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1.
Clin Genitourin Cancer ; 22(2): 56-67.e16, 2024 04.
Artículo en Inglés | MEDLINE | ID: mdl-37798164

RESUMEN

BACKGROUND: Treatment of metastatic hormone-sensitive prostate cancer (mHSPC) dramatically changed. PEACE-1 and ARASENS trials established triplet therapy efficacy. Identifying prognostic factors supporting treatment choice is pivotal. METHODS: TEAM is an observational, retrospective study to evaluate prognostic role of variables in mHSPC patients receiving upfront docetaxel in 11 Italian centers. Outcome measures were progression-free survival (PFS) and overall-survival (OS). RESULTS: From September 2014 to December 2020, 147 patients were included. Median PFS and OS were 11.6 and 37.4 months. At univariate analysis, PFS-related variables were Gleason Score (GS) (P = .001), opioid use (P = .004), bone metastases number (P < .001), baseline PSA (P = .006), Hb (P < .001), ALP (P < .001) and LDH (P = .002), time between ADT and docetaxel start (P = .018), 3-month PSA (P < .001) and ALP (P < .001), and number of docetaxel cycles (P < .001). OS-related variables were PSA at diagnosis (P = .024), primary tumor treatment (P = .022), baseline pain (P = .015), opioid use (P < .001), bone metastases number (P < . 001), baseline Hb (P < .001), ALP (P < .001) and LDH (P = .001), NLR ratio (P = .039), 3-month PSA (P < .001) and ALP (P < .001) and docetaxel cycles number (P < .001). At multivariate analysis, independent prognostic variables were GS, opioid use, baseline LDH and time between ADT and docetaxel initiation for PFS, and baseline Hb and LDH for OS. CONCLUSION: Patients receiving upfront docetaxel with high GS, high disease burden, pain or opioid use, baseline unfavorable laboratory values had worse outcomes. Patients had greater docetaxel benefit when initiated early after ADT start. These parameters could be taken into account when selecting candidates for triplet therapy.


Asunto(s)
Antígeno Prostático Específico , Neoplasias de la Próstata , Masculino , Humanos , Docetaxel , Estudios Retrospectivos , Analgésicos Opioides/uso terapéutico , Antagonistas de Andrógenos/uso terapéutico , Resultado del Tratamiento , Neoplasias de la Próstata/patología , Protocolos de Quimioterapia Combinada Antineoplásica , Dolor/etiología , Hormonas
2.
Artículo en Inglés | MEDLINE | ID: mdl-37704262

RESUMEN

OBJECTIVES: Hospital admission (HA) in cancer history is a common, repeated and frequently unplanned event. The emergency departments (EDs) and the oncological outpatient service (OOS) are the ordinary way of entry. We studied the reasons of admission, pathways of access and discharge and prognostic factors in a population of admitted patients with cancer. METHODS: The health records of the admitted patients in the oncological ward of a referral hospital in a 6-month period were retrieved and analysed. The characteristics of those admitted in the last 3 months of life were compared with the other group. RESULTS: Among the 147 HA, 79.5% were unplanned, 48.9% passing through the ED and 30.6% through the OOS; 56.5% were due to cancer-related symptoms; 50.3% occurred in the last 3 months of life. Median overall survival was 90 days (95% IC 53.1-126.9). Independent prognostic factors for survival were: being admitted for symptoms, referral through the ED and not being discharged at home. CONCLUSIONS: Hospital is a turning point in the cancer care pathway. Patients needing HA have a dismal prognosis, half of them being in the last 3 months of life. This group can be identified using universally available variables.

