ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer

被引：5

作者：

Schneider, Bryan P. ^{[1
]}

Zhao, Fengmin ^{[2
]}

Ballinger, Tarah J. ^{[1
]}

Garcia, Sofia F. ^{[3
]}

Shen, Fei ^{[1
]}

Virani, Shamsuddin ^{[4
]}

Cella, David ^{[3
]}

Bales, Casey ^{[1
]}

Jiang, Guanglong ^{[1
]}

Hayes, Lisa ^{[5
]}

Miller, Nadia ^{[5
]}

Srinivasiah, Jayanthi ^{[6
]}

Stringer-Reasor, Erica M. ^{[7
]}

Chitalia, Ami ^{[8
]}

Davis, Andrew A. ^{[9
]}

Makower, Della F. ^{[10
]}

Incorvati, Jason ^{[11
]}

Simon, Melissa A. ^{[3
]}

Mitchell, Edith P. ^{[12
]}

Demichele, Angela ^{[13
]}

Miller, Kathy D. ^{[1
]}

Sparano, Joseph A. ^{[14
]}

Wagner, Lynne I. ^{[15
]}

Wolff, Antonio C. ^{[16
]}

机构：

[1] Indiana Univ, Melvin & Bren Simon Comprehens Canc Ctr, Indianapolis, IN 46202 USA

[2] Dana Farber Canc Inst, ECOG ACRIN Biostat Ctr, Boston, MA USA

[3] Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Chicago, IL USA

[4] Aurora Canc Care Southern Lakes VLCC, Burlington, WI USA

[5] Pink 4 Ever Ending Dispar, Indianapolis, IN USA

[6] Georgia NCORP, Decatur, GA USA

[7] Univ Alabama Birmingham, ONeal Comprehens Canc Ctr, Birmingham, AL USA

[8] MedStar Washington Hosp Ctr, Washington, DC USA

[9] Washington Univ, Sch Med, St Louis, MO USA

[10] Weiler Hosp, Montefiore Med Ctr, New York, NY USA

[11] Fox Chase Comprehens Canc Ctr, Philadelphia, PA USA

[12] Thomas Jefferson Univ Hosp, Philadelphia, PA USA

[13] Univ Penn, Philadelphia, PA USA

[14] Icahn Sch Med Mt Sinai, Tisch Canc Inst, New York, NY USA

[15] Univ N Carolina, Chapel Hill, NC USA

[16] Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Toledo, OH USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2024年 / 42卷 / 24期

基金：

美国国家卫生研究院;

关键词：

GENOME-WIDE ASSOCIATION; PACLITAXEL; SURVIVAL; CHEMOTHERAPY; DISPARITIES; INSURANCE; RISK; GENE;

D O I：

10.1200/JCO.24.00526

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSE Black women experience higher rates of taxane-induced peripheral neuropathy (TIPN) compared with White women when receiving adjuvant once weekly paclitaxel for early-stage breast cancer, leading to more dose reductions and higher recurrence rates. EAZ171 aimed to prospectively validate germline predictors of TIPN and compare rates of TIPN and dose reductions in Black women receiving (neo)adjuvant once weekly paclitaxel and once every 3 weeks docetaxel for early-stage breast cancer. METHODS Women with early-stage breast cancer who self-identified as Black and had intended to receive (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel were eligible, with planned accrual to 120 patients in each arm. Genotyping was performed to determine germline neuropathy risk. Grade 2-4 TIPN by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 was compared between high- versus low-risk genotypes and between once weekly paclitaxel versus once every 3 weeks docetaxel within 1 year. Patient-rated TIPN and patient-reported outcomes were compared using patient-reported outcome (PRO)-CTCAE and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity. RESULTS Two hundred and forty of 249 enrolled patients had genotype data, and 91 of 117 (77.8%) receiving once weekly paclitaxel and 87 of 118 (73.7%) receiving once every 3 weeks docetaxel were classified as high-risk. Physician-reported grade 2-4 TIPN was not significantly different in high- versus low-risk genotype groups with once weekly paclitaxel (47% v 35%; P = .27) or with once every 3 weeks docetaxel (28% v 19%; P = .47). Grade 2-4 TIPN was significantly higher in the once weekly paclitaxel versus once every 3 weeks docetaxel arm by both physician-rated CTCAE (45% v 29%; P = .02) and PRO-CTCAE (40% v 24%; P = .03). Patients receiving once weekly paclitaxel required more dose reductions because of TIPN (28% v 9%; P < .001) or any cause (39% v 25%; P = .02). CONCLUSION Germline variation did not predict risk of TIPN in Black women receiving (neo)adjuvant once weekly paclitaxel or once every 3 weeks docetaxel. Once weekly paclitaxel was associated with significantly more grade 2-4 TIPN and required more dose reductions than once every 3 weeks docetaxel.

引用

页码：2899 / 2907

页数：15

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