Combined therapy with weekly irinotecan, infusional 5-fluorouracil and the selective COX-2 inhibitor rofecoxib is a safe and effective second-line treatment in metastatic colorectal cancer

Oncologist

Volumn 10, Issue 9, 2005, Pages 710-717

  Gasparini, Giampietro ^a,d   Gattuso, Domenico ^a   Morabito, Alessandro ^a   Longo, Raffaele ^a   Torino, Francesco ^a   Sarmiento, Roberta ^a   Vitale, Stefano ^a   Gamucci, Teresa ^b   Mariani, Luigi ^c  

^a SAN FILIPPO NERI HOSPITAL   (Italy)

^b Umberto I Hospital   (Italy)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d Division of Medical Oncology   (Italy)

Author keywords

5 Fluorouracil; COX 2 inhibitors; Irinotecan; Metastatic colorectal cancer

Indexed keywords

AMINOGLYCOSIDE; ANTIBIOTIC AGENT; ANTIEMETIC AGENT; CELECOXIB; CEPHALOSPORIN; CYCLOOXYGENASE 2 INHIBITOR; FLUOROURACIL; FOLINIC ACID; GROWTH FACTOR; IRINOTECAN; LOPERAMIDE; OXALIPLATIN; ROFECOXIB; VALDECOXIB;

ADULT; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CYSTITIS; DIARRHEA; DOSE CALCULATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; GRANULOCYTOPENIA; HAND FOOT SYNDROME; HEART DISEASE; HEART INFARCTION; HEMATOLOGIC DISEASE; HUMAN; INFECTION; LEUKOPENIA; LIVER TOXICITY; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; PROGNOSIS; STOMACH PAIN; STROKE; SURVIVAL RATE; THROMBOCYTOPENIA; THROMBOEMBOLISM; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FLUOROURACIL; HUMANS; LACTONES; MIDDLE AGED; NEOPLASM METASTASIS; SULFONES;

EID: 27644511251     PISSN: 10837159     EISSN: None     Source Type: Journal    
DOI: 10.1634/theoncologist.10-9-710     Document Type: Article

References (46)

