Homocysteine and methylmalonic acid: Markers to predict and avoid toxicity from pemetrexed therapy

Molecular Cancer Therapeutics

Volumn 1, Issue 7, 2002, Pages 545-552

  Niyikiza, Clet ^a   Baker, Sharyn D ^b   Seitz, David E ^c   Walling, Jackie M ^d   Nelson, Katrina ^a   Rusthoven, James J ^a   Stabler, Sally P ^e   Paoletti, Paolo ^a   Calvert, A Hilary ^f   Allen, Robert H ^e  

^a ELI LILLY AND COMPANY   (United States)

^b UT Health San Antonio   (United States)

^c INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d AMGEN INC   (United States)

^e UNIVERSITY OF COLORADO   (United States)

^f NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CYANOCOBALAMIN; DRUG DERIVATIVE; FOLIC ACID; GLUTAMIC ACID DERIVATIVE; GUANINE; HOMOCYSTEINE; METHYLMALONIC ACID; PEMETREXED;

ADULT; AGED; ARTICLE; BIOLOGICAL MODEL; FEMALE; HUMAN; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; RISK; TIME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; FEMALE; FOLIC ACID; GLUTAMATES; GUANINE; HOMOCYSTEINE; HUMANS; MALE; METHYLMALONIC ACID; MIDDLE AGED; MODELS, BIOLOGICAL; MULTIVARIATE ANALYSIS; ODDS RATIO; TIME FACTORS; VITAMIN B 12;

EID: 0036562507     PISSN: 15357163     EISSN: 15388514     Source Type: Journal    
DOI: None     Document Type: Article

References (34)