3.
J Epidemiol Community Health ; 77(3): 196-201, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36707238

RESUMEN

INTRODUCTION: The ability to return to work after a cancer diagnosis is a key aspect of cancer survivorship and quality of life. Studies have reported a significant risk of income loss for cancer survivors; however, there is limited evidence of the Italian context. METHODS: The Work Histories Italian Panel (WHIP)-Salute database was used to select a cohort of incident cases of colorectal cancer (CRC) among workers in the private sector, based on hospital discharges. A propensity score matching was used to find a balanced control group for several confounders. Ordinary least square and logistic regressions were used to estimate the effect of a CRC diagnosis on annual income and the probability of switching from a full-time contract to a part-time one considering 3 years after the diagnosis. RESULTS: Overall, we identified 925 CRC incident cases from 2006 until 2012. Our results confirm a statistically significant reduction in survivors' income compared with controls. This reduction was greater in the first year and then tend to decrease, with an average income loss over 3 years of about €12 000. Stratified analyses by sex and position confirmed the overall trend while indicating a strong effect modification. Regarding the switching from full-time to part-time employment, the results were never significant. CONCLUSION: Income loss does not seem to be related to an increase in part-time contracts, but rather to survivors' reduced work capacity following the invasive treatments. Further research is needed to investigate the complex dynamics behind this association.


Asunto(s)
Supervivientes de Cáncer , Neoplasias Colorrectales , Humanos , Calidad de Vida , Renta , Sobrevivientes , Neoplasias Colorrectales/epidemiología
4.
Front Oncol ; 12: 925366, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36185306

RESUMEN

Purpose: Anticancer treatment-related toxicities can impact morbidity and mortality, hamper the administration of treatment, worsen the quality of life and increase the burden on the healthcare system. Therefore, their prompt identification is crucial. NICSO (Italian Network for Supportive Care in Cancer) conducted a nationwide randomized trial to evaluate the role of a planned, weekly phone-based nurse monitoring intervention to prevent and treat chemotherapy, targeted therapy- and immunotherapy-related toxicities. Here, we report the results from the chemotherapy arm. Methods: This was a nationwide, randomized, open-label trial conducted among 29 Italian centers (NCT04726020) involving adult patients with breast, colon, or lung cancer and a life expectancy ≥6 months receiving adjuvant chemotherapy. Patients received either a weekly nurse monitoring phone call and an educational leaflet reporting practical advice about prevention and treatment of toxicities (experimental group) or the educational leaflet only (control group). Results: The addition of a nurse monitoring intervention may help reduce time spent with severe toxicities (grade ≥3), particularly those less frequently reported in clinical practice, such as fatigue. When considering grade 1-2 AEs, times with mild/moderate diarrhea, mucositis, fatigue and pain were shorter in the experimental arm. Time spent without AEs was significantly longer in the experimental arms for all the toxicities. The requirement for special medical attention was comparable between groups. Conclusion: This study suggests the need for implementing a better system of toxicity assessment and management for patients treated with adjuvant chemotherapy to promote effective preventive and/or therapeutic intervention against these events.

6.
Cost Eff Resour Alloc ; 19(1): 67, 2021 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-34627288

RESUMEN

BACKGROUND: The problem of correct inpatient scheduling is extremely significant for healthcare management. Extended length of stay can have negative effects on the supply of healthcare treatments, reducing patient accessibility and creating missed opportunities to increase hospital revenues by means of other treatments and additional hospitalizations. METHODS: Adopting available national reference values and focusing on a Department of Internal and Emergency Medicine located in the North-West of Italy, this work assesses prediction models of hospitalizations with length of stay longer than the selected benchmarks and thresholds. The prediction models investigated in this case study are based on Artificial Neural Networks and examine risk factors for prolonged hospitalizations in 2018. With respect current alternative approaches (e.g., logistic models), Artificial Neural Networks give the opportunity to identify whether the model will maximize specificity or sensitivity. RESULTS: Our sample includes administrative data extracted from the hospital database, collecting information on more than 16,000 hospitalizations between January 2018 and December 2019. Considering the overall department in 2018, 40% of the hospitalizations lasted more than the national average, and almost 3.74% were outliers (i.e., they lasted more than the threshold). According to our results, the adoption of the prediction models in 2019 could reduce the average length of stay by up to 2 days, guaranteeing more than 2000 additional hospitalizations in a year. CONCLUSIONS: The proposed models might represent an effective tool for administrators and medical professionals to predict the outcome of hospital admission and design interventions to improve hospital efficiency and effectiveness.

