 17: 1529-1532
27. Park SR, Chun JH, Kim YW, Lee JH, Choi IJ, Kim CG, Lee JS, Bae JM, Kim HK (2005) Phase II study of lowdose docetaxel/fluorouracil/cisplatin in metastatic gastric carcinoma. Am J Clin Oncol 28: 433-438
28. Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55: 74-108
29. Pinto C, Di Fabio F, Siena S, Cascinu S, Rojas Llimpe FL, Ceccarelli C, Mutri V, Giannetta L, Giaquinta S, Funaioli C, Berardi R, Longobardi C, Piana E, Martoni AA (2007) Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastro-esophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol 18: 510-517
30. Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Köberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne-Jones R, Widmer L, Seymour M, de Braud F, Swiss Group for Clinical Cancer Research (2007) Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cispla-tin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): a randomized Phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol 25: 3217-3223
31. Simon R (1989) Optimal two-stages designs for phase II clinical trials. Control Clin Trials 10: 1-10
32. Sobrero AF, Maurel J, Fehrenbacher L, Scheithauer W, Abubakr YA, Lutz MP, Vega-Villegas ME, Eng C, Steinhauer EU, Prausova J, Lenz HJ, Borg C, Middleton G, Kröning H, Luppi G, Kisker O, Zubel A, Langer C, Kopit J, Burris III HA (2008) EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 26: 2311-2319
33. Steiner P, Joynes C, Bassi R, Wang S, Tonra JR, Hadari YR, Hicklin DJ (2007) Tumor growth inhibition with cetuximab and chemotherapy in non-small cell lung cancer xenografts expressing wild-type and mutated epidermal growth factor receptor. Clin Cancer Res 13: 1540-1551
34. Takehana T, Kunitomo K, Suzuki S, Kono K, Fujii H, Matsumoto Y, Ooi A (2003) Expression of epidermal growth factor receptor in gastric carcinomas. Clin Gastroenterol Hepatol 1: 438-445
35. Tebbutt N, Sourjina T, Strickland A, Van Hazel G, Ganju V, Gibbs D, Gebski V, Munro S, Cummins M (2007) ATTAX: randomized multicenter phase III study evaluating weekly docetaxel based chemotherapy combinations in advanced esophago-gastric cancer, final results of an AGITG trial. J Clin Oncol 23: 16S, Proc ASCO, Abstract 4528
36. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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, National Cancer Institute of Canada. J Natl Cancer Inst 92: 205-216
37. Tokunaga A, Onda M, Okuda T, Teramoto T, Fujita I, Mizutani T, Kiyama T, Yoshiyuki T, Nishi K, Matsukura N (1995) Clinical significance of epidermal growth factor (EGF), EGF receptor, and c-erbB-2 in human gastric cancer. Cancer 75: 1418-1425
38. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P (2009) Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360: 1408-1417
39. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Rise ML, Ajani JA, V325 Study Group (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
40. Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R (2008) Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 359: 1116-1127
41. Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE (2006) Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 24: 2903-2909
42. Yeh K, Hsu C, Hsu C, Lin C, Shen Y, Wu S, Chiou T, Chao Y, Cheng A (2009) Phase II study of cetuximab plus weekly cisplatin and 24-hour infusion of high-dose 5-fluorouracil and leucovorin for the first-line treatment of advanced gastric cancer. J Clin Oncol 27: Proc ASCO, Abstract 4567
43. Zhang X, Xu J, Shen L, Wang J, Liang J, Xu N, Bai Y, Wang J (2008) A phase II study of cetuximab (Cetuximab) with cisplatin and capecitabine (Xeloda) as 1st line treatment in advanced gastric cancer. J Clin Oncol 26: 15S, Proc ASCO, Abstract 15663
44. Zheng L, Wang L, Ajani J, Xie K (2004) Molecular basis of gastric cancer development and progression. Gastric Cancer 7: 61-77