Commodity risk assessment of oak logs with bark from the US for the oak wilt pathogen Bretziella fagacearum under an integrated systems approach.

The European Commission submitted to the EFSA Panel on Plant Health a Dossier by USDA proposing a systems approach to mitigate the risk of entry of Bretziella fagacearum to the EU when trading oak logs with bark from the USA. Due to the forthcoming ban of methyl bromide (MB), the Dossier indicates sulfuryl fluoride (SF) as the substitute fumigant for this commodity. After collecting additional evidence from USDA,EU NPPOs, external experts and the published literature, the Panel performed a quantitative assessment on the likelihood of pest freedom for B. fagacearum at the point of entry in the EU, comparing the proposed systems approach with those already implemented by Commission Decision 2005/359/EC. The Panel provided also a non-quantitative assessment for all risk reduction options (RROs) proposed to be undertaken in the EU, from the point of entry to processing at the sawmill. The quantitative assessment until the EU point of entry, based on experts' judgement, indicated that: i) the most effective import option remains the current one with MB (95% certainty that between 9,573 and 10,000 containers per 10,000 would be free of B. fagacearum), followed by that with SF (95% certainty that between 8,639 and 10,000 containers per 10,000 would be free of B. fagacearum) and, last, by the other existing option based on delivering white oak logs in certain periods of the year to certain regions of the EU without fumigation (95% certainty, between 7,803 and 10,000 containers per 10,000). RROs proposed to be undertaken in the EU are expected to further reduce the risk of establishment of B. fagacearum, should these RROs be regulated, correctly implemented and checked by NPPOs. A wood pathway analysis is needed to quantitatively assess the importance of each measure and to optimise regulatory actions and risk management efforts.

Substantial differences occur between canopy and ambient climate: Quantification of interactions in a greenhouse-canopy system.

Organ temperature and variation therein plays a key role in plant functioning and its responses to e.g. climate change. There is a strong feedback between organ, especially leaf, temperature and the climate within the canopy (canopy climate), which in turn interacts with the climate outside the canopy (ambient climate). For greenhouses, the determinants of this interplay and how they drive differences between canopy and ambient climate are poorly understood. Yet, as many experiments on both regular greenhouse crops and field crops are done in greenhouses, this is crucial to know. Therefore, we designed an experiment to quantify the differences between ambient and canopy climate and leaf temperature. A path analysis was performed to quantify the interactions between components of the greenhouse canopy-climate system. We found that with high radiation the canopy climate can be up to 5°C cooler than the ambient climate, while for cloudy days this was only 2°C. Canopy relative humidity (RH) was up to 25% higher compared to ambient RH. We showed that radiation is very important for these climate differences, but that this effect could be partly counteracted by turning off supplementary light (i.e. due to its indirect effects e.g. changing light distribution). Leaf temperature was substantially different, both higher and lower, from the canopy air temperature. This difference was determined by leaf area index (LAI), temperature of the heating pipe and the use of supplementary light, which all strongly influence radiation, either shortwave or thermal radiation. The difference between leaf and ambient air temperature could be decreased by decreasing the LAI or increasing the temperature of the heating pipe.

Demographic, clinical and lifestyle-related correlates of accelerometer assessed physical activity and fitness in newly diagnosed patients with head and neck cancer.

Introduction: Objective measurements of levels of physical activity and fitness in patients with head and neck cancer (HNC) are lacking. Furthermore, demographic, clinical and lifestyle-related correlates of low levels of physical activity and fitness in patients with HNC are unknown. This study aims to investigate the levels of accelerometer that assessed physical activity and fitness in patients with HNC and to identify their demographical, clinical and lifestyle-related correlates.Methods: Two hundred and fifty-four patients who were recently diagnosed with HNC and participated in the NETherlands QUality of life and Biomedical cohort studies In head and neck Cancer (NET-QUBIC) study were included. Physical activity (accelerometer), cardiorespiratory fitness (Chester Step Test), hand grip strength (hand dynamometer) and lower body muscle function (30-second chair-stand test) were assessed. Multivariable linear regression analyses with a stepwise forward selection procedure were used.Results: Patients spent 229 min/d in physical activity of which 18 min/d in moderate-to-vigorous physical activity. The mean predicted VO2max was 27.9 ml/kg/min, the mean hand grip strength was 38.1 kg and the mean number of standings was 14.3. Patients with lower educational level, more comorbidity and higher tumor stage spent significantly less time in physical activity. Older patients, females and patients with a higher tumor stage had significantly lower cardiorespiratory fitness levels. Older patients, females, patients with more comorbidity, patients with normal weight and patients who have never smoked had significantly lower hand grip strength. Older patients, patients with lower educational level, smokers and patients with more comorbidity had a significantly lower function of lower body muscle.Conclusions: Pre-treatment levels of physical activity, cardiorespiratory fitness and lower body muscle function are low in patients with HNC. Based on this study, exercise programs targeted and tailored to patients with low levels of physical activity and fitness can be developed.

