Breast Cancer Patient's Outcomes after Neoadjuvant Chemotherapy and Surgery at 5 and 10 Years for Stage II-III Disease.

Introduction: Neoadjuvant chemotherapy in breast cancer offers the possibility to facilitate breast and axillary surgery; it is a test of chemosensibility in vivo with significant prognostic value and may be used to tailor adjuvant treatment according to the response. Material and Methods: A retrospective single-institution cohort of 482 stage II and III breast cancer patients treated with neoadjuvant chemotherapy based on anthracycline and taxans, plus antiHEr2 in Her2-positive cases, was studied. Survival was calculated at 5 and 10 years. Kaplan-Meier curves with a log-rank test were calculated for differences according to age, BRCA status, menopausal status, TNM, pathological and molecular surrogate subtype, 20% TIL cut-off, surgical procedure, response to chemotherapy and the presence of vascular invasion. Results: The pCR rate was 25.3% and was greater in HER2 (51.3%) and TNBC (31.7%) and in BRCA carriers (41.9%). The factors independently related to patient survival were pathology and molecular surrogate subtype, type of surgery, response to NACT and vascular invasion. BRCA status was a protective prognostic factor without reaching statistical significance, with an HR 0.5 (95%CI 0.1-1.4). Mastectomy presented a double risk of distant recurrence compared to breast-conservative surgery (BCS), supporting BCS as a safe option after NACT. After a mean follow-up of 126 (SD 43) months, luminal tumors presented a substantial difference in survival rates calculated at 5 or 10 years (81.2% compared to 74.7%), whereas that for TNBC was 75.3 and 73.5, respectively. The greatest difference was seen according to the response in patients with pCR, who exhibited a 10 years DDFS of 95.5% vs. 72.4% for those patients without pCR, p < 0001. This difference was especially meaningful in TNBC: the 10 years DDFS according to an RCB of 0 to 3 was 100%, 80.6%, 69% and 49.2%, respectively, p < 0001. Patients with a particularly poor prognosis were those with lobular carcinomas, with a 10 years DDFS of 42.9% vs. 79.7% for ductal carcinomas, p = 0.001, and patients with vascular invasion at the surgical specimen, with a 10 years DDFS of 59.2% vs. 83.6% for those patients without vascular invasion, p < 0.001. Remarkably, BRCA carriers presented a longer survival, with an estimated 10 years DDFS of 89.6% vs. 77.2% for non-carriers, p = 0.054. Conclusions: Long-term outcomes after neoadjuvant chemotherapy can help patients and clinicians make well-informed decisions.

Defining a standard set of health outcomes for patients with relapsing-remitting multiple sclerosis.

BACKGROUND: Standardizing health outcomes is challenging in clinical management, but it also holds the potential for creating a healthcare system that is both more effective and efficient. The aim of the present study is to define a standardized set of health outcomes for managing Relapsing-Remitting Multiple Sclerosis (RRMS). METHODS: The project was led and coordinated by a multidisciplinary scientific committee (SC), which included a literature review, a patient-focused group, three nominal group meetings, and two SC meetings. RESULTS: 36 outcome variables were included in the standard set: 24 clinical (including weight, smoking habit, comorbidities, disability, mobility, diagnosis of secondary progressive multiple sclerosis, relapsed-related variables, radiological variables, cognitive status and disease-related symptoms), nine treatment-related (pharmacological and non-pharmacological information), and 3 related to the impact of RRMS on the patient's life (quality of life, pregnancy desire, work-related difficulties). In addition, experts also agreed to collect 10 case-mix variables that may affect but cannot be controlled as part of the management of the condition: 4 sociodemographic (age, sex, race, and employment status) and 6 clinical (height, date of diagnosis and first episode, serological status, early symptoms, and number of relapses pre-diagnosis). CONCLUSION: The information provided through the present standard set of outcome variables can improve the management of RRMS and promote patient-centred quality care.

Prevalence and clinical significance in our setting of incidental uptake in the thyroid gland found on 18F-fluordeoxyglucose positron emission tomography-computed tomography (PET-CT).

