NEGIRI protokol - DBCG

En fase II-undersøgelse af irinotecan ugentligt til patienter med lokal avanceret eller metastatiskHER 2
negativ brystkræft og øget antal kopier af topoisomerase 1(TOP1) genet.
Protokol version 16. maj 2013, amendment nr. 2
Forsøget er godkendt af Lægemiddelstyrelsen Eudract nr.: 2012-002348-26 og
Den Videnskabsetiske Komite, nr.: H-1-2012-066
46
Slamon DJ, Press MF. Alterations in the TOP2A and HER2 genes: association with
adjuvant anthracycline sensitivity in human breast cancers. J Natl Cancer Inst 2009; 101:
615-9.
Tubbs R, Barlow WE, Budd T et al. Outcome of patients with early-stage breast cancer
treated with doxorubicin-based adjuvant chemotherapy as a function of HER2 and
TOP2A status. J Clin Oncol 2009; 27: 3881-6.
Zidan J, Dashkovsky I, Stayerman C et al. Comparison of HER-2 overexpression in
primary breast cancer and metastatic sites and its effect on biological targeting therapy of
metastatic disease. Br J Cancer 2005; 93: 552-6.
TOP 1
Boonsong A, Curran S, McKay JA et al. Topoisomerase I protein expression in primary
colorectal cancer and lymph node metastases. Hum Pathol 2002; 33: 1114-9.
Braun MS, Richman SD, Quirke P, Daly C, Adlard JW, Elliott F, Barrett JH, Selby P,
Meade AM, Stephens RJ, Parmar MK, Seymour MT. Predictive biomarkers of
chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin
Oncol 2008; 26: 2690-8.
Gilbert DC, Chalmers AJ, El-Khamisy SF. Topoisomerase I inhibition in colorectal cancer:
biomarkers and therapeutic targets. Br J Cancer 2011 Nov 22. doi: 10.1038/bjc.2011.498.
[Epub ahead of print]
Giovanella BC, Stehlin JS, Wall ME et al. DNA topoisomerase I--targeted chemotherapy
of human colon cancer in xenografts. Science 1989; 246: 1046-8.
Gongora C, Vezzio-Vie N, Tuduri S et al. New Topoisomerase I mutations are associated
with resistance to camptothecin. Mol Cancer 2011; 10: 64.
Horisberger K, Erben P, Muessle B et al. Topoisomerase I expression correlates to
response to neoadjuvant irinotecan-based chemoradiation in rectal cancer. Anticancer
Drugs 2009; 20: 519-24.
TIMP-1
Birkedal-Hansen H, et al. Matrix metalloproteinases: a review. Crit Rev Oral Biol Med
1993; 4:197-250.
Clavel C, et al. Immunolocalization of matrix metallo-proteinases and their tissue inhibitor
in human mammary pathology. Bull Cancer 1992;79:261-70.
Cornelius LA, et al. Matrix metalloproteinases generate antiostatin: effects on
neovascularization. J Immunol 1998;16:6845-52.
Dien J, et al. Signal transducers and activators of transcription-3 up-regulates tissue
inhibitor of metalloproteinase-1 expression and decreases invasiveness of breast cancer.
Am J Pathol 2006;169:633-42.