Authors: | Dang, C.; D'Andrea, G.; Lake, D.; Sugarman, S.; Fornier, M.; Moynahan, M. E.; Gilewski, T.; Hurria, A.; Mills, N.; Troso-Sandoval, T.; George, R.; Robson, M.; Dickler, M.; Smith, K.; Panageas, K.; Norton, L.; Hudis, C. |
Article Title: | Prolonged dose-dense epirubicin and cyclophosphamide followed by paclitaxel in breast cancer is feasible |
Abstract: | Purpose: We conducted a pilot study of dose-dense epirubicin/ cyclophosphamide (EC) × 6 → paclitaxel (P) × 6 with pegfilgrastim. A previous dose-dense trial of FEC (5-fluorouracil [5-FU]/EC) × 6 with filgrastim → by weekly paclitaxel alternating with docetaxel × 18 was not feasible because of pneumonitis (with dose-dense FEC) and pericardial/pleural effusion (taxane phase). Dose-dense EC (without the 5-FU) is not associated with pneumonitis, and dose-dense paclitaxel (alone) is feasible. Primary objective was feasibility. Patients and Methods: Patients with resectable breast cancer were enrolled, regardless of surgery status, tumor size, or nodal status. Treatment regimen consisted of every-2-week EC (100/600 mg/m2) × 6 → by 2-weekly P (175 mg/m2) × 6 with pegfilgrastim 6 mg on day 2. Results: Between November 2004 and May 2005, 38 patients were enrolled. The median age was 47 years (range, 30-72 years); 33 of 38 (87%) were treated in the adjuvant setting and 27 of 33 (81%) had involved nodes (range, 1-46); 5 of 38 (13%) were treated pre-operatively; 33 of 38 (87%) completed all chemotherapy as planned; the remaining patients (13%) had treatment modifications for toxicity. Febrile neutropenia occurred in 6 of 38 patients (16 %) and only during EC. There were 12 hospitalizations in 9 of 38 patients (24%) enrolled. Conclusion: Dose-dense every-2-week EC × 6 → P × 6 with pegfilgrastim is feasible based on our prospective definition. |
Keywords: | adult; cancer chemotherapy; clinical article; treatment response; aged; middle aged; cancer surgery; surgical technique; overall survival; clinical trial; constipation; fatigue; neutropenia; fluorouracil; diarrhea; drug dose reduction; drug efficacy; drug safety; side effect; treatment duration; treatment planning; paclitaxel; adjuvant therapy; cancer radiotherapy; antineoplastic agent; preoperative evaluation; tumor localization; multiple cycle treatment; sensory neuropathy; breast cancer; anemia; mastectomy; tumor volume; blood toxicity; leukopenia; mucosa inflammation; nausea; thrombocytopenia; antineoplastic combined chemotherapy protocols; myalgia; aromatase inhibitor; cyclophosphamide; dexamethasone; bone pain; breast neoplasms; docetaxel; arthralgia; coughing; febrile neutropenia; fever; nail disease; pneumonia; chemotherapy induced emesis; drug induced headache; feasibility study; pilot study; pilot projects; adjuvant chemotherapy; breast tumor; lymph node; blood transfusion; granisetron; tamoxifen; epirubicin; pleura effusion; recombinant granulocyte colony stimulating factor; pericardial effusion; bilirubin blood level; congestive heart failure; diphenhydramine; histamine h2 receptor antagonist; novel erythropoiesis stimulating protein; pegfilgrastim; enalapril |
Journal Title: | Clinical Breast Cancer |
Volume: | 8 |
Issue: | 5 |
ISSN: | 1526-8209 |
Publisher: | Elsevier Inc. |
Date Published: | 2008-10-01 |
Start Page: | 418 |
End Page: | 424 |
Language: | English |
DOI: | 10.3816/CBC.2008.n.050 |
PUBMED: | 18952555 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | --- - "Export Date: 17 November 2011" - "CODEN: CBCLB" - "Source: Scopus" |