Phase 1a/1b and pharmacogenetic study of docetaxel, oxaliplatin and capecitabine in patients with advanced cancer of the stomach or the gastroesophageal junction

Cancer Chemotherapy and Pharmacology

Volumn 76, Issue 6, 2015, Pages 1285-1295

  Deenen, Maarten J ^a   Meulendijks, Didier ^a   Boot, Henk ^a   Legdeur, Marie Cecile J C ^b   Beijnen, Jos H ^a,c   Schellens, Jan H M ^a,c   Cats, Annemieke ^a  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b MEDISCH SPECTRUM TWENTE   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Capecitabine; Docetaxel; Gastric cancer; Oxaliplatin; Pharmacogenetics; Pharmacokinetics

Indexed keywords

CAPECITABINE; DOCETAXEL; ENOLASE; ENOLASE SUPERFAMILY 1; EXCISION REPAIR CROSS COMPLEMENTING PROTEIN 1; OXALIPLATIN; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; PLATINUM COMPLEX; TAXOID;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; COHORT ANALYSIS; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DYSGEUSIA; ELIMINATION HALF-LIFE; ESOPHAGUS CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTROESOPHAGEAL JUNCTION CANCER; HAND FOOT SYNDROME; HUMAN; HYPOALBUMINEMIA; INFECTION; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAIL DISEASE; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHARMACOGENETICS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN TOXICITY; STOMACH CANCER; STOMATITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME; VOMITING; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG EFFECTS; ESOPHAGEAL NEOPLASMS; GASTROESOPHAGEAL JUNCTION; GENETIC PREDISPOSITION; GENETICS; METABOLIC CLEARANCE RATE; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; SINGLE NUCLEOTIDE POLYMORPHISM; STOMACH NEOPLASMS;

ADULT; AGED; ALOPECIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CAPECITABINE; DISEASE-FREE SURVIVAL; ESOPHAGEAL NEOPLASMS; ESOPHAGOGASTRIC JUNCTION; FATIGUE; FEMALE; GENETIC PREDISPOSITION TO DISEASE; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NAUSEA; ORGANOPLATINUM COMPOUNDS; PHARMACOGENETICS; POLYMORPHISM, SINGLE NUCLEOTIDE; STOMACH NEOPLASMS; TAXOIDS; TREATMENT OUTCOME;

EID: 84947578076     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-015-2872-y     Document Type: Article

References (41)

