Implications of circadian clocks for the rhythmic delivery of cancer therapeutics

Advanced Drug Delivery Reviews

Volumn 59, Issue 9-10, 2007, Pages 1015-1035

  Lévi, Francis ^a,b,c   Focan, Christian ^d   Karaboué, Abdoulaye ^a,b,c   de la Valette, Virginie ^a,b,c   Focan Henrard, Danielle ^d   Baron, Benoît ^b   Kreutz, Françoise ^d   Giacchetti, Sylvie ^a,b,c  

^a HÔPITAL PAUL BROUSSE   (France)

^b UNIVERSITÉ PARIS SACLAY   (France)

^c ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^d Clinique Saint Joseph   (Belgium)

Author keywords

Chronotherapeutics; Circadian; Clinical trials; Colorectal cancer; Fluorouracil; Gender; Leucovorin; Oxaliplatin; Temporal drug delivery

Indexed keywords

CELL PROLIFERATION; METABOLISM; ONCOLOGY; PATIENT TREATMENT; PHYSIOLOGY; TUMORS;

CANCER THERAPEUTICS; CHRONOTHERAPEUTICS; CIRCADIAN TIMING SYSTEMS; CLINICAL TRIALS; COLORECTAL CANCER; FLUOROURACIL;

DRUG DELIVERY;

ALIZAPRIDE; BUSULFAN; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; ETOPOSIDE; FLUOROURACIL; FOLINIC ACID; GRANISETRON; MERCAPTOPURINE; METHOTREXATE; ONDANSETRON; OXALIPLATIN; PIRARUBICIN; VINBLASTINE; VINDESINE;

ADULT; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; BLOOD TOXICITY; CANCER SURVIVAL; CANCER THERAPY; CHRONOPHARMACOLOGY; CHRONOTHERAPY; CIRCADIAN RHYTHM; CLINICAL TRIAL; COLORECTAL CANCER; DIARRHEA; DOSE TIME EFFECT RELATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL TOXICITY; HEMATOLOGIC DISEASE; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; REVIEW; SENSORY NEUROPATHY; SKIN TOXICITY; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CIRCADIAN RHYTHM; CLINICAL TRIALS AS TOPIC; COLONIC NEOPLASMS; FLUOROURACIL; HUMANS; LUNG NEOPLASMS; ORGANOPLATINUM COMPOUNDS; TIME FACTORS;

EID: 35148845723     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2006.11.001     Document Type: Review

References (109)

