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Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).

Publication ,  Journal Article
Shulman, LN; Berry, DA; Cirrincione, CT; Becker, HP; Perez, EA; O'Regan, R; Martino, S; Shapiro, CL; Schneider, CJ; Kimmick, G; Burstein, HJ ...
Published in: J Clin Oncol
August 1, 2014

PURPOSE: Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity. PATIENTS AND METHODS: Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported. RESULTS: With 3,871 patients enrolled onto the trial, a median follow-up period of 6.1 years, and 437 RFS events, we achieved an HR of 1.26 (one sided 95% UCB, 1.48; favoring AC does not allow a conclusion of noninferiority of T with AC; UCB > 1.3). With 266 patient deaths, the HR for overall survival (OS) was 1.27 favoring AC (UCB, 1.56). The estimated absolute advantage of AC at 5 years is 3% for RFS (91 v 88%) and 1% for OS (95 v 94%). All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS. Hematologic toxicity was more common in patients treated with AC, and neuropathy was more common in patients treated with T. CONCLUSION: This trial did not show noninferiority of T to AC, a conclusion that is unlikely to change with additional events and follow-up. T was less toxic than AC.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

August 1, 2014

Volume

32

Issue

22

Start / End Page

2311 / 2317

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Lymphatic Metastasis
  • Humans
  • Female
  • Doxorubicin
  • Disease-Free Survival
 

Citation

APA
Chicago
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MLA
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Shulman, L. N., Berry, D. A., Cirrincione, C. T., Becker, H. P., Perez, E. A., O’Regan, R., … Winer, E. P. (2014). Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance). J Clin Oncol, 32(22), 2311–2317. https://doi.org/10.1200/JCO.2013.53.7142
Shulman, Lawrence N., Donald A. Berry, Constance T. Cirrincione, Heather P. Becker, Edith A. Perez, Ruth O’Regan, Silvana Martino, et al. “Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).J Clin Oncol 32, no. 22 (August 1, 2014): 2311–17. https://doi.org/10.1200/JCO.2013.53.7142.
Shulman, Lawrence N., et al. “Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance).J Clin Oncol, vol. 32, no. 22, Aug. 2014, pp. 2311–17. Pubmed, doi:10.1200/JCO.2013.53.7142.
Shulman LN, Berry DA, Cirrincione CT, Becker HP, Perez EA, O’Regan R, Martino S, Shapiro CL, Schneider CJ, Kimmick G, Burstein HJ, Norton L, Muss H, Hudis CA, Winer EP. Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance). J Clin Oncol. 2014 Aug 1;32(22):2311–2317.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

August 1, 2014

Volume

32

Issue

22

Start / End Page

2311 / 2317

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Lymphatic Metastasis
  • Humans
  • Female
  • Doxorubicin
  • Disease-Free Survival