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.

Keywords: Chemotherapy; Febrile neutropenia; Granulocyte-colony stimulating factor; Palmar-plantar erythrodysthesia; Pegfilgrastim.

Conflict of interest statement

Conflict of Interest: The pegfilgrastim used in this study was provided by Amgen. The authors declare no other conflicts of interest.

Copyright © 2014 Elsevier Inc. All rights reserved.

Figures

Figure 1

CONSORT diagram demonstrating the number of subjects enrolled, initiating and completing therapy with dose-dense TC.

Figure 2

Days to complete therapy. Most subjects completed 4 cycles of therapy within 43 days. Two subjects had a 1-week delay but completed all therapy. Subjects with dose reduction or incomplete therapy indicated in yellow. The protocol allowed chemotherapy dates to be rescheduled +/− 1 day for convenience, explaining completion in 41 and 43 days.

Figure 3

Rashes observed with protocol therapy A. Grade 1 maculopapular rash (subject 7, cycle 3 day 1). B. Grade 2 maculopapular rash (subject 42, cycle 3 day 7). C. Grade 3 desquamating rash (subject 41, cycle 3 day 1). D. Resolving acral erythrodysesthesia (subject 41).