Phase II open-label study to assess efficacy and safety of lenalidomide in combination with cetuximab in kras-mutant metastatic colorectal cancer

PLoS ONE

Volumn 8, Issue 11, 2013, Pages

  Siena, Salvatore ^a   Van Cutsem, Eric ^b   Li, Mingyu ^c   Jungnelius, Ulf ^c   Romano, Alfredo ^c   Beck, Robert ^c   Bencardino, Katia ^a   Elez, Maria Elena ^d   Prenen, Hans ^b   Sanchis, Mireia ^d   Sartore Bianchi, Andrea ^a   Tejpar, Sabine ^b   Gandhi, Anita ^c   Shi, Tao ^c   Tabernero, Josep ^d  

^a OSPEDALE NIGUARDA CA GRANDA   (Italy)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c CELGENE CORPORATION   (United States)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; LENALIDOMIDE;

ABDOMINAL PAIN; ADULT; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; ERYTHEMA; FATIGUE; FEMALE; FEVER; GENE MUTATION; HUMAN; HYPERBILIRUBINEMIA; INFECTION; MALE; MAXIMUM TOLERATED DOSE; METASTATIC COLORECTAL CANCER; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; ONCOGENE K RAS; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; SKIN DISEASE; SKIN FISSURE; STOMATITIS;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MUTATION; NEOPLASM METASTASIS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; THALIDOMIDE; TIME FACTORS;

EID: 84892713818     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0062264     Document Type: Article

References (37)

1. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, et al. (2010) GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer. Available: http://globocan.iarc.fr. Accessed 07 November 2011.
2. Weinberg RA (2007) Multi-steptumorigenesis. In: Weinberg RA. The biology of cancer. New York: Garland Science. pp. 399-462.
3. Siena S, Sartore-Bianchi A, Di Nicolantonio F, Balfour J, Bardelli A. (2009) Biomarkers predicting clinical outcome of epidermal growth factor receptor - targeted therapy in metastatic colorectal cancer. J Natl Cancer Inst 101: 1308-1324.
4. Gibson TB, Ranganathan A, Grothey A. (2006) Randomized phase III trial results of panitumumab, a fully human anti-epidermal growth factor receptor monoclonal antibody, in metastatic colorectal cancer. Clin Colorectal Cancer 6: 29-31.
5. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, et al. (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351: 337-345.
6. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, et al. (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.
7. Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F, Zanon C, Moroni M, 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.
8. Lièvre A, Bachet JB, Le Corre D, Boige V, Landi B, et al. (2006) KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 66: 3992-3995.
9. NCCN clinical practice guidelines in oncology: Colon Cancer v3.2012. Available: http://www.nccn.org/professionals/physician-gls/pdf/colon.pdf. Accessed 21 November 2012.
10. Grothey A, Cutsem EV, Sobrero A, Siena S, Falcone A, et al. (2012) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet: In press.
11. Bendell JC, Nemunaitis J, Vukelja SJ, Hagenstad C, Campos LT, et al. (2011) Randomized placebo-controlled phase II trial of perifosine plus capecitabine as second- or third-line therapy in patients with metastatic colorectal cancer. J Clin Oncol 29: 4394-4400.
12. Bendell JC, Ervin TJ, Senzer NN, Richards DA, Firdaus I, et al. (2012) Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC). J Clin Oncol 30 suppl 15: Abstract LBA3501.
13. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, et al. (2007) Cetuximab for the treatment of colorectal cancer. N Engl J Med 357: 2040-2048.
14. Yan L, Hsu K, Beckman RA. (2008) Antibody-based therapy for solid tumors. Cancer J 14: 178-183.
15. Normanno N, Bianco C, De Luca A, Maiello MR, Salomon DS (2003) Target-based agents against ErbB receptors and their ligands: a novel approach to cancer treatment. Endocr Relat Cancer 10: 1-21.
16. Li S, Schmitz KR, Jeffrey PD, Wiltzius JJ, Kussie P, et al. (2005) Structural basis for inhibition of the epidermal growth factor receptor by cetuximab. Cancer Cell 7:301-311.
17. Reilly AF, Norris CF, Surrey S, Bruchak FJ, Rappaport EF, et al. (1994) Genetic diversity in human Fc receptor II for immunoglobulin G: Fc gamma receptor IIA ligand-binding polymorphism. Clin Diagn Lab Immunol 1: 640-644.
18. Sanders LA, van de Winkel JG, Rijkers GT, Voorhorst-Ogink MM, de Haas M, et al. (1994) Fc gamma receptor IIa (CD32) heterogeneity in patients with recurrent bacterial respiratory tract infections. J Infect Dis 170: 854-861.
19. Breunis WB, van Mirre E, Bruin M, Geissler J, de Boer M, et al. (2008) Copy number variation of the activating FCGR2C gene predisposes to idiopathic thrombocytopenic purpura. Blood 111: 1029-1038.
20. Kavai M, Szegedi G. (2007) Immune complex clearance by monocytes and macrophages in systemic lupus erythematosus. Autoimmun Rev 6: 497-502.
21. Yesmin K, Hargreaves C, Newby PR, Brand OJ, Heward JM, et al. (2010) Association of FcGRIIa with Graves' disease: a potential role for dysregulated autoantibody clearance in disease onset/progression. Clin Endocrinol (Oxf) 73: 119-125.
22. Cartron G, Dacheux L, Salles G, Solal-Celigny P, Bardos P, et al. (2002) Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Blood 99: 754-758.
23. Nishio M, Endo T, Fujimoto K, Yamamoto S, Obara M, et al. (2009) FCGR3A-158V/F polymorphism may correlate with the levels of immunoglobulin in patients with non-Hodgkin's lymphoma after rituximab treatment as an adjuvant to autologous stem cell transplantation. Eur J Haematol 82:143-147.
24. List A, Dewald G, Bennett J, Giagounidis A, Raza A, et al. (2006) Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 355:1456-1465.
25. Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, et al. (2007) Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 357: 2123-2132.
26. Weber DM, Chen C, Niesvizky R, Wang M, Belch A, et al. (2007) Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 357: 2133-2142.
27. Dredge K, Marriott JB, Macdonald CD, Man H, Chen R, et al. (2002) Novel thalidomide analogues display anti-angiogenic activity independently of immunomodulatory effects. Br J Cancer 87: 1166-1172.
28. Wu L, Parton A, Lu L, Adams M, Schafer P, et al. (2011) Lenalidomide enhances antibody-dependent cellular cytotoxicity of solid tumor cells in vitro: influence of host immune and tumor markers. Cancer Immunol Immunother 60: 61-73.
29. Dahut WL, Aragon-Ching JB, Woo S, Tohnya TM, Gulley JL, et al. (2009) Phase I study of oral lenalidomide in patients with refractory metastatic cancer. J Clin Pharmacol 49: 650-660.
30. Miller AA, Case D, Harmon M, Savage P, Lesser G, et al. (2007) Phase I study of lenalidomide in solid tumors. J Thorac Oncol 2: 445-449.
31. Sharma RA, Steward WP, Daines CA, Knight RD, O'Byrne KJ, et al. (2006) Toxicity profile of the immunomodulatory thalidomide analogue, lenalidomide: phase I clinical trial of three dosing schedules in patients with solid malignancies. Eur J Cancer 42: 2318-2325.
32. López-Albaitero A, Lee SC, Morgan S, Grandis JR, Gooding WE, et al. (2009) Role of polymorphic Fc gamma receptor IIIa and EGFR expression level in cetuximab mediated, NK cell dependent in vitro cytotoxicity of head and neck squamous cell carcinoma cells. Cancer Immunol Immunother 58: 1853-1864.
33. Zhang W, Gordon M, Schultheis AM, Yang DY, Nagashima F, et al. (2007) FCGR2A and FCGR3A polymorphisms associated with clinical outcome of epidermal growth factor receptor expressing metastatic colorectal cancer patients treated with single-agent cetuximab. J Clin Oncol 25:3712-3718.
34. Moroni M, Veronese S, Benvenuti S, Marrapese G, Sartore-Bianchi A, et al. (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.
35. Sartore-Bianchi A, Moroni M, Veronese S, Carnaghi C, Bajetta E, et al. (2007) Epidermal growth factor receptor gene copy number and clinical outcome of metastatic colorectal cancer treated with panitumumab. J Clin Oncol 25:3238-3245.
36. Personeni N, Fieuws S, Piessevaux H, De Hertogh G, De Schutter J, et al. (2008) Clinical usefulness of EGFR gene copy number as a predictive marker in colorectal cancer patients treated with cetuximab: a fluorescent in situ hybridization study. Clin Cancer Res 14: 5869-5876.
37. Sartore-Bianchi A, Fieuws S, Veronese S, Moroni M, Personeni N, et al. (2012) Standardisation of EGFR FISH in colorectal cancer: results of an international interlaboratory reproducibility ring study. J Clin Pathol 65: 218-223.