Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study.

Abstract

INTRODUCTION:

Dose-dense therapies have had a major effect on reducing toxicity and improving outcomes in breast cancer. A combination of TC every 3 weeks has emerged as a common chemotherapy regimen used for treatment of node-negative or lower-risk node-positive breast cancer. We tested whether it is feasible to deliver TC on a dose-dense schedule, with therapy completed within 10 weeks.

PATIENTS AND METHODS:

We enrolled women with early stage breast cancer on a single-arm phase II study of adjuvant dose-dense TC through a regional oncology network. All women completed primary surgery before accrual, and subsequent therapy with TC was deemed appropriate by the treating physician. Planned treatment was docetaxel 75 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 2 weeks for 4 cycles with subcutaneous pegfilgrastim 6 mg administered 24 to 48 hours after the administration of each chemotherapy cycle.

RESULTS:

Of 42 women enrolled, 41 were evaluable using prespecified criteria. Of these, 37 (90.2%) completed therapy within 10 weeks and 34 (83%) completed therapy at 8 weeks without dose modification. Rates of neuropathy were similar to that reported previously. The rate of neutropenic fever was low (2.5%). Rash and plantar-palmar erythrodythesia were common and reached grade 3 in 4 subjects (9.8%).

CONCLUSION:

Dose-dense TC is feasible with tolerability profiles similar to standard TC and a low likelihood of neutropenic fever. This study supports further clinical development of this 8-week adjuvant chemotherapy regimen.

• Authors: Mark E Burkard, Kari B Wisinski, Uchenna O Njiaju, Sarahmaria Donohue, Robert Hegeman, Amy Stella, Patrick Mansky, Varsha Shah, Timothy Goggins, Rubina Qamar, Leah Dietrich, Kyungmann Kim, Anne M Traynor, Amye J Tevaarwerk
• Journal: Clinical breast cancer (Clin Breast Cancer) Vol. 14 Issue 3 Pg. 205-11 (Jun 2014) ISSN: 1938-0666 [Electronic] United States
• PMID: 24342730 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Taxoids
• Docetaxel
• Cyclophosphamide

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy)
• Chemotherapy, Adjuvant (methods)
• Cyclophosphamide (administration & dosage, adverse effects)
• Docetaxel
• Feasibility Studies
• Female
• Humans
• Middle Aged
• Taxoids (administration & dosage, adverse effects)