1. Mormont M.C., and Lévi F. Cancer chronotherapy: principles, applications and perspectives. Cancer 97 (2003) 155-169
2. Clairambault J. Modelling oxaliplatin drug delivery to circadian rhythms in drug metabolism and host tolerance. Adv. Drug Delivery Rev. 59 (2007) 1054-1068 10.1016/j.addr.2006.08.004 (this issue)
3. Altinok A., Lévi F., and Goldbeter A. A cell cycle automaton model for probing circadian patterns of anticancer drug delivery. Adv. Drug Delivery Rev. 59 (2007) 1036-1053 10.1016/j.addr.2006.09.022 (this issue)
4. Hastings M.H., Reddy A.B., and Maywood E.S. A clockwork web: circadian timing in brain and periphery, in health and disease. Nat. Rev. Neurosci. 4 (2003) 649-661
5. Lévi F., and Schibler U. Circadian rhythms: mechanisms and therapeutic implications. Annu. Rev. Pharmacol. Toxicol. 47 (2007) 593-628
6. Fu L., and Lee C.C. The circadian clock: pacemaker and tumour suppressor. Nature 3 (2003) 350-361
7. Matsuo T., Yamaguchi S., Mitsui S., Emi A., Shimoda F., and Okamura H. Control mechanism of the circadian clock for timing of cell division in vivo. Science 302 (2003) 255-259
8. Delaunay F., Gréchez A., Rayet B., Guillaumond F., and Teboul M. Liens moléculaires entre oscillateurs circadiens et cycle cellulaire, 38ème Congrès de la Société Francophone de Chronobiologie (2006), France, Lyon [9-11 May]
9. Gery S., Komatsu N., Baldjyan L., Yu A., Koo D., and Koeffler H.P. The circadian gene per1 plays an important role in cell growth and DNA damage control in human cancer cells. Mol. Cell 22 (2006) 375-382
10. Granda T.G., Liu X.H., Smaaland R., Cermakian N., Filipski E., Sassone-Corsi P., and Lévi F. Circadian regulation of cell cycle and apoptosis proteins in mouse bone marrow and tumour. FASEB J. 19 (2005) 304-306
11. 6-methylguanine-DNA methyltransferase activity in mouse liver. Anticancer Drugs 7 (1996) 1-7
12. Marchenay C., Cellarier E., Lévi F., Rolhion C., Kwiatkowski F., Dubray C., Claustrat B., Madelmont J.C., and Chollet P. Circadian variation in O6-alkylguanine-DNA alkyltransferase activity in circulating blood mononuclear cells of healthy human subjects. Int. J. Cancer 91 (2001) 60-66
13. van der Horst G.T.J., Muijtjens M., Kobayashi K., Takano R., Kanno S., Takao M., de Wit J., Verkerk A., Eker A.P.M., van Leenen D., Buijs R., Bootsma D., Hoeijmakers J.H.J., and Yasui A. Mammalian blue-light photoreceptor homologs CRY1 and CRY2 are essential for maintenance of circadian rhythms. Nature 398 (1999) 627-630
14. Filipski E., Delaunay F., King V.M., Wu M.W., Claustrat B., Gréchez-Cassiau A., Guettier C., Hastings M.H., and Lévi F. Effects of chronic jet lag on malignant growth in mice. Cancer Res. 64 (2004) 7879-7885
15. Koyanagi S., Kuramoto Y., Nakagawa H., Aramaki H., Ohdo S., Soeda S., and Shimeno H. A molecular mechanism regulating circadian expression of vascular endothelial growth factor in tumor cells. Cancer Res. 63 (2003) 7277-7283
16. You S., Wood P.A., Xiong Y., Kobayashi M., Du-Quiton J., and Hrushesky W.J. Daily coordination of cancer growth and circadian clock gene expression. Breast Cancer Res. Treat. 91 (2005) 47-60
17. Iurisci, Filipski E., Reinhardt J., Bach S., Gianella-Borradori A., Iacobelli S., Meijer L., and Levi F. Improved tumor control through circadian clock induction by seliciclib, a cyclin-dependent kinase inhibitor. Cancer Res. 66 (2006) 10720-10728
18. Nagoshi E., Saini C., Bauer C., Laroche T., Naef F., and Schibler U. Circadian gene expression in individual fibroblasts: cell-autonomous and self-sustained oscillators pass time to daughter cells. Cell 119 (2004) 693-705
