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Skin toxicities are very common in patients undergoing cancer treatment and have been found to occur with all types of cancer therapeutic interventions (cytotoxic chemotherapy, targeted therapies, immunotherapy, and radiotherapy). Further, skin toxicities can lead to interruption or even discontinuation of anticancer treatment in some patients, translating to suboptimal outcomes. Dermocosmetics (or cosmeceuticals)-defined as skincare solutions incorporating dermatologically active ingredients (beyond vehicle effects) that directly improve symptoms of various skin conditions-are increasingly being used in cancer care to prevent and manage skin toxicities. The active ingredients in these products have a measurable biological action in skin; they typically improve skin integrity (barrier function/hydration and other factors) while relieving skin symptoms. The Association Francophone des Soins Oncologiques de Support (AFSOS) and Multinational Association of Supportive Care in Cancer (MASCC) partnered to select a multidisciplinary group of healthcare professionals involved in the management of patients with cancer and skin toxicities. The group reviewed existing literature and created a summary of recommendations for managing these toxicities through online meetings and communication. In this publication, the group (1) reviews new skin toxicities seen with oncology drugs and (2) evaluates the role of dermocosmetics in improving patient outcomes and minimizing cancer treatment interruptions. We provide general recommendations for initiation and selection of skin care in all oncology patients as well as recommendations for what factors should be considered when using dermocosmetics in specific types of skin toxicities.
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Neoplasias , Enfermedades de la Piel , Humanos , Consenso , Neoplasias/tratamiento farmacológico , Neoplasias/etiología , Piel , Inmunoterapia/efectos adversosRESUMEN
RATIONAL: The absence of a specific tool to evaluate the impact of supportive care in general and socioesthetics (SE) in particular is undoubtedly at the origin of the lack of published research based on scientific standards. OBJECTIVE: We developed a supportive-care, patient-reported outcome questionnaire using the multistep methods, following COSMIN recommendations. METHODS: The Patient Centricity Questionnaire (PCQ) was developed using the standardized methodology for designing patient-reported outcome (PRO) questionnaires according to the following steps: elaboration of the questionnaire, measurement properties of the questionnaire, internal and external validation, test-retest validation and translation, cross-cultural adaptation, and cognitive debriefing. A multidisciplinary work group was designed including professionals, such as physicians, public health experts, sociologists, supportive-care experts, and socioestheticians. RESULTS: Our questionnaire includes 11 items. It is scored by adding each Visual Analogue Scale [VAS], making it range from 0 to 110, with a higher benefit when the score is higher. The Cronbach's α coefficient is 0.88 for the entire questionnaire. As the questionnaire is a reflection of the patient's feelings, it is quite natural that the name "Patient Centricity Questionnaire" (PCQ) was retained and validated by the Scientific Committee. The PCQ correlated negatively and moderately with the Perceived Stress Scale [PSS], positively and moderately with the mental dimension of the Short Form-12, and poorly with the Well Beng 12 [WB12], the physical dimension of the SF-12, and the satisfaction VAS. CONCLUSION: Constructed according to the recommendations, the PCQ meets the prerequisite for this type of questionnaire. Its short format and simplicity of use allow it to be used by a large number of people. The PCQ is a simple, reliable, easy-to-use, and validated tool for research teams, making it possible for randomized studies to prove the impact of supportive care in general and SE in particular, on the patient's quality of life.
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Electronic patient-reported outcome (ePRO) systems for symptom monitoring in patients with cancer have shown quality of life and survival benefits in controlled trials. They are beginning to be used in routine oncology practice. Many software developers provide software solutions for clinicians, but how should clinicians decide which system to use? We propose a synthesis of the main questions regarding the effectiveness, safety, and functionality of an ePRO system that a clinician should ask software providers to assist in the selection of a software product in order to obtain the best value tools for their patients and their practice.
