RESUMEN
BACKGROUND: With the implementation of multidisciplinary treatment and development of multiple novel anticancer drugs in parallel with expanding knowledge of supportive and palliative care, a need for separate training and specialisation in medical oncology emerged. A Global Curriculum (GC) in medical oncology, developed and updated by a joint European Society for Medical Oncology/American Society of Clinical Oncology (ESMO/ASCO) GC Task Force/Working Group (GC WG), greatly contributed to the recognition of medical oncology worldwide. MATERIAL AND METHODS: ESMO/ASCO GC WG carried out a global survey on medical oncology recognition and GC adoption in 2019. RESULTS: Based on our survey, medical oncology is recognised as a separate specialty or sub-specialty in 47/62 (75%) countries participating in the survey; with a great majority of them (39/47, 83%) recognising medical oncology as a standalone specialty. Additionally, in 9 of 62 (15%) countries, medical oncology is trained together with haematology as a specialty in haemato-oncology or together with radiotherapy as a specialty in clinical oncology. As many as two-thirds of the responding countries reported that the ESMO/ASCO GC has been either fully or partially adopted or adapted in their curriculum. It has been adopted in a vast majority of countries with established training in medical oncology (28/41; 68%) and adapted in 12 countries with mixed training in haemato-oncology, clinical oncology or other specialty responsible for training on systemic anticancer treatment. CONCLUSIONS: With 75% of participating countries reporting medical oncology as a separate specialty or sub-specialty and as high as 68% of them reporting on GC adoption, the results of our survey on global landscape are reassuring. Despite a lack of data for some regions, this survey represents the most comprehensive and up-to-date information about recognition of medical oncology and GC adoption worldwide and will allow both societies to further improve the dissemination of the GC and global recognition of medical oncology, thus contributing to better cancer care worldwide.
Asunto(s)
Antineoplásicos , Oncología Médica , Curriculum , Humanos , Oncología Médica/educación , Cuidados Paliativos , Encuestas y CuestionariosAsunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antígeno B7-H1/metabolismo , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Anticuerpos Monoclonales Humanizados/farmacología , Antígeno B7-H1/antagonistas & inhibidores , Antígeno B7-H1/inmunología , Carcinoma de Pulmón de Células no Pequeñas/inmunología , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Supervivencia sin Enfermedad , Aprobación de Drogas , Humanos , Neoplasias Pulmonares/inmunología , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Supervivencia sin Progresión , Ensayos Clínicos Controlados Aleatorios como Asunto , Nivel de Atención , Estados Unidos , United States Food and Drug Administration/normasRESUMEN
Development of the target therapies of lung cancer was a rapid process which fundamentally changed the pathological diagnosis as well. Furthermore, molecular pathology became essential part of the routine diagnostics of lung cancer. These changes generated several practical problems and in underdeveloped countries or in those with reimbursement problems have been combined with further challenges. The central and eastern region of Europe are characterized by similar problems in this respect which promoted the foundation of NSCLC Working Group to provide up to date protocols or guidelines. This present paper is a summary of the molecular pathology and target therapy guidelines written with the notion that it has to be upgraded continuously according to the development of the field.
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Carcinoma de Pulmón de Células no Pequeñas/diagnóstico , Carcinoma de Pulmón de Células no Pequeñas/genética , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/genética , Quinasa de Linfoma Anaplásico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Consenso , Receptores ErbB/genética , Europa (Continente) , Reordenamiento Génico , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Terapia Molecular Dirigida/métodos , Mutación , Patología Molecular/métodos , Grupo de Atención al Paciente , Guías de Práctica Clínica como Asunto , Proteínas Proto-Oncogénicas/genética , Proteínas Proto-Oncogénicas p21(ras) , Proteínas Tirosina Quinasas Receptoras/genética , Proteínas ras/genéticaRESUMEN
BACKGROUND: Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. PATIENTS AND METHODS: A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. RESULTS: Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. CONCLUSION: The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT.