19. Yeh K.T., Yang M.Y., Liu T.C., Chen J.C., Chan W.L., Lin S.F., and Chang J.G. Abnormal expression of period 1 (PER1) in endometrial carcinoma. J. Pathol. 206 (2005) 111-120
20. Chen S.T., Choo K.B., Hou M.F., Yeh K.T., Kuo S.J., and Chang J.G. Deregulated expression of the PER1; PER2 and PER3 genes in breast cancers. Carcinogenesis 26 (2005) 1241-1246
21. Gery S., Gombart A.F., Yi W.S., Koeffler C., Hofmann W.-K., and Koeffler H.P. Transcription profiling of C/EBP targets identifies Per2 as a gene implicated in myeloid leukaemia. Blood 106 (2005) 2827-2836
22. Pogue-Geile K.L., Lyons-Weiler J., and Whitcomb D.C. Molecular overlap of fly circadian rhythms and human pancreatic cancer. Cancer Lett. 243 (2006) 55-57
23. Granda T.G., and Lévi F. Tumor-based rhythms of anticancer efficacy in experimental models. Chronobiol. Int. 19 (2002) 21-41
24. Garcia-Sainz M., and Halberg F. Mitotic rhythms in human cancer reevaluated by electronic computer programs. Evidence for chronopathology. J. Natl. Cancer Inst. 37 (1966) 279-292
25. Klevecz R., Shymko R., and Braly P. Circadian gating of S phase in human ovarian cancer. Cancer Res. 47 (1987) 6267-6271
26. Smaaland R., Lote K., Sothern R.B., and Laerum O.D. DNA synthesis and ploidy in non-Hodgkin's lymphomas demonstrate variation depending on circadian stage of cell sampling. Cancer Res. 53 (1993) 3129-3138
27. Gachon F., Olela F.F., Schaad O., Descombes P., and Schibler U. The circadian PAR-domain basic leucine zipper transcription factors DBP, TEF, and HLF modulate basal and inducible xenobiotic detoxification. Cell Metab. 4 1 (2006) 25-36
28. Lévi F. Circadian chronotherapy for human cancers. Lancet Oncol. 2 (2001) 307-315
29. Lévi F., Hrushesky W., Blomsquit J., Lakatua D., Haus E., Halberg F., and Kennedy B.J. Reduction of cis-diamminedichloroplatinum nephrotoxicity in rats by optimal circadian drug timing. Cancer Res. 42 (1982) 950-955
30. Boughattas N., Lévi F., Fournier C., Lemaigre G., Roulon A., Hecquet B., Mathé G., and Reinberg A. Circadian rhythms in toxicities and tissues uptake of oxaliplatin in mice. Cancer Res. 49 (1989) 3362-3368
31. Boughattas N., Lévi F., Hecquet B., Lemaigre G., Roulon A., Fournier A., and Reinberg A. Circadian time dependence of murine tolerance for carboplatin. Toxicol. Appl. Pharmacol. 96 (1988) 233-247
32. Boughattas N., Lévi F., Fournier C., Hecquet B., Lemaigre G., Roulon A., Mathé G., and Reinberg A. Stable circadian mechanisms of toxicity of two platinum analogs (cisplatin and carboplatin) despite repeated dosages in mice. J. Pharmacol. Exp. Ther. 255 (1990) 672-679
33. Lévi F. Circadian rhythms in 5-fluorouracil pharmacology and therapeutic applications. In: Rustum Y. (Ed). Fluoropyrimidines in cancer therapy (2003), The Humana Press Inc., New Jersey 107-128
34. Boughattas N.A., Hecquet B., Fournier C., Bruguerolle B., Trabelski H., Bouzouita K., Omrane B., and Lévi F. Comparative pharmacokinetics of oxaliplatin (L-OHP) and carboplatin (CBDCA) in mice with reference to circadian dosing time. Biopharm. Drug Dispos. 15 (1994) 761-773
35. Li X.M., Metzger G., Filipski E., Boughattas N., Lemaigre G., Hecquet B., Filipski J., and Lévi F. Pharmacologic modulation of reduced glutathione (GSH) circadian rhythms by buthionine sulfoximine (BSO) : relationship with cisplatin (CDDP) toxicity in mice. Toxicol. Appl. Pharmacol. 143 (1997) 281-290
