Feasibility of 4 Cycles of Docetaxel and Cyclophosphamide Every 14 Days as an Adjuvant Regimen for Breast Cancer: A Wisconsin Oncology Network Study

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Abstract

Adjuvant therapy for breast cancer can be improved by increasing dose density. We tested the feasibility of delivering dose-dense docetaxel-cyclophosphamide (TC) in a single-arm phase II trial of 42 patients via the Wisconsin Oncology Network. Treatment was safe, tolerable, and most patients completed therapy as planned. Thus, this commonly used regimen can be delivered in 8 weeks.

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/m2 plus cyclophosphamide 600 mg/m2 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.

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