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1.
Head Neck ; 2021 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-34643313

RESUMO

BACKGROUND: Genome analysis could provide tools to assess predictive molecular biomarkers of radioresistance. METHODS: Head and neck squamous cell carcinoma patients included in ProfiLER study and who underwent a curative radiotherapy were screened. Univariate and Cox multivariate analyses were performed to explore the relationships between molecular abnormalities, infield relapse and complete tumor response after radiation. RESULTS: One hundred and forty-three patients were analyzed. PIK3CA mutation and genomic instability of MAP kinases pathway were found to be prognostic factors of loco-regional relapse in multivariate analysis with respectively HR 0.33, 95% CI 0.13-0.83, p = 0.005 and HR 0.61, 95% CI 0.38-0.96, p = 0.025. Instability of apoptosis pathway was found to be a prognostic factor of complete response after radiotherapy with HR 0.24, 95% CI 0.07-0.88, p = 0.04. CONCLUSION: This sub analysis suggests that PIK3CA mutation, variation of copy number of MAP kinases and apoptosis pathways play a significant role in the radioresistance phenomenon.

2.
Artigo em Inglês | MEDLINE | ID: mdl-34363006

RESUMO

After chemotherapy, fewer than 30% of patients with T-cell lymphoma (T-NHL) are long-term disease-free survivors. Thus, there is a growing interest in allogeneic stem cell transplantation (alloSCT) and its potential graft-versus-lymphoma effect (GVL) for patient with high-risk or recurrent T-NHL with the aim at providing durable disease control in T-NHL. We conducted this registry study to evaluate the outcome of recipients of alternative donor alloSCT for T-NHL. Patients transplanted with Haploidentical donor (Haplo, n = 41) or Umbilical Cord Blood (UCB, n = 54) were analyzed for overall survival (OS), non-relapse mortality (NRM), relapse, and acute/chronic graft-versus-host disease (aGVHD/cGVHD) incidence. At 2 years, OS and PFS were, respectively, of 59% and 53%, without significant difference between Haplo and UCB. In multivariate analysis, disease status at transplant was an independent risk factor for OS and PFS, and aGVHD III-IV was the main factor for OS and NRM. While no major impact of donor source on survival and mortality was noted, this study suggests that alternative donor transplantation appears feasible and offers benefits to patients with T-cell lymphoma.

3.
Br J Radiol ; 94(1125): 20210197, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-34233471

RESUMO

OBJECTIVES: The main standard of care for locally advanced cervix carcinoma (LACC) is radiochemotherapy (RCT) followed by brachytherapy. A surgical approach may still be discussed based on pelvic MRI-derived residual tumour evaluation. As no interobserver agreement study has ever been conducted to our knowledge, the aim of the present study was to report on pelvic MRI accuracy and interobserver agreement in LACC. METHODS: We carried out a retrospective study in a French university hospital. Medical records of all consecutive patients treated with curative intent for LACC by RCT followed by brachytherapy and completion pelvic surgery between January 2014 and January 2020 were reviewed. Local response was assessed through pelvis MRI and histological analysis after completion surgery. MRI data were independently evaluated by two radiologists with varying experience. The two main interobserving criteria we used were complete response and residual tumour. RESULTS: 23 patients fulfilled the inclusion criteria. Agreement between the junior and senior radiologist was moderate to strong. Indeed, regarding main criteria, κ was 0.65 for complete response and 0.57 for residual tumour. Interestingly, the present study shows a lower sensitivity whatever the radiologists than in the international literature. CONCLUSION: The present study highlights a low interobserver variability regarding pelvic MRI in the assessment of RCT followed by brachytherapy in LACC. Yet, sensitivity was lower than in literature. ADVANCES IN KNOWLEDGE: Radiology is part of treatment decision-making, the issue of heterogeneity regarding radiologists' training and experience to cancer (sensitivity and specificity) turns essential, so does MRI accuracy.


