Combination of docetaxel, epirubicin and vinorelbine administered every 2 weeks as first-line therapy in patients with metastatic breast cancer: a dose-finding study

• Published in: Breast cancer research and treatment Vol. 80; no. 3; pp. 257 - 265
• Main Authors: ESTEBAN, Emilio, MODOLLEL, Antonio, ESTRADA, Enrique, LACAVE, A. J, GONZALEZ DE SANDE, Luis, PALACIO, Isabel, MUNIZ, Isabel, FERNANDEZ, Yolanda, CORRAL, Norberto, FRA, Joaquin, SALA, Marian, VIEITEZ, Jose Maria
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer 01-08-2003; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic agents; 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; Cancer research; Cancer therapies; Chemotherapy; Disease-Free Survival; Docetaxel; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug therapy; Epirubicin - administration & dosage; Female; Fever - chemically induced; Granulocyte Colony-Stimulating Factor - administration & dosage; Humans; Medical sciences; Middle Aged; Nausea - chemically induced; Neutropenia - chemically induced; Pharmacology. Drug treatments; Studies; Taxoids - administration & dosage; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine; Vomiting - chemically induced; Antineoplastic agent; Administration schedule; Increasing dose; Alkaloid; Taxane derivatives; Clinical trial; Female; Advanced stage; Epirubicin; Mammary gland; Antimitotic; Human; Drug combination; Maximal dose; Docetaxel; combination chemotherapy; Malignant tumor; First line treatment; Mammary gland diseases; Antibiotic; Chemotherapy; Treatment; Anthracyclins; Metastatic; advanced breast cancer; Vinorelbine
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1023/A:1024985309383

To assess efficacy and optimum combination dosage of intravenous docetaxel (T), epirubicin (E) and vinorelbine (N) administered every 2 weeks and without colony stimulating factor (CSF) support in patients with metastatic breast cancer (MBC).
Patients (n = 5 1) with MBC were consecutively assigned to four different dose levels (DL) to receive (in mg/m2): Level I = T35 + E30 + N25; Level II = T30 + E30 + N25; Level III = T30 + E25 + N25; and Level IV = T25 + E25 + N25. Consecutive cycles were delayed if absolute neutrophil and/or platelet counts fell below 1.5 x 10(9) and 100 x 10(9) l(-1), respectively. Treatment at a given dose level was suspended if 33% or more of patients included in a given cohort had unacceptable toxicity.
The patients evaluable for toxicity (n = 48) received 448 cycles (median 9; range 1-23). There was neutropenia G 3-4 in 30 patients (63%) with fever in 3 (6%). The G 2-3 non-hematological toxicities were alopecia in 39 patients (81%), mucositis in 11 (23%), and nausea/vomiting in 8 (17%). There were no toxic deaths. Treatment delay or dose reduction after first cycle occurred in > or = 30% of patients treated in all DLs, except the fourth. Objective response was achieved in 29 of the 47 evaluable patients (58%; 95% CI: 50-66). The median duration of response, time-to-progression and overall survival were 13, 11 (range 8-14) and 20 (range 16-24) months, respectively.
The combination of docetaxel, epirubicin and vinorelbine without CSF support ought not to exceed 25 mg/m2 every 2 weeks. The efficacy is no greater than other existing regimens for first-line treatment of MBC.