Prediction of survival by neutropenia according to delivery schedule of oxaliplatin-5-fluorouracil-leucovorin for metastatic colorectal cancer in a randomized international trial (EORTC 05963)

Chronobiology International

Volumn 28, Issue 7, 2011, Pages 586-600

  Innominato, Pasquale F ^a,b,c   Giacchetti, Sylvie ^a,b,c,d   Moreau, Thierry ^b,e   Smaaland, Rune ^f   Focan, Christian ^g   Bjarnason, Georg A ^h   Garufi, Carlo ⁱ   Iacobelli, Stefano ^j   Tampellini, Marco ^k   Tumolo, Salvatore ^l   Carvalho, Carlos ^m   Karaboué, Abdoulaye ^a,b,c   Lévi, Francis ^a,b,c  

^a INSERM   (France)

^b UNIVERSITÉ PARIS SACLAY   (France)

^c HÔPITAL PAUL BROUSSE   (France)

^d SAINT LOUIS HOSPITAL   (France)

^e CENTRE FOR RESEARCH IN EPIDEMIOLOGY AND POPULATION HEALTH   (France)

^f STAVANGER UNIVERSITY HOSPITAL   (Norway)

^g Clinique Saint Joseph   (Belgium)

^h DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

ⁱ REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^j UNIVERSITY OF CHIETI   (Italy)

^k SAN LUIGI GONZAGA HOSPITAL   (Italy)

^l S MARIA DEGLI ANGELI HOSPITAL   (Italy)

^m F Fonseca Hospital   (Portugal)

more..

Author keywords

Chemotherapy; Chronotherapy; Circadian; Colorectal cancer; Neutropenia; Prognostic factor

Indexed keywords

ANTINEOPLASTIC AGENT; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; PLATINUM COMPLEX;

ADULT; AGED; ARTICLE; BIOLOGICAL RHYTHM; CHEMICALLY INDUCED DISORDER; CIRCADIAN RHYTHM; CLINICAL TRIAL; COLORECTAL TUMOR; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; FEMALE; HUMAN; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MIDDLE AGED; NEUTROPENIA; PATHOLOGY; PHYSIOLOGY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; SURVIVAL; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOLOGICAL CLOCKS; CIRCADIAN RHYTHM; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; NEUTROPENIA; ORGANOPLATINUM COMPOUNDS; PROGNOSIS; SURVIVAL ANALYSIS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80052071637     PISSN: 07420528     EISSN: 15256073     Source Type: Journal    
DOI: 10.3109/07420528.2011.597532     Document Type: Article

References (63)

