Dược động học của các thuốc chống ung thư chọn lọc ở bệnh nhân ung thư cao tuổi: Tập trung vào ung thư vú
Tóm tắt
Nền tảng: Bệnh nhân cao tuổi nhận thuốc chống ung thư có thể có nguy cơ cao hơn trong việc phát triển các độc tính liên quan đến điều trị so với những bệnh nhân trẻ hơn. Tuy nhiên, một cơ sở dược động học (PK) tiềm năng cho nguy cơ tăng lên này vẫn chưa được thiết lập một cách nhất quán. Do đó, mục tiêu của nghiên cứu này là xem xét có hệ thống ảnh hưởng của tuổi tác đến PK của các tác nhân chống ung thư thường được áp dụng cho bệnh nhân ung thư vú cao tuổi. Phương pháp: Một cuộc tìm kiếm tài liệu đã được thực hiện sử dụng cơ sở dữ liệu điện tử PubMed, Tóm tắt đặc điểm sản phẩm (SmPC) và các đánh giá phê duyệt thuốc có sẵn, như đã được công bố bởi EMA và FDA. Các công bố mô tả các hồ sơ PK liên quan đến tuổi của các thuốc chống ung thư chọn lọc trong điều trị ung thư vú, ngoại trừ các hợp chất nội tiết, đã được chọn và đưa vào xem xét. Kết quả: Bài đánh giá này trình bày một cái nhìn tổng quan về các dữ liệu có sẵn mô tả ảnh hưởng của tuổi tác tăng lên đến PK của các thuốc chống ung thư chọn lọc được sử dụng trong điều trị ung thư vú. Kết luận: Các dữ liệu được công bố chọn lọc cho thấy sự khác biệt về tác động và mức độ của tuổi tác tăng lên đến PK của một số thuốc chống ung thư. Có thể tồn tại những khác biệt PK liên quan đến tuổi có ý nghĩa lâm sàng đối với các thuốc anthracycline và các tác nhân platin. Trong phần lớn các trường hợp, tuổi không phải là một dấu hiệu thay thế tốt cho PK của thuốc chống ung thư, và trạng thái sinh lý của bệnh nhân cá thể có thể được tiếp cận tốt hơn bằng cách xem xét chức năng cơ quan, Điểm cộng đồng Charlson hoặc đánh giá chức năng lão khoa.
Từ khóa
Tài liệu tham khảo
Smith, 2009, Future of cancer incidence in the United States: Burdens upon an aging, changing nation, J. Clin. Oncol., 27, 2758, 10.1200/JCO.2008.20.8983
International Conference on Harmonisation (1993). Studies in Support of Special Populations : Geriatrics—E7, European Medicines Agency.
Rothwell, 2005, External validity of randomised controlled trials: “To whom do the results of this trial apply?”, Lancet, 365, 82, 10.1016/S0140-6736(04)17670-8
Zulman, 2011, Examining the evidence: A systematic review of the inclusion and analysis of older adults in randomized controlled trials, J. Gen. Intern. Med., 26, 783, 10.1007/s11606-010-1629-x
Murthy, 2004, Participation in cancer clinical trials: Race-, sex, and aged-based disparities, Prim. Care, 291, 2720
Lewis, 2003, Participation of patients 65 years of age or older in cancer clinical trials, J. Clin. Oncol., 21, 1383, 10.1200/JCO.2003.08.010
Villella, 2005, Optimising treatment of elderly patients with ovarian cancer: Improving their enrollment in clinical trials, Drugs Aging, 22, 95, 10.2165/00002512-200522020-00001
International Conference on Harmonisation (1994). Dose-Response Information to Support Drug Registration—E4, European Medicines Agency.
Food and Drug Administration (2003). Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis and Regulatory Applications.
