Navigating later lines of treatment for advanced colorectal cancer - Optimizing targeted biological therapies to improve outcomes

Cancer Treatment Reviews

Volumn 40, Issue 10, 2014, Pages 1171-1181

  Gill, Sharlene ^a   Dowden, Scot ^b   Colwell, Bruce ^c   Collins, Loretta L ^d   Berry, Scott ^e  

^a BRITISH COLUMBIA CANCER AGENCY   (Canada)

^b TOM BAKER CANCER CENTRE   (Canada)

^c QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^d Kaleidoscope Strategic   (Canada)

^e DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

Author keywords

Chemorefractory; EGFR inhibitor; Second line; Targeted therapy; Third line; VEGF inhibitor

Indexed keywords

AFLIBERCEPT; BEVACIZUMAB; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; FLUOROPYRIMIDINE; IRINOTECAN; OXALIPLATIN; PANITUMUMAB; PROTEIN KINASE B INHIBITOR; REGORAFENIB; VASCULOTROPIN INHIBITOR; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; HYBRID PROTEIN; MONOCLONAL ANTIBODY; PYRIDINE DERIVATIVE; TUMOR MARKER; VASCULOTROPIN A; VASCULOTROPIN RECEPTOR; VEGFA PROTEIN, HUMAN;

ADVANCED CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CLINICAL PROTOCOL; COLORECTAL CANCER; DRUG SAFETY; HUMAN; META ANALYSIS; MOLECULARLY TARGETED THERAPY; MONOTHERAPY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; TREATMENT RESPONSE; ANTAGONISTS AND INHIBITORS; COLORECTAL NEOPLASMS; METABOLISM;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; COLORECTAL NEOPLASMS; HUMANS; MOLECULAR TARGETED THERAPY; PHENYLUREA COMPOUNDS; PYRIDINES; RECEPTORS, VASCULAR ENDOTHELIAL GROWTH FACTOR; RECOMBINANT FUSION PROTEINS; TUMOR MARKERS, BIOLOGICAL; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84923010267     PISSN: 03057372     EISSN: 15321967     Source Type: Journal    
DOI: 10.1016/j.ctrv.2014.10.002     Document Type: Review

References (67)

