Weekly paclitaxel in the adjuvant treatment of breast cancer

Joseph A. Sparano, Molin Wang, Silvana Martino, Vicky Jones, Edith A. Perez, Tom Saphner, Antonio C. Wolff, George W. Sledge, William C. Wood, Nancy E. Davidson

Research output: Contribution to journalArticle

612 Citations (Scopus)

Abstract

BACKGROUND: We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer. METHODS: We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival. RESULTS: As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P = 0.006), 1.23 among those receiving docetaxel every 3 weeks (P = 0.02), and 1.09 among those receiving weekly docetaxel (P = 0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P = 0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%). CONCLUSIONS: Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125.)

Original languageEnglish (US)
Pages (from-to)1663-1671
Number of pages9
JournalNew England Journal of Medicine
Volume358
Issue number16
DOIs
StatePublished - Apr 14 2008

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Paclitaxel
docetaxel
Breast Neoplasms
Disease-Free Survival
Therapeutics
Odds Ratio
Doxorubicin
Cyclophosphamide
Lymph Nodes
Taxoids
Investigational Therapies
Adjuvant Chemotherapy
Random Allocation
Hormones
Survival

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sparano, J. A., Wang, M., Martino, S., Jones, V., Perez, E. A., Saphner, T., ... Davidson, N. E. (2008). Weekly paclitaxel in the adjuvant treatment of breast cancer. New England Journal of Medicine, 358(16), 1663-1671. https://doi.org/10.1056/NEJMoa0707056

Weekly paclitaxel in the adjuvant treatment of breast cancer. / Sparano, Joseph A.; Wang, Molin; Martino, Silvana; Jones, Vicky; Perez, Edith A.; Saphner, Tom; Wolff, Antonio C.; Sledge, George W.; Wood, William C.; Davidson, Nancy E.

In: New England Journal of Medicine, Vol. 358, No. 16, 14.04.2008, p. 1663-1671.

Research output: Contribution to journalArticle

Sparano, JA, Wang, M, Martino, S, Jones, V, Perez, EA, Saphner, T, Wolff, AC, Sledge, GW, Wood, WC & Davidson, NE 2008, 'Weekly paclitaxel in the adjuvant treatment of breast cancer', New England Journal of Medicine, vol. 358, no. 16, pp. 1663-1671. https://doi.org/10.1056/NEJMoa0707056
Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. New England Journal of Medicine. 2008 Apr 14;358(16):1663-1671. https://doi.org/10.1056/NEJMoa0707056
Sparano, Joseph A. ; Wang, Molin ; Martino, Silvana ; Jones, Vicky ; Perez, Edith A. ; Saphner, Tom ; Wolff, Antonio C. ; Sledge, George W. ; Wood, William C. ; Davidson, Nancy E. / Weekly paclitaxel in the adjuvant treatment of breast cancer. In: New England Journal of Medicine. 2008 ; Vol. 358, No. 16. pp. 1663-1671.
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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.

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N2 - BACKGROUND: We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer. METHODS: We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival. RESULTS: As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P = 0.006), 1.23 among those receiving docetaxel every 3 weeks (P = 0.02), and 1.09 among those receiving weekly docetaxel (P = 0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P = 0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%). CONCLUSIONS: Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125.)

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