Assuntos
Imageamento por Ressonância Magnética/métodos , Neoplasias do Colo do Útero/diagnóstico por imagem , Neoplasias do Colo do Útero/terapia , Adulto , Idoso , Braquiterapia/métodos , Colo do Útero/diagnóstico por imagem , Quimiorradioterapia/métodos , Feminino , França , Humanos , Pessoa de Meia-Idade , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Resultado do Tratamento
4.
JAMA Oncol ; 7(6): 853-861, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-33885718

RESUMO

Importance: Single-agent carboplatin is often proposed instead of a conventional carboplatin-paclitaxel doublet in vulnerable older patients with ovarian cancer. Such an approach could have a detrimental effect on outcomes for these patients. Objective: To compare the feasibility, efficacy, and safety of single-agent carboplatin every 3 weeks, weekly carboplatin-paclitaxel, or conventional every-3-weeks carboplatin-paclitaxel in vulnerable older patients with ovarian cancer. Design, Setting, and Participants: This international, open-label, 3-arm randomized clinical trial screened 447 women 70 years and older with newly diagnosed stage III/IV ovarian cancer by determining their Geriatric Vulnerability Score; 120 patients with a Geriatric Vulnerability Score of 3 or higher were stratified by country and surgical outcome. Enrollment took place at 48 academic centers in France, Italy, Finland, Denmark, Sweden, and Canada from December 11, 2013, to April 26, 2017. Final analysis database lock April 2019. Data analysis was performed from February 1 to December 31, 2019. Interventions: Patients were randomized to receive 6 cycles of (1) carboplatin, area under the curve (AUC) 5 mg/mL·min, plus paclitaxel, 175 mg/m2, every 3 weeks; (2) single-agent carboplatin, AUC 5 mg/mL·min or AUC 6 mg/mL·min, every 3 weeks; or (3) weekly carboplatin, AUC 2 mg/mL·min, plus paclitaxel, 60 mg/m2, on days 1, 8, and 15 every 4 weeks. Main Outcomes and Measures: The primary outcome was treatment feasibility, defined as the ability to complete 6 chemotherapy cycles without disease progression, premature toxic effects-related treatment discontinuation, or death. Results: A total of 120 women were randomized. The mean and median age was 80 (interquartile range, 76-83; range, 70-94) years; 43 (36%) had a Geriatric Vulnerability Score of 4 and 13 (11%) had a Geriatric Vulnerability Score of 5; 40 (33%) had stage IV disease. During its third meeting, the independent data monitoring committee's recommendation led to the termination of the trial because single-agent carboplatin was associated with significantly worse survival. Six cycles were completed in 26 of 40 (65%), 19 of 40 (48%), and 24 of 40 (60%) patients in the every-3-weeks combination, single-agent carboplatin, and weekly combination groups, respectively. Treatment-related adverse events were less common with the standard every-3-weeks combination (17 of 40 [43%]) than single-agent carboplatin or weekly combination therapy (both 23 of 40 [58%]). Treatment-related deaths occurred in 4 patients (2 of 40 [5%] in each combination group). Conclusions and Relevance: This randomized clinical trial shows that compared with every-3-weeks or weekly carboplatin-paclitaxel regimens, single-agent carboplatin was less active with significantly worse survival outcomes in vulnerable older patients with ovarian cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02001272.

5.
Int Arch Occup Environ Health ; 94(6): 1317-1325, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33733326

RESUMO

PURPOSE: Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement. METHODS: A monocentric comparative before/after study was carried out in an oncology day hospital to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual infusion practices. The rate of nurses' gloves contamination was estimated. To avoid false negatives and to ensure sampling reproducibility, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate logistic regression analysis. RESULTS: The usual practice led to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 85% in multivariate analysis (Odds ratio = 0.15; 95% confidence interval = 0.05-0.46; p < 0.001). Topotecan was identified in 100% of the samples. Only one case of cross-contamination has occurred. CONCLUSION: Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. Safe Infusion Devices were highly effective but did not completely eliminate exposure.


Assuntos
Antineoplásicos/análise , Infusões Intravenosas/instrumentação , Enfermeiras e Enfermeiros , Exposição Ocupacional/prevenção & controle , Ciclofosfamida/análise , Luvas Protetoras , Humanos , Irinotecano/análise , Pemetrexede/análise , Topotecan/análise
6.
Support Care Cancer ; 29(8): 4257-4267, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33409726

RESUMO

PURPOSE: The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life. METHODS: A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018. RESULTS: Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC à 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point. CONCLUSIONS: In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD. TRIAL REGISTRATION: Clinical trial registration is NCT02459483. Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.