Bastiaannet, 2010, Breast cancer in elderly compared to younger patients in the Netherlands: Stage at diagnosis, treatment and survival in 127,805 unselected patients, Breast Cancer Res. Treat., 124, 801, 10.1007/s10549-010-0898-8
Klotz, 2009, Pharmacokinetics and drug metabolism in the elderly, Drug Metab. Rev., 41, 67, 10.1080/03602530902722679
Cusack, 2004, Pharmacokinetics in older persons, Am. J. Geriatr. Pharmacother., 2, 274, 10.1016/j.amjopharm.2004.12.005
Kiderlen, 2014, Impact of comorbidity on outcome of older breast cancer patients: A FOCUS cohort study, Breast Cancer Res. Treat., 145, 185, 10.1007/s10549-014-2917-7
Popa, 2015, Potential drug interactions and chemotoxicity in older patients with cancer receiving chemotherapy, J. Geriatr. Oncol., 5, 307, 10.1016/j.jgo.2014.04.002
Srokowski, 2009, Impact of diabetes mellitus on complications and outcomes of adjuvant chemotherapy in older patients with breast cancer, J. Clin. Oncol., 27, 2170, 10.1200/JCO.2008.17.5935
Satariano, 1994, The effect of comorbidity on 3-year survival of women with primary breast cancer, Ann. Intern. Med., 120, 104, 10.7326/0003-4819-120-2-199401150-00002
Yancik, 2001, Effect of age and comorbidity in postmenopausal breast cancer patients aged 55 years and older, JAMA, 285, 885, 10.1001/jama.285.7.885
Food and Drug Administration (2011). Taxotere (docetaxel), NDA 020449Adriamycin RDF (Doxorubin Hydrochloride), NDA 050467.
DRUGDEX® (2015). Docetaxel, Truven Health Analytics.
Clarke, 1999, Clinical pharmacokinetics of docetaxel, Clin. Pharmacokinet., 36, 99, 10.2165/00003088-199936020-00002
John, 2003, Pharmacological factors influencing anticancer drug selection in the elderly, Drugs Aging, 20, 737, 10.2165/00002512-200320100-00003
Schmucker, 2001, Liver function and phase I drug metabolism in the elderly: A paradox, Drugs Aging, 18, 837, 10.2165/00002512-200118110-00005
Minami, 2004, Comparison of pharmacokinetics and pharmacodynamics of docetaxel and cisplatin in elderly and non-elderly patients: Why is toxicity increased in elderly patients?, J. Clin. Oncol., 22, 2901, 10.1200/JCO.2004.10.163
Slaviero, 2004, Population pharmacokinetics of weekly docetaxel in patients with advanced cancer, Br. J. Clin. Pharmacol., 57, 44, 10.1046/j.1365-2125.2003.01956.x
Verweij, 2005, Prospective evaluation of the pharmacokinetics and toxicity profile of docetaxel in the elderly, J. Clin. Oncol., 23, 1070, 10.1200/JCO.2005.03.082
Hurria, 2006, Pharmacokinetics and toxicity of weekly docetaxel in older patients, Clin. Cancer Res., 12, 6100, 10.1158/1078-0432.CCR-06-0200
Yamamoto, 2000, Correlation between docetaxel clearance and estimated cytochrome P450 activity by urinary metabolite of exogenous cortisol, J. Clin. Oncol., 18, 2301, 10.1200/JCO.2000.18.11.2301
Michael, 2012, Docetaxel pharmacokinetics and its correlation with two in vivo probes for cytochrome P450 enzymes: The C 14-erythromycin breath test and the antipyine clearance test, Cancer Chemother. Pharmacol., 69, 125, 10.1007/s00280-011-1676-y
Bruno, 2001, Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel, Investig. New Drugs, 19, 163, 10.1023/A:1010687017717
European Medicines Agency (2005). Scientific Discussion: Taxotere (Docetaxel), European Medicines Agency.
European Medicines Agency (2015). Taxotere (Docetaxel), European Medicines Agency.
DRUGDEX® (2015). Paclitaxel, Truven Health Analytics.
