Biweekly vinorelbine and tegafur/uracil in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: GEICAM 2000-02 phase II study.

INTRODUCTION: To assess the efficacy and safety profile of biweekly vinorelbine and tegafur/uracil (UFT) as treatment in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. PATIENTS AND METHODS: Patients with histologically confirmed breast cancer, measurable disease, no more than one prior chemotherapy regimen for metastatic disease, an Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate bone marrow, renal and liver function were eligible. Patients received vinorelbine (30 mg/m(2) on day 1) and UFT (250 mg/m(2) daily) every two weeks for 12 cycles unless progression or unacceptable toxicity was observed. RESULTS: Thirty-seven patients were included and received 311 cycles of chemotherapy. Efficacy and toxicity analyses were carried out on an intention-to-treat basis. The overall response rate was 35% (95% CI: 20-53). With a median follow-up of 18.6 months (95% CI: 1.0-74.3), the median time to progression was 7.0 months (96% CI: 5.2-8.9) and the median overall survival was 19.4 months (95% CI: 11.1-27.8). The most common severe toxicities were neutropenia (38% of patients) and asthenia (11% of patients). CONCLUSION: The combination of biweekly vinorelbine and UFT in patients with metastatic breast cancer pretreated with anthracyclines and taxanes is a well tolerated and effective regimen. AEMPS Trial Registration No.: 00-0534.

Phase I/II study of biweekly vinorelbine and oxaliplatin as first-line treatment in patients with metastatic breast cancer.

The objective of this phase I/II study was to establish the recommended dose of biweekly vinorelbine and oxaliplatin in patients with metastatic breast cancer and to evaluate the efficacy and safety profile of this schedule as first-line treatment. Four different dose levels of vinorelbine and oxaliplatin were selected for the phase I study: (i) 25 and 80 mg/m²; (ii) 25 and 90 mg/m²; (iii) 25 and 100 mg/m²; and (iv) 30 and 90 mg/m²; respectively. At least three patients were treated at each dose level. Overall, 12 patients were included in the phase I trial. No dose-limiting toxicities occurred at any dose level. Therefore, the fourth dose level (30 mg/m² of vinorelbine and 90 mg/m² of oxaliplatin) every 2 weeks was selected for the phase II trial. In this part, 44 patients were included and 61% completed the eight 2-week cycles of study treatment. On an intention-to-treat basis, overall response rate was 59%, and median progression-free survival and overall survival were 9.2 months (95% confidence interval: 7.6-10.9) and 18.6 months (95% confidence interval: 14.4-22.9), respectively. The main severe toxicities were neutropenia (46%) and fatigue (14%). We conclude that the biweekly combination of vinorelbine and oxaliplatin at doses of 30 mg/m² and 90 mg/m², respectively, is highly active and well tolerated as first-line treatment for patients with metastatic breast cancer.

Phase I study of oral vinorelbine and capecitabine in patients with metastatic breast cancer.

BACKGROUND: To determine the recommended doses of oral vinorelbine (VN) and capecitabine (C) in metastatic breast cancer. PATIENTS AND METHODS: Eighteen patients with metastatic breast cancer received oral VN (on days 1 and 8) and C (on days 1 to 14) every three weeks at one of four dose levels: I) 60 mg/m(2) and 1650 mg/m(2)/day; II) 70 mg/m(2) and 1650 mg/m(2)/day; III) 70 mg/m(2) and 2000 mg/m(2)/day; IV) 80 mg/m(2) and 2000 mg/m(2)/day, respectively. The primary endpoint was to determine the recommended doses for the combination of oral VN and C in metastatic breast cancer. Secondary endpoints include evaluating response rate, safety profile and whether or not VN dosage escalation was required. RESULTS: Severe neutropenia occurred in 28% of patients; and severe anaemia and leucopenia were observed in one patient each (6%). One patient developed febrile neutropenia. Non-hematological toxicities were rare. The response rate was 28% (95% CI: 10-54) in the intention-to-treat population. CONCLUSION: The recommended dose is 80 mg/m(2) of oral VN on days 1 and 8, and 2000 mg/m(2)/day of C from days 1 to 14 in three weekly cycles. A phase II study with this schedule is currently under way.