INTRODUCTION: The expanding use of 18F-fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) has resulted in an increased frequency of incidentally discovered areas of FDG uptake within the thyroid gland. In these incidentalomas, high malignancy rates are reported. The study aimed, on the one hand, to determine the prevalence in our setting of thyroid incidentalomas in patients with no previous history of thyroid cancer undergoing an FDG PET-CT as well as the risk of malignancy and, on the other hand, to evaluate the usefulness of the maximum standard uptake value (SUVmax) for detecting thyroid cancer. MATERIAL AND METHODS: The FDG PET-CT scans performed at our hospital between June 2013 and December 2020 were retrospectively reviewed. In those incidentalomas with sufficient additional investigation, a diagnosis of benign or malignant was established based on the complementary tests. RESULTS: From the 21,594 PET-CT scans performed, 398 (1.8%) patients had an incidental FDG uptake, either focal (n=324) or diffuse (n=74). Among incidentalomas with further investigation, the rate of malignancy was higher in patients with focal FDG uptake than in those with diffuse uptake (26.5% versus 4%, respectively, p<0.05). The SUVmax value was significantly lower in benign focal lesions (5.7 [range: 2.3-66] than in malignant ones 10.6 [range: 3.1-51.2]; p<0.05). Nearly a quarter of malignant diagnoses (23.3%) were related to potentially aggressive tumours. CONCLUSION: The high rate of malignant tumours found among PET-CT incidentalomas and the high proportion of aggressive tumours demonstrate the need for a standardised approach in the investigation of incidental focal FDG uptake in the thyroid gland.

Genomically matched therapy in refractory colorectal cancer according to ESMO Scale for Clinical Actionability of Molecular Targets: experience of a comprehensive cancer centre network.

Efficiency of expanded genomic profiling (EGP) programmes in terms of final inclusion of patients in genomically matched therapies is still unknown. Fit patients with advanced and refractory colorectal cancer (CRC) were selected for an EGP programme. Next-generation sequencing (NGS) analysis from formalin-fixed paraffin-embedded tumour samples was performed. The purpose was to describe the prevalence of genomic alterations defined by the ESMO Scale for Clinical Actionability of Molecular Targets (ESCAT), as well as the percentage of patients finally included in genomically guided clinical trials. In total, 187 patients were recruited. Mutational profile was obtained in 177 patients (10 patients were failure due to insufficient tumour sample), copy number alterations in 41 patients and fusions in 31 patients. ESCAT-defined alterations were detected in 28.8% of the intention-to-analyse population. BRAF V600E was clustered in ESCAT I, with a prevalence of 3.7%, KRAS G12C and ERBB2 amplification were clustered in ESCAT II, whose prevalence was 4.2% and 1.6%, respectively. Most alterations were classified in ESCAT III (mutations in ERBB2, PIK3CA or FGFR genes and MET amplification) and IV (mutations in BRAF non-V600E, ERBB3, FBXW7, NOTCH, RNF43), with a single prevalence under 5%, except for PIK3CA mutation (9%). The final rate of inclusion into genomically guided clinical trials was 2.7%, including therapies targeting BRAF V600E or RNF43 mutations in two patients each, and ERBB2 mutation in one patient. In conclusion, EGP programmes in patients with advanced CRC are feasible and identify a subset of patients with potentially druggable genomic alterations. However, further efforts must be made to increase the rate of patients treated with genomically guided therapies.

Self-assessment of a breast care nursing model within a Breast Unit: learning process and keys to improving breast care.

AIM AND OBJECTIVES: To assess the adherence of a nursing care model in a multidisciplinary breast cancer unit in a tertiary hospital to the recommended competencies and quality indicators. BACKGROUND: Aligning the competencies of the breast care nurse with international recommendations for this role helps better fulfil patient needs, increases satisfaction and ensures continuity of care. DESIGN: Cohort study. METHODS: Breast care nursing was assessed in all patients treated at the Functional Breast Unit from 1 July 2016 to 30 June 2017. Patients were followed for 1 year. Sociodemographic, clinical and pathological data, treatments performed and nursing interventions were collected. The strobe checklist has been used to report this study. RESULTS: We analysed nursing interventions carried out in 382 patients attended over 1 year in a multidisciplinary breast cancer unit. All patients with early disease had contact with the nurse at different times during their primary treatment. Only 58% of patients with advanced disease had contact with the nurse during their first year of illness. Moreover, first contact with the nurse was delayed by more than a week from diagnosis, the interval recommended by international guidelines. CONCLUSION: The nursing care model meets the core competencies defined for the breast care nurse in patients with early breast cancer, but the first visit should be organised earlier, and follow-up should extend beyond completion of primary treatment. RELEVANCE TO CLINICAL PRACTICE: This study evaluated the breast care nurse model in one breast cancer unit according to international guidelines. Nursing care adhered to most guideline requirements in patients with early breast cancer, but not in those with advanced disease. New models of care need to be developed for women with advanced breast cancer in order to achieve true patient-centred care. PATIENT OR PUBLIC CONTRIBUTION: No contribution from the patient or the public because the data collected was entered into the clinical history by the health professionals of the Breast Unit as part of their usual clinical practice.

