Panitumumab in combination with cytotoxic chemotherapy for the treatment of metastatic colorectal carcinoma

Clinical Colorectal Cancer

Volumn 11, Issue 1, 2012, Pages 14-23

  Peeters, Marc ^a   Cohn, Allen ^b   Köhne, Claus Henning ^c   Douillard, Jean Yves ^d  

^a ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^b ROCKY MOUNTAIN CANCER CENTERS   (United States)

^c KLINIKUM OLDENBURG   (Germany)

^d CENTRE RENÉ GAUDUCHEAU   (France)

Author keywords

Cetuximab; Chemotherapy; Epidermal growth factor receptor; Metastatic colorectal cancer; Panitumumab

Indexed keywords

B RAF KINASE; BEVACIZUMAB; CAPECITABINE; CETUXIMAB; EPIDERMAL GROWTH FACTOR; EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; K RAS PROTEIN; OXALIPLATIN; PANITUMUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3,4,5 TRISPHOSPHATE 3 PHOSPHATASE;

ADD ON THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; COLORECTAL CARCINOMA; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; GENE MUTATION; HUMAN; HYPOMAGNESEMIA; METASTASIS; MONOTHERAPY; NAUSEA AND VOMITING; NEUTROPENIA; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; REVIEW; SKIN TOXICITY; TREATMENT RESPONSE;

EID: 84861541540     PISSN: 15330028     EISSN: 19380674     Source Type: Journal    
DOI: 10.1016/j.clcc.2011.06.010     Document Type: Review

References (79)