7.
Eur J Case Rep Intern Med ; 8(7): 002639, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34268267

RESUMEN

Hepatic dysfunction, in the absence of liver metastases, occurs in 10-15% of renal cell carcinoma (RCC) patients, while immune hepatitis due to anti-CTLA4 and anti-PD1 administration affects about 3-9% and 0.7-1.8% of treated patients, respectively. Liver toxicity following combination therapy (anti-CTLA4 and anti-PD1) is seen in 29% of patients overall and grade 3-4 toxicity in 14% of patients. Stauffer's syndrome is a rare para-neoplastic phenomenon associated with RCC and characterized by abnormal liver function tests, hepato-splenomegaly and histological changes consistent with non-specific hepatitis. We describe a case of RCC treated with anti-CTLA4 and anti-PD1 therapy resulting in immediate liver toxicity and death after 2 months of progressive hepatic impairment. We hypothesize that high IL-6 levels due to Stauffer's syndrome might have contributed to immune-related hepatic failure. LEARNING POINTS: Consider Stauffer's syndrome in patients who develop liver toxicity unresponsive to immunotherapy.Evaluate IL-6 as high levels are seen in Stauffer's syndrome patients undergoing immunotherapy.Consider taking a liver biopsy to assess the severity of liver injury.

8.
Tumori ; 107(6): NP101-NP104, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34225515

RESUMEN

Sinonasal undifferentiated carcinoma (SNUC) is an uncommon aggressive tumor. Locally advanced disease is usually diagnosed at presentation. Multidisciplinary approach is essential and aims to ensure optimal trimodal strategy. Induction chemotherapy is preferred in order to select patients who will benefit from chemoradiotherapy or surgery. Immunotherapy is not indicated in patients with recurrent SNUC. We describe an impressive response in a young man previously treated with radiotherapy and chemotherapy and demolitive surgery who had metastatic bone and lung disease. We also report data on PD-L1, next-generation sequencing, and neutrophil/platelets ratio.


Asunto(s)
Carcinoma/diagnóstico , Carcinoma/terapia , Inmunoterapia , Neoplasias del Seno Maxilar/diagnóstico , Neoplasias del Seno Maxilar/terapia , Biomarcadores , Carcinoma/etiología , Terapia Combinada , Manejo de la Enfermedad , Susceptibilidad a Enfermedades , Humanos , Inmunoterapia/efectos adversos , Inmunoterapia/métodos , Masculino , Neoplasias del Seno Maxilar/etiología , Clasificación del Tumor , Metástasis de la Neoplasia , Estadificación de Neoplasias , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Adulto Joven
9.
Tumori ; 107(6): 571-577, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33535920

RESUMEN

INTRODUCTION: Chemotherapy-induced nausea, vomiting, and retching (CINVR) remains a common side effect of treatment. Most previous studies have focused on vomiting control; nausea and retching have been less explored. This study aimed at describing the incidence, severity, and impact on daily life (IDL) of CINVR in the acute (0-24 hours), delayed (>24-120 hours), and overall (0-120 hours) postchemotherapy periods and beyond 120 hours (until next chemotherapy administration); and the pharmacologic and nonpharmacologic strategies adopted by patients to relieve symptoms. METHODS: This was a single-center, cross-sectional study of 60 patients undergoing chemotherapy. Participants reported the frequency, severity, and IDL of CINVR from the day of chemotherapy administration up to 120 hours thereafter and nausea and vomiting that occurred beyond 120 hours, as well as pharmacologic and nonpharmacologic remedies used. RESULTS: Forty-seven (78.3%, 95% confidence interval [CI] 66.4-86.9), 37 (61.7%, 95% CI 49.0-72.9), and 35 (58.3%, 95% CI 45.7-69.9) patients reported no nausea (Numeric Rating Scale ⩽1), vomiting, or retching in the acute, delayed, and overall periods, respectively. Nausea was more frequent, more severe, and had a greater IDL than did vomiting and retching across the overall observation period; beyond 120 hours, 11 (18.3%, 95% CI 10.6-29.9) patients reported nausea and none reported vomiting, with a median IDL of 1/10 (interquartile range: 0.75-5.00; 95% CI 0-7.6). Metoclopramide (n = 57 administrations), dexamethasone (n = 28), eating small servings of food (n = 13), and aloe (n = 11) were the most commonly used rescue therapies. CONCLUSIONS: Future studies should set hard outcomes, such as the absence of any symptoms, as a primary end point, and these should be assessed across and beyond the 120-hour period.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Evaluación del Impacto en la Salud , Náusea/epidemiología , Náusea/etiología , Neoplasias/complicaciones , Calidad de Vida , Vómitos/epidemiología , Vómitos/etiología , Anciano , Antieméticos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Estudios Transversales , Femenino , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Náusea/diagnóstico , Náusea/terapia , Neoplasias/diagnóstico , Neoplasias/tratamiento farmacológico , Evaluación del Resultado de la Atención al Paciente , Índice de Severidad de la Enfermedad , Vómitos/diagnóstico , Vómitos/terapia
10.
Eur J Cancer ; 139: 99-106, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32979648

