Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan- refractory metastatic colorectal cancer

New England Journal of Medicine

Volumn 351, Issue 4, 2004, Pages 337-345

  Cunningham, David ^a,j   Humblet, Yves ^b   Siena, Salvatore ^c   Khayat, David ^d   Bleiberg, Harry ^e   Santoro, Armando ^f   Bets, Danny ^g   Mueser, Matthias ^h   Harstrick, Andreas ^h   Verslype, Chris ⁱ   Chau, Ian ^a   Van Cutsem, Eric ⁱ  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

^b CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^c OSPEDALE NIGUARDA CA GRANDA   (Italy)

^d PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^e JULES BORDET INSTITUTE   (Belgium)

^f HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^g E Merck   (Netherlands)

^h MERCK KGAA   (Germany)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^j ROYAL MARSDEN HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; IRINOTECAN; MONOCLONAL ANTIBODY; OXALIPLATIN;

ABDOMINAL PAIN; ACNE; ADULT; AGED; ANAPHYLAXIS; ANEMIA; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG FATALITY; DRUG MECHANISM; DYSPNEA; FEMALE; FEVER; HUMAN; HUMAN TISSUE; HYPERSENSITIVITY REACTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; RADIODIAGNOSIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN MANIFESTATION; STATISTICAL ANALYSIS; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; TUMOR GROWTH; VOMITING;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE PROGRESSION; DNA TOPOISOMERASES, TYPE I; EXANTHEMA; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; RECEPTOR, EPIDERMAL GROWTH FACTOR; SINGLE-BLIND METHOD; SURVIVAL ANALYSIS;

EID: 3242720345     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa033025     Document Type: Article

References (40)

1. de Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18:2938-47.
2. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000;355:1041-7. [Erratum, Lancet 2000; 355:1372.]
3. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000;355:1041-7. [Erratum, Lancet 2000; 355:1372.]
4. Giaccherti S, Perpoint B, Zidani R, et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000;18:136-47.
5. Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004;22:23-30.
6. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000; 343:905-14.
7. Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998; 352:1413-8.
8. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 1998;352:1407-12. [Erratum, Lancet 1998;352:1634.]
9. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 1998;352:1407-12. [Erratum, Lancet 1998;352:1634.]
10. Rothenberg ML, Oza AM, Bigelow RH, et al. Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial. J Clin Oncol 2003;21:2059-69.
11. Messa C, Russo F, Caruso MG, Di Leo A. EGF, TGF-alpha, and EGF-R in human colorectal adenocarcinoma. Acta Oncol 1998; 37;285-9.
12. Porebska I, Harlozinska A, Bojarowski T. Expression of the tyrosine kinase activity growth factor receptors (EGFR, ERB B2, ERB B3) in colorectal adenocarcinomas and adenomas. Tumour Biol 2000;21:105-15.
13. Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 19:183-232.
14. Goldstein NS, Armin M. Epidermal growth factor receptor immunohistochemical reactivity in patients with American Joint Committee on Cancer Stage IV colon adenocarcinoma: implications for a standardized scoring system. Cancer 2001;92:1331-46.
15. Mayer A, Takimoto M, Fritz E, Schellander G, Kofler K, Ludwig H. The prognostic significance of proliferating cell nuclear antigen, epidermal growth factor receptor, and mdr gene expression in colorectal cancer. Cancer 1993;71:2454-60.
16. Klapper LN, Kirschbaum MH, Sela M, Yarden Y. Biochemical and clinical implications of the ErbB/HER signaling network of growth factor receptors. Adv Cancer Res 2000;77:25-79.
17. Ciardiello F, Tortora G. A novel approach in the treatment of cancer: targeting the epidermal growth factor receptor. Clin Cancer Res 2001;7:2958-70.
18. Prewett MC, Hooper AT, Bassi R, Ellis LM, Waksal HW, Hicklin DJ. Enhanced anti-tumor activity of anti-epidermal growth factor receptor monoclonal antibody IMC-C225 in combination with irinotecan (CPT-11) against human colorectal tumor xenografts. Clin Cancer Res 2002;8:994-1003.
19. Saltz L, Rubin MS, Hochster HS, et al. Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11 refractory colorectal cancer that expresses epidermal growth factor receptor. Prog Proc Am Soc Clin Oncol 2001;20:3a. abstract.
20. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 2004; 22:1201-8.
21. Therasse P, Arbuck SG, Eisenhauer EA, 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 2000;92:205-16.
22. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-14.
23. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Star Assoc 1958;53:457-81.
24. Peto R, Peto J. Asymptotically efficient invariant test procedures. J R Stat Soc [A] 1972;135:185-206.
25. Xu Y, Villalona-Calero MA. Irinotecan: mechanisms of tumor resistance and novel strategies for modulating its activity. Ann Oncol 2002;13:1841-51.
26. Chen ZS, Furukawa T, Sumizawa T, et al. ATP-dependent efflux of CPT-11 and SN-38 by the multidrug resistance protein (MRP) and its inhibition by PAK-104P. Mol Pharmacol 1999;55:921-8.
27. Chu XY, Suzuki H, Ueda K, Kato Y, Akiyama S, Sugiyama Y. Active efflux of CPT-11 and its metabolites in human KB-derived cell lines. J Pharmacol Exp Ther 1999;288:735-41.
28. Meyers MB, Merluzzi VJ, Spengler BA, Biedler JL. Epidermal growth factor receptor is increased in multidrug-resistant Chinese hamster and mouse tumor cells. Proc Natl Acad Sci U S A 1986;83:5521-5.
29. Meyers MB, Yu P, Mendelsohn J. Cross-talk between epidermal growth factor receptor and P-glycoprotein in actinomycin D-resistant Chinese hamster lung cells. Biochem Pharmacol 1993;46:1841-8.
30. Naruse I, Ohmori T, Ao Y, et al. Antitumor activity of the selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFK-TKI) Iressa (ZD1839) in an EGFR-expressing multidrug-resistant cell line in vitro and in vivo. Int J Cancer 2002;98: 310-5.
31. Sclabas GM, Fujioka S, Schmidt C, Fan Z, Evans DB, Chiao PJ. Restoring apoptosis in pancreatic cancer cells by targeting the nuclear factor-kappaB signaling pathway with the anti-epidermal growth factor antibody IMC-C225. J Gastrointest Surg 2003;7: 37-43.
32. Bandyopadhyay D, Mandal M, Adam L, Mendelsohn J, Kumar R. Physical interaction between epidermal growth factor receptor and DNA-dependent protein kinase in mammalian cells. J Biol Chem 1998;273: 1568-73.
33. Huang SM, Harari PM. Modulation of radiation response after epidermal growth factor receptor blockade in squamous cell carcinomas: inhibition of damage repair, cell cycle kinetics, and tumor angiogenesis. Clin Cancer Res 2000;6:2166-74.
34. Saltz L, Kies MS, Abbruzzese J, Azarnia N, Needle MN. The presence and intensity of the cetuximab-induced acne-like rash predicts increased survival in studies across multiple malignancies. Prog Proc Am Soc Clin Oncol 2003;22:204. abstract
35. Baselga J, Pfister D, Cooper MR, et al. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J Clin Oncol 2000;18:904-14.
36. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
37. Ciardiello F, Tortora G. Epidermal growth factor receptor (EGFR) as a target in cancer therapy: understanding the role of receptor expression and other molecular determinants that could influence the response to anti-EGFR drugs. Eur J Cancer 2003;39:1348-54.
38. Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003; 290:2149-58.
39. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003;21:2237-46.
40. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129-39.