Clinical-radiomic model in advanced kidney cancer predicts response to tyrosine kinase inhibitors.

Renal cancer has a global incidence and mortality of 2.2 and 1.8%, respectively. Up to 30% of these patients are intrinsically resistant to tyrosine kinase inhibitors (TKI). The National Comprehensive Cancer Network guidelines do not include any predictive factors regarding response to systemic therapy with TKI in recurrent and advanced diseases. The present study aimed to explore whether a model based on radiomics could predict treatment response in patients with advanced kidney cancer treated with TKIs. The current study included 62 patients with advanced kidney cancer (stages 3 and 4) that underwent a CT scan in the arterial phase from March 2016 to November 2020. Texture analysis was run on the largest cross-sectional area of the primary tumor from each CT scan. A total of three different models were built from radiomics features and clinical data to analyze them by logistic regression and determine whether they correlated with the response to TKI. A receiver operating characteristic curve analysis was performed in each model to calculate the area under the curve (AUC) and the 95% confidence interval (CI). Significant radiomics features and clinical variables were identified and then a clinical model was created (AUC=0.90; sensitivity 75%; specificity 82.35%; CI 95%, 0.78-1.00), a radiomic model (AUC=0.66; sensitivity 16.67%; specificity 89.47%, CI 95%, 0.45-0.87) and a combined model (AUC=0.94; sensitivity 83.33%; specificity 94.12%; CI 95%, 0.84-1.00). Overall, models based on clinical data and radiomics could anticipate response to systemic therapy with TKI in patients with advanced kidney cancer.

Steroid 5 alpha-reductase 2 enzyme variants, biomass exposure and tobacco use in Mexican patients with prostate cancer.

The presence of the genetic variants of the steroid 5-alpha reductase 2 enzyme, which is encoded by the SRD5A2 gene, has been associated with an increased risk of developing prostate cancer among certain ethnic groups. However, these molecular studies have not been conducted on the Mexican population. The analysis of the genetic variants, rs9282858 and rs523349, was performed in 101 males with prostate cancer and 100 healthy controls classified as males without prostate abnormalities (n=60) and males with benign prostatic hyperplasia (n=40), to identify a probable association with this cancer type in the Northeast Mexican population. An association was identified between prostate cancer and biomass exposure [P=0.012; odds ratio (OR), 2.89; confidence interval (CI)=1.21-6.88] and tobacco use (P=0.028; OR=1.88; CI=1.07-3.31), while no association was observed between cancer development and the rs9282858 variant, or between a protective effect and the rs523349 variant. Notably, an association was identified between rs523349 and biomass exposure (P=0.013, OR=3.17; CI=1.23-8.17 for the G risk allele, and OR=0.32, CI=0.12-0.81 for the C protective allele) using the dominant genetic model. To the best of our knowledge, the present study was the first of its type to investigate the Mexican population with prostate cancer.

Adjuvant Radiation Therapy After Radical Nephrectomy in Patients with Localized Renal Cell Carcinoma: A Systematic Review and Meta-analysis.

CONTEXT: Adjuvant radiation therapy has been recommended for patients at higher risk of relapse from renal cell carcinoma (RCC) to improve disease-free survival (DFS) and overall survival (OS) after radical nephrectomy. OBJECTIVE: To quantify the benefit of adjuvant radiation therapy. EVIDENCE ACQUISITION: A systematic review of electronic databases identified publications exploring the association between adjuvant radiation therapy and locoregional recurrence (LRR), DFS, and OS among patients after radical nephrectomy for early-stage RCC. Hazard ratios for DFS were weighted and pooled using the generic inverse variance and random effects model. Odds ratios for LRR, DFS, and OS at 5yr were weighted and pooled in a meta-analysis using Mantel-Haenszel random-effects modeling. EVIDENCE SYNTHESIS: Twelve studies comprising 1624 patients were included in the analysis. Ten studies were retrospective and two were randomized controlled trials. Adjuvant radiation therapy was delivered to 37% of patients. The median follow-up was 49mo. Adjuvant radiation therapy was not associated with better DFS or OS at 5yr, but was associated with less LRR. CONCLUSIONS: With the caveat that confounding by indication may result from pooling data from predominantly nonrandomized studies, adjuvant radiation after radical nephrectomy was not associated with improved DFS or OS but was associated with less LRR. PATIENT SUMMARY: Radiation therapy after resection of renal cell carcinoma with a high risk of relapse may reduce the risk of local recurrence but not the risk of disease recurrence or death after 5yr.