RESUMEN

PURPOSE: Hospital admission is a frequent occurrence among patients with cancer, and a significant proportion of patients admitted to medical units have cancer. Their hospital stay has features that may be different compared with patients without cancer. We performed a retrospective analysis of the characteristics of patients with cancer admitted for medical conditions. PATIENTS AND METHODS: We studied the administrative data of patients with solid cancer admitted to the medical department of a large referral hospital over a 12-month period and compared them with those of patients without cancer. RESULTS: Seven thousand eight hundred two consecutive admissions were analysed, of which 1099 (14.1%) had a principal or associated diagnosis of cancer. Admissions were distributed across 12 units, with 44% concentrated in the medical oncology unit and 56% in other units. Patients with cancer were more frequently men and were younger than patients without cancer. Admission less frequently involved the emergency department (ED), while discharge was more frequently assisted. The in-hospital death rate was higher, as was the readmission rate. Length of stay was longer (11.3 days vs. 9.8 days; p < 0.0001). Patients with cancer admitted to the medical oncology unit used the ED even less, and their length of stay was shorter than that of patients with cancer admitted in other units. CONCLUSIONS: The in-hospital pathway of patients with cancer displays specific issues and adds complexity to hospital stay of patients with medical conditions. The medical oncology unit plays a role in reducing ED use and in providing efficient care. The evidence gathered should help in shaping new models of care and in improving adequate clinical competencies.


Asunto(s)
Hospitalización/tendencias , Neoplasias/terapia , Adolescente , Adulto , Anciano , Servicio de Urgencia en Hospital/estadística & datos numéricos , Femenino , Hospitales/estadística & datos numéricos , Humanos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Masculino , Oncología Médica/estadística & datos numéricos , Persona de Mediana Edad , Admisión del Paciente/estadística & datos numéricos , Alta del Paciente/estadística & datos numéricos , Derivación y Consulta/estadística & datos numéricos , Estudios Retrospectivos , Adulto Joven
11.
Oncology ; 98(11): 763-770, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32629446

RESUMEN

OBJECTIVES: Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study. PATIENTS AND METHODS: Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed. RESULTS: 236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008). CONCLUSION: The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.


Asunto(s)
Cetuximab/uso terapéutico , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Neoplasias de Cabeza y Cuello/radioterapia , Carcinoma de Células Escamosas de Cabeza y Cuello/tratamiento farmacológico , Carcinoma de Células Escamosas de Cabeza y Cuello/radioterapia , Antineoplásicos Inmunológicos/efectos adversos , Antineoplásicos Inmunológicos/uso terapéutico , Cetuximab/efectos adversos , Quimioradioterapia , Cisplatino/efectos adversos , Cisplatino/uso terapéutico , Femenino , Neoplasias de Cabeza y Cuello/patología , Humanos , Quimioterapia de Inducción , Masculino , Estadificación de Neoplasias , Supervivencia sin Progresión , Carcinoma de Células Escamosas de Cabeza y Cuello/patología
12.
Minerva Urol Nefrol ; 72(6): 737-745, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32284527

