A dynamic model of hand-and-foot syndrome in patients receiving capecitabine

Clinical Pharmacology and Therapeutics

Volumn 85, Issue 4, 2009, Pages 418-425

  Henin E ^a,b   You, B ^a,b,c   VanCutsem, E ^d   Hoff, P M ^e,f   Cassidy, J ^g   Twelves, C ^h   Zuideveld, K P ⁱ   Sirzen, F ⁱ   Dartois, C ^a,b   Freyer, G ^a,b,c   Tod, M ^a,b   Girard, P ^a,b  

^a UNIVERSITÉ DE LYON   (France)

^b UNIVERSITÉ CLAUDE BERNARD LYON 1   (France)

^c CENTRE HOSPITALIER LYON SUD   (France)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e HOSPITAL SÍRIO LIBANÊS   (Brazil)

^f UNIVERSITY OF SÃO PAULO   (Brazil)

^g UNIVERSITY OF GLASGOW   (United Kingdom)

^h ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

ⁱ F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; FLUOROURACIL; FOLINIC ACID;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; COLORECTAL CANCER; DIARRHEA; DRUG INTERMITTENT THERAPY; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; PREDICTION; PRIORITY JOURNAL; PROBABILITY; RISK ASSESSMENT; SCORING SYSTEM; STATISTICAL MODEL; STOMATITIS; VOMITING;

EID: 62649109804     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.220     Document Type: Article

References (43)

