The efficacy and safety of neoadjuvant chemotherapy +/− letrozole in postmenopausal women with locally advanced breast cancer: a randomized phase III clinical trial

• Published in: Breast cancer research and treatment 2012-04, Vol.132 (3), p.853-861
• Main Authors: Mohammadianpanah, Mohammad, Ashouri, Yaghoub, Hoseini, Sare, Amadloo, Niloofar, Talei, Abdolrasoul, Tahmasebi, Sedigheh, Nasrolahi, Hamid, Mosalaei, Ahmad, Omidvari, Shapour, Ansari, Mansour, Mosleh-Shirazi, Mohammad Amin
• Format: Article
• Language: English
• Subjects: Adjuvant treatment; Aged; Aged, 80 and over; Alopecia - chemically induced; Anthracyclines; 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; Cancer; Cancer research; Cancer therapies; Chemotherapy; Clinical Trial; Clinical trials; Cyclophosphamide; Cyclophosphamide - administration & dosage; Doxorubicin - administration & dosage; Endocrine therapy; Female; Fluorouracil - administration & dosage; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Medicine; Medicine & Public Health; Menopause; Middle Aged; Neoadjuvant Therapy - adverse effects; Neoplasm Staging; Neutropenia - chemically induced; Nitriles - administration & dosage; Oncology; Postmenopausal women; Postmenopause; Product development; Statistics, Nonparametric; Toy industry; Treatment Outcome; Triazoles - administration & dosage; Tumor Burden - drug effects; Tumors
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-011-1814-6

This two-arm randomized clinical study aimed to evaluate the efficacy and safety of neoadjuvant concurrent chemotherapy and letrozole in postmenopausal women with locally advanced breast carcinoma. One hundred and one postmenopausal women aged 50–83 years with pathologically proven locally advanced (clinical stage T3, T4 and/or N2, N3) breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (control arm, n  = 51) or neoadjuvant chemotherapy concurrent with letrozole 2.5 mg (study arm, n  = 50). Chemotherapy consisted of a median 4 (range 3–5) cycles of intravenous 5-fluorouracil 600 mg/m 2 , doxorubicin 60 mg/m 2 , and cyclophosphamide 600 mg/m 2 , every three weeks. All patients subsequently underwent modified radical mastectomy approximately two weeks after the last cycle of chemotherapy. Pathologic complete response rates were 25.5% and 10.2% in the study and the control group, respectively ( P  = 0.049). Similarly, clinical complete response rates were 27.6% and 10.2% in the study and the control group, respectively ( P  = 0.037). In the subgroup analysis of hormone receptor-positive cases, the complete response rates were more prominent in study group compared with control group. Common treatment-related side effects such as nausea, vomiting, bone marrow suppression, and mucositis were similar in both groups, but hot flush was more prevalent in study group compared with control group ( P  = 0.023). The addition of letrozole concurrently with neoadjuvant chemotherapy provides a higher clinical and pathologic response rates with acceptable toxicity compared with chemotherapy alone in postmenopausal women with locally advanced sensitive breast cancer.