A phase III adjuvant randomised trial of 6 cycles of 5-fluorouracil–epirubicine–cyclophosphamide (FEC100 ) versus 4 FEC 100 followed by 4 Taxol (FEC-T) in node positive breast cancer patients (Trial B2000)

• Published in: European journal of cancer (1990) Vol. 50; no. 1; pp. 23 - 30
• Main Authors: Delbaldo, C, Serin, D, Mousseau, M, Greget, S, Audhuy, B, Priou, F, Berdah, J.F, Teissier, E, Laplaige, P, Zelek, L, Quinaux, E, Buyse, M, Piedbois, P
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01-01-2014; Elsevier
• Subjects: Adjuvant chemotherapy; Adult; Aged; Anthracycline; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Chemotherapy, Adjuvant; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Efficacy; Epirubicin - administration & dosage; Epirubicin - adverse effects; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Hematology, Oncology and Palliative Medicine; Humans; Lymphatic Metastasis; Medical sciences; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Paclitaxel; Paclitaxel - administration & dosage; Pharmacology. Drug treatments; Phase III; Treatment Outcome; Tumors; Phase III; Efficacy; Adjuvant chemotherapy; Breast cancer; Anthracycline; Paclitaxel; Antineoplastic agent; Phase III trial; Breast disease; Adjuvant treatment; Randomization; Cancerology; Taxane derivatives; Clinical trial; Adjuvant; Antimitotic; Fluorouracil; Human; Enzyme; Taxol; Fluoropyrimidine derivatives; Transferases; Treatment efficiency; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Cycle; Mammary gland diseases; Alkylating agent; Oxazaphosphinane derivatives; Chemotherapy; Cyclophosphamide; Treatment; Antimetabolic; Methyltransferases; Nitrogen mustard; Pyrimidine derivatives; Anthracyclins; Comparative study; Cancer
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2013.09.023

Abstract Background Standard adjuvant chemotherapy regimens for patients with node positive (N+) breast cancer consisted of anthracycline followed by taxane. The European Association for Research in Oncology embarked in 2000 on a phase III trial comparing 6 cycles of FEC100 versus 4 FEC100 followed by 4 Taxol. Primary end-point was disease free survival. Secondary end-points were overall survival, local recurrence free interval, metastases free interval and safety. Patients and methods Between March 2000 and December 2002, 837 patients were randomised between 6FEC100 for 6 cycles (417 patients) or FEC100 for 4 cycles then Taxol 175 mg/m2 /3 weeks for 4 cycles (4FEC100 -4T) (420 patients). One thousand patients had been planned initially but the trial was closed earlier due to slow accrual. Results Hazard ratios (HRs) were 0.99 for disease-free survival (DFS) (95%CI: 0.77–1.26; p = 0.91), and 0.85 for overall survival (OS) (95%CI: 0.62–1.15; p = 0.29). Nine-year DFS were 62.9% versus 62.5% for 6FEC100 and 4FEC100 -4T, respectively. Nine-year OS were 73.9% versus 77% for 6FEC100 and 4FEC100 -4T, respectively. Toxicity analyses based on 803 evaluable patients showed that overall grade 3–4 toxicities were similar in both arms (63% versus 58% for 6FEC100 arm and 4FEC100 -4T arm, respectively; p = 0.16). Conclusion In this trial replacing the last 2 FEC100 cycles of 6FEC100 regimen by 4 Taxol does not lead to a discernable DFS or OS advantage. The lack of a significant difference between the randomised treatment arms may however be due to a lack of power of this trial to detect small, yet clinically worthwhile, treatment benefits.