1. Grünwald V, Hidalgo M. Developing inhibitors of the epidermal growth factor receptor for cancer treatment. J Natl Cancer Ins 2003; 95:851-67.
2. Winder T, Lenz HJ. Vascular endothelial growth factor and epidermal growth factor signaling pathways as therapeutic targets for colorectal cancer. Gastroenterology 2010; 138:2163-76.
3. Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007; 25:1658-64.
4. Van Cutsem E, Siena S, Humblet Y, et al. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol 2008; 19:92-8.
5. Vectibix® [panitumumab; package insert]. Thousand Oaks, CA: Amgen Inc; 2010.
6. NCCN clinical practice guidelines in oncology: colon cancer v.3.2010. National Comprehensive Cancer Network. [Web site]. Available at: http://www.nccn.org/professionals/physician-gls/PDF/colon.pdf. Accessed: September 13, 2010.
7. Douillard JY, Siena S, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versusFOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010; 28:4697-705.
8. Peeters M, Price TJ, Cervantes A, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 2010; 28:4706-13.
9. Cohn AL, Smith DA, Neubauer MA, et al. Effect of tumor KRAS mutation status on second-line treatment with panitumumab (pmab) and FOLFIRI: interim results from the Pmab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (PRECEPT) study. Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 15-17, 2009; San Francisco, CA [abstract 445]. Available at: http://www.asco.org/ascov2/Meetings/ Abstracts?&vmview-abst-detail-view&confID-63&abstractID-10196.
10. Cohn AL, Smith DA, Neubauer MA, et al. Results from panitumumab (pmab) regimen evaluation in colorectal cancer to estimate primary response to treatment (PRECEPT): second-line treatment with pmab and FOLFIRI by tumor KRAS status. J Clin Oncol 2009; 27(suppl 15):4067 [abstract].
11. Hofheinz R, Mineur L, Greil R, et al. Panitumumab (pmab) with FOLFIRI as first-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): resections and curative surgery in a phase II 0single arm, multicenter study (20060314). J Clin Oncol, 2010; 28(suppl 15):3545 [abstract].
12. Primary analysis of a phase II study (20060314) combining first-line panitumumab (pmab) with FOLFIRI in the treatment of patients (pts) with metastatic colorectal cancer (mCRC). Köhne C, Mineur L, GreilPresented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 22-24, 2010; Orlando, FL [abstract 414]. Available at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview-abst-detail- view&confID-72&abstractID-1456.
13. Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2001; 2:127-37.
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. Messa C, Russo F, Caruso MG, et al. EGF, TGF-alpha, and EGF-R in human colorectal adenocarcinoma. Acta Oncol 1998; 37:285-9.
16. Campanella C, Mottolese M, Cianciulli A, et al. Epidermal growth factor receptor gene copy number in 101 advanced colorectal cancer patients treated with chemotherapy plus cetuximab. J Transl Med 2010; 8:36.
17. Half E, Broaddus R, Danenberg KD, et al. HER-2 receptor expression, localization, and activation in colorectal cancer cell lines and human tumors. Int J Cancer 2004; 108:540-8.
18. Kountourakis P, Pavlakis K, Psyrri A, et al. Prognostic significance of HER3 and HER4 protein expression in colorectal adenocarcinomas. BMC Cancer 2006; 6:46.
19. Spano JP, Lagorce C, Atlan D, et al. Impact of EGFR expression on colorectal cancer patient prognosis and survival. Ann Oncol 2005; 16:102-8.
20. Khorana AA, Ryan CK, Cox C, et al. Vascular endothelial growth factor, CD68, and epidermal growth factor receptor expression and survival in patients with stage II and stage III colon carcinoma: a role for the host response in prognosis. Cancer 2003; 97:960-8.
21. Resnick MB, Routhier J, Konkin T, et al. Epidermal growth factor receptor, c-MET, beta-catenin, and p53 expression as prognostic indicators in stage II colon cancer: a tissue microarray study. Clin Cancer Res 2004; 10:3069-75.
22. Andreyev HJ, Norman AR, Cunningham D, et al. Kirsten ras mutations in patients with colorectal cancer: the multicenter "RASCAL" study. J Natl Cancer Inst 1998; 90:675-84.
23. Vogelstein B, Fearon ER, Hamilton SR, et al. Genetic alterations during colorectaltumor development. N Engl J Med 1988; 319:525-32.
24. Bazan V, Migliavacca M, Zanna I, et al. Specific codon 13 K-ras mutations are predictive of clinical outcome in colorectal cancer patients, whereas codon 12 K-ras mutations are associated with mucinous histotype. Ann Oncol 2002; 13:1438-46.
25. Andreyev HJ, Norman AR, Cunningham D, et al. Kirsten ras mutations in patients with colorectal cancer: the 'RASCAL II' study. Br J Cancer 2001; 85:692-6.
26. Esteller M, Gonzalez S, Risques RA, et al. K-ras and p16 aberrations confer poor prognosis in human colorectal cancer. J Clin Oncol 2001; 19:299-304.
27. De Roock W, Claes B, Bernasconi D, et al. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol 2010; 11:753-62.
28. Kato S, Iida S, Higuchi T, et al. PIK3CA mutation is predictive of poor survival in patients with colorectal cancer. Int J Cancer 2007; 121:1771-8.
29. Souglakos J, Philips J, Wang R, et al. Prognostic and predictive value of common mutations for treatment response and survival in patients with metastatic colorectal cancer. Br J Cancer 2009; 101:465-72.