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Neoplasias , Oncólogos , Electrónica , Humanos , Neoplasias/terapia , Medición de Resultados Informados por el Paciente , Calidad de VidaRESUMEN
PURPOSE: To assess, focusing on population of healthcare professionals providing oncosexology care to men with cancer, clinical practice, attitudes, knowledge, communication, and professional interaction. METHODS: We performed a descriptive cross-sectional study with an online self-administered e-questionnaire addressed to all medical, paramedical, or administrative professionals attending the 4th "Cancer, Sexuality and Fertility" Meeting in Toulouse, France. Their participation was voluntary and totally anonymous. RESULTS: The 165 respondents comprised 44% of physicians, 47% of paramedics, and 9% of other health professionals in oncology, from all French regions. Paramedics were significantly younger than physicians (p = .006). One third of respondents were degreed in sexology, but 75.8% were in demand of oncosexology-specific trainings, particularly paramedics (p = .029). Regarding the oncosexology network, respondents declared being linked to organ specialists (56.8%), psychologists (49.5%), oncologists (47.4%), nurses (31.5%), radiation therapists (27.4%), and general practitioners (25.3%). Compared to paramedics, physicians were more likely to be engaged in oncosexology care (p = .039) and couple counseling (p = .005), but the proportions of counseled patients or couple were identical (p = .430 and p = .252, respectively). Overall, 90% of respondents reported discussing sexuality issues with patients. Regarding the time for discussion, physicians reported communicating more at cancer announcement (p = .004) or after treatments (p = .015), while more paramedics reported discussing at another time (p = .005). Regarding the place for discussion, paramedics more frequently reported talking about sexuality in the hospital room (p = .001) or during a specific consult (p = .007). CONCLUSIONS: Results emphasize various levels for improving existing oncosexology care, such as developing oncosexology-specific educational and practical training programs, particularly for paramedics; consolidating information, counseling, and therapeutic education with formal procedures like implementing medical and paramedical "oncosexology moments," or strengthening the community-hospital networks, from diagnosis to survivorship.
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Actitud del Personal de Salud , Conocimientos, Actitudes y Práctica en Salud , Neoplasias/psicología , Salud Sexual , Adulto , Comunicación , Estudios Transversales , Escolaridad , Femenino , Francia , Humanos , Relaciones Interprofesionales , Masculino , Oncología Médica/estadística & datos numéricos , Persona de Mediana Edad , Médicos/psicología , Médicos/estadística & datos numéricos , Sexología/estadística & datos numéricos , Conducta Sexual/psicología , Sexualidad/psicología , Encuestas y CuestionariosRESUMEN
BACKGROUND: Cancer management in the elderly is often considered as suboptimal, highly variable, and rarely evidence-based. Data are needed to understand decision-making processes in this population. MATERIALS AND METHODS: A survey was performed in France to describe decision-making in gynaecologic patients over 70. It followed a three-step method: (1) 101 representative physicians questioned about treatment decision criteria; (2) simplified individual data were collected; (3) as well as detailed data patients receiving chemotherapy. This analysis refers to breast cancer subgroup of patients. RESULTS: Main decision criteria were performance status, comorbidities, and renal function. In adjuvant setting, the main concern was life expectancy, whereas it was quality of life in metastatic setting. Of the 631 patients entered in the simplified analysis, 41% had been evaluated by a geriatrician, 67% received chemotherapy. In the detailed analysis, patients older than 75 were more likely to receive a monochemotherapy and to be treated with weekly/divided dose. In adjuvant setting, respectively, 19, 55, and 26% of the patients were treated with regimen validated in the elderly, validated in a younger population, and not validated. A G-CSF was prescribed in 48% of the patients, as primary prophylaxis in 78 and in 41% of patients with a risk of febrile neutropenia < 10%. CONCLUSION: Geriatric covariates become an increasing concern in the decision-making process. This survey also suggests an insufficient use of validated chemotherapy regimens. To date, age remains a risk factor for heterogeneity in oncologic practice justifying a persistent effort for elaborating and disclosing specific recommendations.
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Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/terapia , Toma de Decisiones Clínicas , Evaluación Geriátrica/métodos , Encuestas Epidemiológicas/estadística & datos numéricos , Factores de Edad , Anciano , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Adyuvante/métodos , Neutropenia Febril Inducida por Quimioterapia/etiología , Neutropenia Febril Inducida por Quimioterapia/prevención & control , Comorbilidad , Femenino , Francia , Factor Estimulante de Colonias de Granulocitos/uso terapéutico , Ginecología/métodos , Humanos , Esperanza de Vida , Masculino , Mastectomía , Oncología Médica/métodos , Selección de Paciente , Médicos/estadística & datos numéricos , Calidad de Vida , Proteínas Recombinantes/uso terapéuticoRESUMEN
PURPOSE: Medical doctors' (MDs), but not patients', perception of supportive care in cancer (SCC) in France has been previously assessed in a national survey. This study evaluated MDs and patients' perceptions of the SCC organization and implementation in France. METHODS: The French SCC Association conducted two observational studies: study 1 (S1), containing a 30-point questionnaire sent to 2263 MDs, and study 2 (S2), containing a 40-point questionnaire sent to 2000 patients. RESULTS: Overall, 711 MDs completed S1 and 1562 patients completed S2. In S1, 81% of MDs reported relying on a SCC organization and 76% attended SCC multidisciplinary discussions. MDs considered palliative (98%), psychological (98%), and social care (98%) as the top 3 SCC areas of importance for patients. In contrast, patients' priorities were psychology (61%), nutrition (55%) and organization of intake consultations (55%). The concept of SCC was familiar to 34% of patients; according to MDs, this concept was introduced mainly by MDs (78%) and admission nurses (41%). Outpatients identified as professional resources for SCC information general practitioners (84%), nurses (58%), and pharmacists (52%). Patients reported supportive treatment being prescribed in 63% of cases, with 64% receiving information on the negative side-effects. Among MDs, 87% reported proposing palliative and 41% adjuvant SCC treatment. Furthermore, 72% of MDs recommended SCC treatment at the metastatic stage, and 36% immediately following diagnosis. DISCUSSION: Oncologists play a vital role in enhancing SCC efficacy. This can be increased by implementing a multidisciplinary integrated approach or by assuring the availability of patient information.
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Neoplasias/psicología , Derivación y Consulta/normas , Apoyo Social , Femenino , Francia , Humanos , Masculino , Cuidados Paliativos/psicología , Encuestas y CuestionariosRESUMEN
PURPOSE: Venous thromboembolism (VTE) is one of the most frequent events associated with cancer, requiring hospitalization and generating additional healthcare costs. To date, no studies analyzing the additional costs resulting from VTE associated with cancer in France have been published. The objective of this study was to provide an estimation of the additional cost induced by VTE with cancer by analyzing hospital stays reported in the 2013 PMSI French Hospital Database ("Programme de Médicalisation des Systèmes d'Information", a national hospital administrative database) for four cancer types (breast, lung, hepatocellular carcinoma, and colon). METHODS: The analysis is divided into three parts: a descriptive evaluation of hospitalizations for VTE with cancer, an analysis by severity level of diagnosis-related groups (DRG), and an estimation of the hospital costs based on the National Reference Costs (ENC). The French public ATIH ("Agence Technique de l'Information sur l'Hospitalisation", a national Agency for Data on Hospital Care) database was used. The critical approach of this study is based on analysis of the distribution of stays according to levels of severity of DRG. RESULTS: A total of 14,251 hospitalizations were analyzed combining VTE and cancer. Hospitalizations of the two highest levels of severity (levels 3 and 4) for VTE with cancer represented 81.7 % of all hospitalizations in this population. Increased costs were seen for all four cancer types evaluated, with cost coefficients ranging from 1.34 to 2.01. For example, the average cost of lung cancer in cancer patients with VTE in the PMSI database was 7296 versus 4647 in the ATIH database. Cost coefficients were calculated, ranging from 1.34 in colon cancer, 1.50 for breast cancer, 1.57 in lung cancer, and 2.01 for hepatocellular carcinoma. CONCLUSION: As discussed in the article, the current costs are high. Better physician adherence to clinical practice guidelines could potentially reduce these costs by lowering the number of recurrent VTE in patients with cancer.
