Multicenter phase II study of liposomal doxorubicin (M) and docetaxel (T) as neoadjuvant treatment in patients with stage II - III breast cancer

• Published in: Journal of clinical oncology Vol. 24; no. 18_suppl; p. 10662
• Main Authors: Modolell, A., Mayordomo MD, J. I., Garcia-Bueno, J. M., Machengs, I., Alvarez, I., Centelles, M., Palombo, H., Burillo, M., Yubero, A., Murillo, L., Andrés, R.
• Format: Journal Article
• Language: English
• Published: 20-06-2006
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2006.24.18_suppl.10662

Abstract only 10662
Background: T and M is a very active chemotherapy regimen for breast cancer. M has been shown to be as effective as doxorubicin at same doses while reducing the cardiotoxicity and causing less myelosuppression. This study was designed to evaluate clinical and pathological response rate (RR) and toxicity after induction chemotherapy in patient with breast cancer. Methods: Patients with histological confirmation of breast cancer (stage II-III and inflammatory), age > 18 years, left ventricular eject fraction > 45% and adequate bone marrow, renal and hepatic function were included in the study. Prior systemic therapy or radiotherapy and surgery for breast cancer were not allowed. Treatment: T (75 mg/m
2
) iv and M (75 mg/m
2
) iv, every 21 days during 4 cycles, followed by surgery. Results: To date 59 patients have been enrolled; 50 were included in this interim analysis, with a median age of 52 years old (28–76), ECOG PS 0, 88.0%; ECOG PS 1, 12.0%; breast location: right, 52.0%; peri-postmenopausal status, 44.9%. Positive hormonal receptor status was 63.3%. Histology was ductal carcinoma in 84.0%. Patients received a total of 188 cycles (median 4, range 2–4). Median relative dose intensity was 99% for T and for M. Efficacy: Nine patients were non-evaluable (7 on treatment, 1 consent withdrawal and 1 lost of follow-up). Of 41 evaluable patients, 5 achieved complete response (CR) (12.2%), 26 partial response (PR)(63.4%), 9 stable disease (SD) (22.0%) and 1 progressive disease (PD) (2.4%), resulting in a clinical response rate (RR) of 75.6% (95% CI: 62.5–88.7%). Surgery was performed in 40 patients: six (15.0%) of them had pathological (p) CR, 25 (62.5%) pPR, 9 (22.5%) pSD resulting in a pathological RR of 77.5% (95% CI: 64.6–90.4%). Median of time to progression and overall survival has not been achieved yet. Hematological toxicities grades III/IV per patient were neutropenia (14%), thrombocytopenia (4%), leukopenia (2%), anemia (2%) and febrile neutropenia (12%). Non-hematological grade III/IV toxicities per patient were asthenia (6%), nausea / vomiting (4%) and infection (4%). Conclusions: T and M every 21 days during 4 cycles as induction chemotherapy in stage II and III breast cancer is an active and well tolerated treatment.
No significant financial relationships to disclose.