Irinotecan (CPT-11) in patients with advanced colorectal cancer previously treated with 5-fluorouracil-based chemotherapy

Critical Reviews in Oncology/Hematology

Volumn 32, Issue 3, 1999, Pages 209-219

  Aravantinos, Gerassimos ^a   Skarlos, Demosthenis V ^a   Kosmidis, Paris ^b   Georgoulias, Vasilios ^c   Sgouros, Iosif ^a   Bafaloukos, Dimitrios ^b   Androulakis, Nikolaos ^c   Florou, Sofia ^b   Fountzilas, George ^d  

^a AGII ANARGIRI CANCER HOSPITAL   (Greece)

^b METAXA CANCER HOSPITAL   (Greece)

^c UNIVERSITY HOSPITAL OF HERAKLION   (Greece)

^d ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOEMBRYONIC ANTIGEN; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; VOMITING;

EID: 0032760689     PISSN: 10408428     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1040-8428(99)00045-1     Document Type: Review

References (58)

1. Esteve J., Kricker A., Ferlay J., Parkin D.M. Facts and figures of Cancer in the European Community. 1993;International Agency for Research on Cancer, Lyon.
2. Boring C.C., Squires T.S., Tong T., Montgomery S. Cancer statistics, 1994. CA Cancer J. Clin. 44:1994;7-26.
3. Bleiberg H. Colorectal cancer - is there an alternative to 5-FU? Eur. J. Cancer. 33(4):1997;536-541.
4. Moertel C.G., Fleming T.R., Macdonald J.S. et al. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann. Intern. Med. 122:1995;321.
5. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet. 345:1995;939.
6. Mamounas E.P., Rockette H., Jones J. et al. Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B vs Dukes' C colon cancer: results from four NSABP adjuvant studies (C-01, C-02, C-03, C-04). Proc. Am. Soc. Clin. Oncol. 15:1996;205. (abstract 461).
7. Hansen R.M. Systemic therapy in metastatic colorectal cancer. Arch. Intern. Med. 150:1990;2265-2269.
8. Blijham G.H., Labianca R., Bleiberg H. Should patients with advanced colorectal cancer be treated with chemotherapy? Pro. Eur. J. Cancer. 33(6):1997;815-817.
9. Expectancy or primary chemotherapy in patients with advanced asymptomatic colorectal cancer: a randomized trial. J. Clin. Oncol. 10:1992;904-911.
10. Schreithauer W., Rosen H., Kornek G.V., Sebesta C., Despich D. Randomized comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. Br. Med. J. 306:1993;752-755.
11. Poon M.A., O'Connell M.J., Moertel C.G. et al. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J. Clin. Oncol. 7:1989;1407-1417.
12. De Gramont A., Bosset J.F., Milan C. et al. A prospectively randomized trial comparing 5-FU bolus with low dose folinic acid (FUFOL1d) and 5FU bolus plus continuous infusion with high dose folinic acid (LV5FU2) for advanced colorectal cancer. Proc. Am. Soc. Clin. Oncol. 14:1995;455. (abstract).
13. Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J. Clin. Oncol. 10:1992;896-903.
14. Izzo J., Cvitkovic E., Zarba J. et al. Low dose 5FU continuous infusion (FuCL) in advanced colorectal cancer (ACC): clinical evidence for reversal of acquired/intrinsic resistance to 5-FU or 5-FU folinic (FuFo). Ann. Oncol. 3(suppl 5):1992;76. (abstract).
15. Bertrand M., Doroshow J.H., Multhauf P. et al. High dose continuous infusion folinic acid and bolus 5-fluorouracil in patients with advanced colorectal cancer: a phase II study. J. Clin. Oncol. 4:1986;1058-1061.
