European Journal of Cancer
Volume 42, Issue 5 , Pages 574-581 , March 2006

Chronomodulated chemotherapy for colorectal cancer: Failing the test of time?

Received 11 November 2005 ,Accepted 11 November 2005.

References 

  1. Hrushesky WJ. Circadian timing of cancer chemotherapy. Science. 1985;228(4695):73–75
  2. Hrushesky WJ, Bjarnason GA. Circadian cancer therapy. J Clin Oncol. 1993;11(7):1403–1417
  3. von Roemeling R, Hrushesky WJ. Circadian patterning of continuous floxuridine infusion reduces toxicity and allows higher dose intensity in patients with widespread cancer. J Clin Oncol. 1989;7(11):1710–1719
  4. Mormont MC, Levi F. Cancer chronotherapy: principles, applications, and perspectives. Cancer. 2003;97(1):155–169
  5. Garufi C, Vanni B, Aschelter A, et al. Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Eur J Cancer. 2005;
  6. Burns ER, Beland SS. Effect of biological time on the determination of the LD50 of 5-fluorouracil in mice. Pharmacology. 1984;28(5):296–300
  7. Harris BE, Song R, Soong SJ, et al. Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Res. 1990;50(1):197–201
  8. Grem JL, Yee LK, Venzon DJ, et al. Inter- and intraindividual variation in dihydropyrimidine dehydrogenase activity in peripheral blood mononuclearcells. Cancer Chemother Pharmacol. 1997;40(2):117–125
  9. Petit E, Milano G, Levi F, et al. Circadian rhythm-varying plasma concentration of 5-fluorouracil during a five-day continuous venous infusion at a constant rate in cancer patients. Cancer Res. 1988;48(6):1676–1679
  10. Takimoto CH, Yee LK, Venzon DJ, et al. High inter- and intrapatient variation in 5-fluorouracil plasma concentrations during a prolonged drug infusion. Clin Cancer Res. 1999;5(6):1347–1352
  11. Metzger G, Massari C, Etienne MC, et al. Spontaneous or imposed circadian changes in plasma concentrations of 5-fluorouracil coadministered with folinic acid and oxaliplatin: relationship with mucosal toxicity in patients with cancer. Clin Pharmacol Ther. 1994;56(2):190–201
  12. Bressolle F, Joulia JM, Pinguet F, et al. Circadian rhythm of 5-fluorouracil population pharmacokinetics in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 1999;44(4):295–302
  13. Bjarnason GA, Kerr IG, Doyle N, et al. Phase I study of 5-fluorouracil and leucovorin by a 14-day circadian infusion in metastatic adenocarcinoma patients. Cancer Chemother Pharmacol. 1993;33(3):221–228
  14. Adler S, Lang S, Langenmayer I, et al. Chronotherapy with 5-fluorouracil and folinic acid in advanced colorectal carcinoma. Results of a chronopharmacologic phase I trial. Cancer. 1994;73(12):2905–2912
  15. Levi F, Soussan A, Adam R, et al. A phase I–II trial of five-day continuous intravenous infusion of 5-fluorouracil delivered at circadian rhythm modulated rate in patients with metastatic colorectal cancer. J Infus Chemother. 1995;5(3 Suppl. 1):153–158
  16. Garufi C, Levi F, Aschelter AM, et al. A phase I trial of 5-day chronomodulated infusion of 5-fluorouracil and 1-folinic acid in patients with metastatic colorectal cancer. Eur J Cancer. 1997;33(10):1566–1571
  17. Terzoli E, Garufi C, Zappala AR, et al. High-dose chronomodulated infusion of 5-fluorouracil (5-FU) and folinic acid (FA) (FF5-16) in advanced colorectal cancerpatients. J Cancer Res Clin Oncol. 2004;130(8):445–452
  18. Cure H, Chevalier V, Pezet D, et al. Phase II trial of chronomodulated infusion of 5-fluorouracil and folinic acid in metastatic colorectal cancer. Anticancer Res. 2000;20(6C):4649–4653
  19. Cure H, Chevalier V, Adenis A, et al. Phase II trial of chronomodulated infusion of high-dose fluorouracil and l-folinic acid in previously untreated patients with metastatic colorectal cancer. J Clin Oncol. 2002;20(5):1175–1181
  20. Falcone A, Allegrini G, Antonuzzo A, et al. Infusions of fluorouracil and leucovorin: effects of the timing and semi-intermittency of drug delivery. Oncology. 1999;57(3):195–201