1. Jemal A., Bray F., Center M.M., et al. Global cancer statistics. CA Cancer J Clin 2011, 61:69-90.
2. Jemal A., Siegel R., Ward E., et al. Cancer statistics, 2009. CA Cancer J Clin 2009, 59:225-249.
3. Tjandra J.J., Chan M.K. Follow-up after curative resection of colorectal cancer: a meta-analysis. Dis Colon Rectum 2007, 50:1783-1799.
4. Scholefield J.H., Steele R.J. Guidelines for follow up after resection of colorectal cancer. Gut 2002, 51(Suppl. 5):V3-V5.
5. Schmoll H.J., Van Cutsem E., Stein A., et al. ESMO consensus guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 2012, 23:2479-2516.
6. BC Cancer Agency. Treatment options by stage based on current evidence: colon cancer. Available at2012 [accessed 11.07.2014]. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Gastrointestinal/05.Colon/5.6+Treatment+Options+by+Stage+Based+on+Current+Evidence.htm.
7. Cancer Care Ontario. Drug formulary-regimen monographs. Available at2014 [accessed 11.07.2014]. https://www.cancercare.on.ca/cms/one.aspx?pageId=10760.
8. Program in Evidence-Based Care (PEBC) and Cancer Care Ontario (CCO). Strategies of sequential therapies in unresectable, metastatic colorectal cancer treated with palliative intent: guideline recommendations. Available at2014 [accessed 11.07.2014]. https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=295210.
9. Advanced Colorectal Cancer Meta-Analysis Project Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J Clin Oncol 1992, 10:896-903.
10. de Gramont A., Bosset J.F., Milan C., et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997, 15:808-815.
11. Goldberg R.M., Sargent D.J., Morton R.F., 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.
12. Gresham G, Cheung WY, Chan M, et al. Predicting overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) treated with chemotherapy (CT): The British Columbia Cancer Agency (BCCA) mCRC score. ASCO GI Meeting Abstracts 2013;31:419.
13. Heinemann V., von Weikersthal L.F., Decker T., et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 2014, 15:1065-1075.
14. Venook AP, Niedzwiecki D, Lenz H-J, et al. CALGB/SWOG 80405: phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). ASCO Meeting Abstracts 2014;32:LBA3.
15. Dempke W.C., Heinemann V. RAS mutational status is a biomarker for resistance to EGFR inhibitors in colorectal carcinoma. Anticancer Res 2010, 30:4673-4677.
16. Bennouna J., Sastre J., Arnold D., et al. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol 2013, 14:29-37.
17. Giantonio B.J., Catalano P.J., Meropol N.J., et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007, 25:1539-1544.
18. Tamagawa H, Iwamoto S, Takahashi T, et al. FOLFIRI plus bevacizumab (bev) as second-line therapy in patients (pts) with metastatic colorectal cancer (mCRC) who have failed first-line bev plus oxaliplatin-based therapy: the randomized phase III EAGLE study. ASCO Meeting Abstracts 2013;31:3516.
19. Van Cutsem E., Tabernero J., Lakomy R., et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol 2012, 30:3499-3506.
20. Masi G, Loupakis F, Salvatore L, et al. Second-line chemotherapy (CT) with or without bevacizumab (BV) in metastatic colorectal cancer (mCRC) patients (pts) who progressed to a first-line treatment containing BV: updated results of the phase III "BEBYP" trial by the Gruppo Oncologico Nord Ovest (GONO). ASCO Meeting Abstracts 2013;31:3615.
21. Cohn A.L., Bekaii-Saab T., Bendell J.C., et al. Clinical outcomes in bevacizumab (BV)-treated patients (pts) with metastatic colorectal cancer (mCRC): results from ARIES observational cohort study (OCS) and confirmation of BRiTE data on BV beyond progression (BBP). ASCO Meeting Abstracts 2010, 28:3596.
22. Grothey A., Sugrue M.M., Purdie D.M., et al. Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE). J Clin Oncol 2008, 26:5326-5334.
23. Hurwitz H.I., Bekaii-Saab T.S., Bendell J.C., et al. Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study. Clin Oncol 2014, 10.1016/j.clon.2014.03.001.
24. Holash J., Davis S., Papadopoulos N., et al. VEGF-trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci USA 2002, 99:11393-11398.
25. Papadopoulos N., Martin J., Ruan Q., et al. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis 2012, 15:171-185.
26. Tabernero J., Van Cutsem E., Lakomy R., et al. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer 2014, 50:320-331.
27. Aprile G., Macerelli M., Giuliani F. Regorafenib for gastrointestinal malignancies: from preclinical data to clinical results of a novel multi-target inhibitor. BioDrugs 2013, 27:213-224.
28. Grothey A., Van Cutsem E., Sobrero A., et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013, 381:303-312.
29. Siena S., Grothey A., Sobrero A., et al. Effects of regorafenib therapy on health-related quality of life in patients with metastatic colorectal cancer in the phase III CORRECT study 2013, ESMO, Amsterdam, Netherlands, [Abs 2156].
30. Falcone A., VanCutsem E., Sobrero A., et al. Regorafenib dose modifications in patients with metastatic colorectal cancer in the phase III CORRECT study 2013, ESMO, Amsterdam, Netherlands, [Abs 2360].
31. Li J., Qin S., Yau T., et al. O-0023 CONCUR: a randomized double-blind, placebo-controlled phase 3 study of regorafenib monotherapy in Asian patients with previously treated metastatic colorectal cancer (mCRC). Ann Oncol 2014, 25:ii114-ii115.
32. Chou T., Finn R.S. Brivanib: a review of development. Future Oncol 2012, 8:1083-1090.
33. Siu L.L., Shapiro J.D., Jonker D.J., et al. Phase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: the NCIC Clinical Trials Group and AGITG CO.20 Trial. J Clin Oncol 2013, 31:2477-2484.