16. Ahlgren J.D., Trocki O., Gullo J.J. et al. Protracted infusion of 5-Fu with weekly low dose cisplatin as a second line therapy in patients with metastatic colorectal cancer who have failed 5-FU monotherapy. Cancer Invest. 9:1991;27-33.
17. Brienza S., Levi F., Valori V.M. et al. Intensified (every 2 weeks) chronotherapy with 5-fluorouracil (5-FU) folinic acid (FA) and oxaliplatin (L-OHP) in previously treated patients (pts) with metastatic colorectal cancer. Proc. Am. Soc. Oncol. 12:1993;577. (abstract).
18. Bleiberg H. Role of chemotherapy for advanced colorectal cancer: new opportunities. Semin. Oncol. 23(1 (suppl 3)):1996;42-50.
19. Wall M.E., Want M.C., Cook C.E. et al. Plant anti-tumor agents. I - The isolation and structure of camptothecin, a novel alkaloidal leukemia and tumor inhibitor from Camptotheca acuminata. J. Am. Chem. Soc. 88:1996;3888-3890.
20. Gottlieb J.A., Guarino A.M., Call J.B. et al. Preliminary pharmacologic and clinical evaluation of camptothecin sodium (NSC-100880). Cancer Chemother. Rep. 54:1970;461-470.
21. Hsiang Y.M., Hertoberg R., Hechr S. et al. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J. Biol. Chem. 260:1985;14873-14878.
22. Hsiang Y.-H., Liu L.F. Identification of mammalian topoisomerase I as an intracellular terget of the anticancer drug camptothecin. Cancer Res. 48:1988;1722-1726.
23. Pommier Y. Eucaryotic DNA topoisomerase I: genome gatekeeper and its intruders, camptothecins. Semin. Oncol. 23(I (suppl 3)):1996;3-10.
24. Lavelle F., Bissery M.C., Andre S., Roduet F., Rion J.F. Preclinical evaluation of CPT-11 and its active metabolite SN-3. Semin. Oncol. 23(I (suppl 3)):1996;11-20.
25. Kingsbury W.D., Boehm J.C., Jacas D.R. et al. Synthesis of water-soluble (aminoalkyl) camptothecin analogues. Inhibition of topoisomerase I and antitumor activity. J. Med. Chem. 34:1991;98-107.
26. Kunimoto T., Nitta K., Tanaka T. et al. Antitumor activity of 7-ethyl-10-[4-(1-piperidino)-1 piperidino] carbonyloxy-camptothecin, a novel water-soluble derivative of camptothecin, against murine tumors. Cancer Res. 47:1987;5944-5947.
27. Sinca B.K. Topoisomerase inhibitors. A review of their therapeutic potential in cancer. Drugs. 41(1):1995;11-19.
28. Dancey J., Eisenhauer E.A. Current perspectives on camptothecins in cancer treatment. Br. J. Cancer. 74:1996;327-338.
29. Rothenberg M.L. CPT-11: an original spectrum of clinical activity. Semin. Oncol. 23(II (suppl 3)):1996;21-26.
30. Armand JP. CPT-11: clinical experience in phase I studies. Semin Oncol 1996;23(1)(Suppl 3).
31. Shimada Y., Yashino M., Wakui A. et al. Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. J. Clin. Oncol. 11:1993;909-913.
32. Van Cutsem E., Cunningham D., Ten Bokkel Huinink W. et al. Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-Fluorouracil (5-FU). Eur. J. Cancer. 35(1):1999;54-59.
33. Conti J.A., Kemeny N., Saltz L. et al. Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J. Clin. Oncol. 14:1996;709-715.
34. Rothenberg M.L., Eckardt J.R., Kuhn J.G. et al. Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J. Clin. Oncol. 14:1996;1128-1135.
35. Rougier P., Bugat R., Douillard J.Y. et al. Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. J. Clin. Oncol. 15:1997;251-260.
36. Pitot H.C., Wender D.B., O'Connell M.J. et al. Phase II trial of irinotecan in patients with metastatic colorectal carcinoma. J. Clin. Oncol. 15(8):1997;2910-2919.
