Neuropathy is not associated with clinical outcomes in patients receiving adjuvant taxane-containing therapy for operable breast cancer

Bryan P. Schneider, Fengmin Zhao, Molin Wang, Vered Stearns, Silvana Martino, Vicky Jones, Edith A. Perez, Tom Saphner, Antonio C. Wolff, George W. Sledge, William C. Wood, Nancy E. Davidson, Joseph A. Sparano

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Purpose: Neuropathy is a common and potentially disabling complication of adjuvant taxane therapy. Recent studies have identified candidate single nucleotide polymorphisms associated with taxane-induced neuropathy. Therefore, we sought to determine whether neuropathy was associated with breast cancer recurrence in a clinical trial population who received adjuvant taxane therapy. Patients and Methods: Trial E1199 included 4,554 eligible women with operable breast cancer who received up to four cycles of doxorubicin and cyclophosphamide every 3 weeks followed by paclitaxel 175 mg/m 2 every 3 weeks for four cycles (P3), paclitaxel 80 mg/m 2 weekly for 12 cycles (P1), docetaxel 100 mg/m 2 every 3 weeks for four cycles (D3), or docetaxel 35 mg/m 2 weekly for 12 cycles (D1). A Cox proportional hazards model was used to determine the relationship between neuropathy and disease-free survival (DFS), overall survival (OS), and recurrence-free survival (RFS) by treating neuropathy status as a time dependent covariate and using a landmark analysis. Results: Of 4,554 patients who received at least one taxane dose, grade 2 to 4 neuropathy developed in 18%, 22%, 15%, and 13% of patients in the P3, P1, D3, and D1 arms, respectively. In a model that included age, race, obesity, menopausal status, tumor size, nodal status, treatment arm, neuropathy, and hyperglycemia, no significant relationship was found between neuropathy and DFS, OS, or RFS. Conclusion: There was no association between taxane-induced neuropathy and outcome.

Original languageEnglish (US)
Pages (from-to)3051-3057
Number of pages7
JournalJournal of Clinical Oncology
Volume30
Issue number25
DOIs
StatePublished - Sep 1 2012
Externally publishedYes

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docetaxel
Breast Neoplasms
Survival
Paclitaxel
Recurrence
Disease-Free Survival
Therapeutics
Proportional Hazards Models
Hyperglycemia
Doxorubicin
Cyclophosphamide
Single Nucleotide Polymorphism
Obesity
taxane
Clinical Trials
Population
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Neuropathy is not associated with clinical outcomes in patients receiving adjuvant taxane-containing therapy for operable breast cancer. / Schneider, Bryan P.; Zhao, Fengmin; Wang, Molin; Stearns, Vered; Martino, Silvana; Jones, Vicky; Perez, Edith A.; Saphner, Tom; Wolff, Antonio C.; Sledge, George W.; Wood, William C.; Davidson, Nancy E.; Sparano, Joseph A.

In: Journal of Clinical Oncology, Vol. 30, No. 25, 01.09.2012, p. 3051-3057.

Research output: Contribution to journalArticle

Schneider, BP, Zhao, F, Wang, M, Stearns, V, Martino, S, Jones, V, Perez, EA, Saphner, T, Wolff, AC, Sledge, GW, Wood, WC, Davidson, NE & Sparano, JA 2012, 'Neuropathy is not associated with clinical outcomes in patients receiving adjuvant taxane-containing therapy for operable breast cancer', Journal of Clinical Oncology, vol. 30, no. 25, pp. 3051-3057. https://doi.org/10.1200/JCO.2011.39.8446
Schneider, Bryan P. ; Zhao, Fengmin ; Wang, Molin ; Stearns, Vered ; Martino, Silvana ; Jones, Vicky ; Perez, Edith A. ; Saphner, Tom ; Wolff, Antonio C. ; Sledge, George W. ; Wood, William C. ; Davidson, Nancy E. ; Sparano, Joseph A. / Neuropathy is not associated with clinical outcomes in patients receiving adjuvant taxane-containing therapy for operable breast cancer. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 25. pp. 3051-3057.
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AU - Schneider, Bryan P.

AU - Zhao, Fengmin

AU - Wang, Molin

AU - Stearns, Vered

AU - Martino, Silvana

AU - Jones, Vicky

AU - Perez, Edith A.

AU - Saphner, Tom

AU - Wolff, Antonio C.

AU - Sledge, George W.

AU - Wood, William C.

AU - Davidson, Nancy E.

AU - Sparano, Joseph A.

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N2 - Purpose: Neuropathy is a common and potentially disabling complication of adjuvant taxane therapy. Recent studies have identified candidate single nucleotide polymorphisms associated with taxane-induced neuropathy. Therefore, we sought to determine whether neuropathy was associated with breast cancer recurrence in a clinical trial population who received adjuvant taxane therapy. Patients and Methods: Trial E1199 included 4,554 eligible women with operable breast cancer who received up to four cycles of doxorubicin and cyclophosphamide every 3 weeks followed by paclitaxel 175 mg/m 2 every 3 weeks for four cycles (P3), paclitaxel 80 mg/m 2 weekly for 12 cycles (P1), docetaxel 100 mg/m 2 every 3 weeks for four cycles (D3), or docetaxel 35 mg/m 2 weekly for 12 cycles (D1). A Cox proportional hazards model was used to determine the relationship between neuropathy and disease-free survival (DFS), overall survival (OS), and recurrence-free survival (RFS) by treating neuropathy status as a time dependent covariate and using a landmark analysis. Results: Of 4,554 patients who received at least one taxane dose, grade 2 to 4 neuropathy developed in 18%, 22%, 15%, and 13% of patients in the P3, P1, D3, and D1 arms, respectively. In a model that included age, race, obesity, menopausal status, tumor size, nodal status, treatment arm, neuropathy, and hyperglycemia, no significant relationship was found between neuropathy and DFS, OS, or RFS. Conclusion: There was no association between taxane-induced neuropathy and outcome.

AB - Purpose: Neuropathy is a common and potentially disabling complication of adjuvant taxane therapy. Recent studies have identified candidate single nucleotide polymorphisms associated with taxane-induced neuropathy. Therefore, we sought to determine whether neuropathy was associated with breast cancer recurrence in a clinical trial population who received adjuvant taxane therapy. Patients and Methods: Trial E1199 included 4,554 eligible women with operable breast cancer who received up to four cycles of doxorubicin and cyclophosphamide every 3 weeks followed by paclitaxel 175 mg/m 2 every 3 weeks for four cycles (P3), paclitaxel 80 mg/m 2 weekly for 12 cycles (P1), docetaxel 100 mg/m 2 every 3 weeks for four cycles (D3), or docetaxel 35 mg/m 2 weekly for 12 cycles (D1). A Cox proportional hazards model was used to determine the relationship between neuropathy and disease-free survival (DFS), overall survival (OS), and recurrence-free survival (RFS) by treating neuropathy status as a time dependent covariate and using a landmark analysis. Results: Of 4,554 patients who received at least one taxane dose, grade 2 to 4 neuropathy developed in 18%, 22%, 15%, and 13% of patients in the P3, P1, D3, and D1 arms, respectively. In a model that included age, race, obesity, menopausal status, tumor size, nodal status, treatment arm, neuropathy, and hyperglycemia, no significant relationship was found between neuropathy and DFS, OS, or RFS. Conclusion: There was no association between taxane-induced neuropathy and outcome.

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