[Atlantic diet. Nutrition and gastronomy in Galicia]. / Dieta atlántica. Nutrición y gastronomía en Galicia.

INTRODUCTION: The diet of Galicia is the result of a perfect combination between the quality and diversity of the products of their lands and seas and a simple and healthy elaboration. To the benefits of the Galician products already known by the Celts, the Romans or the Early Medieval pilgrims have been added the inheritances received from the American shore of this ocean that we share, constituting the bases of the Atlantic diet. Galician food is characterized by an abundance of seasonal foods from plants (fruits, vegetables, potatoes, bread and cereals, nuts, chestnuts, honey and legumes), high consumption of fish and shellfish, moderate milk, veal meat fed exclusively with breast milk and pastures, olive oil, use of sauces with low energy load and high-quality fat and homemade desserts composed mainly of flour, eggs and nuts. The Galician Atlantic diet is healthy, functional and bioactive, and without doubt along with a favorable genetic profile, and adequate lifestyles, physical activity and inactivity, favored by our urbanism, with a distribution of the population in small rural areas, has collaborated so that we have one of the longest living populations with a high quality of life. Currently, the data reflect alarming figures of overweight and obesity, especially in the infant-juvenile age, most likely in relation to, among others, the loss of adherence to our traditional diet. To continue as before, Galician children and adolescents could live less than their grandparents, but also with more associated comorbidities. It is necessary to establish strategies to promote recovery and adherence of our Atlantic diet in north-western Spain.

INTRODUCCIÓN: La dieta de Galicia es el resultado de una conjunción perfecta entre la calidad y la diversidad de los productos de sus tierras y mares y una elaboración sencilla y saludable. A las bondades de los productos gallegos, ya conocidas por los celtas, los romanos o los peregrinos altomedievales, se han sumado las herencias recibidas desde la orilla americana de este océano que compartimos hasta constituir las bases de la llamada dieta atlántica. La alimentación gallega se caracteriza por la abundancia de alimentos de temporada (plantas, frutas, vegetales, patatas, pan y cereales, nueces, castañas, miel y leguminosas), por el elevado consumo de pescados y mariscos y por el moderado consumo de lácteos; por la carne de terneras alimentadas exclusivamente con leche materna y pastos; por el aceite de oliva, por el uso de salsas con baja carga energética y de alta calidad de la grasa y por los postres caseros compuestos principalmente por harina, huevos y frutos secos. La dieta atlántica gallega es saludable, funcional y bioactiva, y, sin duda, junto a un perfil genético beneficioso y unos estilos de vida, una actividad física e inactividad adecuados, favorecidos por nuestro urbanismo ­con una población distribuida en pequeños núcleos rurales­, ha contribuido a que tengamos una de las poblaciones más longevas y con una alta calidad de vida. Actualmente, los datos reflejan cifras alarmantes de sobrepeso y obesidad, especialmente en la etapa infantil-juvenil, relacionadas, muy probablemente, entre otros aspectos, con la pérdida de adherencia a nuestra dieta tradicional. De seguir como hasta ahora, los niños y adolescentes gallegos podrían vivir menos que sus abuelos y, además, con más comorbilidades asociadas. Se hace necesario establecer estrategias de promoción para la recuperación y fidelización de nuestra dieta atlántica del noroeste de España.

A Prospective Observational Study for Assessment and Outcome Association of Circulating Endothelial Cells in Clear Cell Renal Cell Carcinoma Patients Who Show Initial Benefit from First-line Treatment. The CIRCLES (CIRCuLating Endothelial cellS) Study (SOGUG-CEC-2011-01).

