Increased dose density is feasible: A pilot study of adjuvant epirubicin and cyclophosphamide followed by paclitaxel, at 10- or 11-day intervals with filgrastim support in women with breast cancer Journal Article

  

Authors:	Fornier, M. N.; Seidman, A. D.; Lake, D.; D'Andrea, G.; Bromberg, J.; Robson, M.; Van Poznak, C.; Panageas, K. S.; Atienza, M.; Norton, L.; Hudis, C.
Article Title:	Increased dose density is feasible: A pilot study of adjuvant epirubicin and cyclophosphamide followed by paclitaxel, at 10- or 11-day intervals with filgrastim support in women with breast cancer
Abstract:	Purpose: Because Cancer and Leukemia Group B 9741 trial showed a benefit for every 14-day administration of chemotherapy compared with every 21-day treatment, we hypothesized that even greater dose density would be more effective. We conducted a pilot trial to assess the feasibility of dose-dense chemotherapy consisting of a standard regime at 10- to 11-day intervals in the adjuvant/neoadjuvant setting. A 2-day window was allowed for scheduling logistics. Experimental Design: Thirty-nine women with early-stage breast carcinoma were accrued from April 2004 to October 2004. Median age was 47 years (range, 26-67 years). Patients received therapy with 100 mg/m2 epirubicin and 600 mg/m2 cyclophosphamide (EC) q 10 to 11 days for four cycles followed by 175 mg/m2 paclitaxel q 10 to 11 days for four cycles, all with filgrastim support (300 μg s.c. daily) from day 2 to 24 h before the next treatment. Results: Thirty-five (90%) patients completed all planned therapy. The median intertreatment interval was 10 days (range, 8-28 days). Cycles (80.7%) were delivered at no more than 10- to 11-day intervals. There were five dose reductions of 25% for grade 3 nonhematologic toxicity in five patients. Six (16%) patients developed febrile neutropenia defined as temperature >38 C with absolute neutrophil count <1.000/μL. All febrile neutropenia was during therapy with EC. Other grade 3 toxicities included bone pain, hand and foot syndrome, neuropathy, mucositis. nausea, and vomiting. Conclusions: Therapy with EC for four cycles followed by paclitaxel for four cycles at 10- to 11-day intervals is feasible. The - 30% reduction in intertreatment interval compared with every 14-day treatment could increase the efficacy of adjuvant chemotherapy. © 2007 American Association for Cancer Research.
Keywords:	adult; clinical article; controlled study; treatment response; aged; middle aged; clinical trial; constipation; fatigue; neutropenia; doxorubicin; cancer combination chemotherapy; dose response; drug dose reduction; drug withdrawal; treatment planning; paclitaxel; adjuvant therapy; cancer adjuvant therapy; cancer grading; controlled clinical trial; multiple cycle treatment; neutrophil count; anemia; mucosa inflammation; nausea; neuropathy; randomized controlled trial; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; myalgia; cyclophosphamide; bone pain; breast neoplasms; time factors; drug hypersensitivity; febrile neutropenia; rash; feasibility studies; pilot projects; breast carcinoma; epirubicin; trastuzumab; recombinant granulocyte colony stimulating factor; allergic reaction; filgrastim; hand and foot syndrome
Journal Title:	Clinical Cancer Research
Volume:	13
Issue:	1
ISSN:	1078-0432
Publisher:	American Association for Cancer Research
Date Published:	2007-01-01
Start Page:	223
End Page:	227
Language:	English
DOI:	10.1158/1078-0432.ccr-06-1731
PUBMED:	17200358
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-33846310410&partnerID=40&md5=179f7dfffa2de488cf617983f27bd5d2
Notes:	--- - "Cited By (since 1996): 4" - "Export Date: 17 November 2011" - "CODEN: CCREF" - "Source: Scopus"