1. Abrahamsen JF, Smaaland R, Sothern RB, Laerum OD. (1997). Circadian cell cycle variations of erythro- and myelopoiesis in humans. Eur. J. Haematol. 58:333-345. (Pubitemid 27286666)
2. Bjarnason GA, Jordan R. (2002). Rhythms in human gastrointestinal mucosa and skin. Chronobiol. Int. 19:129-140. (Pubitemid 34310823)
3. Bjarnason GA, Jordan RC, Sothern RB. (1999). Circadian variation in the expression of cell-cycle proteins in human oral epithelium. Am. J. Pathol. 154:613-622. (Pubitemid 29094110)
4. Bjarnason GA, Jordan RC, Wood PA, Li Q, Lincoln DW, Sothern RB, Hrushesky WJ, Ben-David Y. (2001). Circadian expression of clock genes in human oral mucosa and skin: Association with specific cell-cycle phases. Am. J. Pathol. 158:1793-1801. (Pubitemid 32422944)
5. Bross ID, Rimm AA, Slack NH, Ausman RK, Jones R (1966). Is toxicity really necessary? I. The question. Cancer 19:1780-1784.
6. Buchi KN, Moore JG, Hrushesky WJ, Sothern RB, Rubin NH. (1991). Circadian rhythm of cellular proliferation in the human rectal mucosa. Gastroenterology 101:410-415.
7. Chansky K, Benedetti J, Macdonald JS. (2005). Differences in toxicity between men and women treated with 5-fluorouracil therapy for colorectal carcinoma. Cancer 103:1165-1171. (Pubitemid 40328086)
8. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N, Carteni G, Agostara B, Pezzella G, Manzione L, Borsellino N, Misino A, Romito S, Durini E, Cordio S, Di Seri M, Lopez M, Maiello E, Montemurro S, Cramarossa A, Lorusso V, Di Bisceglie M, Chiarenza M, Valerio MR, Guida T, Leonardi V, Pisconti S, Rosati G, Carrozza F, Nettis G, Valdesi M, Filippelli G, Fortunato S, Mancarella S, Brunetti C. (2005). Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: A multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J. Clin. Oncol. 23:4866-4875. (Pubitemid 46223991)
9. Cunningham D, Sirohi B, Pluzanska A, Utracka-Hutka B, Zaluski J, Glynne-Jones R, Koralewski P, Bridgewater J, Mainwaring P, Wasan H, Wang JY, Szczylik C, Clingan P, Chan RT, Tabah-Fisch I, Cassidy J. (2009). Two different first-line 5-fluorouracil regimens with or without oxaliplatin in patients with metastatic colorectal cancer. Ann. Oncol. 20:244-250.
10. de Gramont A, Vignoud J, Tournigand C, Louvet C, Andre T, Varette C, Raymond E, Moreau S, Le Bail N, Krulik M. (1997). Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. Eur. J. Cancer 33:214-219.
11. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. (2000). Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J. Clin. Oncol. 18:2938-2947. (Pubitemid 30644117)
12. Diasio RB, Lu Z. (1994). Dihydropyrimidine dehydrogenase activity and fluorouracil chemotherapy. J. Clin. Oncol.12:2239-2242. (Pubitemid 24346689)
13. Dibner C, Schibler U, Albrecht U. (2010). The Mammalian circadian timing system: Organization and coordination of central and peripheral clocks. Annu. Rev. Physiol. 72:517-549.
14. Felici A, Verweij J, Sparreboom A. (2002). Dosing strategies for anticancer drugs: The good, the bad and body-surface area. Eur. J. Cancer 38:1677-1684.
15. Filipski E, King VM, Li X, Granda TG, Mormont MC, Liu X, Claustrat B, Hastings MH, Lévi F. (2002). Host circadian clock as a control point in tumor progression. J. Natl. Cancer Inst. 94:690-697. (Pubitemid 34552490)
16. Filipski E, Delaunay F, King VM, WuMW, Claustrat B, Grechez-Cassiau A, Guettier C, Hastings MH, Lévi F. (2004). Effects of chronic jet lag on tumor progression in mice. Cancer Res. 64:7879-7885. (Pubitemid 39446921)
