Pharmacokinetic evaluation of gemcitabine hydrochloride for the treatment of cervical cancer

Expert Opinion on Drug Metabolism and Toxicology

Volumn 7, Issue 12, 2011, Pages 1601-1612

  Dueas Gonzalez, Alfonso ^a   Coronel, Jaime ^a   Cetina, Lucely ^a  

^a INSTITUTO NACIONAL DE CANCEROLOGÍA   (Mexico)

Author keywords

Antimetabolite; Cervical cancer; Chemoradiation; Gemcitabine; Radiosensitizers

Indexed keywords

ANTIHISTAMINIC AGENT; BEVACIZUMAB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; CORTICOSTEROID; CREATININE; CYTIDINE DERIVATIVE; DIFLUORODEOXYCYTIDINE TRIPHOSPHATE; GEMCITABINE; IRINOTECAN; NAVELBINE; NEDAPLATIN; OXALIPLATIN; PACLITAXEL; PARACETAMOL; TOPOTECAN; UNCLASSIFIED DRUG;

ADVANCED CANCER; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BLADDER CANCER; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BRACHYTHERAPY; BREAST CANCER; BRONCHOSPASM; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHEMORADIOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; COLITIS; CONTINUOUS INFUSION; CREATININE CLEARANCE; DERMATITIS; DIARRHEA; DRUG APPROVAL; DRUG CHOICE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG MARKETING; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG SYNTHESIS; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; EXTERNAL BEAM RADIOTHERAPY; FATIGUE; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEMATURIA; HUMAN; HYPOTENSION; HYSTERECTOMY; LEUKEMIA; LEUKOPENIA; LUNG NON SMALL CELL CANCER; LYMPHADENECTOMY; MALAISE; MAXIMUM TOLERATED DOSE; METASTASIS; MONOTHERAPY; MORBIDITY; MUCOSA INFLAMMATION; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OVARY CANCER; OVERALL SURVIVAL; PANCREAS CANCER; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROCTITIS; PROGRESSION FREE SURVIVAL; PROTEINURIA; PRURITUS; QUALITY OF LIFE; RADIATION DOSE; RADIATION SICKNESS; RADIOSENSITIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RECURRENT CANCER; SIDE EFFECT; SKIN TOXICITY; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA;

ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRACHYTHERAPY; CISPLATIN; CLINICAL TRIALS AS TOPIC; DEOXYCYTIDINE; FEMALE; HUMANS; NEOPLASM METASTASIS; PACLITAXEL; RADIATION-SENSITIZING AGENTS; SURVIVAL RATE; TOPOTECAN; UTERINE CERVICAL NEOPLASMS; VINBLASTINE;

EID: 81855183739     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2011.625012     Document Type: Article

References (56)