Analysis of the pathogenic variants of BRCA1 and BRCA2 using next-generation sequencing in women with familial breast cancer: a case-control study.

BACKGROUND: Pathogenic variants (PVs) of BRCA genes entail a lifetime risk of developing breast cancer in 50-85% of carriers. Their prevalence in different populations has been previously reported. However, there is scarce information regarding the most common PVs of these genes in Latin-Americans. This study identified BRCA1 and BRCA2 PV frequency in a high-risk female population from Northeastern Mexico and determined the association of these mutations with the patients' clinical and pathological characteristics. METHODS: Women were divided into three groups: aged ≤ 40 years at diagnosis and/or risk factors for hereditary breast cancer (n = 101), aged > 50 years with sporadic breast cancer (n = 22), and healthy women (n = 72). Their DNA was obtained from peripheral blood samples and the variants were examined by next-generation sequencing with Ion AmpliSeq BRCA1 and BRCA2 Panel using next-generation sequencing. RESULTS: PVs were detected in 13.8% group 1 patients (BRCA1, 12 patients; BRCA2, 2 patients). Only two patients in group 2 and none in group 3 exhibited BRCA1 PVs. Variants of uncertain significance were reported in 15.8% patients (n = 16). In group 1, patients with the triple-negative subtype, PV frequency was 40% (12/30). Breast cancer prevalence in young women examined in this study was higher than that reported by the National Cancer Institute Surveillance, Epidemiology (15.5% vs. 5.5%, respectively). CONCLUSIONS: The detected BRCA1 and BRCA2 PV frequency was similar to that reported in other populations. Our results indicate that clinical data should be evaluated before genetic testing and highly recommend genetic testing in patients with the triple-negative subtype and other clinical aspects.

National Clinical Practice Guidelines for the management of non-small cell lung cancer in early, locally advanced and metastatic stages. Extended version. / Guía de Práctica Clínica Nacional para el manejo del cáncer de pulmón de células no pequeñas en estadios tempranos, localmente avanzados y metastásicos.

OBJECTIVE: Lung cancer is one the leading causes of mortality worldwide. Symptomatic manifestations of the disease generally occur in the advanced-stage setting, and therefore an important number of patients have advanced or metastatic disease by the time they are diagnosed. This situation contributes to a poor prognosis in the treatment of lung cancer. Evidencebased clinical recommendations are of great value to support decision-making for daily practice, and thus improving health care quality and patient outcomes. MATERIALS AND METHODS: This document was an initiative of the Mexican Society of Oncology (SMEO) in collaboration with Mexican Center of Clinical Excellence (Cenetec) according to Interna- tional Standards. Such standards included those described by the IOM, NICE, SIGN and GI-N. An interdisciplinary Guideline Development Group (GDG) was put together which included medical oncologists, surgical oncologistsc, radiation therapists, and methodologists with expertise in critical appraisal, sys- tematic reviews and clinical practice guidelines development. RESULTS: 62 clinical questions were agreed among members of the GDG. With the evidence identified from systematic reviews, the GDG developed clinical recommendations using a Modified Delphi Panel technique. Patients' representatives validated them. CONCLUSIONS: These Clinical Practice Guideline aims to support the shared decision-making process for patients with different stages of non-small cell lung cancer. Our goal is to improve health-care quality on these patients.

