Phase I study of 5-fluorouracil and leucovorin by continuous infusion chronotherapy and pelvic radiotherapy in patients with locally advanced or recurrent rectal cancer

International Journal of Radiation Oncology Biology Physics

Volumn 58, Issue 5, 2004, Pages 1487-1495

  Parulekar, Wendy ^a   De Marsh, Robert W ^b   Wong, Rebecca ^c   Mendenhall, William ^b   Davey, Phillip ^d   Zlotecki, Robert ^b   Berry, Scott ^d   Rout, W Robert ^b   Bjarnason, Georg A ^d  

^a Kingston Regional Cancer Center   (Canada)

^b UNIVERSITY OF FLORIDA   (United States)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d DEPARTMENT OF RADIATION ONCOLOGY   (Canada)

Author keywords

5 FU; Chemoradiotherapy; Chronomodulation; Radiotherapy; Rectal cancer

Indexed keywords

CHEMOTHERAPY; DOSIMETRY; PATHOLOGY; PATIENT TREATMENT; SURGERY; TUMORS;

PATHOLOGIC SPECIMENS; RADIATION ONCOLOGY;

RADIOTHERAPY;

FLUOROURACIL; FOLINIC ACID;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER LOCALIZATION; CANCER STAGING; CHRONOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DOSE RESPONSE; DRUG MEGADOSE; DRUG TOLERANCE; FEMALE; HUMAN; INFUSION; INTERMETHOD COMPARISON; MALE; MEDICAL ASSESSMENT; META ANALYSIS; PATIENT SCHEDULING; PATIENT SELECTION; PELVIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RADIATION DOSE; RADIATION RESPONSE; RECTUM CANCER; RECTUM RESECTION; RECURRENT DISEASE; STOMATITIS; SURGICAL TECHNIQUE;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; CHRONOTHERAPY; COMBINED MODALITY THERAPY; DIARRHEA; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PATIENT COMPLIANCE; RADIOTHERAPY DOSAGE; RECTAL NEOPLASMS; STOMATITIS;

EID: 1842528920     PISSN: 03603016     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2003.09.073     Document Type: Article

References (64)