1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011;61:69-90
2. NCI press office NCI issues clinical announcement on cervical cancer: chemotherapy plus radiation improves survival. Available from: http://www.nih. gov/news/pr/feb99/nci-22.htm [Accessed 20 June 2008]
3. Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol 2008;26:5802-12
4. Candelaria M, Garcia-Arias A, Cetina L, Duenas-Gonzalez A. Radiosensitizers in cervical cancer. Cisplatin and beyond. Radiat Oncol 2006;1:15
5. Duenas-Gonzalez A, Zarba JJ, Patel F, et al. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol 2011;29:1678-85
6. DeClercq E. Antiviral activity of 5-substituted pyrimidine nucleoside analogues. Pure Appl Chem 1983;55:623-36
7. Hertel LW, Boder GB, Kroin JS, et al. Evaluation of the antitumor activity of gemcitabine. Cancer Res 1990;50:4417-22
8. Hertel LW, Kroin JS, Misner JW, et al. Synthesis of 2- deoxy-2,2-difluoro-Dribose and 2-deoxy-2,2-difluoro-Dribofuranosyl nucleosides. J Org Chem 1988;S3:2406-9
9. Gandhi V, Plunkett W. Modulatory activity of 2',2'-difluorodeoxycytidine on the phosphorylation and cytotoxicity of arabinosyl nucleosides. Cancer Res 1990;50:3675-80
10. Huang P, Chubb S, Hertel LW. Action of 2-'2'-difluorodeoxycytidine on DNA synthesis. Cancer Res 1991;51:6110-17
11. Gandhi V, Legha J, Chen F. Excision of 2',2'-difluorodeoxycytidine (gemcitabine) monophosphates residues from DNA. Cancer Res 1996;56:4453-9
12. Heinemann V, Xu YZ, Chubb S. Inhibition of ribonucleotide reduction in CCRF-CEM cells by 2',2'- difluorodeoxycytidine. Mol Pharmacol 1990;38:567-72
13. Heinemann V, Xu YZ, Chubb S. Cellular elimination of 2',2'- difluorodeoxycytidine 5¢triphosphate: a mechanism of self-potentiation. Cancer Res 1992;52:533-9
14. Huang P, Plunkitt W. A quantitative assay for fragmented DNA in apoptotic cells. Anal Biochem 1992;207:163-7
15. Braakhuis BJM, Vandongen GAMS, Vermorken JB, et al. Preclinical in vivo activity 2',2-difluorodeoxycytidine (gemcitabine) against human head and neck cancer. Cancer Res 1991;51:211-14
16. Ruiz van Haperen VWT, Veerman G, Vermorken JB, et al. Improved antitumour effect of 2,2 difluorodeoxycytidine (gemcitabine) in murine colon carcinomas when administered as continuous infusion [abstract]. Proc ASCO 994;35:2669
17. Candelaria M, de la Cruz-Hernandez E, Perez-Cardenas E, et al. Pharmacogenetics and pharmacoepigenetics of gemcitabine. Med Oncol 2010;27:1133-43
18. Abbruzzesse JL, Grunewald R, Weeks EA, et al. A phase I clinical plasma and cellular pharmacology study of gemcitabine. J Clin Oncol 1991;9:491-8
19. Pollera CF, Ceribelli A, Crecco M, et al. Weekly gemcitabine: a phase I study with short and prolonged infusion schedules. Proc ASCO 1992;11:329
20. Allerheiligen S, Johnson R, Hatcher B, et al. Gemcitabine pharmacokinetics are influenced by gender, body surface area (BSA), and duration of infusion. Proc ASCO 1994;13:338
21. Grunewald R, Kantarjian H, Du M, et al. Gemcitabine in leukemia: a Phase I clinical, plasma, and cellular pharmacology study. J Clin Oncol 1992;10:406-13
22. Gemzar package insert. Eli Lilly & Co., Indianapolis; 1996
23. Grunewald R, Abbruzzese JL, Tarassoff P, et al. Saturation of 2',2'-difluorodeoxycytidine 5'-triphosphate accumulation by mononuclear cells during a phase I trial of gemcitabine. Cancer Chemother Pharmacol 1991;27:258-62
24. Pauwels B, Korst AE, Lardon F, et al. Combined modality therapy of gemcitabine and radiation. Oncologist 2005;10:34-51
25. Lawrence TS, Eisbruch A, Shewach DS. Gemcitabine-mediated radiosensitization. Semin Oncol 1997;24:24.8
26. Hernandez P, Olivera P, Duenas-Gonzalez A, et al. Gemcitabine activity in cervical cancer cell lines. Cancer Chemother Pharmacol 2001;48:488-92
27. Mose S, Karapetian M, Juling-Pohlit L. The intensification of the radiotherapeutic effect on HeLa cells by gemcitabine. Strahlenther Onkol 1999;175:78-83
28. Duenas-Gonzalez A, Gonzalez EA, Lopez-Graniel C, et al. A phase II study of gemcitabine and cisplatin combination as induction chemotherapy for untreated locally advanced cervical carcinoma. Ann Oncol 2001;12:541-7
29. Duenas-Gonzalez A, Lopez-Graniel C, Gonzalez AE, et al. Induction chemotherapy with gemcitabine and oxaliplatin for locally advanced cervical carcinoma. Am J Clin Oncol 2003;26:22-5
30. McCormack M, Thomas H. A phase Ib study of gemcitabine (GEM) and concurrent radiotherapy (RT) in carcinoma of the cervix [abstract]. Ann Oncol 2000;11:88-9
31. Pattaranutaporn P, Thirapakawong C, Chansilpa Y, et al. Phase II study of concurrent gemcitabine and radiotherapy in locally advanced stage IIIB cervical carcinoma. Gynecol Oncol 2001;81:404-7