Henningsson, 2001, Mechanism-based pharmacokinetic model for paclitaxel, J. Clin. Oncol., 19, 4065, 10.1200/JCO.2001.19.20.4065
Nakamura, 2000, Retrospective comparison of toxicity and efficacy in phase II trials of 3-h infusions of paclitaxel for patients 70 years of age or older and patients under 70 years of age, Cancer Chemother. Pharmacol., 46, 114, 10.1007/s002800000143
Fidias, 2001, Measurement and impact of co-morbidity in elderly patients with advanced non-small cell lung cancer treated with chemotherapy. A phase II study of weekly paclitaxel, Clin. Cancer Res., 7, 3942
Borkowski, 1994, Relation between age and clearance rate of nine investigational anticancer drugs from phase I pharmacokinetic data, Cancer Chemother. Pharmacol., 33, 493, 10.1007/BF00686507
Smorenburg, 2003, Altered clearance of unbound paclitaxel in elderly patients with metastatic breast cancer, Eur. J. Cancer, 39, 196, 10.1016/S0959-8049(02)00611-1
Joerger, 2006, Quantitative effect of gender, age, liver function, and body size on the population pharmacokinetics of Paclitaxel in patients with solid tumors, Clin. Cancer Res., 12, 2150, 10.1158/1078-0432.CCR-05-2069
Joerger, 2012, Evaluation of a pharmacology-driven dosing algorithm of 3-weekly paclitaxel using therapeutic drug monitoring: A pharmacokinetic-pharmacodynamic simulation study, Clin. Pharmacokinet., 51, 607, 10.1007/BF03261934
Lichtman, 2006, Prospective evaluation of the relationship of patient age and paclitaxel clinical pharmacology: Cancer and Leukemia Group B (CALGB 9762), J. Clin. Oncol., 24, 1846, 10.1200/JCO.2005.03.9289
Huizing, 1997, Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer. The European Cancer Centre, J. Clin. Oncol., 15, 317, 10.1200/JCO.1997.15.1.317
DRUGDEX® (2015). Doxorubicin Hydrochloride, Truven Health Analytics.
Food and Drug Administration (Adriamycin RDF (Doxorubin Hydrochloride), NDA 050467, 2013). Adriamycin RDF (Doxorubin Hydrochloride), NDA 050467.
Dobbs, 1995, Gender affects doxorubicin pharmacokinetics in patients with normal liver biochemistry, Cancer Chemother. Pharmacol., 36, 473, 10.1007/BF00685796
Dees, 2000, A prospective pharmacologic evaluation of age-related toxicity of adjuvant chemotherapy in women with breast cancer, Cancer Investig., 18, 521, 10.3109/07357900009012191
Robert, 1983, Age dependence of the early-phase pharmacokinetics of doxorubicin, Cancer Res., 43, 4467
Li, 2003, The effect of age on the early disposition of doxorubicin, Cancer Chemother. Pharmacol., 51, 395, 10.1007/s00280-002-0554-z
Joerger, 2007, Population pharmacokinetics and pharmacodynamics of doxorubicin and cyclophosphamide in breast cancer patients: A study by the EORTC-PAMM-NDDG, Clin. Pharmacokinet., 46, 1051, 10.2165/00003088-200746120-00005
DRUGDEX® (2015). Epirubicin Hydrochloride, Truven Health Analytics.
Jakobsen, 1991, Multiple-dose pharmacokinetics of epirubicin at four different dose levels: Studies in patients with metastatic breast cancer, Cancer Chemother. Pharmacol., 28, 63, 10.1007/BF00684959
Wade, 1992, Variability in the pharmacokinetics of epirubicin: A population analysis, Cancer Chemother. Pharmacol., 29, 391, 10.1007/BF00686009
Eksborg, 1992, Epirubicin as a single agent therapy for the treatment of breast cancer—A pharmacokinetic and clinical study, Med. Oncol. Tumor Pharmacother., 9, 75, 10.1007/BF02989657
Food and Drug Administration (Ellence (Epirubicin Hydrochloride), NDA 050778, 2014). Ellence (Epirubicin Hydrochloride), NDA 050778.
Food and Drug Administration, Center for Drug Evaluation and Research (1999). Clinical Pharmacology and Biopharmaceutics Review: Ellence (Epirubicin Hydrochloride).
DRUGDEX® (2015). Cyclophosphamide, Truven Health Analytics.
Moore, 1991, Clinical pharmacokinetics of cyclophosphamide, Clin. Pharmacokinet., 20, 194, 10.2165/00003088-199120030-00002
Food and Drug Administration (Lyophilized Cytoxan (Cyclophosphamide), NDA 012142, 2013). Lyophilized Cytoxan (Cyclophosphamide), NDA 012142.