OBJETIVO: El cáncer de pulmón es una de las principales causas de mortalidad alrededor del mundo. Su historia natural, con la manifestación de síntomas en etapas avanzadas y el retraso en su diagnóstico hacen que una gran proporción de pacientes se diagnostiquen en estadios tardíos de la enfermedad, lo que hace muy complicado el tratamiento exitoso de la misma. De esto deriva la importancia de dar origen a recomendaciones basadas en evidencia para soportar la toma de decisiones clínicas por parte de los grupos interdisicplinarios que se encargan del manejo de este padecimiento. MATERIAL Y MÉTODOS: Este documento se desarrolló por parte de la Sociedad Mexicana de Oncología en colaboración con el Centro Nacional de Excelencia Tec- nológica de México (Cenetec) a través de la dirección de integración de Guías de Práctica Clínica en cumplimiento a estándares internacionales como los descritos por el Ins- tituto de Medicina de EUA (IOM, por sus siglas en inglés), el Instituto de Excelencia Clínica de Gran Bretaña (NICE, por sus siglas en inglés), la Red Colegiada para el Desarrollo de Guías de Escocia (SIGN, por sus siglas en inglés), la Red Internacional de Guías (G-I-N, por sus siglas en inglés); entre otros. Se integró en representación de la Sociedad Mexicana de Oncología un Grupo de Desarrollo de la Guía (GDG) de manera interdisciplinaria, considerando oncólogos médicos, cirujanos oncólogos, cirujanos de tórax, radio-oncólogos, y metodólogos con experiencia en revisiones sistemáticas de la literatura y guías de práctica clínica. RESULTADOS: Se consensuaron 62 preguntas cllínicas que abarcaron lo establecido previamente por el GDG en el documento de alcances de la Guía. Se identificó la evidencia científica que responde a cada una de estas preguntas clínicas y se evaluó críticamente la misma, antes de ser incorporada en el cuerpo de evidencia de la Guía. El GDG acordó mediante la técnica de consenso formal de expertos Panel Delphi la redacción final de las recomendaciones clínicas. C. CONCLUSIONES: Esta Guía de Práctica Clínica pretende proveer recomendaciones clínicas para el manejo de los distintos estadios de la enfermedad y que asistan en el proceso de toma de decisiones compartida. El GDG espera que esta guía contribuya a mejorar la calidad de la atención clínica en las pacientes con cáncer de pulmón de células no pequeñas.

PD-L1 expression and clinical outcomes in patients with advanced urothelial carcinoma treated with checkpoint inhibitors: A meta-analysis.

CONTEXT: Five checkpoint inhibitors have been approved as 1st line (cisplatin-ineligible) or 2nd line therapies for patients with metastatic urothelial carcinoma of the bladder. As only about 30% of patients respond, the need for a biomarker for patient selection exists. OBJECTIVE: To determine if PD-L1 expression is a prognostic factor of objective response rate (ORR) and overall survival (OS) in patients with urothelial carcinoma being treated with checkpoint inhibitors. EVIDENCE ACQUISITION: A search of PubMed and major conference proceedings identified trials of PD-L1 inhibitors as first- or second-line therapies for metastatic bladder cancer. Odds ratios (OR) for ORR and OS compared PD-L1 positive and PD-L1 negative patients. Data were weighted and pooled in a meta-analysis, and subgroup analyses compared PD-L1 status cut-offs. EVIDENCE SYNTHESIS: Ten studies comprising 2755 patients were identified, of which 2030 patients (74%) received immune checkpoint inhibitors. Eight studies were eligible for ORR analysis (1530 patients) and five studies for OS (829 patients). PD-L1 patients had a significantly higher ORR than PD-L1 negative patients (1.82, 95%CI 1.18-2.77; p = 0.007). Weighted mean OS was 11.5 months (range 8.7-15.9 months). PD-L1 status was not prognostic for 12 month OS (OR = 0.81, 95%CI 0.47-1.40; p = 0.45). CONCLUSION: In patients treated with PD-L1 inhibitors for metastatic urothelial carcinoma, PD-L1 status is prognostic for ORR but not OS. Our findings warrant additional investigation. PATIENT SUMMARY: Five immunotherapy drugs are approved for bladder cancer therapy. PD-L1 expression predicts higher ORR but not OS. More data is needed to identify the patient population most benefitted by immunotherapy.