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Neoplasias de la Mama/terapia , Determinación de Punto Final/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Terminología como Asunto , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/mortalidad , Consenso , Técnica Delphi , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Determinación de Punto Final/clasificación , Femenino , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/clasificación , Factores de Tiempo , Insuficiencia del TratamientoAsunto(s)
Neoplasias de la Mama/terapia , Biomarcadores de Tumor/metabolismo , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/patología , Terapia Combinada , Femenino , Humanos , Neoplasias Inflamatorias de la Mama/metabolismo , Neoplasias Inflamatorias de la Mama/patología , Neoplasias Inflamatorias de la Mama/terapia , Metástasis de la Neoplasia , Estadificación de Neoplasias , Cuidados Paliativos/métodos , Calidad de Vida , Receptor ErbB-2/metabolismo , Receptores de Estrógenos/metabolismoRESUMEN
BACKGROUND: Pathological complete response (pCR) following chemotherapy is strongly associated with both breast cancer subtype and long-term survival. Within a phase III neoadjuvant chemotherapy trial, we sought to determine whether the prognostic implications of pCR, TP53 status and treatment arm (taxane versus non-taxane) differed between intrinsic subtypes. PATIENTS AND METHODS: Patients were randomized to receive either six cycles of anthracycline-based chemotherapy or three cycles of docetaxel then three cycles of eprirubicin/docetaxel (T-ET). pCR was defined as no evidence of residual invasive cancer (or very few scattered tumour cells) in primary tumour and lymph nodes. We used a simplified intrinsic subtypes classification, as suggested by the 2011 St Gallen consensus. Interactions between pCR, TP53 status, treatment arm and intrinsic subtype on event-free survival (EFS), distant metastasis-free survival (DMFS) and overall survival (OS) were studied using a landmark and a two-step approach multivariate analyses. RESULTS: Sufficient data for pCR analyses were available in 1212 (65%) of 1856 patients randomized. pCR occurred in 222 of 1212 (18%) patients: 37 of 496 (7.5%) luminal A, 22 of 147 (15%) luminal B/HER2 negative, 51 of 230 (22%) luminal B/HER2 positive, 43 of 118 (36%) HER2 positive/non-luminal, 69 of 221(31%) triple negative (TN). The prognostic effect of pCR on EFS did not differ between subtypes and was an independent predictor for better EFS [hazard ratio (HR) = 0.40, P < 0.001 in favour of pCR], DMFS (HR = 0.32, P < 0.001) and OS (HR = 0.32, P < 0.001). Chemotherapy arm was an independent predictor only for EFS (HR = 0.73, P = 0.004 in favour of T-ET). The interaction between TP53, intrinsic subtypes and survival outcomes only approached statistical significance for EFS (P = 0.1). CONCLUSIONS: pCR is an independent predictor of favourable clinical outcomes in all molecular subtypes in a two-step multivariate analysis. CLINICALTRIALSGOV: EORTC 10994/BIG 1-00 Trial registration number NCT00017095.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/mortalidad , Carcinoma Ductal de Mama/tratamiento farmacológico , Carcinoma Ductal de Mama/mortalidad , Terapia Neoadyuvante , Adulto , Neoplasias de la Mama/metabolismo , Carcinoma Ductal de Mama/metabolismo , Quimioterapia Adyuvante/mortalidad , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Terapia Neoadyuvante/mortalidad , Pronóstico , Modelos de Riesgos Proporcionales , Resultado del Tratamiento , Proteína p53 Supresora de Tumor/biosíntesisRESUMEN
As compared to tamoxifen aromatase inhibitors (AIs) may increase the risk of heart disease. Here we explored the association between the use of AIs and coronary artery disease (CAD) in a population-based observational study. In a small and heterogeneous population of 74 women with early breast cancer who received adjuvant hormonal therapy and subsequently underwent cardiac angiography, AIs significantly increased the hazard for CAD (HR 3.23, 95% confidence intervals [CI] 1.26-8.25, p = .01) compared to tamoxifen. Our results suggest that therapy with AIs may increase the risk for CAD.
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Antineoplásicos Hormonales/efectos adversos , Inhibidores de la Aromatasa/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/inducido químicamente , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/enzimología , Neoplasias de la Mama/patología , Quimioterapia Adyuvante , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Humanos , Persona de Mediana Edad , Análisis Multivariante , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tamoxifeno/efectos adversos , Factores de TiempoRESUMEN
PURPOSE: Multiple drug resistance limits the efficacy of numerous cytotoxic drugs used in the treatment of small cell lung cancer (SCLC). The drug efflux protein ATP-binding cassette transporter B1 (ABCB1) has an important role in this process, and its gene variability may affect chemotherapy outcomes. PATIENTS AND METHODS: This study aimed to evaluate the associations between ABCB1 polymorphisms G2677T/A, C3435T, and their haplotype with progression-free survival (PFS) and overall survival (OS) in 177 SCLC patients treated with cisplatin-etoposide or cyclophosphamide-epirubicin-vincristine chemotherapy. To determine the ABCB1 genotype, allelic specific TaqMan(®) probes were used in a RT-PCR . RESULTS: Patients carrying the G2677T/A TT + TA + AA genotypes (24 %) or the C3435T CT + TT genotypes (72 %) or the 2677T/A-3435T haplotype (40 %) had a longer PFS (Cox regression, P = 0.052, 0.037 and 0.037, respectively); these associations persisted also in multivariate analyses (Cox regression, P = 0.028, 0.037 and 0.030, respectively). Moreover, patients with the C3435T CT + TT genotypes had a longer OS both in univariate and multivariate analysis (Cox regression, P = 0.022 and 0.028, respectively). A trend toward longer OS was noted for the 2677T/A-3435T haplotype (Cox regression, P = 0.051), but its independent value was not confirmed (Cox regression, P = 0.071). CONCLUSIONS: Our study reported a possible predictive value of ABCB1 polymorphisms G2677T/A, C3435T, and their haplotype for longer PFS and OS in Caucasian SCLC patients treated with chemotherapy. However, to be implemented into routine clinical practice, ABCB1 polymorphisms require further validation.