36. El Kouni M.H., Naguib F.N.M., Park K.S., Cha S., Darnowski J.W., and Soong S.J. Circadian rhythm of hepatic uridine phosphorylase activity and plasma concentration of uridine in mice. Biochem. Pharmacol. 40 (1990) 2479-2485
37. Zhang R., Lu Z., Liu T., Soong S.J., and Diasio R.B. Relationship between circadian-dependent toxicity of 5-fluorodeoxyuridine and circadian rhythms of pyrimidine enzymes: possible relevance to fluoropyrimidine chemotherapy. Cancer Res. 53 (1993) 2816-2822
38. II Lincoln D.W., Hrushesky W.J., and Wood P.A. Circadian organization of thymidylate synthase activity in normal tissues: a possible basis for 5-fluorouracil chronotherapeutic advantage. Int. J. Cancer 88 (2000) 479-485
39. Porsin B., Formento J.L., Filipski E., Etienne M.C., Francoual M., Renée N., Lévi F., and Milano G. Dihydropyrimidine dehydrogenase circadian rhythm in both enzyme activity and gene expression from mouse liver. Eur. J. Cancer 39 (2003) 822-828
40. Milano G., and Chamorey A.L. Clinical pharmacokinetics of 5 fluorouracil with considerations on chronopharmacokinetics. Chronobiol. Int. 19 (2002) 177-189
41. Haus E., Halberg F., Pauly J.E., Cardoso S., Kuhl J.F., Sothern R.B., Shiotsuka R.N., and Hwang D.S. Increased tolerance of leukemic mice to arabinosylcytosine with schedule-adjusted to circadian system. Science 177 (1972) 80-82
42. Sothern R., Lévi F., Haus E., Halberg F., and Hrushesky W.J.M. Control of a murine plasmacytoma with doxorubicin-cisplatin: dependence on circadian stage of treatment. J. Natl. Cancer Inst. 81 (1989) 135-145
43. Filipski E., Amat S., Lemaigre G., Vincenti M., Breillout F., and Lévi F. Relationship between circadian rhythm of vinorelbine toxicity and efficacy in P388-bearing mice. J. Pharm. Exp. Ther. 289 (1999) 231-235
44. Tampellini M., Filipski E., Liu X.-H., Lemaigre G., Li X.-M., Vrignaud P., François E., Bissery M.C., and Lévi F. Docetaxel chronopharmacology in mice. Cancer Res. 58 (1998) 3896-3904
45. Granda T.G., Filipski E., D'Attino R.M., Vrignaud P., Anjo A., Bissery M.C., and Lévi F. Experimental chronotherapy of mouse mammary adenocarcinoma MA13/C with docetaxel and doxorubicin as single agents and in combination. Cancer Res. 61 (2001) 1996-2001
46. Granda T.G., D'Attino R.M., Filipski E., Vrignaud P., Garufi C., Terzoli E., Bissery M.C., and Lévi F. Circadian optimization of irinotecan and oxaliplatin efficacy in mice with Glasgow osteosarcoma. Br. J. Cancer 86 (2002) 999-1005
47. Koyanagi S., Nakagawa H., Kuramoto Y., Ohdo S., Soeda S., and Shimeno H. Optimizing the dosing schedule of TNP-470 [O-(chloroacetyl-carbamoyl) fumagillol] enhances its antitumor and antiangiogenic efficacies. J. Pharmacol. Exp. Ther. 304 (2003) 669-674
48. Li X.M., Tanaka K., Sun J., Filipski E., Kayitalire L., Focan C., and Lévi F. Preclinical relevance of dosing time for the therapeutic index of gemcitabine-cisplatin. Br. J. Cancer 92 (2005) 1684-1689
49. Ohdo S., Koyanagi S., Suyama H., Higuchi S., and Aramaki H. Changing the dosing schedule minimizes the disruptive effects of interferon on clock function. Nat. Med. 7 (2001) 356-360
50. 1 mice. Chronobiol. Int. 19 (2002) 43-55
51. Li X.M., Kanekal S., Crépin D., Guettier C., Carrière J., Elliott G., and Lévi F. Circadian pharmacology of l-alanosine (SDX-102) in mice. Mol. Cancer Ther. 5 (2006) 337-346
52. Focan C. In: Chronotherapeutics P., and Redfern (Eds). Rhythms of cancer chemotherapy, in: P. Redfern (Ed.), Chronotherapeutics (2003), Pharmaceutical Press, London 235-282
