Format

Send to

Choose Destination
J Clin Oncol. 2015 Jan 1;33(1):58-64. doi: 10.1200/JCO.2014.56.3296. Epub 2014 Nov 24.

SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.

Author information

1
George T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ. buddg@ccf.org.
2
George T. Budd, Halle C. F. Moore, Cleveland Clinic, Cleveland; Timothy D. Moore, Mid Ohio Oncology Hematology, Columbus, OH; William E. Barlow, Danika L. Lew, SWOG Statistical Center; Kristine J. Rinn, Swedish Cancer Institute; Julie R Gralow, Seattle Cancer Care Alliance, Seattle, WA; Timothy J. Hobday Mayo Clinic, Rochester, MN; James A. Stewart, Baystate Medical Center, Springfield, MA; Claudine Isaacs, Georgetown University, Washington, DC; Muhammad Salim, Allan Blair Cancer Centre, Regina, Saskatchewan, Canada; Jonathan K. Cho, University of Hawaii MBCCOP, Honolulu, HI; Kathy S. Albain, Loyola University Chicago, Stritch School of Medicine; Chicago, IL; Helen K. Chew, University of California-Davis, Sacramento, CA; Gary V. Burton, Louisiana State University Health Sciences Center, Shreveport, LA; Gordan Srkalovic, Sparrow Regional Cancer Center, Lansing; Lawrence E. Flaherty, Karmanos Cancer Institute/Wayne State University, Detroit, MI; Bradley A. McGregor, Willford Hall Medical Center, Lackland Air Force Base; Gabriel N. Hortobagyi, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert B. Livingston, Arizona Cancer Center, Tucson, AZ.

Abstract

PURPOSE:

To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer.

PATIENTS AND METHODS:

A 2 × 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided α = .05. Overall survival (OS) was a secondary outcome.

RESULTS:

Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens. After a median follow-up of 6 years, a significant interaction developed between the two randomization factors (DFS P = .024; OS P = .010) in the 2,716 patients randomly assigned in the original design, which precluded interpretation of the two factors separately. Comparing all four arms showed a significant difference in OS (P = .040) but not in DFS (P = .11), with all treatments given once every 2 weeks associated with the highest OS. This difference in OS seemed confined to patients with hormone receptor-negative/human epidermal growth factor receptor 2 (HER2) -negative tumors (P = .067), with no differences seen with hormone receptor-positive/HER2-negative (P = .90) or HER2-positive tumors (P = .40).

CONCLUSION:

Patients achieved a similar DFS with any of these regimens. Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/HER2-negative tumors.

PMID:
25422488
PMCID:
PMC4268253
DOI:
10.1200/JCO.2014.56.3296
[Indexed for MEDLINE]
Free PMC Article

Publication types, MeSH terms, Substances, Grant support

Publication types

MeSH terms

Substances

Grant support

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center