Cardiac Tamponade as an Initial Manifestation of Cervical Cancer.

Cervical cancer is the second most common malignancy worldwide in women and the third most common cause of cancer death in developing countries. This type of cancer spreads mainly to the lung, the bone, and the brain; however, the pericardium is an unusual site of invasion, which is associated with a poor prognosis. We present a case of a 35-year-old woman with six months of leg edema and abnormal uterine bleeding. During the initial evaluation, cardiac tamponade and a bilateral pleural effusion were found. A left supraclavicular lymphadenopathy was identified on physical examination, while gynecological examination and MRI were irrelevant. Initial cytology of the pericardial fluid showed a poorly differentiated carcinoma, and a cervical biopsy revealed a squamous cell invasive carcinoma. Chemotherapy was started with carboplatin and paclitaxel, but no clinical improvement was noted and the patient died 46 days after arrival. Cardiac tamponade in a young female patient is a harbinger to widen the differential diagnosis to include not only infectious, cardiac, or metabolic etiology but also oncological causes since this will allow appropriate treatment.

Choriocarcinoma Syndrome as an Initial Presentation of Testicular Cancer.

Choriocarcinoma syndrome (CS) is a rare clinical entity within the spectrum of nonseminomatous germ-cell tumors (NSGCT). It is characterized by the abrupt establishment of rapidly progressive and hemorrhagic tumors associated with very high levels of the beta fraction of human chorionic gonadotropin (ß-hCG) and with a very poor prognosis, particularly in patients with ß-hCG values above 50,000 IU/L. We present the case of a 17-year-old man with a sudden onset nonmassive hemoptysis. Physical examination revealed a right testicular mass. Imaging studies showed metastatic lung, bone, and retroperitoneal disease. ß-hCG serum levels were 222,493.21 IU/L, AFP 1.56 ng/mL, and DHL 457 IU/L. Histopathological study after right radical orchiectomy showed a mixed germ-cell tumor. Based on poor-risk characteristics, chemotherapy was started with an adequate clinical response. Physicians should be aware of the potential complications of CS in the treatment of testicular cancer with high ß-hCG levels since they could be associated with a rapidly progressive and high-volume disease. Patients in this category should be referred to the centers experienced in the treatment of advanced germ-cell tumors. Due to the severity of the presentation, hemodynamic monitoring, ideally in an intensive care unit, is essential as well as timely administration of cytotoxic treatment.

Malignant Spinal Cord Compression Syndrome as an Initial Presentation of Testicular Cancer.

Malignant spinal cord compression syndrome (MSCCS) occurs in 2.5 to 5% of all oncological patients. In 20% of the cases, it is the initial manifestation. This syndrome is a rare event among germ cell tumors (GCT), occurring in only 1.7% of the patients. We present the case of a 24-year-old man who arrived at the emergency department with dysesthesia and paraparesis as well as urinary incontinence. Imaging studies showed an infiltrative lesion in the left testicle, pulmonary and hepatic metastatic disease, and a large retroperitoneal ganglionar conglomerate that infiltrated the spinal cord through the intervertebral foramina of the vertebra level T11 with displacement of the L1 vertebral body. A postoperative biopsy showed a pure embryonal carcinoma. In the initial approach of a young man who presents spinal cord compression, the presence of MSCCS associated with GCT should be considered as a possible cause. A high level of suspicion is required to achieve a timely diagnosis, to grant the patient the best possible outcome.