RESUMEN

BACKGROUND: Previous studies demonstrated a predictive value of prostate-specific antigen (PSA) kinetics for treatment outcome. Our retrospective study evaluates the prognostic role of early PSA drop in metastatic castration resistant prostate cancer (mCRPC) patients receiving abiraterone acetate (AA) or enzalutamide (E). METHODS: All mCRPC patients treated with AA or E at the San Luigi Hospital in Orbassano between 2010 and 2018 and at the Ordine Mauriziano Hospital in Turin between 2014 and 2018 were included in this retrospective study. Only patients with an early PSA (measured 28-60 days after the beginning of the treatment) were included in the analysis. Patients were divided in early responders and non-early responders according to early PSA response (drop≥50% from baseline). Univariate and multivariate analyses for progression free survival (PFS) and overall survival (OS) were performed. RESULTS: Of 144 patients with early PSA value, 61 (42.4%) patients received E (docetaxel-naïve 42, post-docetaxel 19) and 83 (57.6%) received AA (docetaxel-naïve 44, post-docetaxel 39). Seventy-five (52.1%) patients achieved early PSA drop. In docetaxel-naïve setting (N.=86), median PFS was 14.9 (with early PSA drop) vs. 8.8 months (without early PSA drop, P=0.001). In post-docetaxel setting (N.=58) median PFS was 11.9 vs. 4.5 months (P<0.001). Globally, median PFS was 14.9 vs. 6.3 months in patients with and without early PSA drop, respectively (P<0.001). In docetaxel-naïve setting, patients with early PSA drop had a median OS of 39.5 vs. 18.8 months (P=0.12). In post-docetaxel setting median OS was 29.6 vs. 10.7 months (P=0.01). Comprehensively, median OS was 31.9 vs. 16.3 (P=0.002) in patients with and without early PSA drop, respectively. At multivariate analysis, early PSA drop confirmed an independent association with PFS (HR 0.21; 95% CI: 0.12-0.38, P<0.001) and OS (HR 0.25; 95% CI: 0.12-0.50, P<0.001). CONCLUSIONS: mCRPC patients treated with AA or E, in docetaxel-naïve or post-docetaxel setting, with early PSA drop had significantly better OS and PFS.


Asunto(s)
Acetato de Abiraterona , Antineoplásicos , Feniltiohidantoína/análogos & derivados , Antígeno Prostático Específico , Neoplasias de la Próstata Resistentes a la Castración , Acetato de Abiraterona/uso terapéutico , Anciano , Antineoplásicos/uso terapéutico , Benzamidas , Supervivencia sin Enfermedad , Docetaxel/uso terapéutico , Humanos , Calicreínas , Masculino , Persona de Mediana Edad , Nitrilos , Feniltiohidantoína/uso terapéutico , Pronóstico , Supervivencia sin Progresión , Neoplasias de la Próstata Resistentes a la Castración/diagnóstico , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Neoplasias de la Próstata Resistentes a la Castración/patología , Estudios Retrospectivos , Resultado del Tratamiento
14.
Intern Emerg Med ; 15(6): 1011-1019, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-31907767

RESUMEN

Given the high hospital costs, the increasing clinical complexity and the overcrowding of emergency departments, it is crucial to improve the efficiency of medical admissions. We aimed at isolating organizational drivers potentially targetable through a widespread improvement action. We studied all medical admissions in a large tertiary referral hospital from January 1st to December 31st, 2018. Data were retrieved from the administrative database. Available information included age, sex, type (urgent or elective) and Unit of admission, number of internal transfers, main ICD-9 diagnosis, presence of cancer among diagnoses, surgical or medical code, type of discharge, month, day and hour of admission and discharge. National Ministry of Health database was used for comparisons. 8099 admissions were analyzed. Urgent admissions (80.5% of the total) were responsible for longer stays and were the object of the multivariate analysis. The variables most influencing length-of-stay (LOS) were internal transfers and assisted discharge: they contributed, respectively, to 62% and 40% prolongation of LOS. Also, the daily and weekly kinetics of admission accounted for a significant amount of variation in LOS. Long admissions (≥ 30 days) accounted for the 15.5% of total bed availability. Type of discharge and internal transfers were again among the major determinants. A few factors involved in LOS strictly depend on the organizational environment and are potentially modifiable. Re-engineering should be focused on making more efficient internal and external transitions and at ensuring continuity of the clinical process throughout the day and the week.


