A multicenter prospective phase II trial of neoadjuvant epirubicin, cyclophosphamide, and 5-fluorouracil (FEC100) followed by cisplatin-docetaxel with or without trastuzumab in locally advanced breast cancer.

PURPOSE: To evaluate the efficacy and safety profile of the (FEC100) followed by cisplatin/docetaxel with and without trastuzumab as primary chemotherapy for patients with locally advanced breast cancer (LABC). METHODS: Eighty patients with LABC (T2-T4, N0-N2, M0) were enrolled to receive 24 weeks of neoadjuvant chemotherapy using epirubicin, cyclophosphamide, and 5-fluorouracil (FEC100) followed by cisplatin and docetaxel, plus trastuzumab if HER2 positive. The primary endpoint was pathologic complete response (pCR) in breast and axilla in separate HER2-negative and HER2-positive cohort. RESULTS: Eighty patients were evaluable for analysis of which 51 were HER2 negative and 29 HER2 positive: median age: 43 years, premenopausal: 82%, median tumor size: 7.0 cm (4-10), stage IIB: 25% and IIIA/IIIB: 75%, both ER/PR positive: 56%, HER2 positive (3+) by IHC staining: 36%. Clinical complete response was seen in 48%, and clinical partial response was seen in 52%. Overall the pathologic complete response (pCR) was 36% in breast, 64 % in axilla, and 32% in both breast and axilla. Analysis of pCR in breast and axilla, as a function of the hormonal receptor (HR) and HER2, was as follows: HR(+)/HER2(-): 11%; HR(+)/HER(+): 56 %; HR(-)/HER2(-): 36%; HR(-)/HER2(+): 62%. CONCLUSION: In this series of locally advanced breast cancer, the combination of (FEC100) followed by cisplatin/docetaxel with and without trastuzumab was very active obtaining an impressive rate of pCR, particularly in HER2-positive and triple negative disease, which merits further investigation.

Pure dysgerminoma of the ovary: a single institutional experience of 65 patients.

Ovarian dysgerminomas are rare entity and account for only about 2% of all malignant ovarian neoplasm. The aim of this study was to evaluate the clinicopathologic characteristics, treatment, long-term survival, and fertility outcome of women diagnosed with ovarian dysgerminoma at our institution. Sixty-five women with histologically proven pure ovarian dysgerminoma were identified in this retrospective study. They were treated at King Faisal Specialist Hospital, Riyadh; Saudi Arabia between 1976 and 2010. The median age was 20 years. The most frequent symptoms at presentation were abdominal pain and abdominal/pelvic mass. Thirty-three patients (50.7%) presented with stage I, 2 (3.1%) had stage II, 22 (33.8%) had stage III, and 4 (6.2%) had stage IV (4 unknown stage). Unilateral oophorectomy was performed in 50 patients (76.9%) while bilateral oophorectomy±hysterectomy was done in 12 patients (18.4%). Three patients had biopsy only. Forty patients (61.5%) received only chemotherapy, and 4 patients (6.2%) received radiotherapy alone. Recurrence was observed in 6 patients (9.2%). With median follow-up of 54 months, the 5-year disease-free survival (DFS) and overall survival (OS) were 88 and 95%, respectively. On univariate analysis, adjuvant chemotherapy was independent better prognostic factor for DFS (HR, 0.09; 95% CI, 0.01-0.84; P=0.034). Of the 50 patients treated with fertility-sparing surgery, 16 patients (32%) achieved pregnancy with 14 live births. Patients with pure ovarian dysgerminoma have excellent long-term outcome. There is no difference at outcome between fertility-sparing and nonconservative surgeries. Adjuvant chemotherapy was associated with significant improvement in DFS. It is possible to maintain good reproductive function after conservative surgery followed by chemotherapy in our series.