The development of clinical research in CRC

Annals of Oncology

Volumn 16, Issue SUPPL. 4, 2005, Pages

  Labianca, R ^a   Beretta, G D ^a   Mosconi, S ^a   Pessi, M A ^a   Milesi, L ^a  

^a OSPEDALI RIUNITI   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; ERLOTINIB; FLUOROURACIL; FOLINIC ACID; GEFITINIB; IRINOTECAN; LEVAMISOLE; ORZEL; OXALIPLATIN; UFT;

ACNE; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER RESEARCH; CANCER STAGING; CATHETER COMPLICATION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COLON SURGERY; COLORECTAL CARCINOMA; COST BENEFIT ANALYSIS; DIARRHEA; DRUG ABSORPTION; DRUG ERUPTION; DRUG METABOLISM; DYSESTHESIA; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; INFECTION; NAUSEA; NEUROPATHY; NEUTROPENIA; PARESTHESIA; PRIORITY JOURNAL; PROGNOSIS; PROTEINURIA; SKIN FISSURE; STOMATITIS; VEIN THROMBOSIS;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; FLUOROURACIL; HUMANS; LYMPHATIC METASTASIS; NEOPLASM STAGING; PALLIATIVE CARE; PRODRUGS; PROGNOSIS; QUALITY OF LIFE; SENTINEL LYMPH NODE BIOPSY; SURVIVAL RATE;

EID: 30644479335     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdi906     Document Type: Article

References (80)

1. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050-2059.
2. Weeks JC, Nelson H, Gelber S et al. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: A randomized trial. J Amer Med Assoc 2002; 287: 321-328.
3. Lacy AM, García-Valdecasas JC, Delgado S et al. Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: A randomised trial. Lancet 2002; 359 (9325): 2224-2229.
4. Esser S, Reilly WT, Riley LB et al. The role of sentinel lymph node mapping in staging of colon and rectal cancer. Dis Colon Rectum 2001; 44: 850-854. (and discussion 854-856).
5. Bilchik AJ, Nora DT, Sobin LH et al. Effect of lymphatic mapping on the new tumor-node-metastasis classification for colorectal cancer. J Clin Oncol 2003; 21: 668-672.
6. Scheithauer W, Rosen H, Kornek GV, Sebesta C, Depisch D. Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. Brit Med J 1993; 306: 752-755.
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: 1413-1418.
8. Smyth JF, Hardcastle JD, Denton G et al. Two phase III trials of tauromustine (TCNU) in advanced colorectal cancer. Amer Ann Oncol 1995; 6: 948-949.
9. Sobrero A, Guglielmi A, Grossi F, Puglisi F, Aschele C. Mechanism of action of fluoropyrimidines: Relevance to the new developments in colorectal cancer chemotherapy. Semin Oncol 2000; 27 (Suppl 10): 72-77.
10. Zhang ZG, Harstrick A, Rustum YM. Modulation of fluoropyrimidines: Role of dose and schedule of leucovorin administration. Semin Oncol 1992; 19 (Suppl 3): 10-15.
11. 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.
12. Lokich JJ, Ahlgren JD, Gullo JJ, Philips JA, Fryer JG. A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: A Mid-Atlantic Oncology Program study. J Clin Oncol 1989; 7: 425-432.
13. de Gramont A, Bosset JF, 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.
14. Weh HJ, Wilke HJ, Dierlamm J et al. Weekly therapy with folinic acid (FA) and high-dose 5-fluorouracil (5-FU) 24-hours infusion in pretreated patients with metastatic colorectal carcinoma: A multicenter study by the Association of Medical Oncology of the German Cancer Society (AIO). Ann Oncol 1994; 5: 233-237.
15. Fraile RJ, Baker LH, Buroker TR, Horowitz J, Vaitkevicius VK. Pharmacokinetics of 5-fluorouracil administered orally, by rapid intravenous and slow infusion. Cancer Res 1980; 40: 2223-2228.
16. Pentheroudakis G, Twelves C. The rational development of capecitabine from the laboratory to the clinic. Anticancer Res 2002; 22: 3589-3596.
17. Meropol NJ. Oral fluoropyrimidines in the treatment of colorectal cancer. Eur J Cancer 1998; 34: 1509-1513.
18. Sulkes A, Benner SE, Canetta RM. Uracil-ftorafur: An oral fluoropyrimidine active in colorectal cancer. J Clin Oncol 1998; 16: 3461-3475.
19. Malet-Martino M, Martino R. Clinical studies of three oral prodrugs of 5-fluorouracil (Capecitabine, UFT, S-1): A review. The Oncologist 2002; 7: 288-323.
20. Brito RA, Medgyesy D, Zukowski TH et al. Fluoropyrimidines: A critical evaluation. Oncology 1999; 57 (Suppl 1): 2-8.
21. Van Cutsem E, Twelves C, Cassidy J et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: Results of a large phase III study. J Clin Oncol 2001; 19: 4097-4106.
22. Hoff PM, Ansari R, Batist G et al. Camparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study. J Clin Oncol 2001; 19: 2282-2292.
23. Mayer RJ. Oral versus intravenous fluoropyrimidines for advanced colorectal cancer: By either route, it's all the same. J Clin Oncol 2001; 19: 4093-4096.
24. Pazdur R, Lassere Y, Diaz-Canton E, Bready B, Ho DH. Phase I trials of uracil-tegafur (UFT) using 5 and 28 day administration schedules-demonstration of schedule dependent toxicities. Anticancer Drugs 1996; 7: 728-733.
25. Muggia FM, Wu XY, Spicer D et al. A phase I and pharmacokinetic study of oral UFT a combination of the 5-fluorouracil prodrug tegafur and uracil. Clin Cancer Res 1996; 2: 1461-1467.
26. Kuhn JG. Fluorouracil and the new oral fluorinated pyrimidines. Ann Pharmacother 2001; 27: 211-220.
27. Ota K, Taguchi T, Kimura K. Report on nationwide pooled data and cohort investigation in UFT phase II study. Cancer Chemother Pharmacol 1998; 22: 333-338.
28. Pazdur R, Lassere Y, Rhodes V, Ajani JA, Sugarman SM, Patt YZ et al. Phase II trial uracil and tegafur plus oral leucovorin: An effective oral regimen in the treatment of metastatic colorectal carcinoma. J Clin Oncol 1994; 12: 2296-2300.
29. Saltz LB, Leichman CG, Young CW, Muggia FM, Conti JA, Spiess T et al. A fixed-ratio combination of uracil and ftorafur (UFT) with low dose leucovorin: An active oral regimen for advanced colorectal cancer. Cancer 1995; 75: 782-785.