32. Boualga K. A phase II study of gemcitabine (G) and concomitant radiotherapy (R) in locally advanced carcinoma of the cervix (LACC) [abstract]. Int J Cancer 2002;13:378
33. Cetina L, Rivera L, Candelaria M, et al. Chemoradiation with gemcitabine for cervical cancer in patients with renal failure. Anticancer Drugs 2004;15:761-6
34. Alvarez AM, Mickiewicz E, Rodger J, et al. Radiotherapy (RT) with low dose biweekly gemcitabine (LDBG) and cisplatin in locally advanced cervical carcinoma (LACC): stages IIA-IVA [abstract]. Procc ASCO 2002;21:224a
35. Fields MT, Eisbruch A, Normolle D, et al. Radiosensitization produced in vivo by once- vs. twice-weekly 2'2'- difluoro-2'-deoxycytidine (gemcitabine). Int J Radiat Oncol Biol Phys 2000;47:785-91
36. Zarba JJ, Jaremtchuk AV, Gonzalez Jazey P, et al. A phase I-II study of weekly cisplatin and gemcitabine with concurrent radiotherapy in locally advanced cervical carcinoma. Ann Oncol 2003;14:1285-90
37. Candelaria M, Chanona-Vilchis J, Cetina L, et al. Prognostic significance of pathological response after neoadjuvant chemotherapy or chemoradiation for locally advanced cervical carcinoma. Int Semin Surg Oncol 2006;3:3
38. Duenas-Gonzalez A, Cetina-Perez L, Lopez-Graniel C, et al. Pathologic response and toxicity assessment of chemoradiotherapy with cisplatin versus cisplatin plus gemcitabine in cervical cancer: a randomized Phase II study. Int J Radiat Oncol Biol Phys 2005;61:817-23
39. Umanzor J, Aguiluz M, Pineda C, et al. Concurrent cisplatin/gemcitabine chemotherapy along with radiotherapy in locally advanced cervical carcinoma: A phase II trial. Gynecol Oncol 2006;100:70-5
40. Fukuoka M, Noda K, Hasegawa K, et al. An early phase II study of gemcitabine hydrochloride (LY 188011). Emcitabine Cooperative Study Group for Early Phase II. Gan To Kagaku Ryoho 1996;23:1813-24
41. Schilder RJ, Blessing JA, Morgan M, et al. Evaluation of gemcitabine in patients with squamous cell carcinoma of the cervix: a Phase II study of the gynecologic oncology group. Gynecol Oncol 2000;76:204-7
42. Greggi S, D'Agostino G, Smaniotto D, et al. Gemcitabine is ineffective in recurrent, pre-irradiated cervical cancer. Gynecol Oncol 2000;78:76-7
43. Goedhals L, Bezwoda WR. A phase II study of gemcitabine in advanced cervix carcinoma: final data [abstract]. Procc ASCO 1995;14:819
44. Peters GHQ, Bergman AM, Ruin van Haperen VWT, et al. Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol 1995;22:72
45. Matulonis UA, Campos S, Duska L, et al. Phase I/II dose finding study of combination cisplatin and gemcitabine in patients with recurrent cervix cancer. Gynecol Oncol 2006;103:160-4
46. Burnett AF, Roman LD, Garcia AA, et al. A phase II study of gemcitabine and cisplatin in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Gynecol Oncol 2000;76:63-6
47. Lorvidhaya V, Kamnerdsupaphon P, Chitapanarux I, et al. Cisplatin and gemcitabine in patients with metastatic cervical cancer. Gan To Kagaku Ryoho 2004;31:1057-62
48. Bouzid K, Mahfouf H. A phase II study of gemcitabine (G) and cisplatin (C) combination in the treatment of recurrent cervical squamous cell carcinoma (RCSCC) [abstract]. Proc ASCO 2003;22:1900
49. Brewer CA, Blessing JA, Nagourney RA, et al. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 2006;100:385-8
50. Duenas-Gonzalez A, Hinojosa-Garcia LM, Lopez-Graniel C, et al. Weekly cisplatin/low-dose gemcitabine combination for advanced and recurrent cervical carcinoma. Am J Clin Oncol 2001;24:201-3
51. Monk BJ, Sill MW, McMeekin DS, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol 2009;27:4649-55
52. Cella D, Huang HQ, Monk BJ, et al. Health-related quality of life outcomes associated with four cisplatin-based doublet chemotherapy regimens for stage IVB recurrent or persistent cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol 2010;119:531-7
53. Symonds RP, Davidson SE, Chan S, for the Scottish Gynaecological Cancer Trials Group. Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN Scotland. SCOTCERV: a phase II trial of docetaxel and gemcitabine as second line chemotherapy in cervical cancer. Gynecol Oncol 2011;123:105-9
54. Aapro MS, Martin C, Hatty S. Gemcitabine-a safety review. Anticancer Drugs 1998;9:191-201
55. Swisher EM, Swensen RE, Greer B, et al. Weekly gemcitabine and cisplatin in combination with pelvic radiation in the primary therapy of cervical cancer: a phase I trial of the Puget Sound Oncology Consortium. Gynecol Oncol 2006;101:429-35
56. Rose PG, Degeest K, McMeekin S, et al. A phase I study of gemcitabine followed by cisplatin concurrent with whole pelvic radiation therapy in locally advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol2007;107:274-9