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Costos de Hospital , Hospitalización/economía , Neoplasias/complicaciones , Tromboembolia Venosa/terapia , Anciano , Femenino , Humanos , Masculino , Neoplasias/patologíaRESUMEN
BACKGROUND: Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer. METHODS: We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731. FINDINGS: We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths. INTERPRETATION: Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival. FUNDING: Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.
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Antagonistas de Andrógenos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/tratamiento farmacológico , Neoplasias de la Próstata/mortalidad , Anciano , Supervivencia sin Enfermedad , Docetaxel , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Estramustina/administración & dosificación , Estudios de Seguimiento , Francia , Humanos , Estimación de Kaplan-Meier , Masculino , Dosis Máxima Tolerada , Persona de Mediana Edad , Invasividad Neoplásica/patología , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Neoplasias de la Próstata/patología , Análisis de Supervivencia , Taxoides/administración & dosificación , Resultado del TratamientoRESUMEN
The French Cancer Centers (FCC) have a threefold mission, care research and education. Their specificity is multidisciplinary and comprehensive patient support at all stages of cancer. Innovation and research are at the heart of FCC action, but the care of patients in the palliative phase is a major and long-time concern. In each center there is an autonomous or integrated structure of palliative care in a service or Interdisciplinary Department of Support Care for the Patient in Oncology. These include, besides the hospice activity, chronic pain, psychooncology, social support, nutrition, functional rehabilitation, etc. Furthermore, the FCC have, in accordance with a secondary regulatory text to National Plans for palliative care, identified beds of palliative care (IBPC) in oncology day hospitals and in palliative care. In 2006 a Unicancer FCC group was established. One of the group's goals is to promote "early palliative care" together with other FCC teams. A common research dynamic has been implemented, ensuring the development of organizations and palliative culture.
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Instituciones Oncológicas/tendencias , Neoplasias/terapia , Cuidados Paliativos/tendencias , Francia , Humanos , Innovación Organizacional , Objetivos OrganizacionalesRESUMEN
BACKGROUND: Early chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer. METHODS: In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m(2) intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715. FINDINGS: Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39-63). Median overall survival was 58·9 months (95% CI 50·8-69·1) in the group given ADT plus docetaxel and 54·2 months (42·2-not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75-1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group. INTERPRETATION: Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer. FUNDING: French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen.
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Antagonistas de Andrógenos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Próstata/tratamiento farmacológico , Taxoides/administración & dosificación , Taxoides/uso terapéutico , Anciano , Antagonistas de Andrógenos/administración & dosificación , Supervivencia sin Enfermedad , Docetaxel , Humanos , Masculino , Persona de Mediana Edad , Orquiectomía , Neoplasias de la Próstata/mortalidadRESUMEN
BACKGROUND AND OBJECTIVE: Docetaxel has become a standard component of care for advanced prostate cancer (PC); however, its benefits are not universal among patients. A subset of PC cases exhibit TMPRSS2-ERG gene fusion, resulting in ERG overexpression in tumors. Our aim was to assess biomarkers for docetaxel efficacy in men with hormone-sensitive PC (HSPC). METHODS: Pretreatment prostate biopsies were obtained from participants in two randomized phase 3 clinical trials investigating docetaxel in high-risk localized PC (GETUG 12) and metastatic HSPC (GETUG 15). Immunohistochemistry staining for Ki67, PTEN, RB, and phosphorylated RB was conducted for GETUG 12 samples, and ERG staining for GETUG 12 and GETUG 15 samples. We examined biomarker association with outcomes using univariate and multivariable analyses adjusted for other validated prognostic factors. KEY FINDINGS AND LIMITATIONS: Among GETUG 12 patients, Ki67 was associated with a worse relapse-free survival (RFS; hazard ratio [HR] 1.72; p = 0.0092). A pooled analysis for the two trials (pinteraction = 0.056) revealed that docetaxel-based chemotherapy improved failure-free survival for patients with ERG-positive cancer (HR 0.58; p = 0.03), but not patients with ERG-negative cancer (HR 1.08; p = 0.72). In the ERG-positive subgroup in GETUG 12 (high-risk localized PC), median RFS was 7.79 yr with androgen deprivation therapy (ADT) alone, and was not reached with ADT + docetaxel. In the ERG-negative subgroup, median progression-free survival (mPFS) was 7.79 yr with ADT alone versus 7.08 yr with ADT + docetaxel. In the ERG-positive subgroup in GETUG 15 (metastatic HSPC), mPFS was 10.7 mo with ADT alone versus 18.8 mo with ADT + docetaxel. In the ERG-negative subgroup, mPFS was 10.6 mo with ADT alone versus 13.2 mo with ADT + docetaxel. CONCLUSIONS AND CLINICAL IMPLICATIONS: Ki67 may serve as a prognostic factor in HSPC, while ERG expression appears to predict a response to docetaxel in both high-risk localized and metastatic HSPC. PATIENT SUMMARY: We assessed factors that could predict outcomes after docetaxel chemotherapy in patients with advanced prostate cancer. We found that expression of a protein called ERG can predict a good response to docetaxel in these patients.