1. Lamont, E.B. & Schilsky, R.L. The oral fluoropyrimidines in cancer chemotherapy. Clin. Cancer. Res. 5, 2289-2296 (1999).
2. Hoff, P.M., Cassidy, J. & Schmoll, H.J. The evolution of fluoropyrimidine therapy: from intravenous to oral. Oncologist 6 (suppl. 4),3-11 (2001).
3. Blesch, K.S., Gieschke, R., Tsukamoto, Y., Reigner, B.G., Burger, H.U. & Steimer, J.L. Clinical pharmacokinetic/pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: the capecitabine experience. Invest. New Drugs 21, 195-223 (2003).
4. Budman, D.R. Capecitabine. Invest. New Drugs 18, 355-363 (2000).
5. Venturini, M. Rational development of capecitabine. Eur. J. Cancer 38, 3-9 (2002).
6. Dooley, M. & Goa, K.L. Capecitabine. Drugs 58, 69-76 (1999).
7. Hoff, P.M., Ansari, R., Batist, G., Cox, J., Kocha, W. & Kuperminc, M. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J. Clin. Oncol. 19, 2282-2292 (2001).
8. VanCutsem, E. et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J. Clin. Oncol. 19, 4097-4106 (2001).
9. Heo, Y.S. et al. Hand-foot syndrome in patients treated with capecitabine-containing combination chemotherapy. J. Clin. Pharmacol. 44, 1166-1172 (2004).
10. Lokich, J.J. & Moore, C. Chemotherapy-associated palmar-plantar erythrodysesthesia syndrome. Ann. Intern. Med. 101, 798-799 (1984).
11. Kara, I.O., Sahin, B. & Erkisi, M. Palmar-plantar erythrodysesthesia due to docetaxel-capecitabine therapy is treated with vitamin E without dose reduction. Breast 15, 414-424 (2006).
12. Gieschke, R., Reigner, B., Blesch, K.S. & Steimer, J.L. Population pharmacokinetic analysis of the major metabolites of capecitabine. J. Pharmacokinet. Pharmacodyn. 29, 25-47 (2002).
13. Blum, J.L. et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J. Clin. Oncol. 17, 485-493 (1999).
14. Ratain, M.J. Dear doctor: we really are not sure what dose of capecitabine you should prescribe for your patient. J. Clin. Oncol. 20, 1434-1435 (2002).
15. Jansman, F.G., Sleijfer, D.T., de Graaf, J.C., Coenen, J.L. & Brouwers, J.R. Management of chemotherapy-induced adverse effects in the treatment of colorectal cancer. Drug Saf. 24, 353-367 (2001).
16. Paule, I. et al. Model-based dose adaptation of capecitabine for prevention of severe hand-and-foot syndrome: in silico comparison with the standard method. Abstracts of the Annual Meeting of the Population Approach Group in Europe 2008. PAGE 17 (2008). Abstract 1260 〈http://www.page- meeting.org/?abstract=1260〉.
17. Jacqmin, P. et al. Modelling response time profiles in the absence of drug concentrations: definition and performance evaluation of the K-PD model. J. Pharmacokinet. Pharmacodyn. 34, 57-85 (2007).
18. Cockcroft, D.W. & Gault, M.H. Prediction of creatinine clearance from serum creatinine. Nephron 16, 31-41 (1976).
19. Mackean, M. et al. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J. Clin. Oncol. 16, 2977-2985 (1998).
20. Reigner, B., Blesch, K. & Weidekamm, E. Clinical pharmacokinetics of capecitabine. Clin. Pharmacokinet. 40, 85-104 (2001).
21. Abushullaih, S., Saad, E.D., Munsell, M. & Hoff, P.M. Incidence and severity of hand-foot syndrome in colorectal cancer patients treated with capecitabine: a single-institution experience. Cancer Invest. 20, 3-10 (2002).
22. Brendel, K. et al. Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004. Clin. Pharmacokinet. 46, 221-234 (2007).
23. Dartois, C. et al. Overview of model-building strategies in population PK/PD analyses: 2002-2004 literature survey. Br. J. Clin. Pharmacol. 64, 603-612 (2007).
24. Poole, C. et al. Effect of renal impairment on the pharmacokinetics and tolerability of capecitabine (Xeloda) in cancer patients. Cancer Chemother. Pharmacol. 49, 225-234 (2002).
25. Wilkes, G.M. & Doyle, D. Palmar-plantar erythrodysesthesia. Clin. J. Oncol. Nurs. 9, 103-106 (2005).
26. Lin, E., Morris, J.S. & Ayers, G.D. Effect of celecoxib on capecitabine-induced hand-foot syndrome and antitumor activity. Oncology (Williston Park) 16 (12 suppl. 14),31-37 (2002).
27. Asgari, M.M., Haggerty, J.G., McNiff, J.M., Milstone, L.M. & Schwartz, P.M. Expression and localization of thymidine phosphorylase/platelet- derived endothelial cell growth factor in skin and cutaneous tumors. J. Cutan. Pathol. 26, 287-294 (1999).
28. Milano, G. et al. Candidate mechanisms for capecitabine-related hand-foot syndrome. Br. J. Clin. Pharmacol. 66, 88-95 (2008).
29. Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. Meta-Analysis Group In Cancer. J. Clin. Oncol. 16, 3537-3541 (1998).
30. Yen-Revollo, J.L., Goldberg, R.M. & McLeod, H.L. Can inhibiting dihydropyrimidine dehydrogenase limit hand-foot syndrome caused by fluoropyrimidines? Clin. Cancer Res. 14, 8-13 (2008).
31. Sheiner, L.B., Rosenberg, B. & Melmon, K.L. Modelling of individual pharmacokinetics for computer-aided drug dosage. Comput. Biomed. Res. 5, 411-459 (1972).
32. Jelliffe, R.W. et al. Individualizing drug dosage regimens: roles of population pharmacokinetic and dynamic models, Bayesian fitting, and adaptive control. Ther. Drug Monit. 15, 380-393 (1993).
33. Evans, W.E., Relling, M.V., Rodman, J.H., Crom, W.R., Boyett, J.M. & Pui, C.H. Conventional compared with individualized chemotherapy for childhood acute lymphoblastic leukemia. N. Engl. J. Med. 338, 499-505 (1998).
34. Yates, C.R., Pui, C.H. & Evans, W.E. Pharmacodynamic monitoring of cancer chemotherapy: childhood acute lymphoblastic leukemia as a model. Ther. Drug Monit. 20, 453-458 (1998).
35. Salas, S. et al. Therapeutic drug monitoring for dose individualization of Cisplatin in testicular cancer patients based upon total platinum measurement in plasma. Ther. Drug Monit. 28, 532-539 (2006).
36. Sheiner, L.B. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin. Pharmacol. Ther. 56, 309-322 (1994).
37. Zingmark, P.H., Kagedal, M. & Karlsson, M.O. Modelling a spontaneously reported side effect by use of a Markov mixed-effects model. J. Pharmacokinet. Pharmacodyn. 32, 261-281 (2005).
38. Girard, P., Blaschke, T.F., Kastrissios, H. & Sheiner, L.B. A Markov mixed effect regression model for drug compliance. Stat. Med. 17, 2313-2333 (1998).
39. Wahlby, U., Thomson, A.H., Milligan, P.A. & Karlsson, M.O. Models for time-varying covariates in population pharmacokinetic-pharmacodynamic analysis. Br. J. Clin. Pharmacol. 58, 367-377 (2004).
40. Beal, S.L. & Sheiner, L.B. NONMEM User's Guide, Part VII. NONMEM Project Group (University of California, San Francisco, CA, 1992).
41. Beal, S.L. & Sheiner, L.B. NONMEM User's Guides. NONMEM Project Group (University of California, San Francisco, CA, 1992).
42. Yano, Y., Beal, S.L. & Sheiner, L.B. Evaluating pharmacokinetic/ pharmacodynamic models using the posterior predictive check. J. Pharmacokinet. Pharmacodyn. 28, 171-192 (2001).
43. Gelman, A., Carlin, J.B., Stern, H.S. & Rubin, D.B. Bayesian Data Analysis 2nd edn. (Chapman & Hall/CRC Press, Boca Raton, FL, 2004).