A combination of gefitinib and FOLFOX-4 as first-line treatment in advanced colorectal cancer patients. A GISCAD multicentre phase II study including a biological analysis of EGFR overexpression, amplification and NF-kB activation

British Journal of Cancer

Volumn 98, Issue 1, 2008, Pages 71-76

  Cascinu, S ^a   Berardi, R ^a   Salvagni, S ^b   Beretta, G D ^c   Catalano, V ^d   Pucci, F ^b   Sobrero, A ^e   Tagliaferri, P ^f   Labianca, R ^c   Scartozzi, M ^a   Crocicchio, F ^g   Mari, E ^g   Ardizzoni, A ^b  

^a UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^b UNIVERSITY HOSPITAL OF PARMA   (Italy)

^c Azienda Ospedaliera di Bergamo   (Italy)

^d SAN SALVATORE HOSPITAL   (Italy)

^e UNIVERSITY OF GENOA   (Italy)

^f Magna Grecia University   (Italy)

^g ASTRAZENECA   (United Kingdom)

Author keywords

Colorectal cancer; Gefitinib; NF kB

Indexed keywords

AMINOTRANSFERASE; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; FOLINIC ACID; GEFITINIB; IMMUNOGLOBULIN ENHANCER BINDING PROTEIN; OXALIPLATIN; PROTEIN TYROSINE KINASE;

ADULT; ADVANCED CANCER; AGED; AMINOTRANSFERASE BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CHROMOGENIC IN SITU HYBRIDIZATION; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED STUDY; DERMATITIS; DIARRHEA; DRY SKIN; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; GENE OVEREXPRESSION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; LEUKOPENIA; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUROPATHY; NEUROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; GENE DOSAGE; HUMANS; IMMUNOENZYME TECHNIQUES; IN SITU HYBRIDIZATION, FLUORESCENCE; LEUCOVORIN; MALE; MIDDLE AGED; NF-KAPPA B; ORGANOPLATINUM COMPOUNDS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SURVIVAL RATE;

EID: 38049001619     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604121     Document Type: Article

References (33)