1. Minsky B.D., Cohen A.M., Kemeny N., et al. Combined modality therapy of rectal cancer Decreased acute toxicity with the preoperative approach. J Clin Oncol. 10:1992;1218-1224.
2. Minsky B.D., Conti J.A., Huang Y., et al. Relationship of acute gastrointestinal toxicity and the volume of irradiated small bowel in patients receiving combined modality therapy for rectal cancer. J Clin Oncol. 13:1995;1409-1416.
3. Minsky B.D. Sphincter preservation for rectal cancer Fact or fiction? J Clin Oncol. 20:2002;1971-1972.
4. Chen E.T., Mohiuddin M., Brodovsky H., et al. Downstaging of advanced rectal cancer following combined preoperative chemotherapy and high dose radiation. Int J Radiat Oncol Biol Phys. 30:1994;169-175.
5. Dunlap J.C. Molecular bases for circadian clocks. Cell. 96:1999;271-290.
6. Weaver D.R. The suprachiasmatic nucleus A 25-year retrospective. J Biol Rhythms. 13:1998;100-112.
7. Reppert S.M., Weaver D.R. Coordination of circadian timing in mammals. Nature. 418:2002;935-941.
8. Bjarnason G.A., Jordan R.C.K., Wood P.A., et al. Circadian expression of clock genes in human oral mucosa and skin. association with specific cell cycle phases. Am J Pathol. 158:2001;1793-1801.
9. Bjarnason G.A., Hrushesky W.J.M. Preclinical trials of cancer chronotherapy. Hrushesky W.J.M. Circadian cancer therapy. 1994;211-239 CRC Press, Boca Raton, FL.
10. Naguib F.N.M., Soong S.J., El Kouni M.H. Circadian rhythm of orotate phosphoribosyltransferase, pyrimidine nucleoside phosphorylase and dihydrouracil dehydrogenase in mouse liver. Biochem Pharmacol. 45:1993;667-673.
11. Harris B.E., Song R., Soong S., et al. Circadian variation of 5-fluorouracil catabolism in isolated perfused rat liver. Cancer Res. 49:1989;6610-6614.
12. Fujii S., Shimamoto Y., Ohshimo H., et al. Effects of the plasma concentration of 5-fluorouracil and the duration of continuous venous infusion of 5-fluorouracil with an inhibitor of 5-fluorouracil degradation on Yoshida sarcoma in rats. Jpn J Cancer Res. 80:1989;167-172.
13. Harris B.E., Song R., Soong S.J., 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. 50:1990;197-201.
14. Tuchman M., Roemeling R., Lanning R., et al. Sources of variability of dihydropyrimidine dehydrogenase (DPD) activity in human blood mononuclear cells. Reinberg A., Smolensky M., Labrecque G. Annual review of chronopharmacology. Vol 5. 1988;399-402 Pergamon Press, Oxford.
15. Petit E., Milano G., Levi F., et al. Circadian rhythm-varying plasma concentration of 5-fluorouracil during a five day continuous infusion at a constant rate in cancer patients. Cancer Res. 48:1988;1676-1679.
16. Metzger G., Massari C., Etienne M.C., 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. 56:1994;190-201.
17. Takimoto C.H., Yee L.K., Venzon D.J., et al. High inter- and intrapatient variation in 5-fluorouracil plasma concentrations during a prolonged drug infusion. Clin Cancer Res. 5:1999;1347-1352.
18. Fleming G.F., Schilsky R.L., Mick R., et al. Circadian variation of 5-fluorouracil (5-FU) and cortisol plasma levels during continuous-infusion 5-FU and leucovorin (LV) in patients with hepatic or renal dysfunction. [Abstract] Proc Am Soc Clin Oncol. 13:1994;A352.
19. Thiberville L., Compagnon P., Moore N., et al. Plasma 5-fluorouracil and alpha-fluoro-beta-alanine accumulation in lung cancer patients treated with continuous infusion of cisplatin and 5-fluorouracil. Cancer Chemother Pharmacol. 35:1994;64-70.
20. Joly AC, Monnet I, Chouaid C, et al. Continuous infusion of 5-fluorouracil and non-small cell lung cancer (NSCLC): Circadian rhythms and influence of a corticotherapy [Abstract]. Proceedings of the 28th European Symposium of Clinical Pharmacy of the European Society of Clinical Pharmacists. 1999. p. A195.
21. Zhang R., Lu Z., Liu T., et al. 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.
22. Lincoln D.W., Hrushesky W.J.M., 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.
