Fixed-dose capecitabine is feasible: Results from a pharmacokinetic and pharmacogenetic study in metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 139, Issue 1, 2013, Pages 135-143

  Rudek, Michelle A ^a   Connolly, Roisin M ^a   Hoskins, Janelle M ^b,f   Garrett Mayer, Elizabeth ^c   Jeter, Stacie C ^a   Armstrong, Deborah K ^a   Fetting, John H ^a   Stearns, Vered ^a   Wright, Laurie A ^a   Zhao, Ming ^a   Watkins Jr , Stanley P ^d   McLeod, Howard L ^b   Davidson, Nancy E ^e   Wolff, Antonio C ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d ANNE ARUNDEL MEDICAL CENTER   (United States)

^e UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^f Gentris Corporation   (United States)

Author keywords

Breast cancer; Capecitabine; Pharmacogenetics; Pharmacokinetics

Indexed keywords

CAPECITABINE; DRUG METABOLITE; ESTROGEN RECEPTOR; FLUOROURACIL;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BODY SURFACE; BREAST CANCER; CANCER CONTROL; CANCER GROWTH; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DYSPEPSIA; FATIGUE; FEASIBILITY STUDY; FEMALE; HAND FOOT SYNDROME; HUMAN; LOW DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; METASTASIS POTENTIAL; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; OPEN STUDY; PATIENT COMPLIANCE; PHARMACODYNAMICS; PHARMACOGENETICS; PHARMACOKINETICS; PRIORITY JOURNAL; SAMPLE SIZE; SENSORY NEUROPATHY; SIDE EFFECT; TASTE; TREATMENT DURATION;

ADENOCARCINOMA; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; BREAST NEOPLASMS; DEOXYCYTIDINE; FEASIBILITY STUDIES; FEMALE; FLUOROURACIL; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; PHARMACOGENETICS;

EID: 84877575464     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-013-2516-z     Document Type: Article

References (34)