Are patient-reported outcomes of physical function a valid substitute for objective measurements?

Background: Physical function is important for defining treatment strategies in patients with cancer and can be estimated using patient-reported outcomes (pros). Although pros are subjective, physical activity and fitness can be tested objectively with adequate, but more labour-intensive methods that are rarely used in daily clinical practice. To determine whether pros for physical function (pro-pf) accurately predict physical function, we studied their interrelationships with objective measures of physical activity and fitness in patients with cancer who had completed cancer treatment, including adjuvant or neoadjuvant chemotherapy or autologous stem-cell transplantation. Methods: Baseline data from the react (Resistance and Endurance Exercise After Chemotherapy) and exist (Exercise Intervention After Stem-Cell Transplantation) studies were evaluated. In those studies, the effects of an exercise intervention on physical fitness, fatigue, and health-related quality of life in patients with cancer shortly after completion of chemotherapy or stem-cell transplantation were studied. Interrelationships between pro-pf (physical function subscale of the European Organisation for Research and Treatment of Cancer 30-question core Quality of Life Questionnaire), physical activity (accelerometer), and cardiorespiratory fitness (peak oxygen uptake) were assessed using univariable and multivariable multilevel linear mixed-model analyses. Results: After adjustment for age, sex, and body mass index, the pro-pf was significantly associated with physical activity (ß = 1.75; 95% confidence interval: 1.08 to 2.42) and cardiorespiratory fitness (ß = 0.10; 95% confidence interval: 0.06 to 0.13). Standardized coefficients were 0.28 and 0.26 respectively, indicating a weak association. Conclusions: The pro-pf is only weakly associated with objective physical activity and fitness evaluation in patients after curative treatment for cancer. The pro-pf cannot, therefore, be used in clinical practice as a substitute for objective measures of physical function.

Development of a pathway model to assess the exposure of European pine trees to pine wood nematode via the trade of wood.

Pine wood nematode (PWN), Bursaphelenchus xylophilus, is a threat for pine species (Pinus spp.) throughout the world. The nematode is native to North America, and invaded Japan, China, Korea, and Taiwan, and more recently Portugal and Spain. PWN enters new areas through trade in wood products. Once established, eradication is not practically feasible. Therefore, preventing entry of PWN into new areas is crucial. Entry risk analysis can assist in targeting management to reduce the probability of entry. Assessing the entry of PWN is challenging due to the complexity of the wood trade and the wood processing chain. In this paper, we develop a pathway model that describes the wood trade and wood processing chain to determine the structure of the entry process. We consider entry of PWN through imported coniferous wood from China, a possible origin of Portuguese populations, to Europe. We show that exposure increased over years due to an increase in imports of sawn wood. From 2000 to 2012, Europe received an estimated 84 PWN propagules from China, 88% of which arose from imported sawn wood and 12% from round wood. The region in Portugal where the PWN was first reported is among those with the highest PWN transfer per unit of imported wood due to a high host cover and vector activity. An estimated 62% of PWN is expected to enter in countries where PWN is not expected to cause the wilt of pine trees because of low summer temperatures (e.g., Belgium, Sweden, Norway). In these countries, PWN is not easily detected, and such countries can thus serve as potential reservoirs of PWN. The model identifies ports and regions with high exposure, which helps targeting monitoring and surveillance, even in areas where wilt disease is not expected to occur. In addition, we show that exposure is most efficiently reduced by additional treatments in the country of origin, and/or import wood from PWN-free zones. Pathway modelling assists plant health managers in analyzing risks along the pathway and planning measures for enhancing biosecurity.

Palliative care in Dutch hospitals: a rapid increase in the number of expert teams, a limited number of referrals.

BACKGROUND: Palliative care expert teams in hospitals have positive effects on the quality of life and satisfaction with care of patients with advanced disease. Involvement of these teams in medical care is also associated with substantial cost savings. In the Netherlands, professional standards state that each hospital should have a palliative care team by 2017. We studied the number of hospitals that have a palliative care team and the characteristics of these teams. METHODS: In April 2015, questionnaires were mailed to key palliative care professionals in all general, teaching and academic hospitals in the Netherlands. Out of 92 hospitals, 74 responded (80 %). RESULTS: Seventy-seven percent of all participating hospitals had a palliative care team. Other services, such as outpatient clinics (22 %), palliative care inpatient units (7 %), and palliative day care facilities (4 %) were relatively scarce. The mean number of disciplines that were represented in the teams was 6,5. The most common disciplines were nurses (72 %) and nurse practitioners (54 %), physicians specialized in internal medicine (90 %) or anaesthesiology (75 %), and spiritual caregivers (65 %). In most cases, the physicians did not have labeled hours available for their work as palliative care consultant, whereas nurses and nurse practitioners did. Most teams (77 %) were only available during office hours. Twenty-six percent of the teams could not only be consulted by healthcare professionals but also by patients or relatives. The annual number of consultations for inpatients per year ranged from 2 to 680 (median: 77). On average, teams were consulted for 0.6 % of all patients admitted to the hospitals. CONCLUSION: The number of Dutch hospitals with a palliative care team is rapidly increasing. There are substantial differences between teams regarding the disciplines represented in the teams, the procedures and the number of consultations. The development of quality standards and adequate staffing of the teams could improve the quality and effectiveness of the teams.

A 'shocking' finish to the Dam tot Damloop event.

A patient with status epilepticus after long-distance running is described. The patient, a young woman, was brought to our hospital with status epilepticus after completing in a running event, probably caused by an extremely low phosphate level of 0.30 mmol/l. Hypophosphataemia is a rare complication of running and can be caused by the use of phosphate in the glycogenolyticand glycolytic pathway.

Disturbance and resource availability act differently on the same suite of plant traits: revisiting assembly hypotheses.

Understanding the mechanisms of trait selection at the scale of plant communities is a crucial step toward predicting community assembly. Although it is commonly assumed that disturbance and resource availability constrain separate suites of traits, representing the regenerative and established phases, respectively, a quantification and test of this accepted hypothesis is still lacking due to limitations of traditional statistical techniques. In this paper we quantify, using structural equation modeling (SEM), the relative contributions of disturbance and resource availability to the selection of suites of traits at the community scale. Our model specifies and reflects previously obtained ecological insights, taking disturbance and nutrient availability as central drivers affecting leaf, allometric, seed, and phenology traits in 156 (semi-) natural plant communities throughout The Netherlands. The common hypothesis positing that disturbance and resource availability each affect a set of mutually independent traits was not consistent with the data. Instead, our final model shows that most traits are strongly affected by both drivers. In addition, trait-trait constraints are more important in community assembly than environmental drivers in half of the cases. Both aspects of trait selection are crucial for correctly predicting ecosystem processes and community assembly, and they provide new insights into hitherto underappreciated ecological interactions.

The contribution of mosses to the carbon and water exchange of Arctic ecosystems: quantification and relationships with system properties.

Water vapour and CO2 exchange were measured in moss-dominated vegetation using a gas analyser and a 0.3 x 0.3 m chamber at 17 sites near Abisko, Northern Sweden and 21 sites near Longyearbyen, Svalbard, to quantify the contribution of mosses to ecosystem level fluxes. With the help of a simple light-response model, we showed that the moss contribution to ecosystem carbon uptake varied between 14 and 96%, with an average contribution of around 60%. This moss contribution could be related to the normalized difference vegetation index (NDVI) of the vegetation and the leaf area index (LAI) of the vascular plants. NDVI was a good predictor of gross primary production (GPP) of mosses and of the whole ecosystem, across different moss species, vegetation types and two different latitudes. NDVI was also correlated with thickness of the active green moss layer. Mosses played an important role in water exchange. They are expected to be most important to gas exchange during spring when leaves are not fully developed.

Monitoring of platinum surface contamination in seven Dutch hospital pharmacies using inductively coupled plasma mass spectrometry.

OBJECTIVE: To develop, validate, and apply a method for the determination of platinum contamination, originating from cisplatinum, oxaliplatinum, and carboplatinum. METHODS: Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine platinum in wipe samples. The sampling procedure and the analytical conditions were optimised and the assay was validated. The method was applied to measure surface contamination in seven Dutch hospital pharmacies. RESULTS: The developed method allowed reproducible quantification of 0.50 ng l(-1) platinum (5 pg/wipe sample). Recoveries for stainless steel and linoleum surfaces ranged between 50.4 and 81.4% for the different platinum compounds tested. Platinum contamination was reported in 88% of the wipe samples. Although a substantial variation in surface contamination of the pharmacies was noticed, in most pharmacies, the laminar-airflow (LAF) hoods, the floor in front of the LAF hoods, door handles, and handles of service hatches showed positive results. This demonstrates that contamination is spread throughout the preparation rooms. CONCLUSION: We developed and validated an ultra sensitive and reliable ICP-MS method for the determination of platinum in surface samples. Surface contamination with platinum was observed in all hospital pharmacies sampled. The interpretation of these results is, however, complicated.

Randomised study of sequential versus combination chemotherapy with capecitabine, irinotecan and oxaliplatin in advanced colorectal cancer, an interim safety analysis. A Dutch Colorectal Cancer Group (DCCG) phase III study.

BACKGROUND: Results on overall survival in randomised studies of mono- versus combination chemotherapy in advanced colorectal cancer patients may have been biased by an imbalance in salvage treatments. This is the first randomised study that evaluates sequential versus combination chemotherapy with a fluoropyrimidine, irinotecan and oxaliplatin. PATIENTS AND METHODS: A total of 820 patients were randomised between first-line capecitabine, second-line irinotecan and third-line capecitabine + oxaliplatin (arm A) versus first-line capecitabine + irinotecan, and second-line capecitabine + oxaliplatin (arm B). The primary end point was overall survival. We present the results of an interim analysis on the safety data in the first 400 patients. RESULTS: In first-line the incidence of grade 3-4 diarrhoea, nausea, vomiting and febrile neutropenia was significantly higher in arm B. However, when toxicity over all lines was considered only grade 3 hand-foot syndrome occurred more frequently in arm A (12% versus 6%, respectively, P = 0.041). The incidence of cardiovascular toxicity was low. In two out of five patients with sudden death (one in arm A, four in arm B) cardiovascular risk factors were present. CONCLUSIONS: Both treatment arms had an acceptable safety profile. These data imply that the results on survival will be the major determinant for the selection of either strategy. Capecitabine plus irinotecan appears to be a feasible first-line treatment for patients with advanced colorectal carcinoma.

Supporting parents of youths with intellectual disabilities and psychopathology.

BACKGROUND: Parents of children and adolescents with both intellectual disabilities (ID) and psychopathology often experience high levels of parenting stress. To support these parents, information is required regarding the types of support they need and whether their needs are met. METHOD: In a sample of 745 youths (aged 10-24 years) with moderate to borderline ID, 289 parents perceived emotional and/or behavioural problems in their child. They were asked about their needs for support and whether these needs were met. Logistic regression analysis revealed the variables associated with both needing and receiving specific types of support. In addition, we asked those parents who had refrained from seeking support about their reasons. RESULTS: Most parents (88.2%) needed some supports, especially a friendly ear, respite care, child mental health care and information. Parents who perceived both emotional and behavioural problems in their child needed support the most. In addition, parents whose child had any of these problems before the past year, who worried most about their child and suffered from psychopathology themselves, more often needed support. Parents of children with moderate ID or physical problems especially needed 'relief care', that is, respite care, activities for the child and practical/material help. The need for a friendly ear was met most often (75.3%), whereas the need for parental counselling was met least often (35.5%). Not receiving support despite having a need for it was primarily related to the level of need. Parents who indicated to have a stronger need for support received support more often than parents who had a relatively low need for support. The parents' main reasons for not seeking support concerned their evaluation of their child's problems (not so serious or temporary), not knowing where to find support or wanting to solve the problems themselves first. CONCLUSIONS: Most parents had various support needs that were frequently unmet. Service providers should especially aim at providing information, activities, child mental health care and parental counselling. Furthermore, parents need to be informed about where and how they can obtain what kind of support. A case manager can be of help in this.

Trimetrexate as biochemical modulator of 5-fluorouracil/leucovorin in advanced colorectal cancer: final results of a randomised European study.