30. Gonzalez-Baron M, Feliu J, de la Gandara I et al. Efficacy of oral tegafur modulation by uracil (UFT) and leucovorin in advanced colorectal cancer: A phase II study. Eur J Cancer 1995; 31: 2215-2219.
31. Panettiere FJ, Goodman PJ, Costanzi JJ et al. Adjuvant therapy in large bowel adenocarcinoma: Long-term results of a Southwest Oncology Group Study. J Clin Oncol 1988; 6: 947-954.
32. Gastrointestinal Tumor Study Group. Adjuvant therapy of colon cancer-results of a prospectively randomized trial. N Engl J Med 1984; 310: 737-743.
33. Higgins GA Jr, Amadeo JH, McElhinney J et al. Efficacy of prolonged intermittent therapy with combined 5-fluorouracil and methyl-CCNU following resection for carcinoma of the large bowel. A Veterans Administration Surgical Oncology Group report. Cancer 1984; 53: 1-8.
34. Buyse M, Zeleniuch-Jacquotte A, Chalmers TC. Adjuvant therapy of colorectal cancer. Why we still don't know. J Amer Med Assoc 1988; 259: 3571-3578.
35. Moertel CG, Fleming TR, Macdonalds JS et al. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: A final report. Ann Intern Med 1995; 122: 321-326.
36. Haller DG, Lefkopoulou M, Macdonalds JS, Mayer RJ. Some considerations concerning the dose and schedule of 5-FU and leucovorin: Toxicities of two dose schedules from the intergroup colon adjuvant trial (INT-0089). Adv Exp Med Biol 1993; 339: 51-56.
37. Haller DG, Catalano PJ, Macdonald JS, Mayer RJ. Fluorouracil (FU), leucovorin (LV) and levamisole (LEV) adjuvant therapy for colon cancer: five-year final report of INT-0089. Proc Am Soc Clin Oncol 1998; 17: 982 (Abstr).
38. Wolmark N, Rockette H, Mamounas E et al. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole, and fluorouracil, leucovorin, and levamisole in patients with Dukes' B and C carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol 1999; 17: 3553-3559.
39. Wolmark N, Wieand S, Lembersky B et al. A phase III trial comparing oral UFT in stage II and III carcinoma of the colon: Results of NSABP protocol C-06. J Clin Oncol 2004; 22 (Suppl): 3508 (Abstr).
40. Cassidy J, Scheithauer W, Mckendrick J et al. Capecitabine vs bolus 5-FU/ leucovorin as adjuvant therapy for colon cancer (the X-ACT study): positive efficacy results of a phase III trial. J Clin Oncol 2004; 22 (Suppl): 3509 (Abstr).
41. Sargent DJ, Goldberg RM, Jacobson SD et al. A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med 2001; 345: 1091-1097.
42. Mamounas E, Wieand S, Wolmark N et al. Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04). J Clin Oncol 1999; 17: 1349-1355.
43. Moertel CG, Fleming TR, Macdonald JS et al. Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer. J Clin Oncol 1995; 13: 2936-2943.
44. Colacchio TA. Cancer and Leukemia Group B: Phase III randomized study of adjuvant edrecolomab versus no adjuvant therapy after resection in patients with stage II adenocarcinoma of the colon, CLB-9581. Clinical trial (closed).
45. Pazdur R. National Surgical Adjuvant Breast and Bowel Project: Phase III Randomized Study of Oral Uracil/Tegafur (UFT) with Leucovorin vs Fluorouracil with Leucovorin Following Resection for Stage II/III Adenocarcinoma of the Colon (Summary Last Modified 05/1999), NSABP-C-06. Clinical trial (closed).
46. Poplin EA. Southwest Oncology Group: Phase III Randomized Study of Bolus Fluorouracil and Leucovorin Calcium with Levamisole vs Continuous Infusion Fluorouracil with Levamisole as Adjuvant Therapy in Patients with High Risk Colon Cancer (Summary Last Modified 04/SWOG-9415. Clinical trial (closed).
47. Andre T, Bensmaine MA, Louvet C et al. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol 1999; 17: 3560-3568.
48. Bleiberg H, de Gramont A. Oxaliplatin plus 5-fluorouracil: Clinical experience in patients with advanced colorectal cancer. Semin Oncol 1998; 25: 32-39.
49. Cvitkovic E, Bekradda M. Oxaliplatin: A new therapeutic option in colorectal cancer. Semin Oncol 1999; 26: 647-662.
50. de Gramont A, Vignoud J, Tournigand C et al. Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. Eur J Cancer 1997; 33: 214-219.
51. Giacchetti 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: 136-147.
52. 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: 2938-2947.
53. Grothey A, Deschler B, Kroening H, et al. Phase III study of bolus 5-fluorouracil (5-FU)/folinic acid (FA) (Mayo) vs weekly high-dose 24h 5-FU infusion/FA +oxaliplatin (OXA) (FUFOX) in advanced colorectal cancer (ACRC). In: Program and abstracts of the American Society of Clinical Oncology 38th Anual Meeting, Orlando, FL., May 18-21, 2002 (Abstr)