Asunto(s)
Eficiencia Organizacional , Tiempo de Internación/estadística & datos numéricos , Habitaciones de Pacientes/normas , Análisis de Varianza , Distribución de Chi-Cuadrado , Humanos , Admisión del Paciente/estadística & datos numéricos , Alta del Paciente/estadística & datos numéricos , Habitaciones de Pacientes/organización & administración , Habitaciones de Pacientes/estadística & datos numéricos , Distribución de Poisson , Mejoramiento de la Calidad , Factores de Tiempo
15.
Int J Qual Health Care ; 31(10): 781-786, 2019 Dec 31.
Artículo en Inglés | MEDLINE | ID: mdl-30809643

RESUMEN

QUALITY ISSUE: The definition of clinical pathways (CPs) and their application are heterogeneous. Each center is used to choose whether to adopt this instrument or not and to variably conceive its features We consider CPs as the necessary description of the cancer patient journey and we emphasize their role as the user view of clinical processes rather than a local translation of guidelines. CHOICE OF SOLUTION: We proposed a unique CPs model for all the centers of our regional network, with the aim of making CPs accountable and comparable. We also established a central quality evaluation. IMPLEMENTATION: Through a multi-step process, the model was proposed to the 22 Regional centers. Landmark characteristics of the project were: the involvement of hospital administrations; reference to a unique set of guidelines; a peer-review and open evaluation. EVALUATION: Of the 374 expected CPs, 253 (68%) were received and evaluated. A median number of 131 items were the object of evaluation in each hub center and 77 in each spoke center. About 79.5% items were considered well described, 15.5% were absent and 5.0% partially described. The median percentage of fulfilled indicators was 85.6% in hub CPs and 82.2% in spoke CPs. Although, not all diseases were equally covered through the territory a high degree of homogeneity and a good quality of compilation were achieved. LESSONS LEARNED: The project was shown to be feasible and achieved its goal. We suggest this process as a functional way for building uniform cancer CPs.


Asunto(s)
Instituciones Oncológicas/organización & administración , Vías Clínicas/organización & administración , Neoplasias/terapia , Instituciones Oncológicas/normas , Guías como Asunto , Humanos , Italia , Investigación Cualitativa , Mejoramiento de la Calidad
16.
Lung Cancer ; 129: 35-40, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30797489

RESUMEN

OBJECTIVES: Brain metastases are common among patients with non-squamous non-small-cell lung cancer (NSCLC) and result in a poor prognosis. Consequently, such patients are often excluded from clinical trials. In Italy an expanded access program (EAP) was used to evaluate nivolumab efficacy and safety in this subpopulation outside a clinical trial. MATERIALS AND METHODS: In this EAP, nivolumab was available for patients with non-squamous NSCLC in progression after at least one systemic treatment for stage IIIB/IV disease. Nivolumab 3 mg/kg was administered intravenously every 2 weeks. Patients with brain metastases could be included if they were asymptomatic, neurologically stable and either off corticosteroids or on a stable or decreasing dose of ≤10 mg/day prednisone. RESULTS: 409 out of 1588 patients included had asymptomatic or controlled brain metastases. A median of 7 doses (range 1-45) were delivered. Median follow-up was 6.1 months (range 0.1-21.9). The disease control rate was 39%: 4 patients had a complete response, 64 a partial response and 96 showed stable disease. At baseline, 118 patients were on corticosteroids and 74 were undergoing concomitant radiotherapy. The median overall survival in this subpopulation was 8.6 months (95% CI: 6.4-10.8). 337 discontinued treatment for various reasons, 23 (7%) of whom due to adverse events, in line with that observed in the overall population and in previous studies. CONCLUSIONS: Our results confirm that nivolumab is active in non-squamous NSCLC patients with brain metastases, despite their poor prognosis. Its safety profile is also concordant with results in the EAP overall population and in patients with other malignancies.