1. A'Hearn B (2004) A restricted maximum likelihood estimator for truncated height samples. Econ Hum Biol 2(1): 5-19
2. Andre T, Bensmaine MA, Louvet C, Francois E, Lucas V, Desseigne F, Beerblock K, Bouche O, Carola E, Merrouche Y, Morvan F, Dupont-Andre G, de Gramont A (1999) Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol 17(11): 3560-3568
3. Baselga J, Arteaga CL (2005) Critical update and emergine trends in epidermal growth factor receptor targeting in cancer. J Clin Oncol 23: 2445-2459
4. Ciardiello F, Caputo R, Bianco R, Damiano V, Pomatico G, De Placido S, Bianco AR, Tortora G (2000) Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (Iressa), an epidermal growth factor receptor-selective tyrosine kinase inhibitor. Clin Cancer Res 6: 2053-2063
5. Cohen MH, Williams GA, Sridhara R, Chen G, McGuinn Jr WD, Morse D, Abraham S, Rahman A, Liang C, Lostritto R, Baird A, Pazdur R (2004) United States Food and Drug Administration drug approval summary: gefitinib (ZD1839; Iressa) tablets. Clin Cancer Res 10: 1212-1218
6. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N, Carteni G, Agostara B, Pezzella G, Manzione L, Borsellino N, Misino A, Romito S, Durini E, Cordio S, Di Seri M, Lopez M, Maiello E, Montemurro S, Cramarossa A, Lorusso V, Di Bisceglie M, Chiarenza M, Valerio MR, Guida T, Leonardi V, Pisconti S, Rosati G, Carrozza F, Nettis G, Valdesi M, Filippelli G, Fortunato S, Mancarella S, Brunetti C (2005) Phase III randomized trial of FOLFIRI vs FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico dell'Italia Meridionale. J Clin Oncol 23: 4866-4875
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
8. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18(16): 2938-2947
9. Ellis LM, Hoff PM (2004) Targeting the epidermal growth factor receptor: an important incremental step in the battle against colorectal cancer. J Clin Oncol 22: 1177-1179
10. Garufi C, Mottolese M, Cianciulli A, Zeuli M, Buglioni S, Torsello A, Vanni B, Campanella C, Merola R, Terzoli E (2006) Epidermal growth factor gene amplification is not frequent and cannot account for antitumor activity of cetuximab plus chemotherapy in advanced colorectal cancer patients. Proc Am Soc Clin Oncol 161: 3561
11. Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, Natale RB, Schiller JH, Von Pawel J, Pluzanska A, Gatzemeier U, Grous J, Ochs JS, Averbuch SD, Wolf MK, Rennie P, Fandi A, Johnson DH (2004) Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial - INTACT 1. J Clin Oncol 22(5): 777-784
12. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR (2004) A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22: 23-30
13. Grothey A, Sargent D, Goldberg RM, Schmoll HJ (2004) Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22: 1209-1214
14. Guo J, Verma UN, Gaynor RB, Frenkel EP, Becerra CR (2004) Enhanced chemosensitivity to irinotecan by RNA interference-mediated down-regulation of the nuclear factor-kB p65 subunit. Clin Cancer Res 10: 3333-3341
15. Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, Scagliotti G, Rosell R, Oliff I, Reeves JA, Wolf MK, Krebs AD, Averbuch SD, Ochs JS, Grous J, Fandi A, Johnson DH (2004) Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial - INTACT 2. J Clin Oncol 22(5): 785-794
16. Karin M (2006) Nuclear factor-kB in cancer development and progression. Nature 441: 431-436
17. Kindler HL, Friberg G, Skoog L, Wade-Oliver K, Vokes EE (2005) Phase I/II trial of gefitinib and oxaliplatin in patients with advanced colorectal cancer. Am J Clin Oncol 28: 340-344
18. Kuo T, Cho CD, Halsey J, Wakelee HA, Advani RH, Ford JM, Fisher GA, Sikic BI (2005) Phase II study of gefitinib, fluorouracil, leucovorin and oxaliplatin therapy in previously treated patients with metastatic colorectal cancer. J Clin Oncol 23: 5613-5619
19. Laskin JJ, Sandler AB (2004) Epidermal growth factor receptor: a promising target in solid tumours. Cancer Treat Rev 30: 1-17
20. Lenz HJ, Van Cutsem E, Khambata-Ford S, Mayer RJ, Gold P, Stella P, Mirtsching B, Cohn AL, Pippas AW, Azarnia N, Tsuchihashi Z, Mauro DJ, Rowinsky EK (2006) Multicenter phase II and translational study of cetuximab in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines. J Clin Oncol 24: 4914-4921
21. Lind DS, Hochwald SN, Malaty J, Rekkas S, Hebig P, Mishra G, Moldawer LL, Copeland III EM, Mackay S (2001) Nuclear factor-kB is upregulated in colorectal cancer. Surgery 130(2): 363-369
22. Messersmith WA, Laheru DA, Senzer NN, Donehower RC, Grouleff P, Rogers T, Kelley SK, Ramies DA, Lum BL, Hidalgo M (2004) Phase I trial of irinotecan, infusional 5-fluorouracil, and leucovorin (FOLFIRI) with erlotinib (OSI-774): early termination due to increased toxicities. Clin Cancer Res 10: 6522-6527
23. Meyerhardt J, Mayer RJ (2005) Systemic therapy for colorectal cancer. N Engl J Med 352: 476-487
24. Meyerhardt JA, Zhu AX, Enzinger PC, Ryan DP, Clark JW, Kulke MH, Earle CC, Vincitore M, Michelini A, Sheehan S, Fuchs CS (2006) Phase II study of capecitabine, oxaliplatin and erlotinib in previously treated patients with metastatic colorectal cancer. J Clin Oncol 24: 1892-1897
25. Moroni M, Veronese S, Benvenuti S, Marrapese G, Sartore-Bianchi A, Di Nicolantonio F, Gambacorta M, Siena S, Bardelli A (2005) Gene copy number for epidermal growth factor receptor (EGFR) and clinical response to antiEGFR treatment in colorectal cancer: a cohort study. Lancet Oncol 6: 279-286
26. O'Brien PC, Fleming TR (1979) A multiple testing procedure for clinical trials. Biometrics 35: 549-556
27. Rakitinat V, Vasilevskaya IA, O'Dwyer PJ (2003) Additive interaction of oxaliplatin and 17-allylamina-17-demethoxygaldanamycin in colon cancer cell lines results from inhibition of nuclear factor-kb signaling. Cancer Res 63: 8003-8005
28. Scartozzi M, Bearzi I, Berardi R, Mandolesi A, Fabris G, Cascinu S (2004) Epidermal growth factor receptor (EGFR) status in primary colorectal tumors does not correlate with EGFR expression in related metastatic sites: implications for treatment with EGFR-targeted monoclonal antibodies. J Clin Oncol 22(23): 4772-4778
29. Sclabas GM, Fujioka S, Schmidt C, Fan Z, Evans DB, Chiao PJ (2003) Restoring apoptosis in pancreatic carcinoma cells by targeting the nuclear factor-kB signalling pathway with the anti-epidermal growth factor antibody IMC-225. J Gastrointest Surg 7(1): 37-43
30. Van Schaeybroeck S, Karaiskou-McCaul A, Kelly D, Longley D, Galligan L, Van Cutsem E, Johnston P (2005) Epidermal growth factor receptor activity determines response of colorectal cancer cells to gefitinib alone and in combination with chemotherapy. Clin Cancer Res 11: 7480-7489
31. Voboril R, Hochwald SN, Li J, Brank A, Weberova J, Wessels F, Moldawer LL, Camp ER, MacKay SL (2004) Inhibition of NF-kB augments sensitivity to 5-fluorouracil/folinic acid on in colon cancer. J Surg Res 120(2): 178-188
32. Xu JM, Azzariti A, Colucci G, Paradiso A (2003) The effect of gefitinib (Iressa, ZD1839) in combination with oxaliplatin is schedule-dependent in colon cancer cell lines. Cancer Chemother Pharmacol 52: 442-448
33. Zampino MG, Magni E, Massacesi C, Zaniboni A, Martignetti A, Zorzino L, Lorizzo K, Santoro L, Boselli S, de Braud F (2007) First clinical experience of o rally active epidermal growth factor receptor inhibitor combined with simplified FOLFOX6 as first-line treatment for metastatic colorectal cancer. Cancer 110: 752-758