17. Filipski E, Innominato PF, Wu M, Li XM, Iacobelli S, Xian LJ, Lévi F. (2005). Effects of light and food schedules on liver and tumor molecular clocks in mice. J. Natl. Cancer Inst. 97:507-517. (Pubitemid 40590432)
18. Frei E 3rd, Canellos GP. (1980). Dose: A critical factor in cancer chemotherapy. Am. J. Med. 69:585-594. (Pubitemid 10018715)
19. Gamelin E, Delva R, Jacob J, Merrouche Y, Raoul JL, Pezet D, Dorval E, Piot G, Morel A, Boisdron-Celle M. (2008). Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: Results of a multicenter randomized trial of patients with metastatic colorectal cancer. J. Clin. Oncol. 26:2099-2105.
20. Giacchetti S. (2002). Chronotherapy of colorectal cancer. Chronobiol. Int. 19:207-219. (Pubitemid 34310828)
21. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Lévi F. (2000). Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J. Clin. Oncol. 18:136-147 (Pubitemid 30036347)
22. Giacchetti S, Bjarnason G, Garufi C, Genet D, Iacobelli S, Tampellini M, Smaaland R, Focan C, Coudert B, Humblet Y, Canon JL, Adenis A, Lo Re G, Carvalho C, Schueller J, Anciaux N, Lentz MA, Baron B, Gorlia T, Lévi F. (2006). Phase III trial comparing 4-day chronomodulated therapy versus 2-day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: The European Organisation for Research and Treatment of Cancer Chronotherapy Group. J. Clin. Oncol. 24:3562-3569. (Pubitemid 46630527)
23. Granda TG, Lévi F. (2002). Tumor-based rhythms of anticancer efficacy in experimental models. Chronobiol. Int. 19:21-41. (Pubitemid 34310818)
24. Granda TG, D'Attino RM, Filipski E, Vrignaud P, Garufi C, Terzoli E, Bissery MC, Lévi F. (2002). Circadian optimisation of irinotecan and oxaliplatin efficacy in mice with Glasgow osteosarcoma. Br. J. Cancer 86:999-1005. (Pubitemid 34271040)
25. Harris BE, Song R, Soong SJ, Diasio RB. (1990). 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. 50:197-201. (Pubitemid 20030018)
26. Hrushesky WJ. (1985). Circadian timing of cancer chemotherapy. Science 228:73-75. (Pubitemid 15122991)
27. Hrushesky WJ, Bjarnason GA. (1993). Circadian cancer therapy. J. Clin. Oncol. 11:1403-1417. (Pubitemid 23199147)
28. Innominato PF, Focan C, Gorlia T, Moreau T, Garufi C, Waterhouse J, Giacchetti S, Coudert B, Iacobelli S, Genet D, Tampellini M, Chollet P, Lentz MA, Mormont MC, Lévi F, Bjarnason GA. (2009). Circadian rhythm in rest and activity: A biological correlate of quality of life and a predictor of survival in patients with metastatic colorectal cancer. Cancer Res. 69:4700-4707.
29. Innominato PF, Lévi FA, Bjarnason GA. (2010). Chronotherapy and the molecular clock: Clinical implications in oncology. Adv. Drug Deliv. Rev. 62:979-1001.
30. Kim JJ, Park JY, Kim DY, Kim JH, Kim YM, Nam JH, Kim YT. (2010). Is chemotherapy-induced neutropenia a prognostic factor in patients with ovarian canceř Acta Obstet. Gynecol. Scand. 89:623-628.
31. Kohne CH, Cunningham D, Di CF, Glimelius B, Blijham G, Aranda E, Scheithauer W, Rougier P, Palmer M, Wils J, Baron B, Pignatti F, Schoffski P, Micheel S, Hecker H. (2002). Clinical determinants of survival in patients with 5-fluorouracil-based treatment for metastatic colorectal cancer: Results of a multivariate analysis of 3825 patients. Ann. Oncol. 13:308-317. (Pubitemid 34704985)
32. Kvinnsland S. (1999). The leucocyte nadir, a predictor of chemotherapy efficacy? Br. J. Cancer 80:1681. (Pubitemid 29389618)
