First-line panitumumab plus irinotecan/5-Xuorouracil/leucovorin treatment in patients with metastatic colorectal cancer

Journal of Cancer Research and Clinical Oncology

Volumn 138, Issue 1, 2012, Pages 65-72

  Köhne, Claus Henning ^a   Hofheinz, Ralf ^b   Mineur, Laurent ^c   Letocha, Henry ^d   Greil, Richard ^e   Thaler, Josef ^f   Fernebro, Eva ^g   Gamelin, Erick ^h   DeCosta, Lucy ⁱ   Karthaus, Meinolf ^j  

^a KLINIKUM OLDENBURG   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c INSTITUT SAINTE CATHERINE   (France)

^d Department of Clinical Microbiology and Infection Control   (Sweden)

^e St Johanns Spital   (Austria)

^f Klinikum Wels Grieskirchen GmbH   (Austria)

^g LUND UNIVERSITY HOSPITAL   (Sweden)

^h CENTRE PAUL PAPIN   (France)

ⁱ AMGEN LTD   (United Kingdom)

^j Klinikum Neuperlach   (Germany)

more..

Author keywords

Chemotherapy; Fully human monoclonal antibody; Metastatic colorectal cancer; Panitumumab

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; PANITUMUMAB;

ACNE; ADULT; AGED; ARTICLE; BOLUS INJECTION; CANCER COMBINATION CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARDIOTOXICITY; CATHETER INFECTION; CAVA VEIN OBSTRUCTION; CHEILITIS; CLINICAL EVALUATION; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EYE TOXICITY; FATIGUE; FEMALE; FOLLICULITIS; FOLLOW UP; GENERAL CONDITION DETERIORATION; HAIR DISEASE; HEMATEMESIS; HUMAN; HYPOCALCEMIA; HYPOMAGNESEMIA; ILEUS; INJECTION SITE REACTION; INTESTINE OBSTRUCTION; LIVER FAILURE; LUNG EMBOLISM; LUNG TOXICITY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE ORGAN FAILURE; NAIL DISEASE; NEUTROPENIA; PARONYCHIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; RECTUM HEMORRHAGE; SEPTIC SHOCK; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; TREATMENT DURATION; TREATMENT FAILURE; VASCULAR DISEASE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; GENES, RAS; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED;

EID: 84857050570     PISSN: 01715216     EISSN: 14321335     Source Type: Journal    
DOI: 10.1007/s00432-011-1061-6     Document Type: Article

References (35)