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Miembro 1 de la Subfamilia B de Casetes de Unión a ATP/genética , Haplotipos , Neoplasias Pulmonares/genética , Polimorfismo de Nucleótido Simple , Carcinoma Pulmonar de Células Pequeñas/genética , Subfamilia B de Transportador de Casetes de Unión a ATP , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Cisplatino/administración & dosificación , Ciclofosfamida/administración & dosificación , Supervivencia sin Enfermedad , Epirrubicina/administración & dosificación , Etopósido/administración & dosificación , Femenino , Frecuencia de los Genes , Genotipo , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Valor Predictivo de las Pruebas , Pronóstico , Modelos de Riesgos Proporcionales , Carcinoma Pulmonar de Células Pequeñas/diagnóstico , Carcinoma Pulmonar de Células Pequeñas/tratamiento farmacológico , Vincristina/administración & dosificaciónRESUMEN
The 1st international Consensus Conference for Advanced Breast Cancer (ABC 1) took place on November 2011, in Lisbon. Consensus guidelines for the management of this disease were developed. This manuscript summarizes these international consensus guidelines.
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Neoplasias de la Mama/terapia , Guías de Práctica Clínica como Asunto , Adaptación Psicológica , Antineoplásicos , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias de la Mama/prevención & control , Femenino , Humanos , Cooperación Internacional , Masculino , Estadificación de Neoplasias , Portugal , Calidad de Vida , Salud de la MujerAsunto(s)
Neoplasias de la Mama/tratamiento farmacológico , Algoritmos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/patología , Quimioterapia Adyuvante , Toma de Decisiones , Femenino , Humanos , Metástasis de la Neoplasia , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en MedicinaRESUMEN
BACKGROUND: The prognostic significance of DNA ploidy and the S-phase fraction (SPF) have been extensively studied in breast cancer, but their clinical utility remains controversial. The type of tumour material can substantially influence flow cytometric DNA measurements. Material obtained by fine needle aspiration (FNA) biopsy is very suitable for flow cytometric DNA analysis because it contains a low proportion of non-tumour cells and less debris than tissue samples. METHODS: The prognostic significance of DNA ploidy and SPF, determined on FNA samples, was analysed in 770 breast cancer patients, diagnosed between 1992 and 1997. DNA ploidy and SPF were determined at the time of diagnosis as part of the diagnostic work-up. The median follow-up was 90 months. Survival analysis included overall cancer specific survival (OS), disease free survival (DFS) and survival after recurrence (SAR). Other variables included in survival analyses were age, histological grade, histological type, lymph node status and tumour size. Disease free interval and the site of recurrence were also included in SAR analysis. RESULTS: DNA ploidy and SPF correlated with tumour type, size, lymph node involvement and, especially, tumour grade. In a univariate analysis, both aneuploidy and high SPF were associated with shorter OS, DFS and SAR, but only SPF retained its independent prognostic significance in multivariate analyses. Independent prognostic variables for OS were node status, histological grade, SPF and tumour size. Node status, histological grade and SPF were independent predictors of DFS, while the site of recurrence, SPF, histological grade, disease free interval and age were independent predictors of SAR. CONCLUSIONS: DNA ploidy and SPF can be efficiently and routinely determined on FNA samples. High SPF is independently associated with a worse clinical outcome of patients with breast cancer. Although SPF and histological grade share prognostic information to some degree, SPF provides additional, less subjective prognostic information. The prognostic value of SPF determined on FNA samples could be even more relevant in neoadjuvant settings and for patients not amenable for surgical treatment, when histological grade cannot be assessed.