Asunto(s)
Antineoplásicos Inmunológicos/uso terapéutico , Neoplasias Encefálicas/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Inmunoterapia/métodos , Neoplasias Pulmonares/epidemiología , Nivolumab/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Encefálicas/mortalidad , Neoplasias Encefálicas/secundario , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/secundario , Progresión de la Enfermedad , Femenino , Humanos , Italia/epidemiología , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Análisis de Supervivencia , Resultado del Tratamiento
17.
Dent J (Basel) ; 6(3)2018 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-30200393

RESUMEN

The recent randomized trial, published by Raje et al., on Lancet Oncology is potentially practice changing. It proposes that denosumab is a valid alternative to zoledronic acid in the treatment of myeloma patients. However, several points need further data and more details, such as information on incidence, diagnosis, and follow-up of osteonecrosis of the jaw (ONJ) cases, observed among treated patients. Adopted definition to adjudicate ONJ cases, type of registration of potential ONJ cases, length of observation are possible causes of potential underestimation of ONJ incidence in their study. Future updated evaluations with longer follow-up, and including actuarial estimation, are required for final judgment on ONJ risk in myeloma patients receiving denosumab, and comparison with ONJ risk by zoledronic acid.

18.
Int J Health Policy Manag ; 7(8): 728-737, 2018 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-30078293

RESUMEN

BACKGROUND: The current economic constraints cause hospital management to use the available public resources as rationally as possible. At the same time, there is the necessity to improve current scientific knowledge. This is even more relevant in the case of patients with malignant pleural mesothelioma (MPM), given the severity of the disease, its dismal prognosis, and the cost of chemotherapy drugs. This work aims to evaluate the standard cost of patients with MPM, supporting physicians in their decision-making process in relation to budget constraints, as well as policy-makers with respect research policy. METHODS: The authors conducted a retrospective cost analysis on all the patients with MPM who were first admitted to a reference hospital specialized in MPM care between 2014 and 2015, collecting data on their diagnostic pathways and active treatments, as well as on the related official fees for each procedure. Then, using a multiple regression model, we estimated the overall expected cost of a patient with MPM treated in our hospital, to be born by the Regional Healthcare System based on the chosen clinical pathway. RESULTS: According to results, the economic impact of caring for a patient with MPM is mostly related to the selected active treatments, with drug and hospitalization costs as main drivers. Our analysis suggests that the expected reimbursed fee to care for a patient with MPM is equal to € 18 214.99, with chemotherapy and monitoring costs equal to € 12 861.43 and hospitalization cost equal to € 5353.55. This cost decreases to € 320.18 in the case of enrollment in an experimental trial of first-line treatment. In the other cases (second-line or third-line trials), the expected cost borne by the healthcare system for treating patients grows exponentially (€ 40,124.18 and € 59 839.94, respectively). CONCLUSION: Experimental trials might be a solution to decrease the economic burden for the public healthcare system only in the case of first-line treatments, where the cost of chemotherapy is relevant. Nevertheless, policy-makers have to accept the sharing of this economic burden between society and the pharmaceutical industry to broaden the current scientific knowledge.


Asunto(s)
Investigación Biomédica/economía , Análisis Costo-Beneficio , Administración Financiera , Recursos en Salud , Costos de Hospital , Hospitales Públicos/economía , Neoplasias Pulmonares/economía , Mesotelioma/economía , Anciano , Presupuestos , Conducta Cooperativa , Atención a la Salud/economía , Costos de los Medicamentos , Industria Farmacéutica , Femenino , Política de Salud , Hospitalización/economía , Humanos , Italia , Neoplasias Pulmonares/terapia , Masculino , Mesotelioma/terapia , Mesotelioma Maligno , Persona de Mediana Edad , Estudios Retrospectivos
19.
BMJ Open ; 8(6): e020912, 2018 06 30.
Artículo en Inglés | MEDLINE | ID: mdl-29961019