1. Amado RG, Wolf M, Peeters M et al (2008) Wild-type KRAS is required for panitumumab eYcacy in patients with metastatic colorectal cancer. J Clin Oncol 26: 1626-1634. doi: 10.1200/JCO. 2007.14.7116
2. Amgen Inc (2010) Vectibix® prescribing information http://pi.amgen.com/united-states/vectibix/vectibix-pi.pdf
3. Amgen Ltd (2009) Vectibix® (panitumumab) summary of product characteristics http://www.emc.medicines.org.uk/medicine/20528/SPC/Vectibix/
4. Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F et al (2007) Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res 67: 2643-2648. doi: 10.1158/0008-5472.CAN-06-4158 (Pubitemid 46548951)
5. Bokemeyer C, Bondarenko I, Makhson A et al (2009) Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the Wrst-line treatment of metastatic colorectal cancer. J Clin Oncol 27: 663-671. doi: 10.1200/JCO.2008.20.8397
6. Cohenuram M, Saif MW (2007) Panitumumab the Wrst fully human monoclonal antibody: from the bench to the clinic. Anticancer Drugs 18: 7-15. doi: 10.1097/CAD.0b013e32800feecb (Pubitemid 44949790)
7. Cunningham D, Humblet Y, Siena S et al (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351: 337-345. doi: 10.1056/NEJMoa033025 (Pubitemid 38944402)
8. De Roock W, Piessevaux H, De Schutter J et al (2008) KRAS wildtype state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol 19: 508-515. doi: 10.1093/annonc/mdm496 (Pubitemid 351325672)
9. Di Fiore F, Blanchard F, Charbonnier F et al (2007) Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer 96: 1166-1169. doi: 10.1038/sj.bjc.6604451 (Pubitemid 46625066)
10. Dolgin E (2009) FDA narrows drug label usage. Nature 460: 1069. doi: 10.1038/4601069a
11. Douillard JY, Cunningham D, Roth AD et al (2000) Irinotecan combined with Xuorouracil compared with Xuorouracil alone as Wrst-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047. doi: 10.1016/S0140-6736(00)02034-1 (Pubitemid 30162806)
12. Douillard JY, Siena S, Cassidy J et al (2010) Randomized, phase 3 study (PRIME) of panitumumab with FOLFOX4 versus FOLFOX4 alone as Wrst-line treatment in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 28: 4697-4705. doi: 10.1200/JCO.2009.27.4860
13. European Medicines Agency (2009a) Erbitux® (cetuximab) prescribing information http://www.emea.europa.eu/humandocs/PDFs/EPAR/erbitux/H-558-PI-en. pdf
14. European Medicines Agency (2009b) Vectibix® (panitumumab) prescribing information http://www.emea.europa.eu/humandocs/PDFs/EPAR/vectibix/H-741-PI-en. pdf
15. European Medicines Agency (2011) Committee for Medicinal Products for Human Use (CHMP). Summary of opininin (postauthorisation)-Vectibix (panitumumab) 2011 http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion/ human/ 000741/WC500107994.pdf
16. Freeman DJ, Juan T, Reiner M et al (2008) Association of K-ras mutational status and clinical outcomes in patients with metastatic colorectal cancer receiving panitumumab alone. Clin Colorectal Cancer 7: 184-190. doi: 10.3816/CCC.2008.n.024 (Pubitemid 351758148)
17. Fuchs CS, Marshall J, Mitchell E et al (2007) Randomized, controlled trial of irinotecan plus infusional, bolus, or oral Xuoropyrimidines in Wrst-line treatment of metastatic colorectal cancer: results from the BICC-C study. J Clin Oncol 25: 4779-4786. doi: 10.1200/JCO.2007.11.3357 (Pubitemid 350086481)
18. Hurwitz H, Fehrenbacher L, Novotny W et al (2004) Bevacizumab plus irinotecan, Xuorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350: 2335-2342. doi: 10.1056/NEJMoa032691 (Pubitemid 38702844)
19. Kari C, Chan TO, Rocha de Quadros M, Rodeck U (2003) Targeting the epidermal growth factor receptor in cancer: apoptosis takes center stage. Cancer Res 63: 1-5 (Pubitemid 36070409)
20. Koo DH, Lee JL, Kim TW et al (2007) A Phase II study of cetuximab (Erbitux) plus FOLFIRI for irinotecan and oxaliplatin-refractory metastatic colorectal cancer. J Korean Med Sci 22(Suppl): S98-S103
21. Lièvre A, Bachet JB, Le Corre D et al (2006) KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 66: 3992-3995
22. National Cancer Institute Cancer Therapy Evaluation Program [CTEP] (2005) Common toxicity criteria for adverse events v3.0 (CTCAE)http://ctep.cancer.gov/ protocolDevelopment/electronic-applicationa/docs/ctcaev3.pdf
23. National Cancer Institute Cancer Therapy Evaluation Program [CTEP] (2006) Common terminology criteria for adverse events (CTCAE), Version 3.0, DCTD, NCI, NIH, DHHS http://www.ctep.cancer.gov
24. Peeters M, Price T, Cervantes A et al (2010) Randomized phase 3 study of panitumumab with FOLFIRI versus FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 28: 4706-4713
25. Raoul JL, Van Laethem JL, Peeters M et al (2009) Cetuximab in combination with irinotecan/5-Xuorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study. BMC Cancer 9: 112. doi: 10.1186/1471-2407-9-112
26. Saltz LB, Cox JV, Blanke C et al (2000) Irinotecan plus Xuorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343: 905-914
27. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ (2004) Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 22: 1201-1208. doi: 10.1200/JCO.2004.10.182 (Pubitemid 41079832)
28. Santini D, Loupakis F, Vincenzi B et al (2008) High concordance ofKRAS status between primary colorectal tumors and related metastatic sites: implications for clinical practice. Oncologist 13: 1270-1275. doi: 10.1634/theoncologist.2008-0181
29. Segaert S, Van Cutsem E (2005) Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Ann Oncol 16: 1425-1433.doi: 10.1093/annonc/mdi279 (Pubitemid 41222414)
30. Sobrero AF, Maurel J, Fehrenbacher L et al (2008) EPIC: phase III trial of cetuximab plus irinotecan after Xuoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 26: 2311-2319. doi: 10.1200/JCO.2007.13.1193
31. Therasse P, Arbuck SG, Eisenhauer EA et al (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. doi: 10.1093/jnci/92.3.205
32. Tournigand C, André T, Achille E et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22: 229-237. doi: 10.1200/JCO.2004.05.113 (Pubitemid 41095086)
33. Van Cutsem E, Peeters M, Siena S et al (2007) Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapyrefractory metastatic colorectal cancer. J Clin Oncol 25: 1658-1664. doi: 10.1200/JCO.2006.08.1620 (Pubitemid 46797944)
34. Van Cutsem E, Köhne CH, Hitre E et al (2009) Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360: 1408-1417. doi: 10.1056/NEJMoa0805019
35. Yen LC, Yeh YS, Chen CW et al (2009) Detection of KRAS oncogene in peripheral blood as a predictor of the response to cetuximab plus chemotherapy in patients with metastatic colorectal cancer. Clin Cancer Res 15: 4508-4513. doi: 10.1158/1078-0432.CCR-08-3179