34. Ringash J., Au H.J., Siu L.L., et al. Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial. Cancer 2014, 120:181-189.
35. Cunningham D., Humblet Y., Siena S., et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004, 351:337-345.
36. Sobrero A.F., Maurel J., Fehrenbacher L., et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 2008, 26:2311-2319.
37. Peeters M., Price T.J., 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, 28:4706-4713.
38. Seymour M.T., Brown S.R., Middleton G., et al. Panitumumab and irinotecan versus irinotecan alone for patients with KRAS wild-type, fluorouracil-resistant advanced colorectal cancer (PICCOLO): a prospectively stratified randomised trial. Lancet Oncol 2013, 14:749-759.
39. Peeters M., Price T.J., Cervantes A., et al. Final results from a randomized phase 3 study of FOLFIRI +/- panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol 2014, 25:107-116.
40. Bennett L., Zhao Z., Barber B., et al. Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment. Br J Cancer 2011, 105:1495-1502.
41. Jonker D.J., O'Callaghan C.J., Karapetis C.S., et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007, 357:2040-2048.
42. Karapetis C.S., Khambata-Ford S., Jonker D.J., et al. K-RAS mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008, 359:1757-1765.
43. Au H.J., Karapetis C.S., O'Callaghan C.J., et al. Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 trial. J Clin Oncol 2009, 27:1822-1828.
44. Amado R.G., Wolf M., Peeters M., et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008, 26:1626-1634.
45. 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, 25:1658-1664.
46. Odom D., Barber B., Bennett L., et al. Health-related quality of life and colorectal cancer-specific symptoms in patients with chemotherapy-refractory metastatic disease treated with panitumumab. Int J Colorectal Dis 2011, 26:173-181.
47. Price T.J., Peeters M., Kim T.W., et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol 2014, 15:569-579.
48. Bendell J.C., Nemunaitis J., Vukelja S.J., et al. 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 2011, 29:4394-4400.
49. Bendell JC, Ervin TJ, Senzer NN, et al. 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). ASCO Meeting Abstracts 2012;30:LBA3501.
50. Van Cutsem E., Kohne C.H., Hitre E., et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009, 360:1408-1417.
51. Van Cutsem E., Kohne C.H., 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, 29:2011-2019.
52. Stintzing S., Fischer von Weikersthal L., Decker T., et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS: mutated tumours in the randomised German AIO study KRK-0306. Ann Oncol 2012, 23:1693-1699.
53. Peeters M, Oliner KS, Price TJ, et al. Analysis of KRAS/NRAS mutations in phase 3 study 20050181 of panitumumab (pmab) plus FOLFIRI versus FOLFIRI for second-line treatment (tx) of metastatic colorectal cancer (mCRC). ASCO GI Meeting Abstracts 2014;32:LBA387.
54. Douillard J.Y., Oliner K.S., Siena S., et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med 2013, 369:1023-1034.
55. Douillard J.Y., Siena S., Cassidy J., et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010, 28:4697-4705.
56. Langer C., Kopit J., Awad M., et al. Analysis of K-RAS mutations in patients with metastatic colorectal cancer receiving cetuximab in combination with irinotecan: results from the EPIC trial. Ann Oncol 2008, 19:viii133. [Abs P385].
57. Peeters M., Oliner K.S., Parker A., et al. Massively parallel tumor multigene sequencing to evaluate response to panitumumab in a randomized phase III study of metastatic colorectal cancer. Clin Cancer Res 2013, 19:1902-1912.
58. Peeters M., Oliner K.S., Price T.J., et al. Updated analysis of KRAS/NRAS and BRAF mutations in study 20050181 of panitumumab (pmab) plus FOLFIRI for second-line treatment (tx) of metastatic colorectal cancer (mCRC). J Clin Oncol 2014, 32:3568.
59. Schwartzberg L.S., Rivera F., Karthaus M., et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 2014, [Epub ahead of print].
60. Douillard J.Y., Siena S., Cassidy J., et al. Final results from PRIME: randomized phase 3 study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol 2014, [Epub ahead of print].
61. Venook A., Niedzwiecki D., Lenz H.J., et al. O-0019 CALGB/SWOG 80405: phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (PTS) with KRAS wild-type (WT) untreated metastatic adenocarcinoma of the colon. Ann Oncol 2014, 25:ii112-ii113.
62. Alberta Health Services. Clinical practice guidelines - metastatic colorectal cancer; GI-003, Version 7. Available at2014 [accessed 10.07.2014]. http://www.albertahealthservices.ca/hp/if-hp-cancer-guide-gi003-colorectal-metastatic.pdf.
63. Lambrechts D., Lenz H.J., de Haas S., et al. Markers of response for the antiangiogenic agent bevacizumab. J Clin Oncol 2013, 31:1219-1230.
64. Sobrero A., Bordonaro R., Frassineti C., et al. Aflibercept in combination with FOLFIRI for the second-line treatment of patients with metastatic colorectal cancer: interim safety data from the global Aflibercept Safety and Quality-of-Life Program (ASQoP and AFEQT studies) 2013, ESMO, Amsterdam, Netherlands, [Abs 2276].
65. Perez-Soler R., Saltz L. Cutaneous adverse effects with HER1/EGFR-targeted agents: is there a silver lining?. J Clin Oncol 2005, 23:5235-5246.
66. Lacouture M.E., Mitchell E.P., 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, 28:1351-1357.
67. Segelov E., Chan D., Shapiro J., et al. The role of biological therapy in metastatic colorectal cancer after first-line treatment: a meta-analysis of randomised trials. Br J Cancer 2014, 111:1122-1131.