37. Rougier P., Bugat R. CPT-11 in the treatment of colorectal cancer. Clinical efficacy and safety profile. Semin. Oncol. 23(1 (suppl 3)):1996;34-41.
38. Abigerges D., Chabot G.G., Armand J. et al. Phase I and pharmacologic studies of the camptothecin analogue irinotecan administered every 3 weeks in cancer patients. J. Clin. Oncol. 13:1995;210-221.
39. Abigerges D., Armand J.P., Chabot G.G. et al. Irinotecan (CPT-11) high -dose escalation using intensive high-dose loperamide to control diarrhea. J. Natl. Cancer Inst. 86:1994;446-449.
40. Kosmidis P., Skarlos V., Georgoulias V. et al. A randomised phase III multicenter trial of campto (CPT-11) with or without lenograstim (Granocyte) support in 1st or 2nd line metastatic colorectal cancer. Proc. Am. Soc. Clin. Oncol. 17:1998;270a.
41. Miller A.B., Hoogstraten B., Staquet M. et al. Reporting results of cancer treatment. Cancer. 47:1981;207-214.
42. Kaplan E.L., Meier P. Non-parametric estimation from incomplete observations. J. Am. Stat. Assoc. 53:1985;229-232.
43. Mantel N. Evaluation of survival data and the two new rank order statistics arising in its consideration. Cancer Chemother. Rep. 50:1996;163-170.
44. Breslow N.A. A generalized Kruskal-Wallis tests for comparing K samples subject to unequal patterns of censorship. Biometrika. 57:1970;579-594.
45. Tarone R., Ware J. On distribution-free tests for equality of survival distributions. Biometrika. 64:1977;156-160.
46. Cox D.R. Regression models and life tables. J. R. Stat. Soc. Ser. B. 34:1972;187-220.
47. Marsoni S., Hoth D., Simon R. et al. Clinical drug development: An analysis of phase II trials, 1970-1985. Cancer Treat. Rep. 71:1987;71-80.
48. Bedikian A.Y., Stroehlein J., Korinek J. et al. A comparative study of oral tegafur and intravenous 5-fluorouracil in patients with metastatic colorectal cancer. Am. J. Clin. Oncol. 6:1983;181-186.
49. Haskell C.M., Selch M.T., Ramming K.P. Colon and rectum. Haskell C.M. Colon and Rectum in Cancer Treatment. 3 ed. 1990;232-254 Saunders, Philadelphia, PA.
50. De Formi M., Bugat R., Chabot G.G. et al. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 54:1994;4347-4354.
51. Catimel G., Chabot G.G., Guastella J.P. et al. Phase I and pharmacokinetic study of camptothecin derivative irinotecan (CPT-11) administered daily for 3 consecutive days every 3 weeks in patients with advanced solid tumors. Ann. Oncol. 6:1995;133-140.
52. Cunningham D., Pyrhönen S., James R.D. et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 3529(138):1998;1413-1418.
53. Bleiberg H. Should patients with advanced colorectal cancer be treated with chemotherapy? Arbiter. Eur. J. Cancer. 33(6):1997;822-824.
54. Labiance R. Should patients with advanced colorectal cancer be treated with chemotherapy? Contra. Eur. J. Cancer. 33(6):1997;818-822.
55. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J. Clin. Oncol. 14:1996;671-679.
56. Rougier P., Van Cutsem E., Bajetta E. et al. Randomised trial of irinotecan versus fluouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 352(9138):1998;1407-1412.
57. Piedbois P., Buyse M. What can we learn from a meta-analysis of trial testing modulation of 5-fluorouracil by leucovorin? Ann. Oncol. 4:1993;S15-S19.
58. Moertel C.G., Schutt A.J., Hahn R.G., Reitemeier R.J. Effects of patients selection on results of phase II chemotherapy trials in gastrointestinal cancer. Cancer Chemother. Rep. 58:1974;257-259.