23. Bjarnason G.A., Jordan R., Sothern R.B. Circadian variation in the expression of cell-cycle proteins in human oral epithelium. Am J Pathol. 154:1999;613-622.
24. Warnakulasuriya K.A.A.S., MacDonald D.G. Diurnal variation in labeling index in human buccal epithelium. Arch Oral Biol. 38:1993;1107-1111.
25. Buchi K.N., Moore J.G., Hrushesky W.J.M., et al. Circadian rhythm of cellular proliferation in the human rectal mucosa. Gastroenterology. 101:1991;410-415.
26. Marra G., Anti M., Percesepe A., et al. Circadian variation of epithelial cell proliferation in human rectal crypts. Gastroenterology. 106:1994;982-987.
27. Smaaland R., Laerum O.D., Lote K., et al. DNA synthesis in human bone marrow is circadian stage dependent. Blood. 77:1991;2603-2611.
28. Scheving L.E. Mitotic activity in the human epidermis. Anat Rec. 135:1959;7-19.
29. Brown W.R. A review and mathematical analysis of circadian rhythms in cell proliferation in mouse, rat, and human epidermis. J Invest Dermatol. 97:1991;273-280.
30. Fu L., Pelicano H., Liu J., et al. The circadian gene period plays an important role in tumor suppression and DNA damage response in vivo. Cell. 111:2002;41-450.
31. Lévi F., Zidani R., Vannetzel J.M., 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. 86:1994;1608-1617.
32. Lévi F., Zidani R., Misset J.L. Randomized multicentre trial of chronotherapy with oxaliplatin, fluorouracil and folinic acid in metastatic colorectal cancer. Lancet. 350:1997;681-686.
33. Levi F., Zidani R., Llory J.F., et al. Final efficacy update at 7 years of flat vs chronomodulated infusion of oxaliplatin, 5-fluorouracil and leucovorin as first line treatment of metastatic colorectal cancer. [Abstract] Proc Am Soc Clin Oncol. 19:2000;A936.
34. Bjarnason G.A., Kerr I., Doyle N., et al. Phase I study of 5-fluorouracil and leucovorin by a 14 day circadian infusion in patients with metastatic adenocarcinoma. Cancer Chemother Pharmacol. 33:1993;221-228.
35. Anderson N., Lokich J., Bern M., et al. A phase I clinical trial of combined fluoropyrimidines with leucovorin in a 14-day infusion Demonstration of biochemical modulation. Cancer. 63:1989;233-237.
36. Bjarnason G.A., Marsh R., Chu N.M., et al. Phase-II study of 5-fluorouracil and leucovorin by a 14 day chronomodulated infusion in patients with metastatic colorectal cancer. [Abstract] Proc Annu Meet Am Soc Clin Oncol. 17:1998;A1158.
37. Marsh R.D., Chu N.M., Vauthey J.N., et al. Preoperative treatment of patients with locally advanced unresectable rectal adenocarcinoma utilizing continuous chronobiologically shaped 5-fluorouracil infusion and radiation therapy. Cancer. 78:1996;217-225.
38. Calabro-Jones P.M., Byfield J.E., Ward J.F., et al. Time-dose relationships for 5-fluorouracil cytotoxicity against human epithelial cancer cells in vitro. Cancer Res. 42:1982;4413-4420.
39. Smalley S.R., Kimler B.F., Evans R.G. 5-Fluorouracil modulation of radiosensitivity in cultured human carcinoma cells. Int J Radiat Oncol Biol Phys. 20:1991;207-211.
40. Smalley S.R., Kimler B.F., Evans R.G. 5-Fluorouracil modulation of radiosensitivity in cultured human carcinoma cells. Int J Radiat Oncol Biol Phys. 20:1990;207-211.
41. Smalley S.R., Kimler B.F., Evans R.G., et al. Heterogeneity of 5-fluorouracil radiosensitivity modulation in cultured mammalian cell lines. Int J Radiat Oncol Biol Phys. 24:1992;519-525.
42. Byfield J. Theorectical basis and clinical applications of 5-fluorouracil as a radiosensitizer. Rosenthal C.J., Rotman M. Clinical applications of continuous infusion chemotherapy and noncomitant radiation therapy. 1986;113-126 Plenum Press, New York.
43. Kovacs C.J., Dainer P.M., Evans M.J., et al. Biochemical modulation of combined radiation and 5-fluorouracil treatment of murine tumors by D,L-leucovorin. Anticancer Res. 11:1991;905-909.
44. Lawrence T.S., Heimburger D.K., Shewach D.S. The effect of leucovorin and dipyridamole on fluoropyrimidine-induced radiosensitization. Int J Radiat Oncol Biol Phys. 20:1991;377-381.
45. Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer A systematic overview of 8,507 patients from 22 randomised trials. Lancet. 358:2001;1291-1304.
46. Swedish Rectal Cancer Trial. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 336:1997;980-987.
47. Kapiteijn E., Marijnen C.A., Nagtegaal I.D., et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 345:2001;638-646.
48. Janjan N.A., Khoo V.S., Abbruzzese J., et al. Tumor downstaging and sphincter preservation with preoperative chemoradiation in locally advanced rectal cancer The M. D. Anderson Cancer Center experience. Int J Radiat Oncol Biol Phys. 44:1999;1027-1038.
49. Valentini V., Coco C., Cellini N., et al. Preoperative chemoradiation with cisplatin and 5-fluorouracil for extraperitoneal T3 rectal cancer Acute toxicity, tumor response, sphincter preservation. Int J Radiat Oncol Biol Phys. 45:1999;1175-1184.
50. Gerard J.P., Chapet O., Nemoz C., et al. Preoperative concurrent chemoradiotherapy in locally advanced rectal cancer with high-dose radiation and oxaliplatin-containing regimen The Lyon R0-04 phase II trial. J Clin Oncol. 21:2003;1119-1124.
51. Sanfilippo N.J., Crane C.H., Skibber J., et al. T4 rectal cancer treated with preoperative chemoradiation to the posterior pelvis followed by multivisceral resection Patterns of failure and limitations of treatment. Int J Radiat Oncol Biol Phys. 51:2001;176-183.
52. Rich T.A., Skibber J.M., Ajani J.A., et al. Preoperative infusional chemoradiation therapy for stage T3 rectal cancer. Int J Radiat Oncol Biol Phys. 32:1995;1025-1029.
53. Valentini V., Coco C., Cellini N., et al. Preoperative chemoradiation for extraperitoneal T3 rectal cancer Acute toxicity, tumor response, and sphincter preservation. Int J Radiat Oncol Biol Phys. 40:1998;1067-1075.
54. Chari R.S., Tyler D.S., Anscher M.S., et al. Preoperative radiation and chemotherapy in the treatment of adenocarcinoma of the rectum. Ann Surg. 221:1995;778-786.
55. Shumate C.R., Rich T.A., Skibber J.M., et al. Preoperative chemotherapy and radiation therapy for locally advanced primary and recurrent rectal carcinoma A report of surgical morbidity. Cancer. 71:1993;3690-3696.
56. Chan A., Wong A., Langevin J., et al. Preoperative concurrent 5-fluorouracil infusion, mitomycin C and pelvic radiation therapy in tethered and fixed rectal carcinoma. Int J Radiat Oncol Biol Phys. 25:1993;791-799.
57. Weinstein G.D., Rich T.A., Shumate C.R., et al. Preoperative infusional chemoradiation and surgery with or without an electron beam intraoperative boost for advanced primary rectal cancer. Int J Radiat Oncol Biol Phys. 32:1995;197-204.
58. Minsky B.D., Cohen A.M., Enker W.E., et al. Preoperative 5-FU, low-dose leucovorin, and radiation therapy for locally advanced and unresectable rectal cancer. Int J Radiat Oncol Biol Phys. 37:1997;289-295.
59. Movsas B., Hanlon A.L., Lanciano R., et al. Phase I dose escalating trial of hyperfractionated pre-operative chemoradiation for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 42:1998;43-50.
60. Minsky B.D., Kemeny N., Cohen A.M., et al. Preoperative high-dose leucovorin/5-fluorouracil and radiation therapy for unresectable rectal cancer. Cancer. 67:1991;2859-2866.
61. Landry J.C., Koretz M.J., Wood W.C., et al. Preoperative irradiation and fluorouracil chemotherapy for locally advanced rectosigmoid carcinoma Phase I-II study. Radiology. 188:1993;423-426.
62. Leong T., Guiney M., Ngan S., et al. Pre-operative radiotherapy and chemotherapy for non-resectable rectal cancer. Aust N Z J Surg. 67:1997;603-606.
63. Mohiuddin M., Hayne M., Regine W.F., et al. Prognostic significance of postchemoradiation stage following preoperative chemotherapy and radiation for advanced/recurrent rectal cancers. Int J Radiat Oncol Biol Phys. 48:2000;1075-1080.
64. Videtic G.M., Fisher B.J., Perera F.E., et al. Preoperative radiation with concurrent 5-fluorouracil continuous infusion for locally advanced unresectable rectal cancer. Int J Radiat Oncol Biol Phys. 42:1998;319-324.