54. Conti JA, Kemeny NE, Saltz LB et al. Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol 1996; 14: 709-715.
55. Cunningham D, Pyrhonen S, James RD et al. A phase III multicenter randomized study of CPT-11 versus supportive care (SC) alone in patients (Pts) with 5FU-resistant metastatic colorectal cancer (MCRC). Lancet 1998b; 352: 1413-1418.
56. 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 1998b; 352: 1407-1412.
57. Saltz LB, Cox JV, Blanke C et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000a; 343: 905-914.
58. 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: 1041-1047.
59. Saltz LB, Douillard J, Pirrotta N et al. Combined analysis of two phase III randomized trials comparing irinotecan (C), fluorouracil (F), leucovorin (L) vs F alone as first-line therapy of previously untreated metastatic colorectal cancer (MCRC). Proc ASCO 2000b; 19: 242a.
60. Rothenberg ML, Merepol NJ, Poplin EA, Van Cutsem E, Wadler. Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: Summary findings of an independent panel. J Clin Oncol 2001; 19: 3801-3807.
61. Goldberg RM, Sargent DJ, Morton RF et al. N9741: FOLFOX (oxaliplatin (Oxal)/5-fluorouracil (5-FU)/leucovorin (LV) or reduced dose R-IFL (CPT-11+5-FU/LV) in advanced colorectal cancer (CRC): Final efficacy data from an intergroup study. J Clin Oncol 2004; 22 (Suppl): 3621.
62. Hwang JJ, Eisenberg SG, Marshall JL. Improving the toxicity of irinotecan/5-FU/leucovorin: A 21-day schedule. Oncology (Huntingt) 2003; 17 (Suppl 8): 37-43.
63. Kohne CH, Wils J, Lorenz M et al. Randomized phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer: European Organization of Research and Treatment of Cancer Gastrointestinal Group Study 40952. J Clin Oncol 2003; 21: 3721-3728.
64. Meta-Analysis Group in Cancer. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 1998; 16: 301-308.
65. Tournigand C, Andre T, Achille E et al. FOLFIRI followed by FOLFOX 6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 2004; 22: 229-237.
66. Grothey A, Jordan K, Kellner O et al. Randomized phase III trial of capecitabine plus irinotecan (CapIri) vs capecitabine plus oxaliplatin (CapOx) as first-line therapy of advanced colorectal cancer (ACRC). Prog Proc Am Soc Clin Oncol 2003; 22: 255 (Abstr).
67. Saltz LB, Niedzwiecki D, Hollis D et al. Irinotecan plus fluorouracil/ leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). J Clin Oncol 2004; 22 (Suppl): 3500. (Abstr).
68. Andre T, Boni C, Mounedji-Boudiaf L et al. Oxaliplatin, fluoruracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004; 350: 2343-2351.
69. de Gramont A, Boni C, Navarro M et al. Oxaliplatin/5FU/LV in the adjuvant treatment of stage II and stage III colon cancer: Efficacy results with a median follow-up of 4 years. In: Proceedings of the 2005 Gastrointestinal Cancers Symposium, 2005: 167; (Abstr)
70. Baselga J. Why the epidermal growth factor receptor? The rationale for cancer therapy. Oncologist 2002; 7 (Suppl 4): 2-8.
71. Mayer A, Takimoto M, Fritz E et al. The prognostic significance of proliferating nuclear antigen, epidermal growth factor receptor, and mdr gene expression in colorectal cancer. Cancer 1993; 71: 2454-2460.
72. Hemming AW, Davis NL, Kluftinger A et al. Prognostic markers of colorectal cancer: An evaluation of DNA content, epidermal growth factor receptor and Ki-67. J Surg Oncol 1992; 51: 147-152.
73. Saltz L, Rubin M, Hochster H et al. Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11-refractory colorectal cancer (CRC) that express epidermal growth factor receptor (EGFR). Prog Proc Am Soc Soc Clin Oncol 2001; 20: 3a (Abstr).
74. 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: 1201-1208.
75. 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.
76. Kabbinavar F, Hurwitz HI, Fehrenbacher L et al. Phase II randomized trial comparing bevacizumab plus fluoruracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003; 21: 60-65.
77. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350: 2335-2342.
78. Berlin JD. Targeting vascular endothelial growth factor in colorectal cancer. Oncology (Huntingt) 2002; 16 (Suppl 7): 13-15.
79. Giantonio BJ, Catalano PJ, Meropol NJ et al. High-dose bevacizumab in combination with FOLFOX4 improves survival patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Group (ECOG) study E2300. In: Proceedings of the 2005 Gastrointestinal Cancers Symposium, 2005: 168 (Abstr)
80. Jain RK. Normalizing tumor vasculature with anti-angiogenic therapy: A new paradigm for combination therapy. Nat Med 2001; 7: 987-989.