Assuntos
Antineoplásicos/uso terapêutico , Adesão à Medicação/psicologia , Qualidade de Vida/psicologia , Idoso , Antineoplásicos/farmacologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
7.
Cancer Invest ; 39(1): 15-20, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33258396

RESUMO

Coronavirus disease outbreak has affected all aspect of clinical care including cancer clinical trials. To minimize exposure of frail cancer patients, an implementation of telemedicine was retained. The impact of this implementation on primary and secondary endpoints criteria of ongoing clinical trials was analyzed. Out of 128 oncology clinical trials, 25 (19%) had an implementation of teleconsultation. Poor data reporting induced mainly a bias on qualitative and descriptive primary endpoints than those assessing efficacy (80% vs 20%; p < 0.001). The integration of telemedicine and E-technologies in the medical practices and clinical trials must be designed and validated.


Assuntos
COVID-19/prevenção & controle , Ensaios Clínicos como Assunto/métodos , Oncologia/métodos , Neoplasias/terapia , SARS-CoV-2/isolamento & purificação , Telemedicina/métodos , COVID-19/epidemiologia , COVID-19/virologia , Ensaios Clínicos como Assunto/normas , Ensaios Clínicos como Assunto/estatística & dados numéricos , Surtos de Doenças , Humanos , Oncologia/normas , Oncologia/estatística & dados numéricos , Neoplasias/classificação , Neoplasias/diagnóstico , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/normas , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Relatório de Pesquisa/normas , SARS-CoV-2/fisiologia , Telemedicina/normas , Telemedicina/estatística & dados numéricos
8.
Bull Cancer ; 108(3): 250-265, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33358747

RESUMO

OBJECTIVES: Immunotherapy is the current treatment in non-small cell lung cancer (NSCLC). 20% of patients treated with immunotherapy have a prolonged response. What about the remaining 80%? How can we explain that some patients get no benefit from immunotherapy? MATERIEL AND METHODS: We retrospectively analyzed predictive factors of primary or secondary resistance to immunotherapy in NSCLC patients from 2 French hospitals between 2015 and 2018. Moreover, we evaluated whether PD1 inhibitor had an impact on the antitumor effects of salvage chemotherapy administered after immunotherapy. We chose to focus on taxanes. RESULTS: Ninety-six patients were included in this cohort, 65(68%) patients were considered as having primary resistance and 31(32%) secondary resistance. Resistant populations did not differ. At immunotherapy initiation, median survival was 4.6 months for primary resistant patients (95%CI-4.6-6.8) and 15.6 months (95%CI-9.8-NA) for secondary resistant patients. The disease control rates with taxane were 15% in pre immunotherapy conditions vs 50% in post immunotherapy. Response rates improved regardless of the status of resistance. CONCLUSION: This study enriches data about immunotherapy in real-life in NSCLC. Prognostic resistance factors still seem complicated to identify. The high rate of taxane responders in post immunotherapy in this retrospective cohort support the use of taxane in therapeutic escape.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Resistencia a Medicamentos Antineoplásicos , Inibidores de Checkpoint Imunológico/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Nivolumabe/uso terapêutico , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/mortalidade , Feminino , Humanos , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Terapia de Salvação/métodos , Taxoides/uso terapêutico
9.
J Oncol Pharm Pract ; : 1078155220973065, 2020 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-33203300

RESUMO

INTRODUCTION: The aim of the study was to identify risk factors related to human errors in the preparation of anticancer drugs in order to improve the pharmaceutical process by setting corrective actions. METHOD: Risk factors which could increase the probability of error were identified: daily workload, workload on the previous day and subcontractors' workload, time slot of the preparation, understaffing, incidents which could affect workflow, individual experience of technicians and cleanrooms layout. Drug reconstitution or complex fabrications were also considered as risk factors. We used univariate and multivariate logistic regression analyses to screen for correlation between risks and errors. RESULT: Among 11 278 preparations analyzed, 115 were non-compliant. Univariate analysis shows significant variables: individual experience of technicians, technicians working in the same cleanrooms and technicians' rotations. 2 technicians are significantly associated with a higher risk of error and 5 with a lower risk. The multivariate analysis confirmed the conclusions of the univariate. DISCUSSION: As expected, time slot of the manufacture, cleanrooms layout and some technicians increase the risk of error. Surprisingly, technicians' experience led to increase the risk. This study is a first approach to evaluate the human error aspect in non-compliant preparations, in order to optimize security of antineoplastic drugs preparations.

