Phase II study of feasibility of dose-dense FEC followed by alternating weekly taxanes in high-risk, four or more node-positive breast cancer Journal Article
| Authors: | Dang, C. T.; D'Andrea, G. M.; Moynahan, M. E.; Dickler, M. N.; Seidman, A. D.; Fornier, M.; Robson, M. E.; Theodoulou, M.; Lake, D.; Currie, V. E.; Hurria, A.; Panageas, K. S.; Norton, L.; Hudis, C. A. |
| Article Title: | Phase II study of feasibility of dose-dense FEC followed by alternating weekly taxanes in high-risk, four or more node-positive breast cancer |
| Abstract: | Purpose: To develop a potentially superior adjuvant chemotherapy regimen, we conducted a pilot study of dose-dense 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by weekly alternating taxanes. The primary objective was to determine the feasibility of the regimen; the secondary objective was to estimate the disease-free and overall survival. Experimental Design: Patients with ≥4 node-positive breast cancer were studied. Treatment consisted of FEC at 500/100/500 mg/m2, respectively, x6 at two-week intervals with granulocyte colony-stimulating factor, followed by weekly paclitaxel (80 mg/m2) alternating with docetaxel (35 mg/m 2) x18. Results: Between November 2001 and January 2003, 44 patients were enrolled. Median age was 46 years (range, 26-63 years), median number of positive nodes was 9 (range, 4-32), and median tumor size was 2.5 cm (range, 0.6-11.0 cm). Because of unexpected toxicities, the study was stopped when 17 (39%) had fully completed all of the planned treatment. Two of 17 (12%) developed grade 4 pericardial/grade 3 bilateral pleural effusions at treatment completion; both required pericardial window. The remaining patients were treated with taxanes using one of several standard dose and schedule combinations. Furthermore, 4 of 44 (9%) developed pneumonitis attributed to the FEC regimen. Hospital admissions were required for 12 of 44 (27%); 3 of 44 (7%) required blood transfusions. There were no treatment related deaths. Median disease-free and overall survival will not be estimatable because of early closure of study. Conclusion: FEC x6 at 2-week intervals followed by 18 weeks of alternating taxanes is not feasible at the doses tested. Other strategies are needed to improve adjuvant systemic chemotherapy. |
| Keywords: | adult; cancer survival; clinical article; treatment outcome; disease-free survival; middle aged; survival rate; clinical trial; constipation; fatigue; fluorouracil; cancer combination chemotherapy; cancer risk; diarrhea; dose response; side effect; treatment planning; paclitaxel; cancer adjuvant therapy; lymph nodes; phase 2 clinical trial; sensory neuropathy; breast cancer; anemia; tumor volume; blood toxicity; mucosa inflammation; nausea; thrombocytopenia; antineoplastic combined chemotherapy protocols; myalgia; risk factors; cyclophosphamide; herpes zoster; dose-response relationship, drug; breast neoplasms; docetaxel; arthralgia; dizziness; drug hypersensitivity; dyspnea; febrile neutropenia; fever; nail disease; pneumonia; chemotherapy induced emesis; feasibility study; feasibility studies; pilot projects; blood transfusion; peripheral edema; epirubicin; pleura effusion; hospital admission; taxoids; headache; migraine; taxane derivative; dyspepsia; pericardial effusion; granulocyte colony stimulating factor; granulocyte colony-stimulating factor; visual impairment; granulocytopenia; upper respiratory tract infection; cellulitis; pericardiotomy; abscess; parotid gland disease; humans; human; female; priority journal; article; lacrimal gland disease; otitis |
| Journal Title: | Clinical Cancer Research |
| Volume: | 10 |
| Issue: | 17 |
| ISSN: | 1078-0432 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 2004-09-01 |
| Start Page: | 5754 |
| End Page: | 5761 |
| Language: | English |
| DOI: | 10.1158/1078-0432.ccr-04-0634 |
| PROVIDER: | scopus |
| PUBMED: | 15355903 |
| DOI/URL: | |
| Notes: | Clin. Cancer Res. -- Cited By (since 1996):22 -- Export Date: 16 June 2014 -- CODEN: CCREF -- Source: Scopus |
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