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INTRODUCTION: Serum prostate specific antigen (PSA) is a well-known prognostic parameter in men with prostate cancer. The treatment of men with very high PSA values and apparently no detectable metastases is not fully established. PATIENTS AND METHODS: Ancillary analysis from the GETUG 12 phase 3 trial. Patients with non-metastatic high-risk prostate cancer by bone and computerized tomography (CT) scan were randomly assigned to receive androgen deprivation therapy (ADT) and docetaxel plus estramustine or ADT alone. Relapse-free survival (RFS), clinical RFS, metastases-free survival (MFS), overall survival (OS), and prostate cancer-specific survival (PCSS) were estimated using the Kaplan-Meier method for different levels of PSA (50 ng/mL, 75 ng/mL, and 100 ng/mL). The relationship between PSA and outcomes was studied using residual-based approaches and spline functions. RESULTS: The median follow-up was 12 years (range: 0-15.3). Baseline PSA (<50 ng/mL, n = 328; ≥50ng/mL, n = 85) was associated with improved RFS (P = .0005), cRFS (P = .0024), and MFS (P = .0068). The 12-year RFS rate was 46.33% (CI 40.59-51.86), 33.59% (CI 22.55-44.97), and 11.76% (1.96-31.20) in men with PSA values <50 ng/mL (n = 328), 50-100 ng/mL (n = 68), and ≥100 ng/mL (n = 17), respectively. Exploratory analyses revealed no deviation from the linear relationship assumption between PSA and the log hazard of events. CONCLUSIONS: Men with apparently localized prostate cancer and a high baseline PSA value have a reasonable chance of being long-term disease-free when treated with curative intent combining systemic and local therapy.
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Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/patología , Antígeno Prostático Específico , Antagonistas de Andrógenos/efectos adversos , Resultado del Tratamiento , Recurrencia Local de Neoplasia/tratamiento farmacológico , Docetaxel , Estramustina/uso terapéuticoRESUMEN
This French study aimed to evaluate oncologists' and patients' perception of physical activity, particularly adapted physical activity, in order to identify the obstacles and levers to its practice in patients with metastatic cancer. METHOD: Between October 2019 and March 2020, 60 medical oncologists and 305 patients with metastatic cancer were asked to fill in a self-completed questionnaire. RESULTS: The benefits of physical activity are recognised by most oncologists and patients. These benefits were perceived more by oncologists in prevention (78%) or in the early stage (72%) of the disease than in the metastatic stage (55%) (P=0.01). Patient's physical condition (45%) and age (37%) but also the lack of time during the consultation to explain supportive care (35%) are the main obstacles identified by the oncologist to the integration of physical activity into patient care. Furthermore, lack of knowledge of adapted programmes is the main reason given by the physicians who have never prescribed physical activity (51%). On the patient side, while 88% of them had heard of the benefits of physical activity, only 11% had received a prescription. Most oncologists and patients were very interested in receiving information on where and what types of activities to practice, as well as what to avoid. CONCLUSION: Efforts in terms of information for both oncologists and patients seem necessary to increase the level of physical activity prescription and practice for patients followed for metastatic cancer.