10.
BMC Cancer ; 20(1): 337, 2020 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-32398106

RESUMO

BACKGROUND: Concern for cardiovascular disease (particularly atrial fibrillation-AF) among women with breast cancer is becoming a major issue. We aimed at determining the incidence of cardiovascular disease events (AF, arterial and cardiac events, venous-thromboembolism-VTE) in patients diagnosed with breast cancer, and assessing potential risk factors. METHODS: We reviewed medical records of all patients diagnosed with breast cancer from 2010 to 2011 in our cancer center. Baseline characteristics of patients and tumors were collected. The main outcome was the occurrence of cardiovascular disease events (AF, VTE, arterial and cardiac events) during the 5-years follow-up. RESULTS: Among the 682 breast cancer patients, 22 (3.2%) patients had a history of atrial fibrillation. Thirty-four patients (5%) presented at least one cardiovascular disease event, leading to a cumulative incidence of 5.8% events at 5-years ([3.8-7.7] CI 95%), with most of them occurring in the first 2 years. AF cumulative incidence was 1.1% ([0.1-2.1] CI 95%). Factors associated with the occurrence of cardiovascular disease events (including AF) were an overexpression of HER-2 (HR 2.6 [1.21-5.56] p < 0.011), UICC-stage III tumors or more (HR 5.47 [2.78-10.76] p < 0.001) and pre-existing cardiovascular risk factors (HR 2.91 [1.36-6.23] p < 0.004). CONCLUSION: The incidence of cardiovascular disease events was 5.8% ([3.8-7.7] CI 95%), with HER-2 over-expression, UICC-stage III tumors or more and pre-existing cardiovascular diseases being associated with them. These findings call for the development of preventive strategies in patients diagnosed with breast cancer.


Assuntos
Neoplasias da Mama/terapia , Carcinoma Ductal de Mama/terapia , Carcinoma Lobular/terapia , Doenças Cardiovasculares/epidemiologia , Quimiorradioterapia/efeitos adversos , Mastectomia/efeitos adversos , Idoso , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/patologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/patologia , Terapia Combinada , Feminino , Seguimentos , França/epidemiologia , Humanos , Incidência , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida
11.
Oncology ; 97(4): 217-227, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31220846

RESUMO

OBJECTIVE: Little data about the management of drugs in terminally ill palliative care cancer patients is available. The present study aimed at describing the evolution of anticancer and non-anticancer treatments (NACTs) in cancer patients in palliative care units. The second objective was to identify factors leading to the medical decision to withdraw or not NACTs. METHODS: Data from 1,091 cancer patients hospitalized in palliative care units were prospectively collected in 2010-2011, through a multicenter, observational French cohort. RESULTS: The median overall survival after admittance in palliative care units was 15 days. Specific anticancer treatments were systematically stopped in the first 24 h in palliative care units, but for 4.5% of patients. Regarding NACTs, patients were heavily treated with strong opioids (74%), corticosteroids (51%), and antidepressants (21.8%) until death. Antiulcer agents (63.4%), antibiotics (25.7%), thrombosis prevention (21.8%), antidiabetics (7.6%), and transfusions (4%) were often also continuously prescribed. In multivariate analysis, ECOG PS 4 was an independent predictor of continuous prescription of morphine and an independent predictor of discontinuation of corticosteroids, proton-pump inhibitors, antidiabetics, and preventive anticoagulant therapy. Infection symptoms independently predicted continuous prescription of paracetamol. Paralysis and cancer palpable mass independently predicted corticosteroid withdrawal. Brain metastases independently predicted antiulcer withdrawal. Hemorrhage independently predicted preventive anticoagulant withdrawal. Availability to a venous access independently predicted paracetamol and antiulcer continuous prescriptions. Co-prescriptions independently predicted continuous prescriptions (antibiotics with antiulcer, antifungals with antibiotics) or withdrawal (preventive anticoagulant with antiplatelets and antifungals). CONCLUSIONS: NACT prescription remained commonplace in terminally ill palliative cancer patients, although their benefit is questionable.