Phase II study of vinorelbine and estramustine in combination with conformational radiotherapy for patients with high-risk prostate cancer.

PURPOSE: To evaluate the efficacy and safety profile of vinorelbine and estramustine in combination with three-dimensional conformational radiotherapy (3D-CRT) in patients with localized high-risk prostate cancer. METHODS AND MATERIALS: Fifty patients received estramustine, 600 mg/m(2) daily, and vinorelbine, 25 mg/m(2), on days 1 and 8 of a 21-day cycle for three cycles in combination with 8 weeks of 3D-CRT (total dose of 70.2 gray [Gy] at 1.8-Gy fractions or 70 Gy at 2.0-Gy fractions). Additionally, patients received luteinizing hormone-releasing hormone analogs for 3 years. RESULTS: All patients were evaluated for response and toxicity. Progression-free survival at 5 years was 72% (95% confidence interval [CI]: 52-86). All patients who relapsed had only biochemical relapse. The most frequent severe toxicities were cystitis (16% of patients), leucopenia (10% of patients), diarrhea (10% of patients), neutropenia (8% of patients), and proctitis (8% of patients). Six patients (12%) did not complete study treatment due to the patient's decision (n = 1) and to adverse events such as hepatotoxicity, proctitis, paralytic ileus, and acute myocardial infarction. CONCLUSIONS: Vinorelbine and estramustine in combination with 3D-CRT is a safe and effective regimen for patients with localized high-risk prostate cancer. A randomized trial is needed to determine whether the results of this regimen are an improvement over the results obtained with radiotherapy and androgen ablation.

Detection and quantification of species authenticity and adulteration in crabmeat using visible and near-infrared spectroscopy.

Seafood processing often removes morphological properties of seafood species that enable the consumer to distinguish one type of organism from another. For this reason, species substitution is the most common form of economic adulteration in the seafood industry. Visible and near-infrared spectroscopy (Vis/NIR) has been used to detect and quantify species authenticity and adulteration in crabmeat samples. Atlantic blue crabmeat was adulterated with blue swimmer crabmeat in 10% increments. Water absorption bands dominated the main features in the crabmeat spectra, with a decrease in sample absorbance with increasing adulteration percentage. Several data pretreatments, i.e., moving average, combing, first and second derivatives, and multiplicative scatter correction, in addition to the raw data, were investigated for prediction and quantitative data analysis using partial least-squares. In addition, quantitative analysis was done using the full spectrum and a sequential approach in which 50 wavelengths were added sequentially to determine a new model and find an optimal solution. The results suggest that Vis/NIR spectroscopy is a suitable technology that can be applied to detect and quantify species authenticity and adulteration in crabmeat.

Quantitative analysis and detection of adulteration in crab meat using visible and near-infrared spectroscopy.

Visible and near-infrared spectroscopy (VIS/NIR) has been used to detect economic adulteration of crab meat samples. Atlantic blue and blue swimmer crab meat samples were adulterated with surimi-based imitation crab meat in 10% increments. Waveform evaluation revealed that the main features seen in the spectral data arise from water absorptions with a decrease in sample absorbance with increasing adulteration level. Prediction and quantitative analysis was done using raw data, a 15-point smoothing average, a first derivative, a second derivative, and 150 wavelength spectral data gathered from a correlogram. Regression analysis included partial least squares (PLS) and principal component analysis (PCR). Both models were able to perform similarly in predicting crab meat adulteration. The best model for both PLS and PCR used the first derivative spectral data gathered from the correlogram, with a standard error of prediction (SEP) of 0.252 and 0.244, respectively. The results suggest that VIS/NIR technology can be successfully used to detect adulteration in crab meat samples adulterated with surimi-based imitation crab meat.