Abstract
Chemotherapy induced peripheral neuropathy (CIPN) due to paclitaxel versus docetaxel in patients with early-stage breast cancer receiving taxane therapy: SWOG S1714.
Author
person
Meghna S. Trivedi
Columbia University, New York, NY
info_outline
Meghna S. Trivedi, Joseph M. Unger, Dawn L. Hershman, Amy Darke, Daniel Louis Hertz, Thomas Brannagan, Stephanie Smith, Bryan P. Schneider, William Johnson Irvin, Amanda Redden Hathaway, Amy C. Vander Woude, Vinay K. Gudena, Norah Lynn Henry, Michael Jordan Fisch
Full text
Authors
person
Meghna S. Trivedi
Columbia University, New York, NY
info_outline
Meghna S. Trivedi, Joseph M. Unger, Dawn L. Hershman, Amy Darke, Daniel Louis Hertz, Thomas Brannagan, Stephanie Smith, Bryan P. Schneider, William Johnson Irvin, Amanda Redden Hathaway, Amy C. Vander Woude, Vinay K. Gudena, Norah Lynn Henry, Michael Jordan Fisch
Organizations
Columbia University, New York, NY, Fred Hutchinson Cancer Research Center, Seattle, WA, Fred Hutchinson Cancer Center, Seattle, WA, University of Michigan, Ann Arbor, MI, Columbia University Medical Center, NY, NY, Lewis Cancer & Research Pavilion at St. Joseph's Candler/GA NCORP, Savannah, GA, Indiana University, Indianapolis, IN, Bon Secours Cancer Institute at St. Francis, Midlothian, VA, University Cancer & Blood Center, Athens, GA, Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, Cone Health Cancer Center, Greensboro, NC, University of Michigan Rogel Cancer Center, Ann Arbor, MI, AIM Specialty Health, Chicago, IL
Abstract Disclosures
Research Funding
U.S. National Institutes of Health
U.S. National Institutes of Health
Background:
Paclitaxel (Pac) and docetaxel (Doc) are used to treat early-stage breast cancer (BC). CIPN due to taxane therapy can cause sensory and motor deficits. CIPN symptoms caused by Pac versus Doc are not well described.
Methods:
SWOG S1714 enrolled patients ≥ 18 years with Stage I-III primary NSCLC, BC, or ovarian cancer starting treatment with a taxane-based regimen. CIPN was assessed by the patient-reported EORTC QLQ-CIPN20 (CIPN-20) and clinician-assessed NCI-CTCAE. Assessments occurred at baseline and 4, 8, 12, and 24 weeks after registration. Increase in CIPN-20 sensory subscale score ≥ 8 points was considered clinically meaningful. Chi-square and Fisher tests were used for baseline comparisons; logistic regression was used for multivariable analyses.
Results:
Among 1336 enrolled patients, 1106 of eligible patients had a diagnosis of BC, with median age 54.8 y (range 23.9-84.2 y), 99.3% female, and 72.3% White/11.3% Black/4.6% Asian/11.1% Hispanic/Latino. Pac was administered to 615 (55.6%) and Doc to 491(44.3%) patients. Between the Pac and Doc cohorts, there were significant baseline differences in median age, diabetes, and performance status. At 24 weeks, the proportion of patients with ≥8 point increase in CIPN-20 sensory score was lower for Doc (40.5%) vs Pac (50.2%) (odds ratio [OR] 0.64, 95% CI 0.50, 0.82; multivariable adjusted p<.001). At nearly every timepoint through 24 weeks, patients treated with Pac had more sensory and motor neuropathy as measured by both the CIPN-20 and NCI-CTCAE (Table).
Conclusions:
In this diverse cohort of patients with BC, the frequency of CIPN was higher than expected for both Pac and Doc and more severe in patients receiving Pac. These findings based on CIPN-20 can assist in treatment decision-making about taxane therapy. Long term follow up will better characterize the differences in the trajectory of CIPN between Pac and Doc. Funding: NIH/NCI/NCORP grant UG1CA189974. Clinical trial information: NCT03939481.
Week 8 Week 12 Week 24
Pac Doc OR (95% CI) p value Pac Doc OR (95% CI) p value Pac Doc OR (95% CI) p value
Mean change in CIPN-20 sensory subscore (SD) 11.38 (16.19) 4.24 (12.33) <.001 16.06 (18.41) 8.34 (15.47) <.001 14.96 (19.28) 10.50 (17.30) <.001
Mean change in CIPN-20 motor subscore (SD) 4.76 (12.58) 2.72 (10.13) 0.006 7.94 (14.52) 5.79 (13.01) 0.02 8.49 (14.94) 6.46 (13.97) 0.03
1+ Grade increase in CTCAE Peripheral Sensory Neuropathy 38.8% 21.4% 0.41 (0.31, 0.54) <.001 46.8% 30.6% 0.49 (0.38, 0.63) <.001 45.1% 35.4% 0.61 (0.48, 0.79) <.001
1+ Grade increase in CTCAE Peripheral Motor Neuropathy 11.0% 5.8% 0.51 (0.32, 0.82) 0.005 15.9% 11.1% 0.68 (0.48, 0.98) 0.04 14.6% 11.1% 0.76 (0.53, 1.10) 0.15
Note: P-values for all comparisons derived from multivariable analyses adjusted for: age at registration, race (white/nonwhite), diabetes at registration, performance status (0 vs >0), and the baseline score.
1 clinical trial
13 organizations
2 drugs
2 targets
Organization
Fred Hutchinson Cancer Research CenterOrganization
University of MichiganOrganization
Bon Secours Cancer Institute at St. FrancisOrganization
Cancer & Hematology Centers of Western MichiganOrganization
University of Michigan Rogel Cancer CenterOrganization
Columbia UniversityOrganization
Fred Hutchinson Cancer CenterOrganization
Columbia University Medical CenterOrganization
Indiana University School of MedicineOrganization
University Cancer & Blood CenterOrganization
Cone Health Cancer CenterOrganization
AIM Specialty HealthClinical trial
A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer PatientsStatus: Active (not recruiting), Estimated PCD: 2025-02-28
Drug
TiragolumabDrug
docetaxelTarget
microtubulesTarget
Docetaxel