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The study aim is to determine the allele frequencies of 1236 G>A and 3435 G>A in ABCB1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in Egyptian patients. Additionally, the study aimed at fitting and validating logistic regression models with the aforementioned SNPs evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time PCR | Genetic | Genomic DNA was extracted from 2 ml of venous blood. ABCB1 1236 G>A and 3435 G>A were genotyped using predesigned TaqMan SNP genotyping assays on a stepOne PCR instrument in accordance with the manufacturer's protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2 or higher peripheral neuropathy | Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Egyptian women with histologically confirmed Breast Cancer, receiving neoadjuvant and/or adjuvant weekly paclitaxel-containing regimens.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nasser's Institute Hospital | Cairo | Aghakhan | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19143748 | Background | Green H, Soderkvist P, Rosenberg P, Mirghani RA, Rymark P, Lundqvist EA, Peterson C. Pharmacogenetic studies of Paclitaxel in the treatment of ovarian cancer. Basic Clin Pharmacol Toxicol. 2009 Feb;104(2):130-7. doi: 10.1111/j.1742-7843.2008.00351.x. Epub 2008 Dec 16. | |
| 17187507 | Background | Kimchi-Sarfaty C, Marple AH, Shinar S, Kimchi AM, Scavo D, Roma MI, Kim IW, Jones A, Arora M, Gribar J, Gurwitz D, Gottesman MM. Ethnicity-related polymorphisms and haplotypes in the human ABCB1 gene. Pharmacogenomics. 2007 Jan;8(1):29-39. doi: 10.2217/14622416.8.1.29. |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D060888 | Real-Time Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| 25596818 | Background | Rivera E, Cianfrocca M. Overview of neuropathy associated with taxanes for the treatment of metastatic breast cancer. Cancer Chemother Pharmacol. 2015 Apr;75(4):659-70. doi: 10.1007/s00280-014-2607-5. Epub 2015 Jan 18. |
| 18615126 | Background | Scripture CD, Figg WD, Sparreboom A. Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives. Curr Neuropharmacol. 2006 Apr;4(2):165-72. doi: 10.2174/157015906776359568. |
| 24810093 | Background | Gao B, Russell A, Beesley J, Chen XQ, Healey S, Henderson M, Wong M, Emmanuel C, Galletta L, Johnatty SE, Bowtell D; Australian Ovarian Cancer Study Group; Haber M, Norris M, Harnett P, Chenevix-Trench G, Balleine RL, deFazio A. Paclitaxel sensitivity in relation to ABCB1 expression, efflux and single nucleotide polymorphisms in ovarian cancer. Sci Rep. 2014 May 9;4:4669. doi: 10.1038/srep04669. |
| 9491787 | Background | Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. Preclinical pharmacokinetics of paclitaxel and docetaxel. Anticancer Drugs. 1998 Jan;9(1):1-17. doi: 10.1097/00001813-199801000-00001. |
| 25860377 | Background | Wolking S, Schaeffeler E, Lerche H, Schwab M, Nies AT. Impact of Genetic Polymorphisms of ABCB1 (MDR1, P-Glycoprotein) on Drug Disposition and Potential Clinical Implications: Update of the Literature. Clin Pharmacokinet. 2015 Jul;54(7):709-35. doi: 10.1007/s40262-015-0267-1. |
| 27175090 | Background | Tulsyan S, Mittal RD, Mittal B. The effect of ABCB1 polymorphisms on the outcome of breast cancer treatment. Pharmgenomics Pers Med. 2016 Apr 27;9:47-58. doi: 10.2147/PGPM.S86672. eCollection 2016. |
| 21060341 | Background | Cavaletti G, Marmiroli P. Chemotherapy-induced peripheral neurotoxicity. Nat Rev Neurol. 2010 Dec;6(12):657-66. doi: 10.1038/nrneurol.2010.160. Epub 2010 Nov 9. |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |