Effect of feeding olive pomace acid oil on pork lipid composition, oxidative stability, colour, and sensory acceptance.

One of the targets of the meat industry is to reduce production costs and to increase the sustainability of the food chain, which has driven the attention towards the use of by-products as feed ingredients. Acid oils are fat by-products coming from the chemical refining process of edible oils, with a high energy value and that are approved as feed ingredients in the European Union. However, meat producers are hesitant to utilise them due to their varying composition and the limited understanding of their impact on animal performance and meat quality. The objective of this study was to evaluate the effects of using olive pomace acid oil (OPAO) instead of its corresponding crude olive pomace oil (OPO) or crude palm oil (PO) in pig diets on lipid composition, lipid oxidation and quality of pork loin (longissimus dorsi), fresh and after commercial refrigerated storage for 8 days. The experimental design consisted of feeding pigs with four diets supplemented with a 5% of PO, OPO, OPAO or a blend (B) of PO and OPAO (50:50, w/w). Fresh and refrigerated pork loin samples were assessed for fatty acid profile; tocopherol (T) and tocotrienol (T3) composition; lipid oxidative stability with the ferrous oxidation-xylenol orange method; 2-thiobarbituric acid (TBA) value; volatile compounds; colour; and sensory acceptance. Results showed that refrigeration reduced the total T + T3 levels and increased the TBA values and the volatile compound concentrations. The refrigerated storage also affected the instrumental colour parameters (L*, a* and b*) but not the overall acceptance of pork. Regarding the diet, pork from OPAO diet showed a higher unsaturated-to-saturated fatty acid ratio than pork from PO and B diets. The lowest T + T3 concentration was found in OPO and OPAO fresh pork and in OPAO refrigerated pork. The oxidative stability of fresh pork was lower for OPAO than for PO diet, but no significant effect of the diet was observed for this parameter in refrigerated pork. The TBA values and volatile compound concentrations of fresh pork were not affected by the diet. After refrigeration, OPAO pork had the highest TBA value and volatile compound concentrations. In any case, colour and consumer acceptance of pork were not affected by diet. In conclusion, in order to upcycle acid oils in pig diets, and considering results on the lipid oxidative stability of pork, it would be preferable to add the OPAO used in this study blended with PO.

Olive pomace oil and acid oil as alternative fat sources in growing-finishing broiler chicken diets.

The aim of the present study was to investigate the effect of dietary supplementation of olive pomace oil and olive pomace acid oil, which are rich in monounsaturated fatty acids (FA) but differ in free FA content, on growth performance, digestibility and FA profile of abdominal fat and breast meat. A total of 3,048 one-day-old mixed-sex broiler chickens (Ross 308) were randomly distributed into 24 pens and 3 dietary treatments (8 replicates per treatment). Experimental diets were administered for growing (from 22 to 29 d) and finishing (from 30 to 39 d) periods, consisting of a basal diet supplemented with 6% (as-fed basis) palm oil (PO), olive pomace oil (O), or olive pomace acid oil (OA). Animals fed O achieved the lowest feed conversion ratio (P < 0.01), together with the highest AME value (P = 0.003), but no differences were observed between OA and PO. Regarding FA digestibility, O and OA showed higher values than PO for all FA in both apparent ileal digestibility (AID) and apparent total tract digestibility. Comparing the AID between O and OA, no differences were observed for total FA, monounsaturated FA, or polyunsaturated FA, but animals fed OA showed lower AID values for saturated FA than those fed O (P < 0.001). The FA profile of abdominal fat and breast meat reflected that of the diet, with higher monounsaturated FA and lower saturated FA in animals fed O and OA compared to those fed PO. In sum, the inclusion of both olive pomace oil and acid oil in growing-finishing broiler chicken diets led to great performance parameters and high FA digestibility values, together with an enrichment with monounsaturated FA in abdominal fat and breast meat compared to the use of palm oil. However, a better AID of saturated FA and feed conversion ratio is achieved with O compared to OA.

Effects of free-fatty-acid content and saturation degree of the dietary oil sources on lipid-class content and fatty-acid digestibility along the gastrointestinal tract in broilers from 22 to 37 days of age.

The aim of the present study is to assess the effect of the free-fatty-acid (FFA) content and saturation degree of dietary fat (added at 6%) on the fatty-acid (FA) digestibility and lipid-class content along the gastrointestinal tract and excreta in broilers from 22 to 37 d of age. This is essential to determine the potential use of acid oils (refining by-products rich in FFA) in broiler diets as an alternative to crude oils. The study consisted of a 2 × 4 factorial arrangement, which included 2 fat sources (soybean oils - unsaturated, or palm oils - saturated) and 4 levels of FFA (5, 15, 35, and 50%). Samples of digestive content of the gizzard, duodenum, jejunum, ileum and of the excreta were obtained at 37 d of age. Irrespective of the dietary fat source, more than 80% of total FA (TFA) was absorbed in the jejunum. Broilers fed with unsaturated diets had a higher absorption efficiency of FA than did those fed with saturated diets. This conclusion is supported by the lower FFA content and the higher TFA and polyunsaturated FA (PUFA) digestibility coefficients in the ileum (P < 0.001) observed in the former group. The dietary FFA level did not affect the FA absorption process as much as the dietary fat source did. This was supported by the lack of statistical differences among the diets with a similar saturation degree but rather different levels of FFA, for TFA, saturated FA, and PUFA digestibility coefficients both in the jejunum and ileum. However, the interactions reported in the ileum for triacylglycerol and diacylglycerol contents (P < 0.001), as well as for monounsaturated FA digestibility coefficients (P < 0.05) show that the dietary FFA content affects the FA absorption process. The present results show that the inclusion of acid oils in grower-finisher broiler diets with FFA levels up to 35% does not have a negative impact on the FA absorption process.

Re-esterified palm oils, compared to native palm oil, do not alter fat absorption, postprandial lipemia or growth performance in broiler chicks.

Re-esterified palm oils are obtained from the chemical esterification of palm acid oils (rich in free fatty acids) with glycerol, both economically interesting by-products from oil refining and biodiesel industries, respectively. Thus, re-esterified palm oils could be an economically interesting alternative to native palm oil in broiler chick diets. However, because they may have different physicochemical properties than have their corresponding native oil, we assessed the effect of fatty acid (FA) positional distribution within acylglycerol molecules and the effect of acylglycerol composition on FA apparent absorption, and their possible consequences on the evolution of postprandial lipemia and growth performance in broiler chicks. Seventy-two 1-day-old female broiler chicks were randomly distributed into 18 cages. The three treatments used were the result of a basal diet supplemented with 6 wt% of native palm oil (N-TAG), re-esterified palm oil (E-TAG), or re-esterified palm oil high in mono- and diacylglycerols (E-MDAG). Chemical esterification raised the fraction of palmitic acid at the sn-2 position from 9.63 mol% in N-TAG oil to 17.9 mol% in E-TAG oil. Furthermore, E-MDAG oil presented a high proportion of mono- (23.1 wt%) and diacylglycerols (51.2 wt%), with FA mainly located at the sn-1,3 positions, which resulted in a lower gross-energy content and an increased solid-fat index at the chicken's body temperature. However, re-esterified palm oils did not alter fat absorption, postprandial lipemia, or growth performance, compared to native palm oil, so they can be used as alternative fat sources in broiler chick diets.

Association of BRCA1 germline mutations in young onset triple-negative breast cancer (TNBC).

BACKGROUND: BRCA1-associated breast cancers have been associated to a triple-negative phenotype. The prevalence of BRCA1 germline mutations in young onset TNBC based on informativeness of family history has not been reported. PATIENTS AND METHODS: From January 2008 to May 2009 were collected blood and tumor samples from patients with TNBC younger than 50 years and without a family history of breast and ovarian cancer in first- and second-degree relatives. Analysis of BRCA1 germline mutations was made. Age at diagnosis and informativeness of family history (presence of female in first- and second-degree relatives alive until age 45) was collected in all cases. Immunohistochemistry of basal-like features was performed centrally in all available tumors. RESULTS: Seven pathogenic mutations were detected in 92 patients (7.6 %), two of them in patients younger than 35 years (28.6 %) (Fisher's exact test, p = 0.631). Three non-classified variants were detected (3.2 %). Family history was informative in two patients with a pathogenic mutation (28.6 %) and not informative in five (71.4 %) (Fisher's exact test, p = 0.121). Of the seven patients with a pathogenic mutation, four had a basal-like phenotype. CONCLUSION: Patients with apparently sporadic TNBC younger than 50 years and a non-informative family history are candidates for germline genetic testing of BRCA1.

Induced cell toxicity originates dendritic cell death following magnetic hyperthermia treatment.

Magnetic hyperthermia (MH) is based on the use of magnetic nanoparticles (MNPs) to selectively increase the temperature of MNP-loaded target tissues when applying an alternating magnetic field (AMF) in the range of radiofrequency. To date, all MH research has focused on heat generation in an attempt to elucidate the mechanisms for the death of MNP-loaded cells submitted to AMF. However, recent in vitro studies have demonstrated the feasibility of inducing dramatic cell death without increasing the macroscopic temperature during AMF exposure. Here, we show that the cell death observed following AMF exposure, specifically that of MNP-loaded dendritic cells (DCs) in culture, was caused by the release of toxic agents into the cell culture supernatants and not due to a macroscopic temperature increase. We performed MH in vitro experiments to demonstrate that the supernatant of the cell culture following AMF exposure was highly toxic when added to control unloaded DCs, as this treatment led to nearly 100% cell death. Therefore, our results demonstrate that heat is not the only agent responsible for triggering cell death following MH treatment. This finding offers new perspectives for the use of DCs as the proverbial Trojan horse to vectorise MNPs to the target tumour area and these results further support the use of DCs as therapeutic agents against cancer when submitted to AMF. Furthermore, this discovery may help in understanding the mechanism of cell death mediated by exposure to AMF.

Geographical provenance of palm oil by fatty acid and volatile compound fingerprinting techniques.

Analytical methods are required in addition to administrative controls to verify the geographical origin of vegetable oils such as palm oil in an objective manner. In this study the application of fatty acid and volatile organic compound fingerprinting in combination with chemometrics have been applied to verify the geographical origin of crude palm oil (continental scale). For this purpose 94 crude palm oil samples were collected from South East Asia (55), South America (11) and Africa (28). Partial least squares discriminant analysis (PLS-DA) was used to develop a hierarchical classification model by combining two consecutive binary PLS-DA models. First, a PLS-DA model was built to distinguish South East Asian from non-South East Asian palm oil samples. Then a second model was developed, only for the non-Asian samples, to discriminate African from South American crude palm oil. Models were externally validated by using them to predict the identity of new authentic samples. The fatty acid fingerprinting model revealed three misclassified samples. The volatile compound fingerprinting models showed an 88%, 100% and 100% accuracy for the South East Asian, African and American class, respectively. The verification of the geographical origin of crude palm oil is feasible by fatty acid and volatile compound fingerprinting. Further research is required to further validate the approach and to increase its spatial specificity to country/province scale.

Use of palm-oil by-products in chicken and rabbit feeds: effect on the fatty acid and tocol composition of meat, liver and plasma.

This study was undertaken in the framework of a larger European project dealing with the characterization of fat co- and by-products from the food chain, available for feed uses. In this study, we compare the effects, on the fatty acid (FA) and tocol composition of chicken and rabbit tissues, of the addition to feeds of a palm fatty acid distillate, very low in trans fatty acids (TFA), and two levels of the corresponding hydrogenated by-product, containing intermediate and high levels of TFA. Thus, the experimental design included three treatments, formulated for each species, containing the three levels of TFA defined above. Obviously, due to the use of hydrogenated fats, the levels of saturated fatty acids (SFA) show clear differences between the three dietary treatments. The results show that diets high in TFA (76 g/kg fat) compared with those low in TFA (4.4 g/kg fat) led to a lower content of tocopherols and tocotrienols in tissues, although these differences were not always statistically significant, and show a different pattern for rabbit and chicken. The TFA content in meat, liver and plasma increased from low-to-high TFA feeds in both chicken and rabbit. However, the transfer ratios from feed were not proportional to the TFA levels in feeds, reflecting certain differences according to the animal species. Moreover, feeds containing fats higher in TFA induced significant changes in tissue SFA, monounsaturated fatty acids and polyunsaturated fatty acids composition, but different patterns can be described for chicken and rabbit and for each type of tissue.

Cell death induced by the application of alternating magnetic fields to nanoparticle-loaded dendritic cells.

In this work, the capability of primary, monocyte-derived dendritic cells (DCs) to uptake iron oxide magnetic nanoparticles (MNPs) is assessed and a strategy to induce selective cell death in these MNP-loaded DCs using external alternating magnetic fields (AMFs) is reported. No significant decrease in the cell viability of MNP-loaded DCs, compared to the control samples, was observed after five days of culture. The number of MNPs incorporated into the cytoplasm was measured by magnetometry, which confirmed that 1-5 pg of the particles were uploaded per cell. The intracellular distribution of these MNPs, assessed by transmission electron microscopy, was found to be primarily inside the endosomic structures. These cells were then subjected to an AMF for 30 min and the viability of the blank DCs (i.e. without MNPs), which were used as control samples, remained essentially unaffected. However, a remarkable decrease of viability from approximately 90% to 2-5% of DCs previously loaded with MNPs was observed after the same 30 min exposure to an AMF. The same results were obtained using MNPs having either positive (NH(2)(+)) or negative (COOH(-)) surface functional groups. In spite of the massive cell death induced by application of AMF to MNP-loaded DCs, the number of incorporated magnetic particles did not raise the temperature of the cell culture. Clear morphological changes at the cell structure after magnetic field application were observed using scanning electron microscopy. Therefore, local damage produced by the MNPs could be the main mechanism for the selective cell death of MNP-loaded DCs under an AMF. Based on the ability of these cells to evade the reticuloendothelial system, these complexes combined with an AMF should be considered as a potentially powerful tool for tumour therapy.

Dendritic cell uptake of iron-based magnetic nanoparticles.

We have investigated the internalization of magnetic nanoparticles (NPs) into dendritic cells (DCs) in order to assess both the final location of the particles and the viability of the cultured cells. The particles, consisting of a metallic iron core covered with carbon, showed no toxic effects on the DCs and had no effect in their viability. We found that mature DCs are able to incorporate magnetic nanoparticles in a range of size from 10 nm to ca. 200 nm, after 24 h of incubation. We describe a method to separate cells loaded with NPs, and analyze the resulting material by electron microscopy and magnetic measurements. It is found that NPs are internalized in lysosomes, providing a large magnetic signal. Our results suggest that loading DCs with properly functionalized magnetic NPs could be a promising strategy for improved vectorization in cancer diagnosis and treatment.

Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG.

BACKGROUND: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil+adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm. PATIENTS AND METHODS: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan-Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial. RESULTS: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P=0.87) or OS (hazards ratio: 0.98, P=0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively. CONCLUSION: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.

[Surveillance of commensal flora evolution and infections in neutropenic cancer patients submitted to chemoprophylaxis]. / Vigilancia de la evolución de la flora comensal y de las infecciones en pacientes oncológicos con neutropenia sometidos a quimioprofilaxis.

The evolution of the flora and its resistance to different antimicrobials in neutropenic patients submitted to high-dose chemotherapy with autologous blood stem-cell transplantation, and the relation of these findings to the etiology of the infections the patients developed was studied in order to evaluate the suitability of the chemoprophylaxis and the empirical antibiotic therapy used. Forty-one patients were analyzed in a period of 28 months. The chemoprophylaxis used was levofloxacin, fluconazole and acyclovir. The empirical sequential treatment was an initial administration of cefepime, followed by teicoplanin and amikacin. Cultures were done of nasal and pharyngeal smears, Hickman catheter and stools, 1 day before chemoprophylaxis started and then on days 5 and 9. In the case of fever, three sets of blood cultures and urine cultures were done and samples from areas related to the clinical condition were analyzed. Levofloxacin induced the selection of resistant strains or species in the flora and in the infectious agents. Fluconazole also selected resistant species in the flora. Seventeen infections were documented in eleven patients, produced by Gram-positive bacteria in thirteen cases (81.25%) and by Gram-negative bacteria in three (18.75%). The coagulase negative staphylococci and Enterococcus faecalis were the most frequent agents of infection. We identified on nine occasions the same microorganism in the flora and in the pathological product; this suggests its endogenous origin and supports the use of prospective cultures of the flora, monitoring the sensibility of the microorganisms isolated to the antimicrobials used in chemoprophylaxis and empirical treatment.

High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial.

BACKGROUND: The purpose of this study was to assess whether a short course of anthracycline containing chemotherapy followed by high dose therapy with autologous stem-cell support improves disease-free and overall survival as compared with conventional, anthracycline containing chemotherapy, in patients with primary breast cancer and four or more histologically involved lymph nodes. PATIENTS AND METHODS: Two hundred and eighty one patients entered into a randomised clinical trial were allocated to receive standard, conventional treatment (5-fluorouracil, epirubicin and cyclophosphamide-FEC for six cycles) or FEC for three cycles followed by high dose therapy consisting of cyclophosphamide, thiotepa and carboplatin and stem cell rescue (HDT). To be eligible, patients had to be free of overt metastatic disease and be < or =60 years of age. Analyses were according to intention to treat. RESULTS: At a median follow up of 68 months, 118 patients have experienced a relapse or death from breast cancer (62 in the FEC followed by HDT arm and 56 in the conventional FEC arm) and a total of 100 patients have died (54 in the FEC followed by HDT arm and 46 in the conventional FEC arm). No significant difference was observed in relapse-free survival [hazard ratio 1.06, 95% CI 0.74-1.52, p = 0.76] or overall survival [hazard ratio 1.18, 95% CI 0.80-1.75, p = 0.40]. Five patients died from treatment related causes, three as a consequence of HDT and two in the conventional FEC arm. CONCLUSIONS: At the present time, no benefit has been observed from replacing three cycles of conventional chemotherapy with the HDT regimen described here. Patients should continue to receive conventional chemotherapy as adjuvant therapy for breast cancer.

Effect of dietary fish oil, alpha-tocopheryl acetate, and zinc supplementation on the composition and consumer acceptability of chicken meat.

A factorial design was used to study the effect of dietary fish oil (1.25% and 2.5%), all-rac-alpha-tocopheryl acetate (70 and 140 mg/kg), and Zn supplementation (0 and 200 mg/kg) on the composition and consumer acceptability of chicken meat stored at -20 degrees C for 5 mo. Supplementation of the diet with all-rac-alpha-tocopheryl acetate increased the alpha-tocopherol content in meat. The fatty acid composition of the meat was affected only by the amount of fish oil. Diets supplied with 2.5% fish oil produced meat with an eicosapentaenoic and docosahexaenoic acid content double that of diets supplied with 1.25% fish oil. Zn supplementation did not affect the content of this mineral in the meat. Moreover, the consumer acceptability of meat samples showed no significant differences between dietary treatments after 5 mo of storage at -20 degrees C or with respect to a freshly cooked commercial sample used as a blind control.

Epirubicin-cyclophosphamide adjuvant chemotherapy plus tamoxifen administered concurrently versus sequentially: randomized phase III trial in postmenopausal node-positive breast cancer patients. A GEICAM 9401 study.

BACKGROUND: A prospective randomized clinical trial was implemented to assess whether the concomitant or the sequential addition of tamoxifen to chemotherapy provides improved clinical benefit in the adjuvant treatment of breast cancer in postmenopausal patients. PATIENTS AND METHODS: Four-hundred and eighty-five patients with node-positive operable disease were randomized to receive tamoxifen (20 mg/day) concomitantly (CON) or sequentially (SEQ) to EC chemotherapy (epirubicin 75 mg/m(2) + cyclophosphamide 600 mg/m(2) on day 1, every 21 days for four cycles). RESULTS: In the 474 fully evaluable patients there were 96 events; eight being second neoplasms and 88 being related to the breast cancer. Of these, 48 of 88 occurred in the CON arm and 40 of 88 in the SEQ arm. The Kaplan-Meier estimation of disease-free survival (DFS) at 5 years was 70% in the CON and 75% in the SEQ group (log-rank test, P = 0.43). Adjusted hazard ratio for treatment was 1.11 (95% confidence interval 0.71-1.73; P = 0.64). CONCLUSION: This study fails to show an advantage of one treatment arm over the other, but a trend, albeit non-significant, appears to favor the sequential addition of tamoxifen to epirubicin + cyclophosphamide and, as such, warrants further investigation.

[Study of cancer-associated asthenia: foundation of the ASTHENOS group]. / Estudio de la astenia tumoral: constitución del grupo ASTHENOS.

Asthenia in cancer patients is a highly controversial subject. A distinct definition of asthenia in medical literature is lacking as well as its prevalence and incidence. Also, no simple tools for its diagnosis are available. Moreover its etiopathogenesis is complex and multifactorial, thereby making therapeutic approaches difficult. Recently, a Spanish group has been set up for the study and treatment of asthenia in cancer patients. This paper reports on its establishment, objectives and first conclusions.

Phase I trial of weekly irinotecan combined with UFT as second-line treatment for advanced colorectal cancer.

The aim of this study was to determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly Irinotecan (CPT-11) plus UFT, and to assess the antitumour activity of this combination as second-line chemotherapy in patients with advanced colorectal carcinoma, 31 patients with measurable advanced colorectal carcinoma were treated. Cohorts of 3 patients received increasing dose levels of the combination. Levels 1 to 4 included a fixed dose of oral (p.o.) UFT (250 mg/m(2)/day) for 21 days of a 28-day cycle combined with increasing intravenous (i.v.) doses of CPT-11 (80, 100, 110 and 120 mg/m(2)) on days 1, 8 and 15. Levels 5 and 6 included a higher fixed dose of oral UFT (300 mg/m(2)) combined with increasing i.v. doses of CPT-11 (100 and 110 mg/m(2)) on days 1, 8 and 15. 147 courses were administered. MTD were reached at level 4 (2 cases of grade 4 diarrhoea and 1 grade 3 asthenia), and level 6 (1 grade 4 diarrhoea, 1 grade 3 diarrhoea and 1 grade 3 febrile neutropenia). Responses in 30 evaluable patients were: 3 partial responses (10%), 15 stable disease (50%) and progressive disease in 12 patients (40%). Median time to progression was 4.5 months (95% Confidence Interval (CI): 3.4-6.6 months) and median survival was 11 months (95% CI: 7.9-14.1 months). The recommended doses for phase II trials are: (a) CPT-11 110 mg/m(2) i.v. on days 1, 8 and 15 every 28 days plus UFT 250 mg/m(2) p.o. on days 1 through to 21 or (b) CPT-11 100 mg/m(2) and UFT 300 mg/m(2).

Combination chemotherapy with docetaxel plus vinorelbine in metastatic breast cancer patients with prior exposure to anthracyclines.

PURPOSE: To evaluate the anti-tumor activity and tolerance of docetaxel plus vinorelbine in metastatic breast cancer (MBC) patients previously treated with anthracyclines. PATIENTS AND METHODS: Fifty patients with MBC were treated with docetaxel 75 mg/m2 (subsequently reduced to 60 mg/m2) plus vinorelbine 30 mg/m2 (subsequently reduced to 24 mg/m2). both on day 1, every 3 weeks, for a maximum of six cycles. All patients had previously received anthracyclines as adjuvant treatment (< 12 months disease-free interval) or first-line therapy for MBC. Thirty-seven patients had received at least one prior regimen for MBC. Twenty-five patients had prior high-dose chemotherapy with stem-cell rescue. Thirty patients had multiple metastatic sites. Liver and lung disease were the predominant metastatic site in 31 patients. RESULTS: Forty-nine patients were assessable for response. Nineteen patients achieved a partial response and four a complete response (overall response rate, 46%; 95% confidence interval (95% CI): 32%-60%). Fourteen patients (28%) had stable disease on treatment. Median Kaplan-Meier estimated progression-free and duration of response times are 21 and 29 weeks. Median survival time is 47 weeks. Hematological dose-limiting toxicity, prompted a 20% dose reduction for both drugs after the first thirteen patients were treated. Neutropenia > or = grade 3 occurred in nineteen (34%) patients, neutropenic fever in 15 (7) courses, and mucositis > or = grade 3 in 6 (3%) courses. CONCLUSIONS: The combination of docetaxel plus vinorelbine on day 1 every 3 weeks is feasible and active in MBC patients with prior anthracycline exposure. This regimen is safe, well-tolerated and convenient for the patients.