1. Gibaldi M, Perrier D (1982) Noncompartmental analysis based on statistical moment theory. In: Pharmacokinetics, Marcel Dekker, New York, pp 409-417
2. Ahluwalia R, Freimuth R, McLeod HL, Marsh S (2003) Use of pyrosequencing to detect clinically relevant polymorphisms in dihydropyrimidine dehydrogenase. Clin Chem 49:1661-1664
3. Bajetta E, Procopio G, Celio L, Gattinoni L, Della Torre S, Mariani L, Catena L, Ricotta R, Longarini R, Zilembo N, Buzzoni R (2005) Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol 23:2155-2161. doi: JCO.2005.02.167
4. Baker SD, Verweij J, Rowinsky EK, Donehower RC, Schellens JH, Grochow LB, Sparreboom A (2002) Role of body surface area in dosing of investigational anticancer agents in adults, 1991-2001. J Natl Cancer Inst 94:1883-1888
5. Besnard T, Renee N, Etienne-Grimaldi MC, Francois E, Milano G (2008) Optimized blood sampling with cytidine deaminase inhibitor for improved analysis of capecitabine metabolites. J Chromatogr B 870:117-120. doi: 10.1016/j.jchromb.2008.05.040
6. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485-493
7. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247. doi: S0959-8049(08)00873-3
8. El-Helw L, Coleman RE (2005) Reduced dose capecitabine is an effective and well-tolerated treatment in patients with metastatic breast cancer. Breast 14:368-374. doi: S0960-9776(04)00245-0
9. Fukunaga AK, Marsh S, Murry DJ, Hurley TD, McLeod HL (2004) Identification and analysis of single-nucleotide polymorphisms in the gemcitabine pharmacologic pathway. Pharmacogenomics J 4:307-314. doi: 10.1038/sj.tpj.6500259
10. Gajria D, Feigin K, Tan LK, Patil S, Geneus S, Theodoulou M, Norton L, Hudis CA, Traina TA (2011) Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer. Cancer 117:4125-4131. doi: 10.1002/cncr.25992
11. ® (capecitabine) Tablets, Film Coated for Oral Use: Package Insert, South San Francisco (http://www.gene.com/gene/products/information/xeloda/pdf/pi.pdf). Accessed 20 Jan 2013
12. 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
13. Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H (2009) Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol 10:1145-1151. doi: S1470-2045(09)70307-9
14. Laheru D, Croghan G, Bukowski R, Rudek M, Messersmith W, Erlichman C, Pelley R, Jimeno A, Donehower R, Boni J, Abbas R, Martins P, Zacharchuk C, Hidalgo M (2008) A phase I study of EKB-569 in combination with capecitabine in patients with advanced colorectal cancer. Clin Cancer Res 14:5602-5609. doi: 10.1158/1078-0432.CCR-08-0433
15. Leonard R, Hennessy BT, Blum JL, O'Shaughnessy J (2011) Dose-adjusting capecitabine minimizes adverse effects while maintaining efficacy: a retrospective review of capecitabine for metastatic breast cancer. Clinical breast cancer 11:349-356. doi: 10.1016/j.clbc.2011.06.005
16. Leonard RC, Twelves C, Breddy J, Chaturvedi A, Hutcheon A, Salazar R, Cameron D (2002) Capecitabine named-patient programme for patients with advanced breast cancer: the UK experience. Eur J Cancer 38:2020-2024
17. Marsh S, Xiao M, Yu J, Ahluwalia R, Minton M, Freimuth RR, Kwok PY, McLeod HL (2004) Pharmacogenomic assessment of carboxylesterases 1 and 2. Genomics 84:661-668. doi: 10.1016/j.ygeno.2004.07.008
18. Mata JF, Garcia-Manteiga JM, Lostao MP, Fernandez-Veledo S, Guillen-Gomez E, Larrayoz IM, Lloberas J, Casado FJ, Pastor-Anglada M (2001) Role of the human concentrative nucleoside transporter (hCNT1) in the cytotoxic action of 5[Prime]-deoxy-5-fluorouridine, an active intermediate metabolite of capecitabine, a novel oral anticancer drug. Mol Pharmacol 59:1542-1548
19. Miller AA (2002) Body surface area in dosing anticancer agents: scratch the surface! J Natl Cancer Inst 94:1822-1823
20. Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP (2009) Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 360:2055-2065. doi: 10.1056/NEJMoa0810266
21. O'Shaughnessy J, Paul D, Stokoe C (2010) First efficacy results of a randomized, open-label, phase III study of adjuvant doxorubicin plus cyclophosphamide followed by docetaxel with or without capecitabine in high-risk early breast cancer. Cancer Res 70(suppl 24): S4-2
22. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812-2823
23. Ratain MJ (1998) Body-surface area as a basis for dosing of anticancer agents: science, myth, or habit? J Clin Oncol 16:2297-2298
24. Reigner B, Blesch K, Weidekamm E (2001) Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 40:85-104
25. Rossi D, Alessandroni P, Catalano V, Giordani P, Fedeli SL, Fedeli A, Baldelli AM, Casadei V, Ceccolini M, Catalano G (2007) Safety profile and activity of lower capecitabine dose in patients with metastatic breast cancer. Clin Breast Cancer 7:857-860. doi: S1526-8209(11)70792-3
26. Rudek MA, Zhao M, He P, Hartke C, Gilbert J, Gore SD, Carducci MA, Baker SD (2005) Pharmacokinetics of 5-azacitidine administered with phenylbutyrate in patients with refractory solid tumors or hematologic malignancies. J Clin Oncol 23:3906-3911. doi: 10.1200/JCO.2005.07.450
27. Sawyer M, Ratain MJ (2001) Body surface area as a determinant of pharmacokinetics and drug dosing. Invest New Drugs 19:171-177
28. Schuller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L, Utoh M, Mori K, Weidekamm E, Reigner B (2000) Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 45:291-297
29. Sledge GW, Miller KD, Moisa CF, Gradishar WJ Safety and Efficacy of Capecitabine Plus Bevacizumab as First-Line in Metastatic Breast Cancer (XCALIBr Trial). Paper presented at the Annual ASCO meeting (Abs 1013), 2007
30. Soepenberg O, Dumez H, Verweij J, Semiond D, deJonge MJ, Eskens FA, ter Steeg J, Selleslach J, Assadourian S, Sanderink GJ, Sparreboom A, van Oosterom AT (2005) Phase I and pharmacokinetic study of oral irinotecan given once daily for 5 days every 3 weeks in combination with capecitabine in patients with solid tumors. J Clin Oncol 23:889-898. doi: 10.1200/JCO.2005.01.008
31. Stockler MR, Harvey VJ, Francis PA, Byrne MJ, Ackland SP, Fitzharris B, Van Hazel G, Wilcken NR, Grimison PS, Nowak AK, Gainford MC, Fong A, Paksec L, Sourjina T, Zannino D, Gebski V, Simes RJ, Forbes JF, Coates AS (2011) Capecitabine versus classical cyclophosphamide, methotrexate, and fluorouracil as first-line chemotherapy for advanced breast cancer. J Clin Oncol 29:4498-4504. doi: 10.1200/JCO.2010.33.9101
32. Traina TA, Theodoulou M, Feigin K, Patil S, Tan KL, Edwards C, Dugan U, Norton L, Hudis C (2008) Phase I study of a novel capecitabine schedule based on the Norton-Simon mathematical model in patients with metastatic breast cancer. J Clin Oncol 26:1797-1802. doi: 10.1200/JCO.2007.13.8388
33. Untch M, Loibl S, Bischoff J, Eidtmann H, Kaufmann M, Blohmer JU, Hilfrich J, Strumberg D, Fasching PA, Kreienberg R, Tesch H, Hanusch C, Gerber B, Rezai M, Jackisch C, Huober J, Kuhn T, Nekljudova V, von Minckwitz G (2012) Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-taxane-based chemotherapy (GeparQuinto, GBG 44): a randomised phase 3 trial. Lancet Oncol 13:135-144. doi: S1470-2045(11)70397-7
34. Xu Y, Grem JL (2003) Liquid chromatography-mass spectrometry method for the analysis of the anti-cancer agent capecitabine and its nucleoside metabolites in human plasma. J Chromatogr B 783:273-285