Authors: | Drullinsky, P.; Sugarman, S. M.; Fornier, M. N.; D'Andrea, G.; Gilewski, T.; Lake, D.; Traina, T.; Wasserheit-Lieblich, C.; Sklarin, N.; Atieh-Graham, D.; Mills, N.; Troso-Sandoval, T.; Seidman, A. D.; Yuan, J.; Patel, H.; Patil, S.; Norton, L.; Hudis, C. |
Article Title: | Dose dense cyclophosphamide, methotrexate, fluorouracil is feasible at 14-day intervals: a pilot study of every-14-day dosing as adjuvant therapy for breast cancer |
Abstract: | Cyclophosphamide/methotrexate/fluorouracil (CMF) is a proven adjuvant option for patients with early-stage breast cancer. Randomized trials with other regimens demonstrate that dose-dense (DD) scheduling can offer greater efficacy. We investigated the feasibility of administering CMF using a DD schedule. Thirty-eight patients with early-stage breast cancer were accrued from March 2008 through June 2008. They were treated every 14 days with C 600, M 40, F 600 (all mg/m2) with PEG-filgrastim (Neulasta®) support on day 2 of each cycle. The primary endpoint was tolerability using a Simon's 2-stage optimal design. The design would effectively discriminate between true tolerability (as protocol-defined) rates of ≤ 60% and ≥ 80%. The median age was 52-years-old (range, 38-78 years of age). Twenty-nine of the 38 patients completed 8 cycles of CMF at 14-day intervals. Dose-dense adjuvant CMF is tolerable and feasible at 14-day intervals with PEG-filgrastim support. |
Keywords: | adult; treatment outcome; aged; middle aged; clinical trial; fluorouracil; dose response; antineoplastic agents; chemotherapy, adjuvant; methotrexate; cancer staging; antineoplastic agent; neoplasm staging; adenocarcinoma; antineoplastic combined chemotherapy protocols; drug administration schedule; cyclophosphamide; pathology; dose-response relationship, drug; breast neoplasms; feasibility study; pilot study; feasibility studies; pilot projects; adjuvant chemotherapy; breast tumor; drug administration |
Journal Title: | Clinical Breast Cancer |
Volume: | 10 |
Issue: | 6 |
ISSN: | 1526-8209 |
Publisher: | Elsevier Inc. |
Date Published: | 2010-12-01 |
Start Page: | 440 |
End Page: | 444 |
Language: | English |
PUBMED: | 21147686 |
PROVIDER: | scopus |
DOI: | 10.3816/CBC.2010.n.057 |
PMCID: | PMC3661192 |
DOI/URL: | |
Notes: | --- - "Export Date: 20 April 2011" - "Source: Scopus" |