1. World Health Organization (2014) World cancer report 2014. http://www.who.org
2. Wagner AD, Unverzagt S, Grothe W, Kleber G, Grothey A, Haerting J, Fleig WE (2010) Chemotherapy for advanced gastric cancer. Cochrane Database Syst 3:CD004064
3. Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J (1994) Docetaxel (Taxotere) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer 70:380-383
4. Hejna M, Raderer M, Zacherl J, Ba-Ssalamah A, Puspok A, Schmidinger M, Pluschnig U, Brodowicz T, Zielinski CC (2008) Phase II study of docetaxel in combination with oxaliplatin in patients with metastatic or locally advanced esophagogastric cancer previously untreated with chemotherapy for advanced disease: results of the Central European Cooperative Oncology Group Study ESGAS.1.2.001. Anticancer Drugs 19:535-539
5. Roth AD, Maibach R, Martinelli G, Fazio N, Aapro MS, Pagani O, Morant R, Borner MM, Herrmann R, Honegger H, Cavalli F, Alberto P, Castiglione M, Goldhirsch A (2000) Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Swiss Group for Clinical Cancer Research (SAKK), and the European Institute of Oncology (EIO). Ann Oncol 11:301-306
6. Roth AD, Maibach R, Fazio N, Sessa C, Stupp R, Morant R, Herrmann R, Borner MM, Goldhirsch A, de Braud F (2004) 5-Fluorouracil as protracted continuous intravenous infusion can be added to full-dose docetaxel (Taxotere)-cisplatin in advanced gastric carcinoma: a phase I-II trial. Ann Oncol 15:759-764
7. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 24:4991-4997
8. Lorenzen S, Hentrich M, Haberl C, Heinemann V, Schuster T, Seroneit T, Roethling N, Peschel C, Lordick F (2007) Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial. Ann Oncol 18:1673-1679
9. Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Koberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne-Jones R, Widmer L, Seymour M, de Braud F (2007) Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 25:3217-3223
10. Guimbaud R, Louvet C, Ries P, Ychou M, Maillard E, Andre T, Gornet JM, Aparicio T, Nguyen S, Azzedine A, Etienne PL, Boucher E, Rebischung C, Hammel P, Rougier P, Bedenne L, Bouche O (2014) Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French Intergroup (Federation Francophone de Cancerologie Digestive, Federation Nationale des Centres de Lutte Contre le Cancer, and Groupe Cooperateur Multidisciplinaire en Oncologie) Study. J Clin Oncol 32:3520-3526
11. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, Hughes M, Mansi J, Findlay M, Hill A, Oates J, Nicolson M, Hickish T, O'Brien M, Iveson T, Watson M, Underhill C, Wardley A, Meehan M (1997) Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15:261-267
12. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358:36-46
13. Sawada N, Ishikawa T, Fukase Y, Nishida M, Yoshikubo T, Ishitsuka H (1998) Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res 4:1013-1019
14. 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
15. Kuppens IE, van Maanen MJ, Rosing H, Schellens JH, Beijnen JH (2005) Quantitative analysis of docetaxel in human plasma using liquid chromatography coupled with tandem mass spectrometry. Biomed Chromatogr 19:355-361
16. Deenen MJ, Rosing H, Hillebrand MJ, Schellens JH, Beijnen JH (2013) Quantitative determination of capecitabine and its six metabolites in human plasma using liquid chromatography coupled to electrospray tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 913-914:30-40
17. Bruno R, Hille D, Riva A, Vivier N, Bokkel Huinnink WW, van Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD, Chevallier B, Fumoleau P, Burris HA, Ravdin PM, Sheiner LB (1998) Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol 16:187-196
18. Reigner B, Blesch K, Weidekamm E (2001) Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 40:85-104
19. Thuss-Patience PC, Kretzschmar A, Repp M, Kingreen D, Hennesser D, Micheel S, Pink D, Scholz C, Dorken B, Reichardt P (2005) Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol 23:494-501
20. Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jager E (2008) Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol 19:1882-1887
21. Stein A, Arnold D, Thuss-Patience PC, Moehler M, Grothe W, Seufferlein T, Reinacher-Schick A, Geissler M, Hofheinz RD, Schmoll HJ (2014) Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study. Acta Oncol 53:392-398
22. Yu JJ, Lee KB, Mu C, Li Q, Abernathy TV, Bostick-Bruton F, Reed E (2000) Comparison of two human ovarian carcinoma cell lines (A2780/CP70 and MCAS) that are equally resistant to platinum, but differ at codon 118 of the ERCC1 gene. Int J Oncol 16:555-560
23. Yin M, Yan J, Martinez-Balibrea E, Graziano F, Lenz HJ, Kim HJ, Robert J, Im SA, Wang WS, Etienne-Grimaldi MC, Wei Q (2011) ERCC1 and ERCC2 polymorphisms predict clinical outcomes of oxaliplatin-based chemotherapies in gastric and colorectal cancer: a systemic review and meta-analysis. Clin Cancer Res 17:1632-1640
