ABCB1 SNPs as Predictors of PIPN

Ain Shams University92 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Paclitaxel Adverse Reaction Neuropathy;Peripheral Breast Cancer

Interventions

Real-Time PCRGENETIC

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Egyptian females ≥18 years of age. 2. Histologically confirmed Breast Cancer. 3. Receiving conventional neoadjuvant or adjuvant weekly paclitaxel. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (UNL), total bilirubin ≤1.5x UNL, absolute neutrophil count ≥1.5 x 10\^9/L, platelet count ≥100 x 10\^9/L, AST and ALT ≤3.0x UNL, and alkaline phosphatase ≤3.0x UNL). 6. No major neurological disease or symptoms prior to the start of paclitaxel therapy. 7. neither subjective nor objective evidence of metastatic disease. Exclusion Criteria: 1. Pregnancy. 2. Patients with recurrent or metastatic (local or distant) breast cancer. 3. Neuropathic at the time of recruitment. 4. History of neuropathy prior to recruitment. 5. Previously exposed to taxanes or any other microtubule Inhibitors, or regimens including platinates. 6. Patients currently receiving dose-dense biweekly taxane-containing regimens.

Locations (1)

Nasser's Institute Hospital

Cairo, Aghakhan, Egypt

Outcomes

Primary Outcomes

Grade 2 or higher peripheral neuropathy

Grade 2 or higher peripheral neuropathy evaluated by the National Cancer Institute Common Toxicity Criteria (version 5.0)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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