53. Metzger G., Massari C., Etienne M.C., Commisso M., Brienza S., Touitou Y., Milano G., Bastian G., Misset J.L., and Lévi F. Spontaneous or imposed circadian changes in plasma concentrations of 5-fluorouracil coadministered with folinic acid and oxaliplatin: relationship with mucosal toxicity in cancer patients. Clin. Pharmacol. Ther. 56 (1994) 190-201
54. Harris B., Song R., Soong S., and Diasio R.B. Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels: evidence for circadian variation of plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Res. 50 (1990) 197-201
55. Zeng Z.L., Sun J., Guo L., Li S., Wu M.W., Qiu F., Jiang W.Q., Lévi F., and Xian L.J. Circadian rhythm in dihydropyrimidine dehydrogenase activity and reduced glutathione content in peripheral blood of nasopharyngeal carcinoma patients. Chronobiol. Int. 22 (2005) 741-754
56. Bjarnason G.A., and Jordan R. Rhythms in human gastrointestinal mucosa and skin. Chronobiol. Int. 19 (2002) 129-140
57. Smaaland R., Sothern R.B., Laerum O.D., and Abrahamsen J.F. Rhythms in human bone marrow and blood cells. Chronobiol. Int. 19 (2002) 101-127
58. Smaaland R., Laerum O.D., Lote K., Sletvold O., Sothern R.B., and Bjerknes R. DNA synthesis in human bonne marrow is circadian stage dependent. Blood 77 (1991) 2603-2611
59. Petit E., Milano G., Lévi F., Thyss A., Bailleul F., and Schneider M. Circadian varying plasma concentration of 5-FU during 5-day continuous venous infusion at constant rate in cancer patients. Cancer Res. 48 (1988) 1676-1679
60. Focan C. Sequential chemotherapy and circadian rhythm in human solid tumors. Cancer Chemother. Pharmacol. 3 (1979) 197-202
61. Rivard G., Infante-Rivard C., Hoyeux C., and Champagne J. Maintenance chemotherapy for childhood acute lymphoblastic leukemia: better in the evening. Lancet 2 (1985) 1264-1266
62. Schmiegelow K., Glomstein A., Kristinsson J., Salmi T., Schroder H., and Bjork O. Impact of morning versus evening schedule for oral methotrexate and 6-mercaptopurine on relapse risk for children with acute lymphoblastic leukemia. Nordic Society for Pediatric Hematology and Oncology (NOPHO). J. Pediatr. Hematol./Oncol. 19 (1997) 102-109
63. Hrushesky W. Circadian timing of cancer chemotherapy. Science 228 (1985) 73-75
64. Lévi F., Benavides M., Chevelle C., Le Saulnier F., Bailleul F., Misset J.L., Regensberg C., Vannetzel J.M., Reinberg A., and Mathé G. Chemotherapy of advanced ovarian cancer with 4'-0-tetrahydropyranyl doxorubicin (THP) and cisplatin: a phase II trial with an evaluation of circadian timing and dose intensity. J. Clin. Oncol. 8 (1990) 705-714
65. Lévi F. From circadian rhythms to cancer chronotherapeutics. Chronobiol. Int. 19 (2002) 1-19
66. Advanced Colorectal Cancer Meta-analysis Project (Piedbois P. et al.). Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. J. Clin. Oncol. 10 (1992) 896-903
67. Lévi F., Misset J.L., Brienza S., Adam R., Metzger G., Itzakhi M., Caussanel J.P., Kunstlinger F., Lecouturier S., Descorps-Declère A., Jasmin C., Bismuth H., and Reinberg A. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid and oxaliplatinum using an ambulatory multichannel programmable pump: high antitumor effectiveness against metastatic colorectal cancer. Cancer 69 (1992) 893-900
68. Lévi F., Zidani R., Vannetzel J.M., Perpoint B., Focan C., Faggiuolo R., Chollet P., Garufi C., Itzhaki M., Dogliotti L., Iacobelli S., Adam R., Kunstlinger F., Gastiaburu J., Bismuth H., Jasmin C., and Misset J.L. Chronomodulated versus fixed infusion rate delivery of ambulatory chemotherapy with oxaliplatin, 5-fluorouracil and folinic acid in patients with colorectal cancer metastases. A randomized multiinstitutional trial. J. Natl. Cancer Inst. 86 (1994) 1608-1617