DRUGDEX® (2015). Vinorelbine Tartrate, Truven Health Analytics.
Sorio, 1997, Pharmacokinetics and tolerance of vinorelbine in elderly patients with metastatic breast cancer, Eur. J. Cancer, 33, 301, 10.1016/S0959-8049(96)00426-1
Nguyen, 2002, Population pharmacokinetics model and limited sampling strategy for intravenous vinorelbine derived from phase I clinical trials, Br. J. Clin. Pharmacol., 53, 459, 10.1046/j.1365-2125.2002.01581.x
Variol, 2002, A simultaneous oral/intravenous population pharmacokinetic model for vinorelbine, Eur. J. Clin. Pharmacol., 58, 467, 10.1007/s00228-002-0506-x
Lush, 2005, The absolute bioavailability of oral vinorelbine in patients with solid tumors, Cancer Chemother. Pharmacol., 56, 578, 10.1007/s00280-005-1025-0
Wong, 2006, Predictors of vinorelbine pharmacokinetics and pharmacodynamics in patients with cancer, J. Clin. Oncol., 24, 2448, 10.1200/JCO.2005.02.1295
Gauvin, 2000, Bayesian estimate of vinorelbine pharmacokinetic parameters in elderly patients with advanced metastatic cancer, Clin. Cancer Res., 6, 2690
Gauvin, 2002, A limited-sampling strategy to estimate individual pharmacokinetic parameters of vinorelbine in elderly patients with advanced metastatic cancer, Anticancer Drugs, 13, 473, 10.1097/00001813-200206000-00005
Food and Drug Administration (Navelbine (Vinorelbine), NDA 020388, 2014). Navelbine (Vinorelbine), NDA 020388.
Depierre, 2001, Oral vinorelbine: Feasibility and safety profile, Ann. Oncol., 12, 1677, 10.1023/A:1013567022670
Colomer, 2010, Treatment of cancer with oral drugs: A position statement by the Spanish Society of Medical Oncology (SEOM), Ann. Oncol., 21, 195, 10.1093/annonc/mdp595
Pierre Fabre Press Release: Pierre Fabre Médicament Obtains MA in China for NAVELBINE®Oral (Vinorelbine) in the Treatment of Advanced Lung and Breast Cancer. Available online: http://www.pierre-fabre.com/sites/default/files/files/document/file/amm_chine_navelbine_oralven.pdf.
Therapeutic Goods Administration (2012). Australian Public Assessment Report: Navelbine Oral (Vinorelbine Capsules), Therapeutic Goods Administration.
Marty, 2001, Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors, Ann. Oncol., 12, 1643, 10.1023/A:1013180903805
Puozzo, 2004, Non-Small-Cell Lung Cancer in Elderly Patients: Influence of Age on Vinorelbine Oral Pharmacokinetics, Clin. Lung Cancer, 5, 237, 10.3816/CLC.2004.n.005
Gridelli, 2004, Oral vinorelbine given as monotherapy to advanced, elderly NSCLC patients: A multicentre phase II trial, Eur. J. Cancer, 40, 2424, 10.1016/j.ejca.2004.07.028
DRUGDEX® (2015). Fluorouracil, Truven Health Analytics.