Epidermal growth factor receptor overexpression and outcomes in early breast cancer: A systematic review and a meta-analysis.

BACKGROUND: The epidermal growth factor receptor (EGFR) is a member of the ErbB family of membrane tyrosine-kinase receptors. Studies exploring the prognostic role of EGFR-overexpression in early breast cancer have shown variable results, and the true prognostic value of EGFR is unknown. METHODS: A systematic review of identified publications exploring the association between EGFR-overexpression (as defined from different techniques and cut-offs) and outcomes [disease-free (DFS) and, overall survival (OS)] in women with early breast cancer. The hazard ratios (HR) for DFS and OS were weighted and pooled in a meta-analysis using generic inverse variance and random effects modeling. RESULTS: Fifty-three studies comprising 21,418 women were included. EGFR-overexpression was found in 27% of the patients. Primary analysis included studies reporting HRs from multivariable analyses (10 studies including 4857 patients with HRs for OS and 17 studies comprising 8747 patients with HRs for DFS), EGFR-overexpression was associated with worse OS (HR 1.98, 95% CI: 1.59-2.47, p < .001) and DFS (HR 1.59, 95% CI 1.30-1.95, p < .001). The influence of EGFR overexpression on DFS was greater in women with triple negative tumors compared to women with non-triple negative tumors (HR 2.35 versus HR 1.45, respectively; p = .01). Analysis looking at odd ratios for both 5-year and 10-year for DFS and OS showed similar results. CONCLUSION: EGFR-overexpression appears to be associated with reduced OS and DFS in women with early breast cancer. Patients with triple negative and EGFR-overexpression have poorer OS and DFS than those with triple negative tumors and normal EGFR expression.

Testicular Cancer Presenting as Gastric Variceal Hemorrhage.

Testicular cancer is the most common solid malignancy affecting males between the ages of 15 and 35. The symptomatology caused by this tumor varies according to the site of metastasis. We present the case of a 26-year-old male who arrived to the emergency department with hematemesis. He had no previous medical history. On arrival, we noted enlargement of the left scrotal sac. There was also a mass in the left scrotum which provoked displacement of the penis and right testis. The serum alpha-fetoprotein level was 17,090 ng/mL, lactate dehydrogenase was 1480 U/L, and human chorionic gonadotropin was 287.4 IU/mL. Upper endoscopy revealed a type 1 isolated gastric varix, treated with cyanoacrylate. A CT scan showed extrinsic compression of the portal vein by lymphadenopathy along with splenic vein partial thrombosis, which caused left-sided portal hypertension. Neoadjuvant chemotherapy was started with etoposide and cisplatin, and seven days later the patient underwent left radical orchiectomy. A postoperative biopsy revealed a pure testicular teratoma. Noncirrhotic left portal hypertension with bleeding from an isolated gastric varix secondary to metastasic testicular cancer has not been described before. Clinicians must consider the possibility of malignancy in the differential diagnosis of a young man presenting with unexplained gastrointestinal bleeding.

Prognostic role of Ki-67 score in localized prostate cancer: A systematic review and meta-analysis.