33. Lévi F. (2002). From circadian rhythms to cancer chronotherapeutics. Chronobiol. Int. 19:1-19. (Pubitemid 34310817)
34. Lévi F, Schibler U. (2007). Circadian rhythms: Mechanisms and therapeutic implications. Annu. Rev. Pharmacol. Toxicol. 47:593-628.
35. Lévi F, Benavides M, Chevelle C, Le Saunier F, Bailleul F, Misset JL, Regensberg C, Vannetzel JM, Reinberg A, Mathe G. (1990). Chemotherapy of advanced ovarian cancer with 4'-O-tetrahydropyranyl doxorubicin and cisplatin: A randomized phase II trial with an evaluation of circadian timing and dose-intensity. J. Clin. Oncol. 8:705-714. (Pubitemid 20127255)
36. Lévi F, Zidani R, Misset JL. (1997). Randomised multicentre trial of chronotherapy with oxaliplatin, fluorouracil, and folinic acid in metastatic colorectal cancer. International Organization for Cancer Chronotherapy. Lancet 350:681-686. (Pubitemid 27371165)
37. Lévi F, Zidani R, Brienza S, Dogliotti L, Perpoint B, Rotarski M, Letourneau Y, Llory JF, Chollet P, Le Rol A, Focan C. (1999). 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 85:2532-2540. (Pubitemid 29272737)
38. Lévi F, Filipski E, Iurisci I, Li XM, Innominato P. (2007a). Cross-talks between circadian timing system and cell division cycle determine cancer biology and therapeutics. Cold Spring Harb. Symp. Quant. Biol. 72:465-475.
39. Lévi F, Focan C, Karaboue A, de la Valette V, Focan-Henrard D, Baron B, Kreutz F, Giacchetti S. (2007b). Implications of circadian clocks for the rhythmic delivery of cancer therapeutics. Adv. Drug Deliv. Rev. 59:1015-1035. (Pubitemid 47542287)
40. Lévi F, Okyar A, Dulong S, Innominato PF, Clairambault J. (2010). Circadian timing in cancer treatments. Annu. Rev. Pharmacol. Toxicol. 50:377-421.
41. Liu AC, Lewis WG, Kay SA. (2007). Mammalian circadian signaling networks and therapeutic targets. Nat. Chem. Biol. 3:630-639. (Pubitemid 47417711)
42. Maindrault-Goebel F, de Gramont A, Louvet C, Andre T, Carola E, Mabro M, Artru P, Gilles V, Lotz JP, Izrael V, Krulik M. (2001). High-dose intensity oxaliplatin added to the simplified bimonthly leucovorin and 5-fluorouracil regimen as second-line therapy for metastatic colorectal cancer (FOLFOX 7). Eur. J. Cancer 37:1000-1005. (Pubitemid 32397685)
43. Miyoshi N, Yano M, Takachi K, Kishi K, Noura S, Eguchi H, Yamada T, Miyashiro I, Ohue M, Ohigashi H, Sasaki Y, Ishikawa O, Doki Y, Imaoka S. (2009). Myelotoxicity of preoperative chemoradiotherapy is a significant determinant of poor prognosis in patients with T4 esophageal cancer. J. Surg. Oncol. 99:302-306.
44. Mormont MC, Waterhouse J, Bleuzen P, Giacchetti S, Jami A, Bogdan A, Lellouch J, Misset JL, Touitou Y, Lévi F. (2000). 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. 6:3038-3045. (Pubitemid 30637726)
45. Paschos GK, Baggs JE, Hogenesch JB, FitzGerald GA. (2010). The role of clock genes in pharmacology. Annu. Rev. Pharmacol. Toxicol. 50:187-214.
46. Peters GJ, Van Dijk J, Nadal JC, Van Groeningen CJ, Lankelma J, Pinedo HM. (1987). Diurnal variation in the therapeutic efficacy of 5-fluorouracil against murine colon cancer. In Vivo 1:113-117.
47. Portaluppi F, Smolensky MH, Touitou Y. (2010). Ethics and methods for biological rhythm research on animals and human beings. Chronobiol. Int. 27:1911-1929.