Deenen, 2011, Relationship between single nucleotide polymorphisms and haplotypes in DPYD and toxicity and efficacy of capecitabine in advanced colorectal cancer, Clin. Cancer Res., 17, 3455, 10.1158/1078-0432.CCR-10-2209
Cai, 2014, The role of IVS14+1 G > A genotype detection in the dihydropyimidine dehydrogenase gene and pharmacokinetic monitoring of 5-fluorouracil in the individualized adjustment of 5-fluorouracil for patients with local advanced and metastatic colorectal cancer: Eur, Rev. Med. Pharmacol. Sci., 18, 1247
Denham, 1999, Causes for increased myelosuppression with increasing age in patients with oesophageal cancer treated by chemoradiotherapy, Eur. J. Cancer, 35, 921, 10.1016/S0959-8049(99)00065-9
Port, 1991, Relative importance of dose, body surface area, sex, and age for 5-fluorouracil clearance, Oncology, 48, 277, 10.1159/000226942
Mueller, 2013, Gender-specific elimination of continuous-infusional 5-fluorouracil in patients with gastrointestinal malignancies: Results from a prospective population pharmacokinetic study, Cancer Chemother. Pharmacol., 71, 361, 10.1007/s00280-012-2018-4
Milano, 1992, Influence of sex and age on fluorouracil clearance, J. Clin. Oncol., 10, 1171, 10.1200/JCO.1992.10.7.1171
Duffour, 2010, Clinical impact of intesified 5-Fluorouracil-based chemotherapy using a prospective pharmacokinetically-guided dosing approach: Comparative study in elderly and non-elderly patients with metastatic colorectal cancer, J. Chemother., 22, 179, 10.1179/joc.2010.22.3.179
Medicines and Healthcare products Regulatory Agency (2014). Public Assessment Report: Fluorouracil, Medicines and Healthcare products Regulatory Agency.
Seymour, 2011, Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): An open-label, randomised factorial trial, Lancet, 377, 1749, 10.1016/S0140-6736(11)60399-1
Kim, 2013, Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer, Radiat. Oncol., 8, 160, 10.1186/1748-717X-8-160
Chang, 2012, Adjuvant capecitabine chemotherapy using a tailored-dose strategy in elderly patients with colon cancer, Ann. Oncol., 23, 911, 10.1093/annonc/mdr329
Twelves, 2012, Capecitabine versus 5-fluorouracil/folinic acid as adjuvant therapy for stage III colon cancer: Final results from the X-ACT trial with analysis by age and preliminary evidence of a pharmacodynamic marker of efficacy, Ann. Oncol., 23, 1190, 10.1093/annonc/mdr366
Bajetta, 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, 10.1200/JCO.2005.02.167
Cunningham, 2013, Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): An open-label, randomised phase 3 trial, Lancet Oncol., 14, 1077, 10.1016/S1470-2045(13)70154-2
Twelves, 2005, Capecitabine as adjuvant treatment for stage III colon cancer, N. Engl. J. Med., 352, 2696, 10.1056/NEJMoa043116
Blum, 2001, Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients, Cancer, 92, 1759, 10.1002/1097-0142(20011001)92:7<1759::AID-CNCR1691>3.0.CO;2-A
Fumoleau, 2004, Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer, Eur. J. Cancer, 40, 536, 10.1016/j.ejca.2003.11.007
He, 2015, Low-dose capecitabine adjuvant chemotherapy in elderly stage II/III colorectal cancer patients (LC-ACEC): Study protocol for a randomized controlled trial, Trials, 16, 238, 10.1186/s13063-015-0753-7
Food and Drug Administration (1998). Medical Review: Xeloda (Capecitabine).
Food and Drug Administration (Xeloda (Capecitbine), NDA 020896, 2015). Xeloda (Capecitbine), NDA 020896.
Gieschke, 2003, Population pharmacokinetics and concentration-effect relationships of capecitabine metabolites in colorectal cancer patients, Br. J. Clin. Pharmacol., 55, 252, 10.1046/j.1365-2125.2003.01765.x
Cassidy, 1999, Bioequivalence of two tablet formulations of capecitabine and exploration of age, gender, body surface area, and creatinine clearance as factors influencing systemic exposure in cancer patients, Cancer Chemother. Pharmacol., 44, 453, 10.1007/s002800051118
Gieschke, 2002, Population pharmacokinetic analysis of the major metabolites of capecitabine, J. Pharmacokinet. Pharmacodyn., 29, 25, 10.1023/A:1015716617967
Fischel, 2004, Lack of contribution of dihydrofluorouracil and alpha-fluoro-beta-alanine to the cytotoxicity of 5’-deoxy-5-fluorouridine on human keratinocytes, Anticancer Drugs, 15, 969, 10.1097/00001813-200411000-00006
Urien, 2014, Pharmacokinetics and exposure-effect relationships of capecitabine in elderly patients with breast or colorectal cancer, Cancer Chemother. Pharmacol., 73, 1285, 10.1007/s00280-014-2466-0
Louie, 2013, Higher capecitabine AUC in elderly patients with advanced colorectal cancer (SWOGS0030), Br. J. Cancer, 109, 1744, 10.1038/bjc.2013.517
European Medicines Agency (2014). Xeloda (Capecitabine), European Medicines Agency.