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Biopsia con Aguja Fina , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/patología , Fase S , Neoplasias de la Mama/genética , Femenino , Humanos , Persona de Mediana Edad , Análisis Multivariante , Pronóstico , Modelos de Riesgos Proporcionales , Recurrencia , Análisis de SupervivenciaRESUMEN
Women with early breast cancer are exposed to an ongoing risk of relapse, even after successful surgical resection of the primary tumor and, where given, radiotherapy. Adjuvant chemotherapy and/or endocrine therapy can further help to prevent relapses by targeting metastatic disease deposits, which may be present but clinically undetectable. The benefits of adjuvant therapy are well documented, and millions of relapses have undoubtedly been prevented by treatment in this setting. Adjuvant tamoxifen has proven particularly effective in preventing relapses in hormone-receptor-positive (HR+) disease, and has been the standard treatment for affected women for over 30 years. However, long-term exposure to tamoxifen is associated with an unfavorable risk: benefit profile due to decreasing efficacy and an increasing incidence of harmful side effects. Although the risk of relapse is highest during the first 2-3 years after surgery, a residual risk remains indefinitely for those women who do not experience disease relapse in these early years, and the majority of all breast cancer recurrences and deaths occur after completion of 5 years of adjuvant tamoxifen. Hence, there is a great need for additional adjuvant therapies to reduce the considerable risk of late relapses in patients with HR+ disease: until recently no agent had been shown to provide a significant benefit over no further treatment. In 2003, upon publication of the first interim analysis of the MA.17 trial, letrozole became the first agent to be shown to significantly reduce relapses in women with HR+ early breast cancer who had completed 5 years of adjuvant tamoxifen. Subsequent analyses confirmed that letrozole significantly reduced recurrences, including distant metastases, and, in patients with node-positive disease, the agent also significantly improved overall survival, with the benefit of letrozole increasing with duration of therapy, at least up to 48 months. Preliminary results from a small, open-label study suggest that extended anastrozole therapy can also improve outcomes after completion of standard adjuvant tamoxifen. Ongoing analyses from MA.17, investigating how estrogen and progesterone receptor status and the length of time since finishing tamoxifen influence the effectiveness of letrozole, and studies evaluating the safety and efficacy of 10 years of extended aromatase inhibitor therapy, will help to optimize extended adjuvant therapy and improve outcomes for women with HR+ early breast cancer.
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Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Recurrencia Local de Neoplasia/prevención & control , Neoplasias Hormono-Dependientes/tratamiento farmacológico , Anastrozol , Supervivencia sin Enfermedad , Femenino , Humanos , Letrozol , Nitrilos/uso terapéutico , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Factores de Riesgo , Tamoxifeno/uso terapéutico , Triazoles/uso terapéuticoRESUMEN
According to EUSOMA position paper 'The requirements of a specialist breast unit', each breast unit should have a core team made up of health professionals who have undergone specialist training in breast cancer. In this paper, on behalf of EUSOMA, authors have identified the standards of training in breast cancer, to harmonise and foster breast care training in Europe. The aim of this paper is to contribute to the increase in the level of care in a breast unit, as the input of qualified health professionals increases the quality of breast cancer patient care.
