Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.

UNLABELLED: The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines. PATIENTS AND METHODS: Sixty-eight women received gemcitabine 1,000 mg/m(2) as 30-minute infusion on days 1 and 8, and docetaxel 80 mg/m(2) as 1-hour infusion on day 8, with cycles repeated every 3 weeks. RESULTS: Objective responses were observed in 32 out of 68 evaluable patients (45%; 95% confidence interval, 35.2-58.8%). Responses were 44%, 42%, 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2-positive/-negative tumors, and 50% in both ER- positive/-negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients. CONCLUSION: Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines.

Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide.

PURPOSE: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. PATIENTS AND METHODS: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). RESULTS: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non-G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non-G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). CONCLUSION: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Liver metastases from breast cancer. Results of surgical resection.

BACKGROUND/AIMS: Purpose of this study is to define the effectiveness of surgical resection of liver metastases from operated breast cancer. METHODOLOGY: Nineteen patients underwent surgical exploration to resect liver metastases from previously operated breast carcinoma. Seventeen patients were resected: 15 patients had unique metastases and were submitted to a wedge liver resection while 2 had multiple lesions; in these cases a V-VI segmentectomy and a right hepatectomy was required. After liver resection 11 patients received chemotherapy, 2 chemotherapy plus hormone therapy, 2 hormone therapy alone and in the remaining 2 no adjuvant treatment was done. RESULTS: Postoperative mortality was nil and morbidity consisted of 1 subphrenic abscess and 1 pleural effusion. Actuarial 5-year survival rate was 46%. Eight patients are still alive, 7 of whom are disease-free. Nine patients died for neoplastic progression. CONCLUSIONS: Surgical resection of liver metastases from breast cancer seems to be able to improve long-term survival in selected patients with unique and isolated lesions especially in association to systemic chemotherapy and hormone therapy.