BACKGROUND: Markers able to predict the response to antiangiogenics in metastatic clear cell renal cell carcinoma (ccRCC) are not available. The development of new treatment options like immunotherapy are reaching the clinic; therefore, predictors of benefit from these different available treatments are increasingly needed. OBJECTIVE: In this study, we prospectively assessed the association of circulating endothelial cells (CECs) in peripheral blood with long-term benefit from first-line treatment in ccRCC. DESIGN, SETTING, AND PARTICIPANTS: A prospective observational study was designed involving 13 institutions of the Spanish Oncology Genitourinary Group. Adult patients diagnosed with advanced ccRCC who had achieved response or disease stabilization after 3 mo on first-line therapy were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: CECs were isolated from peripheral blood, captured with ferrofluids coated with monoclonal antibodies directed against the CD146 antigen, and assessed centrally with an automated standardized system. CECs were defined as 4',6-diamidino-2-phenylindole+, CD105+, and CD45-. Blood samples were systematically taken every 6 wk for 15 mo or until tumor progression, whichever occurred first. Clinical data were externally monitored at all centers. RESULTS AND LIMITATIONS: From August 9, 2011, to January 17, 2013, 75 patients were enrolled in the study. Patients with baseline CECs above the median showed a significantly longer progression-free survival than those with low CECs (22.2 mo vs 12.2 mo) with a hazard ratio of 2.5 (95% confidence interval: 1.2-5.3, p=0.016). There was no difference between CEC levels at baseline and at tumor progression (medians of 50 CECs/4ml and 52 CECs/4ml, respectively). CONCLUSIONS: Under antiangiogenic treatment, the detection of higher CEC levels is associated with clinical benefit in terms of progression-free survival in ccRCC. PATIENT SUMMARY: Antiangiogenics are the cornerstone of treatment in kidney cancer. Since they target endothelial rather than tumor cells, we studied the correlation between levels of circulating endothelial cells in peripheral blood and long-term benefit in patients on antiangiogenic therapy. Higher levels were associated with long-term benefit, suggesting that this determination could help to separate best responders from those who could require a more intensive approach.

Barriers to adherence to COPD guidelines among primary care providers.

BACKGROUND: Despite efforts to disseminate guidelines for managing chronic obstructive pulmonary disease (COPD), adherence to COPD guidelines remains suboptimal. Barriers to adhering to guidelines remain poorly understood. METHODS: Clinicians from two general medicine practices in New York City were surveyed to identify barriers to implementing seven recommendations from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. Barriers assessed included unfamiliarity, disagreement, low perceived benefit, low self-efficacy, and time constraints. Exact conditional regression was used to identify barriers independently associated with non-adherence. RESULTS: The survey was completed by 154 clinicians. Adherence was lowest to referring patients with a forced expiratory volume in 1 s (FEV(1)) <80% predicted to pulmonary rehabilitation (5%); using FEV(1) to guide management (12%); and ordering pulmonary function tests (PFTs) in smokers (17%). Adherence was intermediate to prescribing inhaled corticosteroids when FEV(1) <50% predicted (41%) and long-acting bronchodilators when FEV(1) <80% predicted (54%). Adherence was highest for influenza vaccination (90%) and smoking cessation counseling (91%). In unadjusted analyses, low familiarity with the guidelines, low self-efficacy, and time constraints were significantly associated with non-adherence to ≥2 recommendations. In adjusted analyses, low self-efficacy was associated with less adherence to prescribing inhaled corticosteroids (OR: 0.28; 95% CI: 0.10, 0.74) and time constraints were associated with less adherence to ordering PFTs in smokers (OR: 0.31; 95% CI: 0.08, 0.99). CONCLUSIONS: Poor familiarity with recommendations, low self-efficacy, and time constraints are important barriers to adherence to COPD guidelines. This information can be used to develop tailored interventions to improve guideline adherence.

CA-125 response patterns in patients with recurrent ovarian cancer treated with pegylated liposomal doxorubicin (PLD).