BACKGROUND: Ki-67 for quantifying tumor proliferation is widely used. In localized prostate cancer (PCa), despite a suggested predictive role of Ki-67 for outcomes after therapies, it has not been incorporated into clinical practice. Herein, we conduct a systematic review and meta-analysis of the literature reporting the association of Ki-67 and disease outcomes in PCa treated radically. METHODS: Medline and EMBASE databases were searched without date or language restrictions, using "KI67" and "prostate cancer" MeSH terms. Studies reporting Ki-67 association with clinical outcomes (disease-free survival [DFS], biochemical failure-free survival, rate of distant metastases [DM], disease-specific survival [DSS], or overall survival [OS], or all of these) in patients with PCa managed actively were included, and relevant data extracted by 2 independent reviewers. Odds ratios (OR) were weighted and pooled in a meta-analysis using Mantel-Haenszel random-effect modeling. RESULTS: Twenty-one studies comprising 5,419 patients met eligibility for analysis, and 67.6% of patients had low Ki-67. Mean Ki-67 was 6.14%. High Ki-67 was strongly associated with worse clinical outcomes. DFS was better in those patients with low Ki-67 at 5 and 10 years (OR = 0.32, 95% CI: 0.23-0.44, P<0.00001; OR = 0.31, 95% CI: 0.20-0.48, P<0.00001). Similarly, low Ki-67 was related to improved DSS at 5 and 10 years (OR = 0.15, 95% CI: 0.10-0.21, P<0.00001; OR = 0.16, 95% CI: 0.06-0.40, P<0.00001). Association between low Ki-67 scores with improved OS (OR = 0.47; 95% CI: 0.37-0.61; P<0.00001) and high Ki-67 scores with DM at 5 years (OR = 4.07; 95% CI: 2.52-6.58; P<0.00001) was consistently observed. CONCLUSIONS: High Ki-67 expression in localized PCa is a factor of poor prognosis for DSS, biochemical failure-free survival, DFS, DM, and OS after curative-intent treatments. Incorporation into clinical routine of this widely available and standardized biomarker should be strongly considered.

Myocardial ischemia as presenting manifestation of IgG4-related disease: a case-based review.

Coronary involvement in IgG4-related disease (IgG4-RD) has been scarcely reported, and myocardial ischemia as its presenting feature is even rarer. Here, we describe an additional case with novel and relevant observations. The patient was a previously healthy, middle-aged woman who presented to the clinic with new-onset typical angina. One tumefactive lesion encasing the left anterior descending artery was found during her workup. The most common underlying malignancies with secondary cardiac involvement were rationally ruled out. Symptoms persisted despite medical treatment, and she was therefore referred to surgery. Tumor excision was successfully performed, and she received coronary bypass grafting. IgG4-related coronary arteritis with pseudotumor formation was subsequently diagnosed following the comprehensive diagnostic criteria. This condition was clinically classified as active and circulating plasmablasts were found to be increased (5480/mL), even when these were determined 38 days after surgery. A PET/CT revealed an additional hypermetabolic lymph node. She was therefore treated with rituximab as induction therapy (two 1000 mg doses, administered 15 days apart). Three months later, her disease remained clinically inactive. Circulating plasmablasts were repeated and these had dropped to 0/mL. We thereafter review the current and pertinent literature on the topic, emphasizing the previous cases with similar presenting features (n = 7). We lastly suggest that IgG4-RD should be part of the differential diagnosis of any patient with tumefactive lesions surrounding the coronary arteries, since it can initially presented as sudden cardiac death.

Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma.

BACKGROUND: Sunitinib at 50 mg/day on the 4-weeks-on-2-weeks-off schedule is the current approved regimen for advanced/metastatic renal cell carcinoma (mRCC). Escudier et al reported that continuous, once-daily dosing with sunitinib 37.5 mg had a manageable safety profile and significant antitumor activity as second-line mRCC therapy. In this prospective, multicenter, phase II study, we evaluated the activity of continuous once-daily dosing with sunitinib 37.5 mg as first-line mRCC treatment. METHODS: One hundred nineteen treatment-naive patients with measurable mRCC received sunitinib. The primary endpoint was objective response; secondary endpoints included progression-free survival (PFS), safety, pharmacokinetic measurements, exploration of response biomarkers, and patient reported outcomes (PRO). RESULTS: Objective response rate (ORR) was 35.3%; median response duration was 10.4 months; 36% of patients had stable disease ≥12 weeks. Median PFS at 1 year was 9 months, and 1-year survival probability was 67.8%. The most common any-grade treatment-related adverse events (AEs) were diarrhea (50%) and hand-foot syndrome (43%); the most common grade 3-4 treatment-related AEs were hand-foot syndrome (13%), neutropenia (11%), and diarrhea (9%). Steady-state pharmacokinetics were reached within 3 weeks, with no disproportionate accumulation of sunitinib or its active metabolite throughout the study. No significant correlations between trough drug, active metabolite, or soluble protein levels and clinical response were observed. PRO was largely maintained, although fatigue appeared to worsen after treatment started, with improvement over time. CONCLUSIONS: Continuous once-daily dosing with sunitinib 37.5 mg was active with a manageable safety profile as first-line mRCC therapy, making this a feasible alternative dosing regimen.