BACKGROUND: Trimetrexate (TMTX) is a biochemical modulator of 5-fluorouracil (5-FU) and leucovorin (LV). Phase II trials have shown promising activity of 5-FU/LV/TMTX in patients with advanced colorectal cancer (ACC). This trial evaluated the effect of TMTX in combination with 5-FU/LV as first-line treatment in ACC. PATIENTS AND METHODS: Patients with ACC were randomised to receive either intravenous LV 200 mg/m2/5-FU 600 mg/m2 or TMTX 110 mg/m2 followed 24 h later by LV 200 mg/m2/5-FU 500 mg/m2 plus oral LV rescue. Both schedules were given weekly for 6 weeks every 8 weeks. Patients were evaluated for progression-free survival (PFS), overall survival (OS), tumour response, quality of life (QoL) and toxicity. RESULTS: A total of 365 patients were randomised. A statistically significant prolongation of median PFS was seen in patients treated with TMTX/5-FU/LV compared with 5-FU/LV (5.4 months versus 4.1 months, respectively; P = 0.03), and a trend towards a significant benefit for OS (13.4 months versus 10.5 months, respectively; P = 0.08). Tumour response, QoL and toxicity were comparable between the two arms. Diarrhoea was the most frequently occurring grade 3 or 4 toxicity (22% and 30%, respectively). CONCLUSIONS: The addition of TMTX to a weekly regimen of 5-FU/LV results in a small but significant improvement in PFS without adding toxicity or worsening QoL in patients with ACC.

Screening for the presence of drugs in serum and urine using different separation modes of capillary electrophoresis.

Capillary electrophoresis (CE) is a modern separation technique that has some distinct advantages for toxicological analysis, such as a high efficiency, fast analysis, flexibility, and complementary separation mechanisms to chromatographic methods. CE can be applied in various modes, which each have a different separation mechanism or selectivity. The most common mode is capillary zone electrophoresis (CZE), in which charged analytes migrate in a buffer under the influence of an electric field. In micellar electrokinetic chromatography (MEKC), micelles are added to the buffer which interact with the analytes. MEKC can also be used for the separation of neutral compounds. In non-aqueous CE (NACE), the aqueous buffer is replaced by a background of electrolytes in organic solvents. A sample that needs to be screened can easily be analyzed subsequently by these CE modes using the same instrumentation. The aim of the study was to develop procedures for the analysis of basic and acidic drugs in serum and urine using CZE, MEKC, and NACE. A test mixture that consisted of six basic and six acidic compounds was used to study the separation behavior of five CE methods. The results showed that three methods (based on CZE, MEKC, and NACE) were suitable for the analysis of basic compounds and three methods (based on CZE and MEKC) for the analysis of acidic compounds. For the extraction of analytes from serum and urine, a solid-phase extraction (SPE) and a liquid-liquid extraction (LLE) method were compared. Both SPE and LLE methods provided clean extracts after extraction of the basic compounds from serum and urine. The extracts of acidic compounds contained more matrix interferences, especially for urine. The SPE method had some advantages compared to LLE, as it lead to cleaner extracts and higher peaks, and as it elutes basic and acidic compounds in one fraction. The potentials and pitfalls of the various methods for screening purposes in analytical toxicology are discussed.

Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate.

PURPOSE: To compare two doses of letrozole (0.5 mg and 2.5 mg every day) and megestrol acetate (40 mg qid) as endocrine therapy in postmenopausal women with advanced breast cancer previously treated with antiestrogens. PATIENTS AND METHODS: This double-blind, randomized, multicenter, multinational study enrolled 602 patients, all of whom were included in the primary analysis in the protocol. Patients had advanced or metastatic breast cancer with evidence of disease progression while receiving continuous adjuvant antiestrogen therapy, had experienced relapse within 12 months of stopping adjuvant antiestrogen therapy given for at least 6 months, or had experienced disease progression while receiving antiestrogen therapy for advanced disease. Tumors were required to be estrogen receptor- and/or progesterone receptor-positive or of unknown status. Confirmed objective response rate was the primary efficacy variable. Karnofsky Performance Status and European Organization for Research and Treatment of Cancer quality-of-life assessments were collected for 1 year. RESULTS: There were no statistically significant differences among the three treatment groups for overall objective tumor response. Patients treated with letrozole 0.5 mg had improvements in disease progression (P =.044) and a decreased risk of treatment failure (P =.018), compared with patients treated with megestrol acetate. Letrozole 0.5 mg showed a trend (P =.053) for survival benefit when compared with megestrol acetate. Megestrol acetate was more likely to produce weight gain, dyspnea, and vaginal bleeding, and the letrozole groups were more likely to experience headache, hair thinning, and diarrhea. CONCLUSION: Given a favorable tolerability profile, once-daily dosing, and evidence of clinically relevant benefit, letrozole is equivalent to megestrol acetate and should be considered for use as an alternative treatment of advanced breast cancer in postmenopausal women after treatment failure with antiestrogens.