Assuntos
Neoplasias/tratamento farmacológico , Cuidados Paliativos/métodos , Assistência Terminal/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Feminino , França , Hospitalização , Humanos , Masculino , Oncologia/métodos , Pessoa de Meia-Idade , Neoplasias/patologia , Estudos Prospectivos , Doente Terminal , Adulto Jovem
12.
J Infect ; 79(1): 36-42, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31075291

RESUMO

OBJECTIVES: to prospectively evaluate the incidence and the clinical relevance on hematopoietic reconstitution of HHV-6 infection in autologous hematopoietic stem cell transplantation (ASCT) recipients. METHODS: HHV-6 DNA load was measured in whole blood specimens once during the 7 days before stem cell re-infusion and once a week after transplantation until hematopoietic recovery. Active HHV-6 infection was defined by 2 consecutive positive DNA loads. RESULTS: from July 2012 to February 2015, 196 adult patients undergoing ASCT were enrolled. Twenty-two (11.2%) patients developed active HHV-6 infection with a cumulative incidence of 19% at 40 days after transplantation. The onset of active HHV-6 infection occurred with a median of 13 days after stem cell re-infusion. HHV-6 infection was associated with an increased frequency of non-infectious complications (OR = 5.05; 95%CI 1.78-14.32; P < 0.001). Moreover, the severity of these non-infectious complications was higher in recipients exhibiting HHV-6 infection (OR = 4.62; 95%CI 1.32-16.2; p < 0.01). Delayed neutrophils 10 (IQR: 8-14) vs 8 (IQR: 6-11) days and platelets recoveries 15 (IQR: 11.8-18.5) vs 8 (IQR: 4-14) days were observed in patients with active HHV-6 infection compared to non-infected ones. CONCLUSIONS: in this study, 11.2% ASCT recipients presented active HHV-6 infection associated with significantly delayed hematologic reconstitution.


Assuntos
Herpesvirus Humano 6/isolamento & purificação , Infecções por Roseolovirus/epidemiologia , Transplante de Células-Tronco/efeitos adversos , Transplante Autólogo/efeitos adversos , Adulto , Idoso , DNA Viral/sangue , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Carga Viral
13.
Clin Genitourin Cancer ; 17(1): e38-e43, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30279115

RESUMO

BACKGROUND: About one-third of patients with renal cell carcinoma (RCC) have detectable metastases at diagnosis. Among them, bone is the second most frequent metastatic site. Treatment of metastatic RCC mostly relies on anti-angiogenic (AA) therapies and, more recently, immunotherapy. Skeletal-related events (SREs) can be prevented with bone-targeted therapies such as denosumab (Dmab), which has demonstrated superiority when compared with zoledronic acid in solid tumors. However, there is limited available data on Dmab toxicity in combination with AA therapies in patients with kidney cancer. The objective of this study was to retrospectively analyze the toxicity profile (mainly osteonecrosis of the jaw [ONJ] and hypocalcemia) in patients with metastatic renal cell carcinoma (mRCC) treated with Dmab and AA therapy combination. PATIENTS AND METHODS: We conducted a multicenter retrospective study among centers from the French Groupe d'Etudes des Tumeurs Uro Genitales (GETUG). Patients with bone metastases who received concurrently or sequentially AA therapy and Dmab were included in this study. RESULTS: A total of 41 patients with mRCC were enrolled. Although no patient presented with severe hypocalcemia, ONJ occurred in 7 (17%) of 41 patients. Interestingly, all patients with ONJ received the Dmab and AA combination in the first line of treatment; among these patients, 3 patients had no risk factor other than the Dmab and AA combination. CONCLUSION: The incidence of ONJ was high in this real-life population of patients with mRCC treated with AA therapies combined with Dmab. This toxicity signal should warn physicians about this combination in the mRCC population.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/etiologia , Conservadores da Densidade Óssea/efeitos adversos , Carcinoma de Células Renais/tratamento farmacológico , Denosumab/efeitos adversos , Hipocalcemia/induzido quimicamente , Neoplasias Renais/tratamento farmacológico , Idoso , Axitinibe/administração & dosagem , Carcinoma de Células Renais/secundário , Quimioterapia Combinada , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Neoplasias Renais/patologia , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Prognóstico , Pirimidinas/administração & dosagem , Estudos Retrospectivos , Sulfonamidas/administração & dosagem , Sunitinibe/administração & dosagem
14.
Crit Care ; 22(1): 326, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30514339