30. Tol J, Dijkstra JR, Klomp M, et al. Markers for EGFR pathway activation as predictor of outcome in metastatic colorectal cancer patients treated with or without cetuximab. Eur J Cancer 2010; 46:1997-2009.
31. Saridaki Z, Papadatos-Pastos D, Tzardi M, et al. BRAF mutations, microsatellite instability status and cyclin D1 expression predict metastatic colorectal patients' outcome. Br J Cancer 2010; 102:1762-8.
32. Samowitz WS, Sweeney C, Herrick J, et al. Poor survival associated with the BRAF V600E mutation in microsatellite-stable colon cancers. Cancer Res 2005; 65: 6063-9.
33. Yang XD, Jia XC, Corvalan JR, et al. Eradication of established tumors by a fully human monoclonal antibody to the epidermal growth factor receptor without concomitant chemotherapy. Cancer Res 1999; 59:1236-43.
34. European Medicines Agency. Vectibix European Public Assessment Report, Summary of Product Characteristics. 2010. Available at: http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product-Information/human/000741/ WC500047710.pdf.
35. Erbitux® [cetuximab; package insert]. Princeton, NJ: ImClone Systems Incorporated and Bristol-Myers Squibb Company; 2010.
36. European Medicines Agency. Erbitux European Public Assessment Report, Summary of Product Characteristics. 2010. Available at: http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product-Information/human/000558/ WC500029119.pdf.
37. Bristol Myers Squibb Canada. Erbitux® (cetuximab) Product Monograph. May 25, 2010. Available at: http://www.bmscanada.ca/static/products/en/pm-pdf/ ERBITUX-PM-25May10-APP-DIST.pdf.
38. Hecht JR, Patnaik A, Berlin J, et al. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer 2007; 110:980-8.
39. Hecht JR, Mitchell E, Neubauer MA, et al. Lack of correlation between epidermal growth factor receptor status and response to panitumumab monotherapy in metastatic colorectal cancer. Clin Cancer Res 2010; 16:2205-13.
40. Muro K, Yoshino T, Doi T, et al. A phase 2 clinical trial of panitumumab monotherapy in Japanese patients with metastatic colorectal cancer. Jpn J Clin Oncol 2009; 39:321-6.
41. Distribution of somatic mutations in KRAS. COSMIC Database, Sanger Institute. [Web site]. Available at: http://www.sanger.ac.uk/perl/genetics/CGP/ cosmic?action-bycancer&ln-KRAS&sn-large-intestine&ss-NS;&ss- anus;&ss-appendix;&ss-caecum;&ss-colon;&ss-left;&ss- rectum;&ss-right. Accessed September 8, 2010.
42. Freeman DJ, Juan T, Reiner M, et al. Association of K-ras mutational status and clinical outcomes in patients with metastatic colorectal cancer receiving panitumumab alone. Clin Colorectal Cancer 2008; 7:184-90.
43. Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26:1626-34.
44. Van Cutsem E, Köhne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360:1408-17.
45. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359:1757-65.
46. De Roock W, Jonker DJ, Di Nicolantonio F, et al. Association of KRAS p.G13D mutation with outcome in patients with chemotherapy-refractory metastatic colorectal cancer treated with cetuximab. JAMA 2010; 304:1812-20.
47. Bokemeyer C, Bondarenko I, Makhson A, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009; 27:663-71.
48. Maughan TS, Adams R, Smith CG, et al. Oxaliplatin and fluoropyrimidine chemotherapy plus or minus cetuximab: the effect of infusional 5-FU or capecitabine on the outcomes of the MRC COIN trial in advanced colorectal cancer (ACRC). Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 22-24, 2010; 27:Orlando, FL. [abstract 402]. Available at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview-abst- detail-view& confID-72&abstractID-2127.
49. Tveit K, Guren T, Glimelius B, et al. Randomized phase III study of 5-fluorouracil/folinate/oxaliplatin given continuously or intermittently with or without cetuximab, as first-line treatment of metastatic colorectal cancer: the Nordic VII study (NCT00145314), by the Nordic colorectal cancer biomodulation group. Ann Oncol 2010; 21(suppl 8):LBA20 [abstract].
50. Hecht JR, Mitchell E, Chidiac T, et al. A randomized phase IIIb trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 2009; 27:672-80.
51. Tol J, Koopman M, Cats A, et al. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009; 360:563-72.
52. Marshall JL. Vascular endothelial growth factor plus epidermal growth factor receptor dual targeted therapy in metastatic colorectal cancer: synergy or antagonism? J Oncol; 2009:937305.
53. Blanke CD. Dual-antibody therapy in advanced colorectal cancer: gather ye rosebuds while ye may. J Clin Oncol 2009; 27:655-8.
54. Bardelli A, Siena S. Molecular mechanisms of resistance to cetuximab and panitumumab in colorectal cancer. J Clin Oncol 2010; 28:1254-61.
55. Di Nicolantonio F, Martini M, Molinari F, et al. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol 2008; 26:5705-12.
56. Tie J, Gibbs P, Lipton L, et al. Optimizing targeted therapeutic development: Analysis of a colorectal cancer patient population with the BRAFV600E mutation. Int J Cancer 2010; 128:2075-84
57. Van Cutsem E, Kohne CH, Lang I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: Updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011; 29:2011-9.
