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

Abstract

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.

Pathologic complete response after neoadjuvant therapy of breast cancer: pitfalls and shortcomings

“…It was suspected that pCR rates might be higher in HR-positive tumors if endocrine treatment is added. Indeed, a small trial presented in this issue of the journal found a significantly higher pCR rate when letrozole was given in combination with chemotherapy compared to chemotherapy alone [7]. However, this is in contrast to larger trials reported earlier by our group and as well the ECTO group again in this issue of the journal where neither tamoxifen [8] nor exemestane [9] in combination with chemotherapy achieved sufficient pCR rates.…”

Cost-Utility of "Doxorubicin and Cyclophosphamide" versus "Gemcitabine and Paclitaxel" for Treatment of Patients with Breast Cancer in Iran

“…Breast cancer was increasing over the years in Iran and is now ranked as the first among cancers diagnosed in women. Based on the latest statistics announced by the Health Ministry of Iran, 27 people per hundred thousand women are diagnosed with breast cancer (Mohammadianpanah et al, 2012).…”

“…Lower age of incidence is very important and causes loss of more QALY in the health care system (Armour et al, 1996;Mohammadianpanah et al, 2012). One of the most common treatments for cancer is chemotherapy that causes long-term improvement in these patients.…”

The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

“…Later, taxanes were added to this combination chemotherapy and 5-fluorouracil was omitted. Various combinations and sequences have been studied to find the most effective and safe combination regimen [3,[7][8][9].…”