INTRODUCTION: : In recurrent ovarian cancer, CA-125 could be the only objective response criteria. This study analyzes response patterns regarding CA-125 in responders versus nonresponders and determines whether a specific cutoff value for CA-125 could predict clinical response, compared with response evaluation criteria in solid tumors, in patients receiving pegylated liposomal doxorubicin (PLD). METHODS: : Sixty-eight patients were identified, 78% were platinum resistant. Relative changes in CA-125 values were calculated, and response was defined as higher than 50% reduction in CA-125 from baseline. Receiver operating characteristic (ROC) curves were constructed based on CA-125 value after the first cycle of PLD to evaluate the most precise cutoff point for the decision model predicting response. RESULTS: : Fifty-three patients were assessable for response: 16 patients responded and 37 did not; the median increase of CA-125 was 0.20 (-63; 312) and 52 (-29; 620), respectively. Our ROC curve generated a cutoff value with a sensitivity of 35% (positive test, the proportion of patients who will not respond) and a predictive positive value of 80%. According to the predictive positive value, 20% of the responder patients will be identified as nonresponders; P = 0.025. CONCLUSIONS: : Our ROC analysis did not demonstrate any reliable CA-125 cutoff on response. Discontinuation of the therapy before cycle 3 may exclude some patients who will benefit from PLD.

Validation of a model to predict perioperative mortality from lung cancer resection in the elderly.

RATIONALE: Surgical resection is the mainstay therapy for localized non-small cell lung cancer (NSCLC), yet elderly patients are less likely to be treated due to concerns about morbidity and mortality related to surgery. OBJECTIVES: To validate and refine a clinical model to predict 30-day perioperative mortality (POM) in elderly patients undergoing curative resection for lung cancer. METHODS: We identified 14,297 patients aged 65 years and older with stage I, II, or IIIA NCSLC from the Surveillance, Epidemiology, and End-Results Registry linked to Medicare claims. We used logistic regression analysis to identify independent risk factors for POM and to validate and refine a previously derived prediction model. MEASUREMENTS AND MAIN RESULTS: Overall, POM was 4.6% (95% confidence interval, 4.2-4.9%). Multiple regression analysis revealed that greater age, male sex, resections of multiple lobes, advanced stage, greater tumor size, and certain comorbidities were associated with increased risk for POM. These risk factors were similar to those observed in the prior model. When patients were stratified according to their predicted risk of POM, the observed mortality increased from 1.2 to more than 10%. CONCLUSIONS: Among elderly patients with lung cancer, a prediction rule can identify those patients at higher risk for fatal complications from surgery. Further studies should evaluate whether use of the model can lead to improvements in treatment decision making.

Chemotherapy as an alternative to radiotherapy in the treatment of stage IIA and IIB testicular seminoma: a Spanish Germ Cell Cancer Group Study.

PURPOSE: To assess the long-term efficacy and toxicity of front-line cisplatin-based chemotherapy in patients with stage IIA or IIB testicular seminoma. PATIENTS AND METHODS: Untreated patients with pure seminoma of the testis after orchiectomy, with clinical stage IIA or IIB, were considered eligible for this prospective observational study. Chemotherapy consisted of either four cycles of cisplatin and etoposide or three cycles of cisplatin, etoposide, and bleomycin. RESULTS: Between April 1994 and March 2003, 72 patients were entered onto the study at 26 participating centers. Eighteen patients had stage IIA disease, and 54 patients had stage IIB disease. Eighty-three percent of patients achieved complete response, and 17% achieved partial response with residual mass. After a median follow-up time of 71.5 months, six patients with stage IIB disease experienced relapse, and one of these patients died as a result of seminoma. Three patients experienced non-seminoma-related deaths (two died from a further esophageal carcinoma, and one died from an upper digestive hemorrhage). The estimated 5-year progression-free survival rates for patients with stage IIA or IIB disease were 100% and 87% (95% CI, 77.5% to 97%), respectively. Five-year progression-free and overall survival rates for the whole group were 90% (95% CI, 82% to 98%) and 95% (95% CI, 89% to 100%), respectively. Severe granulocytopenia and thrombocytopenia were observed in eight and two patients, respectively. Mild to moderate emesis, stomatitis, and diarrhea were the most common nonhematologic effects. CONCLUSION: Chemotherapy is a highly effective and well-tolerated treatment for patients with stage IIA or IIB seminoma and represents an available alternative that could avoid some of the serious late effects associated with radiotherapy. Further studies focusing on long-term toxicities of different treatment modalities are needed.

Phase II multicentre study of temozolomide in combination with interferon alpha-2b in metastatic malignant melanoma.