[Effectiveness of 5-fluoruracil and vinorelbine in patients who had received multi-treatments for metastatic breast cancer]. / Efectividad de 5-fluoruracilo y vinorelbina en pacientes multitratadas por cáncer de mama metastásico.

PURPOSE: In this study we evaluated the activity and toxicity of a combination of 5-fluorouracil continuous infusion and vinorelbine as second or third line chemotherapy in metastatic breast cancer (MBC). PATIENTS AN METHODS: A total 24 patients who had received doxorrubicin and/or paclitaxel were included in this study. The regimen consisted in 5-fluorouracil 1 gr/m(2) BSA continuous infusion for 3 days and vinorelbine 30 mg/m(2) intravenous (IV) on day 1. The cycles were repeated every 21 days for 6 cycles. RESULTS: Objective responses were recorded in 37.5% (12.5% complete remission). The median disease-free survival was calculated 6.33 +/- 8.12 months (CI 95% of 3.43 months). Toxicity was observed in 12.5% of the patients and no treatment related deaths were recorded. CONCLUSION: The combination of 5-fluorouracil/vinorelbine at the dose administered is an effective regime in patients with MBC, with low toxicity and cost.

Efectividad de 5-fluoruracilo y vinorelbina en pacientes multitratadas por cáncer de mama metastásico / Efectiveness of 5-fluoruracil and vinorelbine in patients who had received multi-treatments for metastatic breast cancer

Objetivo. Evaluar la actividad y toxicidad de fluoruracilo en infusión continua y vinorelbina en segunda o tercera línea de tratamiento del cáncer de mama metastásico (CMM).Método y pacientes. En este estudio fase II se incluyeron 24 pacientes que habían recibido doxorrubicina y/o paclitaxel. Se administró 5-fluoruracilo a 1g/m²/día en infusión continua por 3 días y vinorelbina a 30 mg/m² D1 cada 21 días por 6 ciclos. Resultados. Las respuestas globales observadas fueron del 37,5% (12,5% respuestas completas). El período libre de enfermedad se calculó una media de 6,33 ± 8,12 meses (IC 95% de 3,43 meses). Se observó toxicidad en el 12,5% de las pacientes y no se registró toxicidad grave ni muertes relacionadas a tratamiento. Conclusión. El 5-fluoruracilo/vinorelbina a las dosis administradas es un esquema efectivo en pacientes con CMM multitratadas, con un bajo perfil de toxicidad y costo

Purpose. In this study we evaluated the activity and toxicity of a combination of 5-fluoruracil continuous infusion and vinorelbine as second or third line chemotherapy in metastatic breast cancer (MBC). Patients an methods. A total 24 patients who had received doxorrubicin and/or paclitaxel were included in this study. The regimen consisted in 5-fluoruracil lgr/m² BSA continous infusion for 3 days and vinorelbine 30 mg/m² intravenous (IV) on day 1. The cycles were repeated every 21 days for 6 cycles. Results. Objective responses were recorded in 37.5% (12.5% complete remission). The median desease-free survival was calculated 6.33 ± 8.12 months (CI 95% of 3.43 months). Toxicity was observed in 12.5% of the patients and no treatment related deaths were recorded. Conclusion. The combination of 5-fluoruracil/vinorelbine at the dose administered is an effective regime in patients with MBC, with low toxicity and cost