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Neoplasias Primarias Secundarias , Neoplasias , Oncólogos , Humanos , Motivación , Neoplasias/terapia , Neoplasias/patología , Derivación y Consulta , Ejercicio FísicoRESUMEN
OBJECTIVE: To investigate the potential benefit of reintroducing docetaxel chemotherapy in patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who had initially responded to first-line docetaxel-based regimen. PATIENTS AND METHODS: Records were evaluated retrospectively from French patients with mCRPC who had been included in seven controlled clinical studies of docetaxel as first-line treatment. We identified patients who were confirmed as responders to first-line treatment, discontinued for reasons other than disease progression or unacceptable toxicity, and who received further docetaxel chemotherapy for disease progression. The primary objective was to assess efficacy in terms of the prostate-specific antigen (PSA) response after resuming a docetaxel-based chemotherapy. Secondary objectives were overall survival and tolerance. RESULTS: Of the 148 patients who responded to first-line docetaxel, 50 received further therapy with docetaxel and were analysed. The median (range) response duration to first-line docetaxel was 10.3 (4.6-45.7) months and the median docetaxel-free interval was 18.4 (5.0-46.7) months. Docetaxel was reintroduced as second-line therapy in 52% of patients and as further lines in 48%. After docetaxel reintroduction, 24 patients (48%) had a 50% decrease in PSA level (95% confidence interval, CI, 34.1-61.8%). The median (95% CI) overall survival from docetaxel reintroduction was 16 (13-20) months. Re-treatment was well tolerated (6% of grade 3-4 haemotoxicity). CONCLUSION: Docetaxel reintroduction appears to be effective, with favourable tolerance profiles, in patients with mCRPC having responded to first-line docetaxel, and should be prospectively assessed in clinical trials against alternative therapies or investigational agents given alone or in combination, to define further management.
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Antineoplásicos/uso terapéutico , Resistencia a Antineoplásicos/efectos de los fármacos , Neoplasias Hormono-Dependientes/tratamiento farmacológico , Neoplasias de la Próstata/tratamiento farmacológico , Taxoides/uso terapéutico , Anciano , Anciano de 80 o más Años , Antineoplásicos/efectos adversos , Progresión de la Enfermedad , Docetaxel , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Neoplasias Hormono-Dependientes/cirugía , Orquiectomía , Neoplasias de la Próstata/cirugía , Retratamiento , Estudios Retrospectivos , Taxoides/efectos adversos , Resultado del TratamientoRESUMEN
INTRODUCTION: Most patients (>70%) experience acute neuropathic symptoms shortly after oxaliplatin infusions. These symptoms are not always resolved between infusions. Overall, 30%-50% of patients suffer from chronic oxaliplatin-induced peripheral neuropathy (OIPN). This cumulative and dose-dependent sensory neuropathy limits compliance or results in oxaliplatin-based chemotherapies to be substituted with less neurotoxic agents. These treatment changes impair clinical outcomes, and may be associated with comorbidities, such as distress, depression and anxiety. Currently, no drug used to prevent or treat OIPN is sufficiently effective to be used routinely in clinical practice. There is, thus, an unmet therapeutic need to reduce the intensity of and/or prevent OIPN. We hypothesised that riluzole would be an excellent candidate to address this public health issue. Riluzole is approved for treating amyotrophic lateral sclerosis. In animals, there is a beneficial effect on sensorimotor and pain disorders, as well as related comorbidities, after repeated administration of oxaliplatin. In humans, riluzole has shown neuroprotective, anxiolytic and antidepressive effects. METHODS AND ANALYSIS: RILUZOX-01 trial was designed as a randomised, controlled, double-blind study to evaluate the efficacy of riluzole to prevent OIPN. Patients with colorectal cancer and initiating adjuvant oxaliplatin-based chemotherapy are eligible. Patients (n=210) will be randomly assigned to either riluzole or placebo, concomitantly with chemotherapy. The primary endpoint is the change in OIPN intensity, assessed by the sensory scale of the QLQ-CIPN20, after six 2-week cycles of chemotherapy. Secondary endpoints include incidence and severity of neuropathy, grade of sensory neuropathy, intensity and features of neuropathic pain, health-related quality of life, disease-free survival, overall survival and safety. ETHICS AND DESSIMINATION: The study was approved by a French ethics committee (ref:39/18_1, 'Comité de Protection des Personnes' Ouest-IV, France) and plans to start enroling patients in September 2019. The trial is registered in EudraCT and clinicaltrials.gov. TRIAL REGISTRATION NUMBER: N°2017-002320-25; NCT03722680.