  21. Caussanel JP, Levi F, Brienza S, et al. Phase I trial of 5-day continuous venous infusion of oxaliplatin at circadian rhythm-modulated rate compared with constant rate. J Natl Cancer Inst. 1990;82(12):1046–1050
  22. Levi F, Perpoint B, Garufi C, et al. Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous venous infusion at circadian rhythm modulated rate. Eur J Cancer. 1993;29A(9):1280–1284
  23. Levi F, Misset JL, Brienza S, et al. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using an ambulatory multichannel programmable pump. High antitumour effectiveness against metastatic colorectal cancer. Cancer. 1992;69(4):893–900
  24. Levi FA, Zidani R, Vannetzel JM, et al. Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid (leucovorin) in patients with colorectal cancer metastases: a randomized multi-institutional trial. J Natl Cancer Inst. 1994;86(21):1608–1617
  25. Levi F, Zidani R, Misset JL. Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet. 1997;350(9079):681–686
  26. Sandor V. Chronotherapy with 5-fluorouracil, oxaliplatin, and folinic acid in colorectal cancer. Lancet. 1997;350(9087):1325–1326
  27. Bertheault-Cvitkovic F, Jami A, Ithzaki M, et al. Bi-weekly intensified ambulatory chronomodulated chemotherapy with oxaliplatin, fluorouracil, and leucovorin in patients with metastatic colorectal cancer. J Clin Oncol. 1996;14(11):2950–2958
  28. Levi F, Zidani R, Brienza S, et al. A multicenter evaluation of intensified, ambulatory, chronomodulated chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin as initial treatment of patients with metastatic colorectal carcinoma. International Organization for Cancer Chronotherapy. Cancer. 1999;85(12):2532–2540
  29. 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(1):136–147
  30. Giacchetti S, Bjarnason G, Garufi C, et al. First line infusion of 5-fluorouracil, leucovorin and oxaliplatin for metastatic colorectal cancer: 4-day chronomodulated (FFL4-10) versus 2-day FOLFOX2. A multicenter randomized Phase III trial of the Chronotherapy Group of the European Organization for Research and Treatment of Cancer (EORTC 05963). Proc ASCO. 2004;(14S (July 15 Suppl.)):3526
  31. Garufi C, Dogliotti L, D’Attino RM, et al. Irinotecan and chronomodulated infusion of 5-fluorouracil and folinic acid in the treatment of patients with advanced colorectal carcinoma: a phase I study. Cancer. 2001;91(4):712–720
  32. Liu PY, LeBlanc M, Desai M. False positive rates of randomized phase II designs. Control Clin Trials. 1999;20(4):343–352
  33. Kliche KO, Kubsch K, Raida M, et al. Chronomodulated chemotherapy in metastatic gastrointestinal cancer combining 5-FU and sodium folinate with oxaliplatin, irinotecan or gemcitabine: the Jena experience in 79 patients. J Cancer Res Clin Oncol. 2002;128(9):516–524
  34. Falcone A, Allegrini G, Masi G, et al. 5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: a randomized phase II study in metastatic colorectal cancer. Oncology. 2001;61(1):28–35
  35. Focan C, Kreutz F, Focan-Henrard D, et al. Chronotherapy with 5-fluorouracil, folinic acid and carboplatin for metastatic colorectal cancer; an interesting therapeutic index in a phase II trial. Eur J Cancer. 2000;36(3):341–347
  36. Price TJ, Ross PJ, Hickish T, et al. Phase III study of mitomycin-C with protracted venous infusion or circadian-timed infusion of 5-fluorouracil in advanced colorectal carcinoma. Clin Colorectal Cancer. 2004;3(4):235–242
  37. Garufi C, Bria E, Vanni B, et al. A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Br J Cancer. 2003;89(10):1870–1875

PII: S0959-8049(05)01074-9

doi: 10.1016/j.ejca.2005.11.017

European Journal of Cancer
Volume 42, Issue 5 , Pages 574-581 , March 2006

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