Organisational design for an integrated oncological department.

OBJECTIVE: The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncological Department in- and outside (i.e. home care) the hospital. RESEARCH DESIGN: Comparative Qualitative Case Study. METHODS: Auditing based on care-as-usual norms by an external, experienced auditing committee. RESEARCH SETTING: Integrated Oncological Departments of three hospitals. RESULTS: Successful multidisciplinary care in an integrated, oncological department needs broad support inside the hospital and a well-defined organisational plan.

Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group.

PURPOSE: This phase III study compared docetaxel with mitomycin plus vinblastine (MV) in patients with metastatic breast cancer (MBC) progressing despite previous anthracycline-containing chemotherapy. PATIENTS AND METHODS: Patients (n=392) were randomized to receive either docetaxel 100 mg/m2 intravenously (i.v.) every 3 weeks (n=203) or mitomycin 12 mg/m2 i.v. every 6 weeks plus vinblastine 6 mg/m2 i.v. every 3 weeks (n=189), for a maximum of 10 3-week cycles. RESULTS: In an intention-to-treat analysis, docetaxel produced significantly higher response rates than MV overall (30.0% v 11.6%; P < .0001), as well as in patients with visceral involvement (30% v 11%), liver metastases (33% v 7%), or resistance to previous anthracycline agents (30% v 7%). Median time to progression (TTP) and overall survival were significantly longer with docetaxel than MV (19 v 1 weeks, P=.001, and 1 1.4 v 8.7 months, P=.0097, respectively). Neutropenia grade 3/4 was more frequent with docetaxel (93.1 % v62.5%; P < .05); thrombocytopenia grade 3/4 was more frequent with MV (12.0% v 4.1%; P < .05). Severe acute or chronic nonhematologic adverse events were infrequent in both groups. Withdrawal rates because of adverse events (MV, 10.1%; docetaxel, 13.8%) or toxic death (MV, 1.6%; docetaxel, 2.0%) were similar in both groups. Quality-of-life analysis was limited by a number of factors, but results were similar in both groups. CONCLUSION: Docetaxel is significantly superior to MV in terms of response, TTP, and survival. The safety profiles of both therapies are manageable and tolerable. Docetaxel represents a clear treatment option for patients with MBC progressing despite previous anthracycline-containing chemotherapy.

Docetaxel vs mitomycin plus vinblastine in anthracycline-resistant metastatic breast cancer.

This nonblinded, multicenter, randomized phase III study compares the median time to progression (primary endpoint), response rate, and quality of life, safety, and survival of docetaxel (Taxotere) vs mitomycin (Mutamycin) plus vinblastine (Velban) in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. Patients were randomized to receive an intravenous infusion of either 100 mg/m2 of docetaxel for 1 hour every 3 weeks, or 12 mg/m2 of mitomycin every 6 weeks plus 6 mg/m2 of vinblastine every 3 weeks. This preliminary analysis presents data on 200 patients among 392 patients recruited. Median time to progression was longer in the group treated with docetaxel compared with the mitomycin/vinblastine group (17 vs 9 weeks). The overall response rates were higher with docetaxel (28% vs 13%, respectively), and fewer patients in the docetaxel group had progressive disease as their best overall response (29% vs 48%). As expected, thrombocytopenia was more common in the mitomycin/vinblastine group, and neutropenia occurred more frequently in the docetaxel group. Severe fluid retention in the docetaxel group (8.7%) resulted in treatment discontinuation in 5 patients (5%). Severe thrombocytopenia (12%) and constipation (6%) led to treatment discontinuation in 7 and 3 patients, respectively, in the mitomycin/vinblastine group. Based on this preliminary analysis, docetaxel appears to be equally as safe as and more active than mitomycin/ vinblastine in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. These results are subject to cautious interpretation because this analysis was conducted on the first 200 patients who finished the study treatments, and these preliminary results may underestimate response and overstate treatment discontinuation rates. Thus, the final analysis on the entire patient population is necessary to confirm these preliminary findings.