DRUGDEX® (2015). Carboplatin, Truven Health Analytics.
Ainsworth, 2012, Evaluation of glomerular filtration rate estimation by Cockcroft-Gault, Jelliffe, Wright and Modification of Diet in Renal Disease (MDRD) formulae in oncology patients, Ann. Oncol., 23, 1845, 10.1093/annonc/mdr539
Food and Drug Administration (Paraplatin (Carboplatin), NDA 020452, 2004). Paraplatin (Carboplatin), NDA 020452.
Monteiro, 2011, Effect of age on systemic exposure and haematological toxicity of carboplatin in advanced non-small cell lung cancer patients, Basic Clin. Pharmacol. Toxicol., 109, 457, 10.1111/j.1742-7843.2011.00753.x
DRUGDEX® (2015). Cisplatin, Truven Health Analytics.
Himmelstein, 1981, Clinical kinetics on intact cisplatin and some related species, Clin. Pharmacol. Ther., 29, 658, 10.1038/clpt.1981.91
CBG-MEB (2011). SmPC Platinol, CBG-MEB.
Food and Drug Administration (2015). Platinol (Cisplatin), NDA 018057.
Medicines and Healthcare products Regulatory Agency (2010). Public Assessment Report: Platinol (Cisplatin), Medicines and Healthcare products Regulatory Agency.
Reece, 1987, Creatinine clearance as a predictor of ultrafilterable platinum disposition in cancer patients treated with cisplatin: Relationship between peak ultrafilterable platinum plasma levels and nephrotoxicity, J. Clin. Oncol., 5, 304, 10.1200/JCO.1987.5.2.304
Yamamoto, 1995, The influence of ageing on cisplatin pharmacokinetics in lung cancer patients with normal organ function, Cancer Chemother. Pharmacol., 36, 102, 10.1007/BF00689192
Thyss, 1994, Renal tolerance of cisplatin in patients more than 80 years old, J. Clin. Oncol., 12, 2121, 10.1200/JCO.1994.12.10.2121
Cubillo, 2001, Renal tolerance to cisplatin in patients 70 years and older, Am. J. Clin. Oncol., 24, 192, 10.1097/00000421-200104000-00018
Procter, 2005, Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer, N. Engl. J. Med., 353, 1659, 10.1056/NEJMoa052306
Seidman, 2008, Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: Final results of Cancer and Leukemia Group B Protocol 9840, J. Clin. Oncol., 26, 1642, 10.1200/JCO.2007.11.6699
Boekhout, 2012, Population pharmacokinetic-pharmacodynamic analysis of trastuzumab-associated cardiotoxicity, Clin. Pharmacol. Ther., 29, 3499
Food and Drug Administration (2015). Kadcyla (Ado-Trastuzumab Emtansine), BLA 125427.
Food and Drug Administration (2013). Drug Approvals: Kadcyla (Ado-Trastuzumab Emtansine).
European Medicines Agency (2013). Summary of Opinion: Kadcyla (Trastuzumab Emtansine), European Medicines Agency.
Lu, 2013, An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer, Clin. Pharmacokinet., 52, 657, 10.1007/s40262-013-0060-y
Gupta, 2012, Clinical Implications of Pathophysiological and Demographic Covariates on the Population Pharmacokinetics of Trastuzumab Emtansine, a HER2-Targeted Antibody-Drug Conjugate, in Patients With HER2-Positive Metastatic Breast Cancer, J. Clin. Pharmacol., 52, 691, 10.1177/0091270011403742
Lu, D., Girish, S., Gao, Y., Wang, B., Yi, J.H., Guardino, E., Samant, M., Cobleigh, M., Rimawi, M., and Conte, P. (2014). Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: Clinical implications of the effect of covariates. Cancer Chemother. Pharmacol., 399–410.