RESUMO

BACKGROUND: The study objective was to assess the influence of neutropenia on outcome of critically ill cancer patients by meta-analysis of individual data. Secondary objectives were to assess the influence of neutropenia on outcome of critically ill patients in prespecified subgroups (according to underlying tumor, period of admission, need for mechanical ventilation and use of granulocyte colony stimulating factor (G-CSF)). METHODS: Data sources were PubMed and the Cochrane database. Study selection included articles focusing on critically ill cancer patients published in English and studies in humans from May 2005 to May 2015. For study selection, the study eligibility was assessed by two investigators. Individual data from selected studies were obtained from corresponding authors. RESULTS: Overall, 114 studies were identified and authors of 30 studies (26.3% of selected studies) agreed to participate in this study. Of the 7515 included patients, three were excluded due to a missing major variable (neutropenia or mortality) leading to analysis of 7512 patients, including 1702 neutropenic patients (22.6%). After adjustment for confounders, and taking study effect into account, neutropenia was independently associated with mortality (OR 1.41; 95% CI 1.23-1.62; P = 0.03). When analyzed separately, neither admission period, underlying malignancy nor need for mechanical ventilation modified the prognostic influence of neutropenia on outcome. However, among patients for whom data on G-CSF administration were available (n = 1949; 25.9%), neutropenia was no longer associated with outcome in patients receiving G-CSF (OR 1.03; 95% CI 0.70-1.51; P = 0.90). CONCLUSION: Among 7512 critically ill cancer patients included in this systematic review, neutropenia was independently associated with poor outcome despite a meaningful survival. Neutropenia was no longer significantly associated with outcome in patients treated by G-CSF, which may suggest a beneficial effect of G-CSF in neutropenic critically ill cancer patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015026347 . Date of registration: Sept 18 2015.


Assuntos
Neoplasias/mortalidade , Neutropenia/complicações , Estado Terminal/mortalidade , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Neutropenia/mortalidade , Avaliação de Resultados em Cuidados de Saúde/métodos , Respiração Artificial/métodos
15.
Patient Prefer Adherence ; 12: 1853-1861, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30288026

RESUMO

Introduction: The announcement of cancer coupled with initiation of its treatment impacts patients' psychological and physical states as well as their lifestyles. The objective of this study was to identify and confirm the needs of patients starting off on anticancer chemotherapy treatment. Methods: This study was based on a qualitative-quantitative mixed method. In 2009, a qualitative study was conducted at the Lucien Neuwirth Cancer Institut for cancer patients undergoing intravenous chemotherapy for the first time. Exploratory and semi-directed interviews were carried out by a sociologist. In 2014, a questionnaire was hetero-administered to 100 patients starting off on chemotherapy. Results: Forty patients were interviewed in 2009. Ninety-seven patients answered the questionnaire in 2014. Food was a theme that was identified by a majority of patients in 2009 (13/40) and confirmed in 2014: 63% needed help in identifying favorable food and 67% in identifying those that had to be avoided. The other needs identified were those linked to better understanding of the treatment, of how it may affect the couple, its side effects, hygiene and beauty, and knowledge about other treatments. These needs were confirmed in 2014. New needs were elicited in 2014: activities and leisure (33%), psychological needs (32.6%), and family relations (29.9%). Conclusion: This study enabled us to identify, confirm, and enrich our knowledge of the needs of cancer patients starting off on intravenous chemotherapy. These results led to the modification of an existing patient education program for these patients, in order to fulfill their needs in an updated and tailored manner.