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Neoplasias de la Mama/terapia , Educación Médica , Personal de Salud/educación , Oncología Médica/educación , Educación en Enfermería/métodos , Femenino , Cirugía General/educación , Humanos , Medicina Nuclear/educación , Radiología/educaciónRESUMEN
The 2003 St. Gallen consensus panel divided the many available adjuvant chemotherapy (CT) regimens into those with "standard efficacy" (ACx4, CMFx6) and those with "superior efficacy" (FA(E)Cx6, CA(E)Fx6, A(E)-->CMF, TACx6, ACx4--> paclitaxel (P)x4 or docetaxel (D)x4) but also greater complexity, toxicity and cost. This paper will summarize the latest information on long-term side effects of the "superior" regimens and 5-year benefits reported in taxane trials, including those of a "new" sequential regimen, FECx3--> docetaxelx3. Rapidly expanding evidence of marked heterogeneity in the magnitude of CT benefits according to the tumour oestrogen receptor (ER) status, a claim made for many years by IBCSG investigators, will be reviewed; it will lead to the conclusion that a revolution needs to take place in the way oncologists think about the CT added value and design adjuvant clinical trials. The conclusions proposed to the 2005 St. Gallen consensus panel are that: adequately dosed anthracycline-based CT regimens remain an acceptable standard for many women; a lower threshold for using taxanes in sequence or combination with anthracyclines (A) is justified in the presence of an ER-negative or low-ER tumour status, other aggressive biologic features (such as HER-2 overexpression), fear about A-induced cardiotoxicity; no recommendation can yet be made as far as the optimal taxane-A regimen, the best taxane or the best taxane schedule.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Guías de Práctica Clínica como Asunto/normas , Quimioterapia Adyuvante/normas , Quimioterapia Adyuvante/tendencias , Conferencias de Consenso como Asunto , Europa (Continente) , Femenino , HumanosRESUMEN
None of the established prognostic factors in breast cancer (BC) is able to determine the final outcome with certainity. Tumor biological factors involved in tumor invasion and metastasis, such as cathepsins and proteins of u-PA system, have been put forward in the recent literature as strong novel prognostic factors in BC. We therefore evaluated prognostic and predictive value of cathepsin-D (CD) and cathepsin-L (CL) in 715 operable BC patients. CD and CL were determined in tumor extracts using immunoradiometric and ELISA assays, respectively. During follow-up (median 37 months), 151 (21%) patients relapsed. In a multivariate analysis of disease-free survival (DFS), CL (p=0.04), nodal status (p<0.001) and hormone receptor status (p<0.001) were the only independent significant prognostic factors. CL thus provided independent prognostic information on DFS and could also predict a response to adjuvant chemotherapy (ChT), while CD had no significant prognostic and predictive impact.
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Biomarcadores de Tumor/sangre , Neoplasias de la Mama/patología , Catepsina D/sangre , Catepsinas/sangre , Cisteína Endopeptidasas/sangre , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Catepsina L , Quimioterapia Adyuvante , Supervivencia sin Enfermedad , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Metástasis Linfática , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , PronósticoRESUMEN
AIM: The aim of the present study was to determine the ability of radiography and ultrasonography to detect normal pleural fluid in healthy individuals and to assess the frequency of this finding. MATERIALS AND METHODS: Chest ultrasonography of both pleural spaces was performed in a group of 106 healthy volunteers to identify pleural fluid, first in the lateral decubitus position and than leaning on one elbow. Posteroanterior (PA) and lateral decubitus expiratory radiography were subsequently performed. An anechoic layer at least 2 mm thick on chest ultrasonography and a density with a horizontal level at least 3 mm in depth on lateral decubitus radiography were taken as positive results. RESULTS: On ultrasonography the fluid layer with a typical wedge-shaped appearance was visible in the pleural space of 28 of 106 (26%) volunteers, on both sides in 17 of 28 (61%) and unilaterally in 11 of 28 (39%). The mean fluid layer thickness in both positions was 2.84 mm (SD 0.41 mm, range 2.0-4.3 mm). Mean thickness in the decubitus position was found to be significantly larger than in the elbow position (P < 0.01). Lateral decubitus expiratory radiography showed physiological pleural fluid in only one case. CONCLUSION: Chest ultrasonography is superior to lateral decubitus expiratory chest radiography for demonstrating small amounts of normal pleural fluid in healthy individuals. A positive result, if detected, should not be taken as a sign of occult thoracic disease.
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Líquidos Corporales/diagnóstico por imagen , Cavidad Pleural/diagnóstico por imagen , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Derrame Pleural/diagnóstico por imagen , Postura , Radiografía , UltrasonografíaRESUMEN
The potential value of baseline health-related quality-of-life (HRQOL) and clinical factors in predicting prognosis was examined using data from an international randomised phase III trial which compared doxorubicin and paclitaxel with doxorubicin and cylophosphamide as first line chemotherapy in 275 women with metastatic breast cancer. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the related breast module (QLQ-BR23) were used to assess baseline HRQOL data. The Cox proportional-hazards regression model was used for both univariate and multivariate analyses of survival. In the univariate analyses, performance status (P<0.001) and number of sites involved (P=0.001) were the most important clinical prognostic factors. The HRQOL variables at baseline most strongly associated with longer survival were better appetite, physical and role functioning, as well as less fatigue (P<0.001). The final multivariate model retained performance status (P<0.001) and appetite loss (P=0.005) as the variables best predicting survival. Substantial loss of appetite was the only independent HRQOL factor predicting poor survival and was strongly correlated (/r/>0.5) with fatigue, role and physical functioning. In addition to known clinical factors, appetite loss appears to be a significant prognostic factor for survival in women with metastatic breast cancer. However, the mechanism underlying this association remains to be precisely defined in future studies.