58. Tol J, Dijkstra JR, Klomp M, et al. Markers for EGFR pathway activation as predictor of outcome in metastatic colorectal cancer patients treated with or without cetuximab. Eur J Cancer 2010; 46:1997-2009.
59. Ogino S, Nosho K, Kirkner GJ, et al. PIK3CA mutation is associated with poor prognosis among patients with curatively resected colon cancer. J Clin Oncol 2009; 27:1477-84.
60. Sartore-Bianchi A, Martini M, Molinari F, et al. PIK3CA mutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Res 2009; 69:1851-7.
61. Negri FV, Bozzetti C, Lagrasta CA, et al. PTEN status in advanced colorectal cancer treated with cetuximab. Br J Cancer 2010; 102:162-4.
62. Laurent-Puig P, Cayre A, Manceau G, et al. Analysis of PTEN, BRAF, and EGFR status in determining benefit from cetuximab therapy in wild-type KRAS metastatic colon cancer. J Clin Oncol 2009; 27:5924-30.
63. Loupakis F, Pollina L, Stasi I, et al. PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer. J Clin Oncol 2009; 27: 2622-9.
64. Frattini M, Saletti P, Romagnani E, et al. PTEN loss of expression predicts cetuximab efficacy in metastatic colorectal cancer patients. Br J Cancer 2007; 97:1139-45.
65. Peeters M, Oliner KS, Parker A, et al. Use of massively parallel, next-generation sequencing to identify gene mutations beyond KRAS that predict response to panitumumab in a randomized, phase 3, monotherapy study of metastatic colorectal cancer (mCRC). Presented at: American Association of Cancer Research 101st Annual Meeting, 2010; Washington, DC. [abstract LB-174]. Available at: http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey- 2b81acd4-ae9a-49a9-996a-b4e1b1447fe8&cKey-a3358940-1f9e-4395-bfa3- c46a9e862597&mKey-%7b0591FA3B-AFEF-49D2-8E65-55F41EE8117E%7d.
66. Mitchell E, Hecht JR, Baranda J, et al. Panitumumab activity in metastatic colorectal cancer (mCRC) patients (pts) with low or negative tumor epidermal growth factor receptor (EGFr) levels: an updated analysis. J Clin Oncol 2007; 25(suppl 18):4082. [abstract].
67. Siena S, Tabernero J, Cunningham D, et al. Randomized phase III study of panitumumab (pmab) with FOLFOX4 compared to FOLFOX4 alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): PRIME trial analysis by epidermal growth factor receptor (EGFR) tumor stainin. J Clin Oncol 2010; 28(suppl 15):3566. [abstract].
68. Peeters M, Cervantes-Ruiperez A, Strickland A, et al. Randomized phase III study of panitumumab (pmab) with FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): analysis by tumor epidermal growth factor receptor (EGFR) staining. J Clin Oncol 2010; 28(suppl 15):3565. [abstract].
69. Segaert S, Van Cutsem E. Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Ann Oncol 2005; 16:1425-33.
70. Peeters M, Siena S, Van Cutsem E, et al. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer 2009; 115:1544-54.
71. Price TJ, Sobrero AF, Wilson G, et al. Randomized, open-label, phase III study of panitumumab (pmab) with FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): efficacy by skin toxicity (ST). J Clin Oncol 2010; 28(suppl 15):3529. [abstract].
72. Douillard J, Cassidy J, Jassem J, et al. Randomized, open-label, phase III study of panitumumab (pmab) with FOLFOX4 versus FOLFOX4 alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): efficacy by skin toxicity (ST). J Clin Oncol 2010; 28(suppl 15):3528. [abstract].
73. Weiner LM, Belldegrun AS, Crawford J, et al. Dose and schedule study of panitumumab monotherapy in patients with advanced solid malignancies. Clin Cancer Res 2008; 14:502-8.
74. Karthaus M, Hofheinz R, Mineur L, et al. Epidermal growth factor receptor (EGFR) inhibitor-related skin toxicity: review of primary analysis data from a phase II study (20060314) of panitumumab (pmab) with FOLFIRI in the first-line treatment of metastatic colorectal cancer (mCRC). Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 22-24, 2010; Orlando, FL. [abstract 429]. Available at: http://www.asco.org/ASCOv2/Meetings/ Abstracts?&vmview-abst-detail-view&confID-72&abstractID-1682.
75. Karthaus M, Letocha H, Greil R, et al. Interim analysis of a single arm, phase II study (20060314) of panitumumab (pmab) with FOLFIRI as first-line treatment of patients (pts) with metastatic colorectal cancer (mCRC). Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium; January 15-17, 2009; San Francisco, CA. [abstract 388]. Available at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview-abst-detail- view&confID-63&abstractID-10329.
76. Boone SL, Rademaker A, Liu D, et al. Impact and management of skin toxicity associated with anti-epidermal growth factor receptor therapy: survey results. Oncology 2007; 72:152-9.
77. Lacouture ME, Mitchell EP, Piperdi B, et al. Skin Toxicity Evaluation Protocol with Panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-emptive skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol 2010; 28:1351-7.
78. Amgen Canada Inc. Vectibix® (panitumumab) Product Monograph. February 26, 2010. Available at: http://www.amgen.ca/Vectibix-PM.pdf.
79. Scott BJ, Quant EC, McNamara MB, et al. Bevacizumab salvage therapy following progression in high-grade glioma patients treated with VEGF receptor tyrosine kinase inhibitors. Neuro Oncol 2010; 12:603-7.