1. Tebbutt NC, Cattell E, Midgley R et al. Systemic treatment of colorectal cancer. Eur J Cancer 2002;38:1000-1015.
2. Lévi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chemotherapy. Lancet 1997;350:681-686.
3. 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.
4. Saltz LB, Cox JV, Blanke C et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000;343:905-914.
5. 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.
6. 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;352:1407-1412.
7. Cunningham D, Glimelius B. A phase III study of irinotecan (CPT-11) versus best supportive care in patients with metastatic colorectal cancer who have failed 5-fluorouracil therapy. V301 Study Group. Semin Oncol 1999;26(suppl 5):6-12.
8. 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.
9. 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;21:2059-2069.
10. 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.
11. Grothey A, Sargent D, Goldberg RM et al. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 2004;22:1209-1214.
12. Markowitz SD, Dawson DM, Willis J et al. Focus on colon cancer. Cancer Cell 2002;1:233-236.
13. Thun MJ, Namboodiri MM, Heath CW Jr. Aspirin use and reduced risk of fatal colon cancer. N Engl J Med 1991;325:1593-1596.
14. Williams CS, Mann M, DuBois RN. The role of cyclooxygenases in inflammation, cancer, and development. Oncogene 1999;18:7908-7916.
15. Chan TA. Nonsteroidal anti-inflammatory drugs, apoptosis, and colon-cancer chemoprevention. Lancet Oncol 2002;3:166-174.
16. Arbabi S, Rosengart MR, Garcia I et al. Epithelial cyclooxygenase-2 expression: a model for pathogenesis of colon cancer. J Surg Res 2001;97:60-64.
17. Tomozawa S, Tsuno NH, Sunami E et al. Cyclooxygenase-2 overexpression correlates with tumour recurrence, especially haematogenous metastasis, of colorectal cancer. Br J Cancer 2000;83:324-348.
18. Steinbach G, Lynch PM, Phillips RK et al. The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 2000;342:1946-1952.
19. Thun MJ, Henley SJ, Patrono C. Nonsteroidal anti-inflammatory drugs as anticancer agents: mechanistic, pharmacologic, and clinical issues. J Natl Cancer Inst 2002;94:252-266.
20. Masferrer JL, Leahy KM, Koki AT et al. Antiangiogenic and antitumor activities of cyclooxygenase-2 inhibitors. Cancer Res 2000;60:1306-1311.
21. Sheng H, Shao J, Kirkland SC et al. Inhibition of human colon cancer cell growth by selective inhibition of cyclooxygenase-2. J Clin Invest 1997;99:2254-2259.
22. Tsujii M, Kawano S, Tsuji S et al. Cyclooxygenase regulates angiogenesis induced by colon cancer cells. Cell 1998;93:705-716.
23. D12, which facilitates the outgrowth of murine C26 colorectal liver metastases. Clin Cancer Res 2005;11:41-48.
24. Gasparini G, Longo R, Sarmiento R et al. Inhibitors of cyclo-oxygenase 2: a new class of anticancer agents? Lancet Oncol 2003;4:605-615.
25. 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;92:205-216.
26. 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.
27. Takimoto CH, Morrison G, Harold N et al. Phase I and pharmacologic study of irinotecan administered as a 96-hour infusion weekly to adult cancer patients. J Clin Oncol 2000;18:659-667.
28. Michael M, Hedley D, Oza A et al. The palliative benefit of irinotecan in 5-fluorouracil-refractory colorectal cancer: its prospective evaluation by a Multicenter Canadian Trial. Clin Colorectal Cancer 2002;2:93-101.
29. Hofheinz R, Hartung G, Samel S et al. Adding weekly irinotecan to high-dose 5-fluorouracil and folinic acid (HD-5-FU/FA) after failure for first-line HD-5-FU/FA in advanced colorectal cancer-a phase II study. Anticancer Drugs 2002;13:999-1004.
30. Dimberg J, Hugander A, Sirsjo A et al. Enhanced expression of cyclooxygenase-2 and nuclear beta-catenin are related to mutations in the APC gene in human colorectal cancer. Anticancer Res 2001;21:911-915.
31. Chen WS, Wei SJ, Liu JM et al. Tumor invasiveness and liver metastasis of colon cancer cells correlated with cyclooxygenase-2 (COX-2) expression and inhibited by a COX-2-selective inhibitor, etodolac. Int J Cancer 2001;91:894-899.
32. Jacoby RF, Seibert K, Cole CE et al. The cyclooxygenase-2 inhibitor celecoxib is a potent preventive and therapeutic agent in the min mouse model of adenomatous polyposis. Cancer Res 2000;60:5040-5044.
33. Bresalier RS. Chemoprevention comes to clinical practice: COX-2 inhibition in familial adenomatous polyposis. Gastroenterology 2000;119:1797-1798.
34. Kawamori T, Rao CV, Seibert K et al. Chemopreventive activity of celecoxib, a specific cyclooxygenase-2 inhibitor, against colon carcinogenesis. Cancer Res 1998;58:409-412.
35. 3 integrin-mediated and Cdc42/Rac-dependent endothelial-cell spreading, migration, and angiogenesis. Nat Med 2001;7:1041-1047.
36. Brown WA, Skinner SA, Malcontenti-Wilson C et al. Non-steroidal anti-inflammatory drugs with activity against either cyclooxygenase 1 or cyclooxygenase 2 inhibit colorectal cancer in a DMH rodent model by inducing apoptosis and inhibiting cell proliferation. Gut 2001;48:660-666.
37. Masferrer JL, Koki A, Seibert K. COX-2 inhibitors: a new class of antiangiogenic agents. Ann N Y Acad Sci 1999;889:84-86.
38. Leahy KM, Koki AT Masferrer JL. Role of cyclooxygenases in angiogenesis. Curr Med Chem 2000;7:1163-1170.
39. Leahy KM, Ornberg RL, Wang Y et al. Cyclooxygenase-2 inhibition by celecoxib reduces proliferation and induces apoptosis in angiogenic endothelial cells in vivo. Cancer Res 2002;62:625-631.
40. Li M, Wu X, Xu XC. Induction of apoptosis in colon cancer cells by cyclooxygenase-2 inhibitor NS398 through a cytochrome c-dependent pathway. Clin Cancer Res 2001;7:1010-1016.
41. Pai R, Soreghan B, Szabo IL et al. Prostaglandin E2 transactivates EGF receptor: a novel mechanism for promoting colon cancer growth and gastrointestinal hypertrophy. Nat Med 2002;8:289-293.
42. Baigent C, Patrono C. Selective cyclooxygenase 2 inhibitors, aspirin, and cardiovascular disease: a reappraisal. Arthritis Rheum 2003;48:12-20.
43. Trifan OC, Durham WF, Salazar VS et al. Cyclooxygenase-2 inhibition with celecoxib enhances antitumor efficacy and reduces diarrhea side effect of CPT-11. Cancer Res 2002;62:5778-5784.
44. Tournigand C, André T, Achille E et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004;22:229-237.
45. Ohtsu A, Boku N, Yoshioka T et al. A phase II study of irinotecan in combination with 120-h infusion of 5-fluorouracil in patients with metastatic colorectal carcinoma: Japan Clinical Oncology Group Study (JCOG9703). Jpn J Clin Oncol 2002;33:28-32.
46. Blanke CD, Benson AB, Dragovich T et al. A phase II trial of celecoxib (CX), irinotecan (I), 5-fluorouracil (5-FU), and leucovorin (LCV) in patients (pts) with unresectable or metastatic colorectal cancer (CRC). Proc Am Soc Clin Oncol 2002;21:127a (abstract 505).