69. Lévi F., Zidani R., Misset J.L., and for the International Organization for Cancer Chronotherapy. Randomized multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. Lancet 350 (1997) 681-686
70. Bertheault-Cvitkovic F., Jami A., Ithzaki M., Deprés-Brummer P., Brienza S., Adam R., Bismuth H., Misset J.L., and Lévi F. Biweekly intensified ambulatory chronomodulated chemotherapy with oxaliplatin, 5-fluorouracil and folinic acid in patients with metastatic colorectal cancer. J. Clin. Oncol. 14 (1996) 2950-2958
71. Lévi F., Zidani R., Brienza S., Dogliotti L., Perpoint B., Rotarski M., Letourneau Y., Llory J.F., Chollet P., Le Rol A., Focan, and International Organization for Cancer Chronotherapy C. A multicenter evaluation of intensified ambulatory chronomodulated chemotherapy with oxaliplatin, fluorouracil and leucovorin as initial treatment of patients with metastatic colorectal cancer. Cancer 85 (1999) 2532-2540
72. Giacchetti S., Itzhaki M., Gruia G., Adam R., Zidani R., Deprés-Brummer P., Bleuzen P., Bertheault-Cvitkovic F., Kunstlinger F., Brienza S., Jasmin C., Alafaci E., Reynes M., Bismuth H., Misset J.L., and Lévi F. Long term survival of patients with unresectable colorectal cancer liver metastases following infusional chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and surgery. Ann. Oncol. 10 (1999) 663-669
73. Adam R., Delvart V., Pascal G., Valeanu A., Castaing D., Azoulay D., Giacchetti S., Brézeault-Bonnet C., Paule B., Kunstlinger F., Ghémard O., Lévi F., and Bismuth H. Rescue surgery for non-resectable colorectal liver metastases downstaged by chemotherapy: a model to predict long-term survival. Ann. Surgery 240 (2004) 644-658
74. De Gramont A., Vignoud J., Tournigand C., Louvet C., André T., Varette C., Raymond E., Moreau S., Le Bail N., and Krulik M. Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. Eur. J. Cancer 33 (1997) 214-219
75. Giacchetti S., Bjarnason G., Garufi C., Genet D., Iacobelli S., Tampellini M., Smaaland R., Focan C., Coudert B., Humblet Y., Canon J.L., Adenis A., Lo Re G., Carvalho C., Schueller J., Anciaux N., Lentz M.A., Baron B., Gorlia T., Lévi F., and on behalf the Chronotherapy Group of EORTC. Phase III trial of 4-day chronomodulated vs 2-day conventional delivery of 5-fluorouracil, leucovorin and oxaliplatin as first line chemotherapy of metastatic colorectal cancer by the EORTC chronotherapy group. J. Clin. Oncol. 24 (2006) 3562-3569
76. Focan C., Bastens B., Driesschaert P., Mendes P., Lévi F., Pujol J.L., and Thyss A. Circadian tolerance to etoposide and cisplatin as first line treatment for advanced lung carcinoma. Ann. Rev. Chronopharmacol. 7 (1990) 219-222
77. Krakowski I., Lévi F., Mechkouri M., Conroy T., Luporsi E., Weber B., and Metz R. Dose-intensity of etoposide-cisplatin depends upon dosing time. Annu. Rev. Chronopharmacol. 5 (1988) 373-376
78. Vincent M., Lévi F., Girodet B., Laennec E., Poirie P., Guibert B., Ardiet J.M., Boisson A., and Van-Straaten L. Circadian chemotherapy against IIIB-IV non-small-cell lung cancer (NSCLC) with 5-fluorouracil (5-FU) and cisplatinum (CDDP) via a multichannel programmable pump. Proc. XVIIth Cong. Eur. Soc. Med. Oncol., Lyon, France, 7-10 Nov., 1992. Ann. Oncol. 3 (1992) 129