RESUMEN

OBJECTIVES: To assess Italian medical oncologists' opinion on the implications of conflict of interest (COI) on medical education, care and research, and to evaluate their direct financial relationships. DESIGN: National cross-sectional survey conducted between March and April 2017 among Italian oncologists. SETTING: Online survey sponsored by the Italian College of Medical Oncology Chiefs through its website. PARTICIPANTS: Italian oncologists who filled out an anonymous questionnaire including 19 items and individual and working characteristics. MAIN OUTCOME MEASURE: The proportion of medical oncologists perceiving COI as an outstanding issue and those receiving direct payments from industry. RESULTS: There were 321 respondents, representing 13% of Italian tenured medical oncologists. Overall, 62% declared direct payments from the pharmaceutical industry in the last 3 years. Sixty-eight per cent felt the majority of Italian oncologists have a COI with industry, but 59% suppose this is not greater than that of other specialties. Eighty-two per cent consider that most oncology education is supported by industry. More than 75% believe that current allocation of industry budget on marketing and promotion rather than research and development is unfair, but 75% consider it appropriate to receive travel and lodging hospitality from industry. A median net profit margin of €5000 per patient enrolled in an industry trial was considered appropriate for the employee institution. Sixty per cent agree to receive a personal fee for patients enrolled in industry trials, but 79% state this should be reported in the informed consent. Over 90% believe that scientific societies should publish a financial report of industry support. Finally, 79% disagree to being a coauthor of an article written by a medical writer when no substantial scientific contribution is made. CONCLUSIONS: Among Italian oncologists COI is perceived as an important issue influencing costs, education, care and science. A more rigorous policy on COI should be implemented.


Asunto(s)
Conflicto de Intereses , Industria Farmacéutica/ética , Oncología Médica/ética , Oncólogos/ética , Adulto , Anciano , Estudios Transversales , Revelación , Femenino , Apoyo Financiero , Humanos , Internet , Italia , Masculino , Oncología Médica/economía , Persona de Mediana Edad , Encuestas y Cuestionarios
20.
Clin Genitourin Cancer ; 16(4): 318-324, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29866495

RESUMEN

BACKGROUND: Neutropenia is a common side effect associated with docetaxel use. We retrospectively investigated the association between chemotherapy-induced neutropenia and survival in metastatic castration-resistant prostate cancer (mCRPC) patients receiving first-line docetaxel. PATIENTS AND METHODS: Metastatic castration-resistant prostate cancer patients treated with first-line docetaxel, with known neutrophils value 10 days after first administration, were included in this retrospective analysis. Neutropenia was categorized in Grade 0 to 1 (G0-1), Grade 2 to 3 (G2-3), and Grade 4 (G4). Outcome measures were progression-free survival (PFS) and overall survival (OS). RESULTS: Eighty patients were analyzed. Median PFS was 5.4 months in patients with G0-1 neutropenia, 6.9 months with G2-3 neutropenia (hazard ratio [HR] vs. G0-1, 0.69; 95% confidence interval [CI], 0.35-1.35; P = .27) and 9.5 months with G4 neutropenia (HR vs. G0-1, 0.30; 95% CI, 0.16-0.57; P < .0001). Median OS was 11.6 months in patients with G0-1 neutropenia, 25.5 months in patients with G2-3 neutropenia (HR vs. G0-1, 0.36; 95% CI, 0.16-0.80; P = .012) and 39.3 months in patients with G4 neutropenia (HR vs. G0-1, 0.19; 95% CI, 0.09-0.41; P < .0001). In multivariate analysis, the occurrence of severe neutropenia showed a statistically significant association with OS (HR G4 vs. G0-1, 0.14; 95% CI, 0.03-0.67; P = .013; HR G2-3 vs. G0-1, 0.42; 95% CI, 0.11-1.57; P = .20) and PFS (HR G4 vs. G0-1, 0.28; 95% CI, 0.09-0.86; P = .03; HR G2-3 vs. G0-1, 1.07; 95% CI, 0.38-2.96; P = .90). CONCLUSION: Docetaxel-induced neutropenia is associated with better survival of mCRPC.


Asunto(s)
Antineoplásicos/administración & dosificación , Docetaxel/administración & dosificación , Neutropenia/inducido químicamente , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Antineoplásicos/efectos adversos , Recuento de Células Sanguíneas , Docetaxel/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Evaluación del Resultado de la Atención al Paciente , Supervivencia sin Progresión , Estudios Retrospectivos , Análisis de Supervivencia , Resultado del Tratamiento
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