48. Rich T, Innominato PF, Boerner J, Mormont MC, Iacobelli S, Baron B, Jasmin C, Lévi F. (2005). Elevated serum cytokines correlated with altered behavior, serum cortisol rhythm, and dampened 24-hour rest-activity patterns in patients with metastatic colorectal cancer. Clin. Cancer Res. 11:1757-1764. (Pubitemid 40471837)
49. Sahar S, Sassone-Corsi P. (2009). Metabolism and cancer: The circadian clock connection. Nat. Rev. Cancer 9:886-896.
50. Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. (2008). Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J. Clin. Oncol. 26:5721-5727.
51. Schwab M, Zanger UM, Marx C, Schaeffeler E, Klein K, Dippon J, Kerb R, Blievernicht J, Fischer J, Hofmann U, Bokemeyer C, Eichelbaum M. (2008). Role of genetic and nongenetic factors for fluorouracil treatment-related severe toxicity: A prospective clinical trial by the German 5-FU Toxicity Study Group. J. Clin. Oncol. 26:2131-2138.
52. Sephton SE, Sapolsky RM, Kraemer HC, Spiegel D. (2000). Diurnal cortisol rhythm as a predictor of breast cancer survival. J. Natl. Cancer Inst. 92:994-1000. (Pubitemid 30469965)
53. Shitara K, Matsuo K, Takahari D, Yokota T, Inaba Y, Yamaura H, Sato Y, Najima M, Ura T, Muro K. (2009). Neutropaenia as a prognostic factor in metastatic colorectal cancer patients undergoing chemotherapy with first-line FOLFOX. Eur. J. Cancer 45:1757-1763.
54. Shitara K, Matsuo K, Oze I, Mizota A, Kondo C, Nomura M, Yokota T, Takahari D, Ura T, Muro K. (2011). Meta-analysis of neutropenia or leukopenia as a prognostic factor in patients with malignant disease undergoing chemotherapy. Cancer Chemother. Pharmacol. 68(2):301-307.
55. Shitara K, Matsuo K, Takahari D, Yokota T, Shibata T, Ura T, Ito S, Sawaki A, Tajika M, Kawai H, Muro K. (2010b). Neutropenia as a prognostic factor in advanced gastric cancer patients undergoing second-line chemotherapy with weekly paclitaxel. Ann. Oncol. 21:2403-2409.
56. Smaaland R, Laerum OD, Lote K, Sletvold O, Sothern RB, Bjerknes R. (1991). DNA synthesis in human bone marrow is circadian stage dependent. Blood 77:2603-2611.
57. Smaaland R, Abrahamsen JF, Svardal AM, Lote K, Ueland PM. (1992a). DNA cell cycle distribution and glutathione (GSH) content according to circadian stage in bone marrow of cancer patients. Br. J. Cancer 66:39-45.
58. Smaaland R, Laerum OD, Sothern RB, Sletvold O, Bjerknes R, Lote K. (1992b). Colony-forming unit-granulocyte-macrophage and DNA synthesis of human bone marrow are circadian stage-dependent and show covariation. Blood 79:2281-2287.
59. Smaaland R, Lote K, Sothern RB, Laerum OD. (1993). DNA synthesis and ploidy in non-Hodgkin's lymphomas demonstrate intrapatient variation depending on circadian stage of cell sampling. Cancer Res. 53:3129-3138. (Pubitemid 23210324)
60. Smaaland R, Sothern RB, Laerum OD, Abrahamsen JF. (2002). Rhythms in human bone marrow and blood cells. Chronobiol. Int. 19:101-127. (Pubitemid 34326438)
61. Takahashi JS, Hong HK, Ko CH, McDearmon EL. (2008). The genetics of mammalian circadian order and disorder: Implications for physiology and disease. Nat. Rev. Genet. 9:764-775.
62. Yamanaka T, Matsumoto S, Teramukai S, Ishiwata R, Nagai Y, Fukushima M. (2007). Predictive value of chemotherapy-induced neutropenia for the efficacy of oral fluoropyrimidine S-1 in advanced gastric carcinoma. Br. J. Cancer 97:37-42. (Pubitemid 47012089)
63. Yang R, Niepel M, Mitchison TK, Sorger PK. (2010). Dissecting variability in responses to cancer chemotherapy through systems pharmacology. Clin. Pharmacol. Ther. 88:34-38.