Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial

The Lancet Oncology

Volumn 9, Issue 1, 2008, Pages 39-44

  Cascinu, Stefano ^a   Berardi, Rossana ^a   Labianca, Roberto ^b   Siena, Salvatore ^c   Falcone, Alfredo ^d   Aitini, Enrico ^e   Barni, Sandro ^f   Di Costanzo, Francesco ^g   Dapretto, Elisa ^h   Tonini, Giuseppe ⁱ   Pierantoni, Chiara ^a   Artale, Salvatore ^c   Rota, Silvia ^j   Floriani, Irene ^k   Scartozzi, Mario ^a   Zaniboni, Alberto ^l  

^a Azienda Ospedaliera Umberto I   (Italy)

^b OSPEDALI RIUNITI   (Italy)

^c OSPEDALE NIGUARDA CA GRANDA   (Italy)

^d Livorno Hospital   (Italy)

^e CARLO POMA HOSPITAL   (Italy)

^f Treviglio Hospital   (Italy)

^g CAREGGI UNIVERSITY HOSPITAL   (Italy)

^h SAN GERARDO HOSPITAL   (Italy)

ⁱ UNIVERSITY CAMPUS BIO MEDICO   (Italy)

^j GISCAD   (Italy)

^k MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^l Poliambulanza Hospital   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; CISPLATIN; GEMCITABINE;

ADJUVANT THERAPY; ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ANEMIA; ARTICLE; CANCER CONTROL; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG RESPONSE; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN TOXICITY; THROMBOCYTOPENIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PANCREATIC NEOPLASMS;

EID: 37549027274     PISSN: 14702045     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1470-2045(07)70383-2     Document Type: Article

References (29)

1. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M. Cancer Statistics, 2007. CA Cancer J Clin 57 (2007) 43-66
2. Burris III H., Moore M., Anderson J., et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 15 (1997) 2403-2413
3. Heinemann V., Quietzsch D., Gieseler F., et al. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic carcinoma. J Clin Oncol 24 (2006) 3946-3952
4. Rocha Lima C., Green M., Rotche R., et al. Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate. J Clin Oncol 22 (2004) 3776-3783
5. Louvet C., Labianca R., Hammel P., et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol 23 (2005) 3509-3516
6. Kindler H., Friberg G., Singh D., et al. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 23 (2005) 8033-8040
7. Cunningham D., Chau I., Stocken D., et al. Phase III randomised comparison of gemcitabine (GEM) versus GEM plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. Eur J Cancer Suppl 3 (2005) 12 (abstr PS11).
8. Herrmann R., Bodoky G., Ruhstaller T., et al. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 25 (2007) 2212-2217
9. Bruns C., Solorzano C., and Harbison M. Blockade of the epidermal growth factor receptor signaling by a novel tyrosine kinase inhibitor leads to apoptosis of endothelial cells and therapy of human pancreatic carcinoma. Cancer Res 60 (2000) 2926-2935
10. Fjällskog M., Lejonklou M., Öberg K., et al. Expression of molecular targets for tyrosine kinase receptor antagonists in malignant endocrine pancreatic tumors. Clin Cancer Res 9 (2003) 1469-1473
11. Ueda S., Ogata S., Tsuda H., et al. The correlation between cytoplasmic overexpression of epidermal growth factor receptor and tumor aggressiveness: poor prognosis in patients with pancreatic ductal adenocarcinoma. Pancreas 29 (2004) E1-E8
12. Yamanaka Y., Friess H., Kobrin M., Buchler M., Beger H., and Korc M. Coexpression of epidermal growth factor receptor and ligands in human pancreatic cancer is associated with enhanced tumor aggressiveness. Anticancer Res 13 (1993) 565-569
13. Bruns C., Harbison M., Davis D., et al. Epidermal growth factor receptor blockade with C225 plus GEM results in regression of human pancreatic carcinoma growing orthotopically in nude mice by antiangiogenic mechanisms. Clin Cancer Res 6 (2000) 1936-1948
14. Xiong H., Rosenberg A., LoBuglio A., et al. Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, in combination with gemcitabine for advanced pancreatic cancer: a multicenter phase II Trial. J Clin Oncol 22 (2004) 2610-2616
15. Shin D., Donato N., Perez-Soler R., et al. Epidermal growth factor receptor-targeted therapy with C225 and cisplatin in patients with head and neck cancer. Clin Cancer Res 7 (2001) 1204-1213
16. Baselga J., Norton L., Masui H., et al. Antitumor effects of doxorubicin in combination with anti-epidermal growth factor receptor monoclonal antibodies. J Natl Cancer Inst 85 (1993) 1327-1333
17. Burtness B., Goldwasser M., Flood W., Mattar B., and Forastiere A. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group Study. J Clin Oncol 23 (2005) 8646-8654
18. Peters G., Bergman A., van Haperen V.R., et al. Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol 22 4 suppl 11 (1995) 72-79
19. Heinemann V., Labianca R., Hinke A., and Louvet C. Increased survival using platinum analog combined with gemcitabine as compared to single-agent gemcitabine in advanced pancreatic cancer: pooled analysis of two randomised trials, the GERCOR/GISCAD intergroup study and a German multicenter study. Ann Oncol 18 (2007) 1652-1659
20. Sultana A., Smith C., Cunningham D., Starling N., Neoptolemos J., and Ghaneh P. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol 25 (2007) 2607-2615
21. Therasse P., Arbuck S., Eisenhaur E., 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, National Cancer Institute of Canada. J Natl Cancer Inst 92 (2004) 205-216
22. A'Hern R. Sample size tables for exact single-stage phase II designs. Stat Med 20 (2001) 859-866
23. Taylor J., Braun T., and Li Z. Comparing an experimental agent to a standard agent: relative merits of a one-arm or randomized two-arm Phase II design. Clin Trials 3 (2006) 335-348
24. Kullmann F, Hollerbach S, Dollinger M, et al. Cetuximab plus gemcitabine/oxaliplatin (GEMOXCET) in 1st line metastatic pancreatic cancer. First results from a multicenter phase II study. ASCO Gastrointestinal Cancers Symposium; Orlando, Florida; Jan 19-21, 2007. Abstract 128.
25. Louvet C., Andre T., Lledo G., et al. Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study. J Clin Oncol 20 (2002) 1512-1518
26. Philip P., Benedetti J., Fenoglio-Preiser C., et al. Phase III study of gemcitabine [G] plus cetuximab [C] versus [G] in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. Proc Am Soc Clin Oncol 25 (2007) (abstr 18S).
27. Moore M., Goldstein D., Hamm J., et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 25 (2007) 1960-1966
28. Lee J., and Feng L. Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol 23 (2005) 4450-4457
29. Rubinstein L., Korn E., Freidlin B., et al. Design issues of randomised phase II trials and a proposal for phase II screening trials. J Clin Oncol 23 (2005) 7199-7206