79. Focan C., Denis B., Kreutz F., Focan-Henrard D., and Lévi F. Ambulatory chronotherapy with 5-fluorouracil, folinic acid and carboplatin for advanced non small cell lung cancer. A Phase II feasibility trial. J. Infus. Chemother. 5 (1995) 148-152
80. Focan C. Chronobiological concepts underlying the chronotherapy of human lung cancer. Chronobiol. Int. 19 (2002) 253-273
81. In: DeVita V.T., Hellman S., and Rosenberg S.A. (Eds). Cancer: Principles and Practice of Oncology. 7th edition (2005), Lippincott Co, Philadelphia 3120
82. Simon R. Design and conduct of clinical trials. Chapter 19. In: De Vita V., Hellman S., and Rosenberg S. (Eds). Cancer. Principles and practice of Oncology. Fourth edition (1993), Lippincott Co, Philadelphia 418-441
83. Baron B., Legrand C., Lévi F., and Hoctin-Boes G. Chronomodulation: optimal time finding design. Proc. Society of Clinical Trials Meeting (2001), Denver, U.S.A. May 20-23
84. Iurisci I., Beau J., Karaboué A., Giacchetti S., Innominato P., Carnino S., Laskowski P., Richard S., Iacobelli S., Jasmin C., and Lévi F. Prolonged monitoring of rest-activity rhythm for assessing chemotherapy effects on circadian system. Chronobiol. Int. 22 (2005) 1176-1178
85. Lévi F. Chronothérapie par oxaliplatine, 5-fluorouracile et acide folinique. Essai randomisé multicentrique de Phase III d'une administration en perfusion veineuse continue de 5 jours à débits constants ou chronomodulés, Report on file, Chronotherapy unit, Paul Brousse hospital, Villejuif, France (1994)
86. Chronotherapy Group of the European Organisation for Research and Treatment of Cancer. First line infusional 5-FU, folinic acid and oxaliplatin for metastatic colorectal cancer or loco-regional recurrency. Role of chronomodulated delivery upon survival. A multicenter randomized Phase III trial, Reports on file, Chronotherapy unit, Paul Brousse hospital, Villejuif, France (2005)
87. Grothey A., Sargent D., Goldberg R.M., and Schmoll H.J. 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. 22 (2004) 1209-1214
88. Pandi-Perumal S.R., Srinivas V., Maestroni G.J., Cardinali D.P., Poeggeler B., and Hardeland R. Melatonin. FEBS J. 273 (2006) 2813-2838
89. Li X.M., Liu X.H., Filipski E., Metzger G., Delagrange P., Jeanniot J.P., and Lévi F. Relationship of atypical melatonin rhythm with two circadian clock outputs in B6D2F1 mice. Am. J. Physiol., Regul. Integr. Comp. Physiol. 278 (2000) R924-R930
90. Mormont M.C., Langouët A.M., Claustrat B., Bogdan A., Marion S., Waterhouse J., Touitou Y., and Lévi F. Marker rhythms of the circadian system function: a study in patients with metastatic colorectal cancer and good performance status. Chronobiol. Int. 19 (2002) 141-156
91. Bouchahda M., Adam R., Giacchetti S., Li X.M., Castaing D., Gholam D., Kunstlinger F., Jasmin C., Machover D., and Lévi F. Effective salvage therapy of liver-only colorectal cancer metastases with chronomodulated irinotecan-fluorouracil-oxaliplatin via hepatic artery infusion, Proc. 42nd Annual Meeting Am. Soc. Clin. Oncol., Atlanta, USA, June 2-6 2006. J. Clin. Oncol. 24 18 S (2006) 167s (abstr. 3585)
92. Santini D., Vincenzi B., La Cesa A., Caricato M., Schiavon G., Spalletta B., Di Seri M., Coppola R., Rocci L., and Tonini G. Continuous infusion of oxaliplatin plus chronomodulated capecitabine in 5-fluorouracil-and irinotecan-resistant advanced colorectal cancer patients. Oncology 69 (2005) 27-34
93. Coudert B., Focan C., di Paola D., Lévi F., and for the EORTC Chronotherapy Group. It's time for chronotherapy!. Eur. J. Cancer 38 (2002) S50-S53 (Suppl)
94. Garufi C., Vanni B., Aschelter A.M., Zappala A.R., Bria E., Nistico C., Sperduti I., Cognetti F., and Terzolia E. 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 42 (2006) 608-616
95. Milano G., Etienne M.C., and Cassuto-Viguier E. Influence of sex and age on fluorouracil clearance. J. Clin. Oncol. 10 (1992) 1171-1175
96. Mattison L., Soong R., and Diasio R.B. Implications of dihydropyrimidine dehydrogenase on 5-fluorouracil pharmacogenetics and pharmacogenomics. Pharmacogenomics 3 (2002) 485-492
97. Bressolle F., Joulia J.M., and Pinguet F. Circadian rhythm of 5-fluorouracil population pharmacokinetics in patients with metastatic colorectal cancer. Cancer Chemother. Pharmacol. 44 (1999) 295-302
98. Rich T., Innominato P.F., Boerner J., Mormont M.C., Iacobelli S., Baron B., Jasmin C., and Lévi F. Elevated serum cytokines correlated with altered behaviour, serum cortisol rhythm, and dampened 24 hour rest-activity patterns in patients with metastatic colorectal cancer. Clin. Cancer Res. 11 (2005) 1757-1764
99. Kramer A., Yang F.C., Snodgrass P., Li X., Scammell T.E., Davis F.C., and Weitz C.J. Regulation of daily locomotor activity and sleep by hypothalamic EGF receptor signaling. Science 294 (2001) 2511-2515
100. Motzkus D., Albrecht U., and Maronde E. The human Per 1 gene is inducible by interleukin-6. J. Mol. Neurosci. 18 (2002) 105-109
101. Monteleone P., Esposito G., La Rocca A., and Maj M. Does bright light suppress nocturnal melatonin secretion more in women than men?. J. Neural Transm. Gen. Sect. 102 (1995) 75-80
102. Burke H.M., Davis M.C., Otte C., and Mohr D.C. Depression and cortisol responses to psychological stress: a meta-analysis?. Psychoneuroendocrinology 30 (2005) 846-856
103. Filipski E., King V.M., Li X.M., Granda T., Mormont M.C., Liu X.H., Claustrat B., Hastings M.H., and Lévi F. Host circadian clock as a control point in tumor progression. J. Natl. Cancer Inst. 94 (2002) 690-697
104. Filipski E., Innominato P.F., Wu M.W., Li X.M., Iacobelli S., Xian L.J., and Lévi F. Effects of light and food schedules on liver and tumor molecular clocks. J. Natl. Cancer Inst. 97 (2005) 507-517
105. Mormont M.C., Waterhouse J., Bleuzen P., Giacchetti S., Jami A., Bogdan A., Lellouch J., Misset J.L., Touitou Y., and Lévi F. Marked 24-h rest-activity rhythms are associated with better quality of life, better response and longer survival in patients with metastatic colorectal cancer and good performance status. Clin. Cancer Res. 6 (2000) 3038-3045
106. Sephton S.E., Sapolsky R.M., Kraemer H.C., and Spiegel D. Diurnal cortisol rhythm as a predictor of breast cancer survival. J. Natl. Cancer Inst. 92 (2000) 994-1000
107. Lévi F., Zidani R., Focan C., Garufi C., Chollet P., Iacobelli S., Dogliotti L., Le Rol A., Giacchetti S., and Jasmin C. Age-independent benefit of chronotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with metastatic colorectal cancer within multicenter randomized Phase III trials. Am. Soc. Clin. Oncol. 21 (2002) 358a (abstr. # 1431)
108. Gorbacheva V.Y., Kondratov R.V., Zhang R., Cherukuri S., Gudkov A.V., Takahashi J.S., and Antoch M.P. Circadian sensitivity to the chemotherapeutic agent cyclophosphamide depends on the functional status of the CLOCK_BMAL1 transactivation complex. PNAS 102 (2005) 3407-3412 10
109. Shih M.C., Yeh K.T., Tang R.P., Chen J.C., and Chang J.G. Promoter methylation in circadian genes of endometrial cancers detected by methylation specific PCR. Mol. Carcinog. 45 (2006) 732-740