Dubbelman, 2012, Mass Balance Study of [ 14 C ] Eribulin in Patients with Advanced Solid Tumors, Drug Metab. Dispos., 40, 313, 10.1124/dmd.111.042762
Food and Drug Administration (Halaven (Eribulin Mesylate), NDA 201532, 2014). Halaven (Eribulin Mesylate), NDA 201532.
European Medicines Agency (2015). Halaven (Erybulin Mesylate), European Medicines Agency.
Food and Drug Administration, Center for Drug Evaluation and Research (2010). Clinical Pharmacology and Biopharmaceutics Review(s): Halaven (Erybulin Mesylate).
DRUGDEX® (2015). Everolimus, Truven Health Analytics.
Food and Drug Administration (Afinitor (Everolimus), NDA 022334, 2015). Afinitor (Everolimus), NDA 022334.
Motzer, 2008, Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase III trial, Lancet, 372, 449, 10.1016/S0140-6736(08)61039-9
Food and Drug Administration, Center for Drug Evaluation and Research (2009). Clinical Pharmacology and Biopharmaceutics Review(s): AFINITOR (everolimus).
Xu, 2011, Two-dose-level confirmatory study of the pharmacokinetics and tolerability of everolimus in Chinese patients with advanced solid tumors, J. Hematol. Oncol., 4, 3, 10.1186/1756-8722-4-3
DRUGDEX® (2015). Lapatinib, Truven Health Analytics.
Food and Drug Administration (Tykerb (Lapatinib Ditosylate), NDA 022059, 2015). Tykerb (Lapatinib Ditosylate), NDA 022059.
Scheffler, 2011, Clinical pharmacokinetics of tyosine kinase inhibitors, Clin. Pharmacokinet., 50, 371, 10.2165/11587020-000000000-00000
Food and Drug Administration, Center for Drug Evaluation and Research (2007). Clinical Pharmacology and Biopharmaceutics Review(s): Tykerb (Lapatinib Ditosylate).
European Medicines Agency (2015). Tyverb (Lapatinib Ditosylate Monohydrate), European Medicines Agency.
Kanefendt, 2011, Clinical pharmacokinetics of tyosine kinase inhibitors: Focus on pyimidines, pyidines and pyroles, Clin. Pharmacokinet., 50, 551, 10.2165/11593320-000000000-00000
Joerger, 2012, Covariate pharmacokinetic model building in oncology and its potential clinical relevance, AAPS J., 14, 119, 10.1208/s12248-012-9320-2
Giordano, 2014, Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline, J. Clin. Oncol., 32, 1, 10.1200/JCO.2013.54.0948
National Institute for Health and Care Excellence (2014). Early and Locally Advanced Breast Cancer (Update): Diagnosis and Treatment, National Institute for Health and Care Excellence.
National Institute for Health and Care Excellence (2014). Advanced Breast Cancer (Update): Diagnosis and Treatment, National Institute for Health and Care Excellence.
Partridge, 2014, Chemotherapy and Targeted Therapy for Women With Human Epidermal Growth Factor Receptor 2-Negative (or unknown) Advanced Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline, J. Clin. Oncol., 32, 3307, 10.1200/JCO.2014.56.7479
Biganzoli, 2012, Management of elderly patients with breast cancer: Updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA), Lancet Oncol., 13, e148, 10.1016/S1470-2045(11)70383-7
Comprehensive Cancer Centre the Netherlands (IKNL) (2015). Guideline: Breast Cancer (Draft), Comprehensive Cancer Centre the Netherlands (IKNL).
Balducci, 2010, Assessment and treatment of elderly patients with cancer, Surg. Oncol., 19, 117, 10.1016/j.suronc.2009.11.008
Hamaker, 2012, Frailty screening methods for predicting outcome of a comprehensive geriatric assessment in elderly patients with cancer: A systematic review, Lancet Oncol., 13, e437, 10.1016/S1470-2045(12)70259-0
Bellera, 2013, Screening methods for geriatric frailty, Lancet Oncol., 14, e1, 10.1016/S1470-2045(12)70554-5
Aaldriks, 2016, Prognostic factors for the feasibility of chemotherapy and the Geriatric Prognostic Index (GPI) as risk profile for mortality before chemotherapy in the elderly, Acta Oncol., 55, 15, 10.3109/0284186X.2015.1068446