24. Ma SC, Zhao Y, Zhang T, Ling XL, Zhao D (2015) Association between the ERCC1 rs11615 polymorphism and clinical outcomes of oxaliplatin-based chemotherapies in gastrointestinal cancer: a meta-analysis. Onco Targets Ther 8:641-648
25. Bradbury PA, Kulke MH, Heist RS, Zhou W, Ma C, Xu W, Marshall AL, Zhai R, Hooshmand SM, Asomaning K, Su L, Shepherd FA, Lynch TJ, Wain JC, Christiani DC, Liu G (2009) Cisplatin pharmacogenetics, DNA repair polymorphisms, and esophageal cancer outcomes. Pharmacogn Genom 19:613-625
26. Lunn RM, Helzlsouer KJ, Parshad R, Umbach DM, Harris EL, Sanford KK, Bell DA (2000) XPD polymorphisms: effects on DNA repair proficiency. Carcinogenesis 21:551-555
27. Qian YY, Liu XY, Pei D, Xu JL, Shen H, Chen XF, Liu YQ, Shen LZ, Shu YQ (2014) The XPD Lys751Gln polymorphism has predictive value in colorectal cancer patients receiving oxaliplatin-based chemotherapy: a systematic review and meta-analysis. Asian Pac J Cancer Prev 15:9699-9706
28. Xue H, Lu Y, Lin B, Chen J, Tang F, Huang G (2012) The effect of XPD/ERCC2 polymorphisms on gastric cancer risk among different ethnicities: a systematic review and meta-analysis. PLoS ONE 7:e43431
29. Goekkurt E, Hoehn S, Wolschke C, Wittmer C, Stueber C, Hossfeld DK, Stoehlmacher J (2006) Polymorphisms of glutathione S-transferases (GST) and thymidylate synthase (TS) - novel predictors for response and survival in gastric cancer patients. Br J Cancer 94:281-286
30. Ruzzo A, Graziano F, Kawakami K, Watanabe G, Santini D, Catalano V, Bisonni R, Canestrari E, Ficarelli R, Menichetti ET, Mari D, Testa E, Silva R, Vincenzi B, Giordani P, Cascinu S, Giustini L, Tonini G, Magnani M (2006) Pharmacogenetic profiling and clinical outcome of patients with advanced gastric cancer treated with palliative chemotherapy. J Clin Oncol 24:1883-1891
31. Tibaldi C, Giovannetti E, Vasile E, Mey V, Laan AC, Nannizzi S, Di MR, Antonuzzo A, Orlandini C, Ricciardi S, Del TM, Peters GJ, Falcone A, Danesi R (2008) Correlation of CDA, ERCC1, and XPD polymorphisms with response and survival in gemcitabine/cisplatin-treated advanced non-small cell lung cancer patients. Clin Cancer Res 14:1797-1803
32. Rosmarin D, Palles C, Pagnamenta A, Kaur K, Pita G, Martin M, Domingo E, Jones A, Howarth K, Freeman-Mills L, Johnstone E, Wang H, Love S, Scudder C, Julier P, Fernandez-Rozadilla C, Ruiz-Ponte C, Carracedo A, Castellvi-Bel S, Castells A, Gonzalez-Neira A, Taylor J, Kerr R, Kerr D, Tomlinson I (2015) A candidate gene study of capecitabine-related toxicity in colorectal cancer identifies new toxicity variants at DPYD and a putative role for ENOSF1 rather than TYMS. Gut 64:111-120
33. Evans D, Miner T, Akerman P, Millis R, Jean M, Kennedy T, Safran H (2007) A phase I study of docetaxel, oxaliplatin, and capecitabine in patients with metastatic gastroesophageal cancer. Am J Clin Oncol 30:346-349
34. Sym SJ, Ryu MH, Kang HJ, Lee SS, Chang HM, Lee JL, Kim TW, Yook JH, Oh ST, Kim BS, Kang YK (2010) Phase I study of 3-weekly docetaxel, capecitabine and oxaliplatin combination chemotherapy in patients with previously untreated advanced gastric cancer. Cancer Chemother Pharmacol 66:373-380
35. Goel G, Jauhri M, Negi A, Aggarwal S (2010) Feasibility study of docetaxel, oxaliplatin and capecitabine combination regimen in advanced gastric or gastroesophageal adenocarcinoma. Hematol Oncol Stem Cell Ther 3:55-59
36. Andersen M, Schonnemann KR, Yilmaz M, Jensen HA, Vestermark LW, Pfeiffer P (2010) Phase I study of docetaxel, oxaliplatin and capecitabine (TEX) as first line therapy to patients with advanced gastro-oesophageal cancer. Acta Oncol 49:1246-1252
37. Schonnemann KR, Yilmaz M, Andersen M, Pfeiffer P (2011) New recommendation of doses in an ongoing phase II study of docetaxel, oxaliplatin and capecitabine as first line therapy in advanced gastro-oesophageal cancer. Acta Oncol 50:151-152
38. Malik I, Bernal P, Byrd J (2010) A phase I study of docetaxel, oxaliplatin, & capecitabine (DOC) as first-line therapy of patients with locally advanced or metastatic adenocarcinoma of stomach and GE junction. Cancer Invest 28:833-838
39. Amarantidis K, Xenidis N, Chelis L, Chamalidou E, Dimopoulos P, Michailidis P, Tentes A, Deftereos S, Karanikas M, Karayiannakis A, Kakolyris S (2011) Docetaxel plus oxaliplatin in combination with capecitabine as first-line treatment for advanced gastric cancer. Oncology 80:359-365
40. Di Lauro L, Vici P, Belli F, Tomao S, Fattoruso SI, Arena MG, Pizzuti L, Giannarelli D, Paoletti G, Barba M, Sergi D, Maugeri-Sacca M (2014) Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer. Gastric Cancer 17:718-724
41. Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P (2015) Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol 26:149-156