OBJECTIVE: Temozolomide is a novel oral alkylating agent, active against metastatic melanoma. Combinations of chemotherapy and biological response modifiers have been associated with increased antitumour activity. A multicentre phase II study was performed to assess the activity and toxicity of temozolomide in combination with interferon alpha-2b. PATIENTS AND METHODS: Eligible patients had histologically confirmed metastatic melanoma. Previously untreated patients received temozolomide administered orally at a dose of 150 mg/m/day for 5 days every 4 weeks, in combination with interferon given continuously subcutaneously twice a week at a dose of 10 MU/m. Treatment continued until disease progression or for a maximum of 12 months. RESULTS: From June 1999 to August 2002, 27 eligible patients were included in the study at six centres. Median age was 59 (28-77) years; 17 male and 10 female patients were recruited; the median Karnofsky performance score was 90 (70-100); three patients had received prior adjuvant interferon; the majority of patients had fewer than three involved sites. A total of 96 cycles were administered; there were one complete response, four partial response and five stable disease (overall response rate: 18.5%, 95% confidence interval: 6.3-38.1). All responses were seen in patients with exclusively lymph node and pulmonary disease [M1a (one patient); M1b (four patients)]. The median response duration was 6.9 months. One patient remains in complete remission at 4 years. The median time to progression and the median survival were 1.87 and 9.5 months, respectively. Haematological toxicity was neutropenia G-IV: 1, G-III: 4, thrombocytopenia G-III: 2, and anaemia G-III: 2. Predominant non-haematological toxicity was hepatotoxicity G-III: 4. Other toxicities were mild or moderate. Dose reduction was required for nine cycles of interferon, one of temozolomide and two of both drugs. CONCLUSIONS: Temozolomide in combination with interferon is a well-tolerated palliative regimen that has moderate activity against metastatic melanoma. Further evaluation of this regimen in comparative studies or in combination with other drugs is warranted.

A phase I clinical and pharmacokinetic study of paclitaxel and docetaxel given in combination in patients with solid tumours.

The aim of this study was to determine the safety and feasibility profile of paclitaxel (PTX) and docetaxel (DTX) in combination and the pharmacokinetic and pharmacodynamic interaction between these two drugs in two different alternated sequences of administration. The starting dose was PTX (100 mg/m(2)) as a 3-h IV infusion followed by DTX (50 mg/m(2)) as 1-h IV infusion or the alternative sequence in every other patient. The sequence was alternated in the second course in each patient treated. Cycle duration was 21 days. Twenty patients received 103 cycles of treatment through three dose levels. Febrile neutropenia and grade 4 neutropenia lasting longer than 7 days were dose-limiting and defined the toxic dose of DTX (50 mg/m(2)) and PTX (135 mg/m(2)) in patients with prior treatment and the recommended dose in patients without prior treatment. Non-hematological toxicities included asthenia, neuropathy, arthralgia/myalgia and stomatitis. Pharmacokinetics of DTX were significantly affected by the sequence. Nadir ANC was more profound when DTX was administered first (P=0.022). There were one complete response and six partial responses, giving an overall response rate of 35%. DTX (50 mg/m(2)) followed by PTX (135 mg/m(2)) can be administered safely and it is an active regimen. The pharmacokinetics of PTX are not influenced by DTX but DTX pharmacokinetics depend on the sequence of administration, which influences its haematological toxicity profile.

[Evaluation of clinical research studies in a comprehensive cancer center]. / Evaluación de los proyectos de investigación clínica en un centro monográfico de cáncer.

BACKGROUND AND OBJECTIVE: The number of clinical trials in cancer patients has experienced an important growth during last years. However, it is difficult to find data showing this activity in Spanish Hospitals. This study analyses the clinical trials data bases between 1996 and 2002 in a cancer center. MATERIAL AND METHODS: We perform a descriptive analysis of data from: selection of protocols, origin of proposals, sponsors, investigators, studies performed and published; demographic data about patients and phase of the studies in which they have been included. RESULTS: Evaluation was undertaken with a standardised protocol review assessment. 337 proposals of clinical trials were evaluated during 1996-2002, with a decreasing acceptance index (62.5% to 39.18%, respectively), the number of proposals has grown from 16 in 1996 to 74 in 2002. The general recruitment index was 6.64%. Between 1995-2002, 1479 patients were registered; only 5% were older than 75 years. Pharmaceutical Companies sponsored the majority of the studies, although Co-operative Groups promote an important number of studies, especially in Haematology and Radiotherapy. Thirteen studies performed between 1996-1998 had been published, and 3 more are accepted for publication (69.5%). CONCLUSIONS: The number of patients included in clinical trials is limited and older patients are not well represented in them.