16.
Eur J Pediatr ; 177(8): 1219-1230, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29808238

RESUMO

Reducing inequalities in the field of cancer involves studying the knowledge and mental representations of cancer among children. A qualitative study was conducted on 191 children aged 9 to 12 using the "write and draw" technique to get spontaneous mental representations of "healthy things", "unhealthy things" and "cancer". We grouped the voluntary schools according to two deprivation levels. In response to the request to "write or draw anything you think keeps you healthy", the main responses categories were physical activity, healthy food and basic needs. Smoking, drinking alcohol, sedentary lifestyles/lack of sport were identified as "unhealthy". The first theme associated with "cancer" is the "cancer site" implying children have a segmented perception of cancer. Deprived children have radically different views about the key items representing cancer: they are more likely to believe the illness is systematically deadly. They are less likely to believe it is a treatable illness. They are less likely to associate cancer with risky behaviors, particularly alcohol consumption. CONCLUSION: Social inequalities affect representations of cancer and health literacy from early childhood. Prevention programs taking into account these representations need to be introduced at school. What is Known: • Social inequalities for cancer mortality are observed in all European countries and are particularly pronounced in France. • Reducing these inequalities in prevention programs implies studying the knowledge and mental representations of cancer among children. What is New: • This study identified representations of cancer in young children according to social level. • At age 9, children living in deprived areas are less able to produce content in discussions about cancer and have narrower mental representations and a more fatalistic view.


Assuntos
Atitude Frente a Saúde , Letramento em Saúde , Neoplasias/psicologia , Pobreza/psicologia , Classe Social , Determinantes Sociais da Saúde , Criança , Feminino , França , Humanos , Masculino , Neoplasias/terapia , Pesquisa Qualitativa
17.
Crit Rev Oncol Hematol ; 125: 78-83, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29650280

RESUMO

OBJECTIVE: To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. METHODS: databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. RESULTS: Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. CONCLUSION: The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies.


Assuntos
Ensaios Clínicos Fase II como Assunto/normas , Confiabilidade dos Dados , Oncologia/normas , Projetos de Pesquisa/normas , Ensaios Clínicos Fase II como Assunto/estatística & dados numéricos , Humanos , Oncologia/métodos
18.
PLoS One ; 12(12): e0185536, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29216190

RESUMO

BACKGROUND: Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. DATA SOURCES: A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). STUDY ELIGIBILITY CRITERIA: All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. INTERVENTION: Quality of reporting was assessed using the Key Methodological Score. RESULTS: 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). LIMITATIONS: Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. CONCLUSIONS & IMPLICATIONS OF KEY FINDINGS: This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.


Assuntos
Ensaios Clínicos Fase II como Assunto , Neoplasias/terapia , Ensaios Clínicos Fase III como Assunto , Humanos
19.
Crit Rev Oncol Hematol ; 112: 179-189, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28325258

RESUMO

The present review gives an overview of systematic reviews published in peer reviewed Journals analysing quality of reporting in oncology studies. PUBMED and Cochrane library were searched to identify systematic reviews assessing quality of reporting for randomized controlled trials (RCTs) and observational studies (OBS). Recommendations and primary endpoints used to assess the quality of reporting were described. Intrinsic quality of reporting was analyzed using an Overall Quality Score for literature Reviews (OQSR). Main evaluation themes were overall quality of reporting (20/58) and reporting of Health-Related Quality Of Life (HRQOL) in RCTs (7/58). Reporting recommendations used were not detailed in 56.9% of reviews. Insufficient reporting for the methodological description (randomization, blinding details, and allocation concealment) and the rationale for using specific measure of HRQOL were highlighted. OQSR was significantly higher for reviews published between 2010 and 2014 (after the PRISMA Publication), as compared to those published between 1996-2009 (median OQSR 10 (10-11) versus median OQSR 9 (6-10) respectively, p=0.0053). Intrinsic quality of reporting is satisfactory and has been improved in the last years.


Assuntos
Oncologia/normas , Literatura de Revisão como Assunto , Humanos
20.
PLoS One ; 11(10): e0164275, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27716793

RESUMO

BACKGROUND: Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. METHODS: From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. RESULTS: 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009). CONCLUSION: Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.


Assuntos
Oncologia/estatística & dados numéricos , Oncologia/normas , Editoração/normas , Relatório de Pesquisa/normas , Humanos , Escrita Médica/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos
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