1. Von Hoff, D. D. Special lecture: there are no bad anticancer agents, only bad clinical trial designs. Twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin Cancer Res., 4: 1079-1086, 1998. (Pubitemid 28213317)
2. Farber, S., Diamond, L. K., Mercer, R. D., Sylvester, R. F., and Wolff, J. A. Temporary remissions in acute leukemia in children produced by folic acid antagonist, 4-aminopteroyl glutamic acid (aminopterin). N. Engl. J. Med., 238: 787-793, 1948.
3. Longo, D. L., DeVita, V. T., Duffey, P. L., Wesley, M. N., Ihde, D. C., Hubbard, S. M., Gilliom, M., Jaffe, E. S., Cossman, J., Fisher, R. I., and Young, R. C. Superiority of ProMACE-CytaBOM over ProMACE-MOPP in the treatment of advanced diffuse aggressive lymphoma: results of a prospective randomized trial. J. Clin. Oncol., 9: 25-38, 1991.
4. Bonnadonna, G., Zambetti, M., and Valagussa, P. Sequential or alternating doxorubicin and CMF regimens in breast cancer with more than three positive nodes: ten year results. JAMA, 273: 542-547, 1995.
5. Bonnadonna, G., Valagussa, P., Moliterni, A., Zambetti, M., and Brambilla, C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N. Engl. J. Med., 332: 901-906, 1995.
6. Hong, W. K., Schaefer, S., Issell, B., Cummings, C., Luedke, D., Bromer, R., Fofonoff, S., D'Aoust, J., Shapshay, S., Welch, J., Levin, E., Vincent, M., Vaughan, C., and Strong, S. A prospective randomized trial of methotrexate versus cisplatin in the treatment of recurrent squamous cell carcinoma of the head and neck. Cancer (Phila.), 52: 206-210, 1983. (Pubitemid 13063158)
7. Jackman, A. L., and Calvert, A. H. Folate-based thymidylate synthase inhibitors as anticancer drugs. Ann. Oncol., 6: 871-881, 1995.
8. Laohavinij, S., Wedge, S. R., Lind, M. J., Bailey, N., Humphreys, A., Proctor, M., Chapman F. Simmons D. Oakley, A., Robson, L., Gumbrell, L., Taylor, G. A., Thomas, H. D., Boddy, A. V., Newell, D. R., and Calvert, A. H. A Phase I clinical study of the antipurine antifolate lometrexol (DDATHF) given with oral folic acid. Investig. New Drugs, 14: 325-335, 1996.
9. Maughan, T. S., James, R. D., Kerr, D., McArdie, C., Ledermann, J. A., Seymour, M., Johnston, C., and Stephens, R. J. on behalf of the British MRC Colorectal Cancer Working Party. Preliminary results of a multicenter randomized trial comparing 3 chemotherapy regimens (de- Gramont, Lokich, and raltitrexed) in metastatic colorectal cancer. Proc. Am. Soc. Clin. Oncol., 18: 262a, 1999.
10. Grindey, G. B., Alati, T., and Shih, C. Reversal of the toxicity but not the antitumor activity of lometrexol by folic acid. Proc. Am. Assoc. Cancer Res., 32: 324, 1991.
11. Alati, T., Shih, C., Pohland, R. C., Lantz, R. J., and Grindey, G. B. Evaluation of the mechanism(s) of inhibition of the toxicity, but not the antitumor activity of lometrexol (DDATHF) by folic acid. Proc. Am. Assoc. Cancer Res., 33: 407, 1992.
12. Wedge, S. R., Laohavinij, S., Taylor, G. A., Boddy, A., Calvert, A. H., and Newell, D. R. Clinical pharmacokinetics of the antipurine antifolate (6R)-5, 10-dideaza-5,6,7,8-tetrahydrofolic acid (lometrexol) administration with an oral folic acid supplement. Clin. Cancer Res., 1: 1479-1486, 1995. (Pubitemid 26028083)
13. Hanauske, A., Chen, V., Paoletti, P., and Niyikiza C. Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors. Oncologist, 6: 363-373, 2001. (Pubitemid 32816541)
14. Shih, C., Habeck, L. L., Mendelsohn, L. G., Chen, V. J., and Schultz, R. M. Multiple folate enzyme inhibition: mechanism of a novel pyrrolopyrimidine- based antifolate LY231514 (MTA). Adv. Enzyme Regul., 38: 135-152, 1998. (Pubitemid 28381388)
15. Lucock, M. D., Daskalakis, I., Schorah, C. J., Lumb, C. H., Oliver, M., Devitt, H., Wild, J., Dowell, A. C., and Levene, M. I. Folate-homocysteine interrelations: potential new markers of folate status. Mol. Genet. Metab., 67: 23-35, 1999. (Pubitemid 29393249)
16. Stabler, S. P., Marcell, P. D., Savage, D. G., and Lindenbaum, J. Elevation of total homocysteine in the serum of patients with cobalamin or folate deficiency detected by capillary gas chromatography-mass spectrometry. J Clin Investig., 81: 466-474, 1988. (Pubitemid 18075242)
17. Savage, D. G., Lindenbaum, J., Stabler, S. P., and Allen, R. H. Sensitivity of serum methylmalonic acid and total homocysteine determinations for diagnosing cobalamin and folate deficiencies. Am. J. Med., 96: 239-246, 1994. (Pubitemid 24099223)
18. Rosenberg, L. E., and Fentonk, W. A. Disorders of propionate and methylmalonate metabolism. In: C. Scriver, A. Beaudet, W. Sly, and D. Valle (eds.), Metabolic Basis of Inherited Disease, pp. 821-844. New York: McGraw-Hill, 1989.
19. Stabler, S. P., Lindenbaum, J., Savage, D. G., and Allen, R. H. Elevation of serum cystathionine levels in patients with cobalamin and folate deficiency. Blood, 81: 3404-3413, 1993. (Pubitemid 23172927)
20. Hammond, L., Villalona-Calero, M., Eckhardt, S. G., Drengler, R., Aylesworth, C., Johnson, T., Hidalgo, M., Rodriguez, G., Diab, S., Monroe, P., Thornton, D., Von Hoff, D., and Rowinsky, E. A Phase I and pharmacokinetic (PK) study of the multitargeted antifolate (MTA) LY231514 with folic acid. Proc. Am. Soc. Clin Oncol; 17: 225, 1998.
21. Allen, R. H., Stabler, S. P., Savage, D. G., and Lindenbaum, J. Elevation of 2-methylcitric acid I and II levels in serum, urine, and cerebrospinal fluid of patients with cobalamin deficiency. Metabolism, 42: 978-988, 1993. (Pubitemid 23230428)
22. NCI CTC Guidelines for Reporting of Adverse Drug Reactions. Bethesda, MD: Division of Cancer Treatment, National Cancer Institute, 1998.
23. SAS Institute Inc. Statistics and Graphics Guide, Version 3, pp. 197-234. Cary, NC: SAS Institute, 1995.
24. Lehman, E. L. Testing Statistical Hypotheses, Ed. 2, pp. 447-490. New York: John Wiley and Sons, 1986.
25. Eikelboom, J. W., Lonn, E., Genest, J., Henkey, G., and Yusuf, S. Homocyst(e)ine and cardiovascular disease: a critical review of the epidemiological evidence. Ann. Intern. Med., 131: 363-375, 1999. (Pubitemid 29424631)
26. 6 reduce cardiovascular risk?. Design of clinical trials to test the homocysteine hypothesis of vascular disease. J. Cardiovasc. Risk, 5: 249-255, 1998.
27. Bostom, A. G., Rosenberg, I. H., Silbershatz, H., Jacques, P. F., Selhub, J., D'Agostino, R. B., Wilson, P. W., and Wolf, P. A. Nonfasting plasma total homocysteine levels and stroke incidence in elderly persons: the Framingham Study. Ann. Intern. Med., 131: 352-355, 1999. (Pubitemid 29424629)
28. Finkelstein, J. D. The metabolism of homocysteine: pathways and regulation. Eur. J. Pediatr., 157 (Suppl. 2): 840-844, 1998.
29. Selhub, J., and Miller, J. W. The pathogenesis of homocysteinemia: interruption of the coordinate regulation by S-adenosylmethionine of the remethylation and transsulfuration of homocysteine. Am J Clin Nutr., 55: 131-138, 1991.
30. Carmel, R. Cobalamin: the stomach, and aging. Am. J. Clin. Nutr., 66: 750-759, 1998.
31. Selhub, J., Jacques, P. F., Wilson, P. W., Rush, D., and Rosenberg, I. H. Vitamin status and intake as primary determinants of homocysteinemia in an elderly population. JAMA, 270: 2693-2698, 1993. (Pubitemid 23350966)
32. Homocysteine Lowering Trialists' Collaboration. Lowering blood homocysteine with folic acid based supplements: meta-analysis of randomized trials. BMJ, 316: 894-898, 1998.
33. 6 supplements in elderly people with normal serum vitamin concentrations. Lancet, 346: 85-89, 1995.
34. Bunn, P., Paoletti, P., Niyikiza, C., Rusthoven, J., Nelson, K., Hanauske, A., Stabler, S., Calvert, H., and Allen, R. Vitamin B12 and folate reduce toxicity of ALIMTA (pemetrexed disodium, LY231514, MTA), a novel antifolate/antimetabolite. Proc. Am. Soc. Clin. Oncol., 76a: A300, 2001.