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Antineoplásicos/efectos adversos , Fármacos Neuroprotectores/uso terapéutico , Síndromes de Neurotoxicidad/prevención & control , Oxaliplatino/administración & dosificación , Enfermedades del Sistema Nervioso Periférico/prevención & control , Riluzol/uso terapéutico , Método Doble Ciego , Humanos , Estudios Multicéntricos como Asunto/métodos , Síndromes de Neurotoxicidad/etiología , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Resultado del TratamientoRESUMEN
Antineoplastic drug induced nausea and vomiting (ANDINV) (previously named: Chemotherapy-induced nausea and vomiting [CINV]) are one of the most feared adverse effect for patients who begin treatment with anti-cancer treatments and their bad control have a negative impact in the management of these patients. In this review article, it is proposed an update of French-speaking Association for oncologic supportive care (AFSOS) clinical practice of CINV guidelines. This update became necessary for several reasons: newly available anti-emetic drugs; new data published about individual risk factors of CINV; new antineoplastic agents available; changing in emetic risk levels for some molecules in the international guidelines. To address these guidelines, the various clinical presentations of ANDINV and their intensity classification are discussed. Then, the different therapeutic solutions are presented: classes of conventional drug therapies, complementary therapies and advice to patients. Then, the implementation of primary prophylaxis are presented in four steps: (1) to evaluate the emetic risk level of antineoplastic agent; (2) to set the emetic risk level of antineoplastic protocols; (3) to set types of antiemetic drugs to implement; (4) "Outperform" prophylaxis in case of individual risk factors. Finally, implementation of secondary prophylaxis and rescue treatments are adressed.
Asunto(s)
Antineoplásicos/efectos adversos , Náusea/inducido químicamente , Náusea/prevención & control , Vómitos/inducido químicamente , Vómitos/prevención & control , HumanosRESUMEN
BACKGROUND: An international consensus proposed in 2011 a definition and classification system for cachexia (CAX), mainly based on weight loss, sarcopenia [skeletal muscle mass (SMM) loss], inflammation, and anorexia. The aim of this study was to stage CAX in non-small-cell lung cancer (NSCLC) patients by using a classification based on the Fearon criteria and supported by quantifiable parameters. METHODS: This was a cross-sectional and non-interventional multicentre study. SMM was assessed by analysing L3 computed tomography-scan images. Patients completed the anorexia/CAX subscale of the Functional Assessment of Anorexia/Cachexia Therapy, EORTC QLQ-C30 quality of life (QoL) and International Physical Activity Questionnaire (IPAQ). RESULTS: Patients were recruited in 56 sites. The analysis population comprised 531 patients, and SMM was assessed in 312 patients. Male patients were 66.5%, with a mean (SD) age of 65.2 (10.0) years, 79.9% were PS 0-1, and the tumour stage was mainly IIIB-IV (87.3%). Overall, 38.7% of patients had CAX, 33.8% pre-CAX, and 0.9% refractory CAX. Molecular tumour profiles were significantly associated with the presence of CAX: 23.9% in EGFR, ALK, ROS1, BRAF, or HER2+ patients, 41.4% in K-RAS+, and 43.2% in patients with no molecular abnormality (P = 0.003). The more advanced the CAX stage, the poorer the scores of functional items of the QoL (P < 0.001) and International Physical Activity Questionnaire (P < 0.001). Sarcopenia was present in 66.7% of CAX and 68.5% of pre-CAX patients. Overall, 43.8% of pre-CAX patients had only sarcopenia with limited weight loss (≤2%) and no anorexia. CONCLUSIONS: This is the first study to show the distribution of CAX in a population of NSCLC patients and an association between molecular abnormality in NSCLC and CAX. The original Fearon classification for CAX stages was supported by the associated functional QoL scores and physical activity levels, resulting in a clinically relevant system for detection of early stages of CAX.
Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas/complicaciones , Neoplasias Pulmonares/complicaciones , Músculo Esquelético/patología , Trastornos Nutricionales/diagnóstico , Anciano , Carcinoma de Pulmón de Células no Pequeñas/patología , Femenino , Humanos , Neoplasias Pulmonares/patología , Masculino , Estadificación de NeoplasiasRESUMEN
IMPORTANCE: Androgen-deprivation therapy (ADT) plus docetaxel is the standard of care in hormone-naive metastatic prostate cancer but is of uncertain benefit in a nonmetastatic, high-risk prostate cancer setting. OBJECTIVE: To assess the benefit of ADT plus docetaxel in patients presenting with rising prostate-specific antigen (PSA) levels after primary local therapy and high-risk factors but no evidence of metastatic disease. DESIGN, SETTING, AND PARTICIPANTS: This open-label, phase 3, randomized superiority trial comparing ADT plus docetaxel vs ADT alone enrolled patients from 28 centers in France between June 4, 2003, and September 25, 2007; final follow-up was conducted April 12, 2017, and analysis was performed May 2 to July 31, 2017. Patients had undergone primary local therapy for prostate cancer, were experiencing rising PSA levels, and were considered to be at high risk of metastatic disease. Stratification was by prior local therapy and PSA-level doubling time (≤6 vs >6 months), and intention-to-treat analysis was used. INTERVENTIONS: Patients were randomly assigned to receive ADT (1 year) plus docetaxel, 70 mg/m2 (every 3 weeks [6 cycles]), or ADT alone (1 year). MAIN OUTCOMES AND MEASURES: The primary outcome was PSA progression-free survival (PSA-PFS). Secondary end points were PSA response, radiologic PFS, overall survival, safety, and quality of life. RESULTS: Overall, 254 patients were randomized (1:1) to the trial; median age, 64 years in the ADT plus docetaxel arm, 66 years in the ADT alone arm. At a median follow-up of 30.0 months, the median PSA-PFS was 20.3 (95% CI, 19.0-21.6) months in the ADT plus docetaxel arm vs 19.3 (95% CI, 18.2-20.8) months in the ADT alone arm (hazard ratio [HR], 0.85; 95% CI, 0.62-1.16; P = .31). At a median follow-up of 10.5 years, there was no significant between-arm difference in radiologic PFS (HR, 1.03; 95% CI, 0.74-1.43; P = .88). Overall survival data were not mature. The most common grade 3 or 4 hematologic toxic effects in the ADT plus docetaxel arm were neutropenia (60 of 125 patients [48.0%]), febrile neutropenia (10 [8.0%]), and thrombocytopenia (4 [3.0%]). There was no significant between-arm difference in overall quality of life. CONCLUSIONS AND RELEVANCE: Compared with ADT alone, combined ADT plus docetaxel therapy with curative intent did not significantly improve PSA-PFS in patients with high-risk prostate cancer and rising PSA levels and no evidence of metastatic disease. TRIAL REGISTRATION: French Health Products Safety Agency identifier: 030591; ClinicalTrials.gov identifier: NCT00764166.
Asunto(s)
Antagonistas de Andrógenos/administración & dosificación , Anilidas/administración & dosificación , Antineoplásicos/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Docetaxel/administración & dosificación , Nitrilos/administración & dosificación , Neoplasias de la Próstata/tratamiento farmacológico , Compuestos de Tosilo/administración & dosificación , Pamoato de Triptorelina/administración & dosificación , Anciano , Antagonistas de Andrógenos/efectos adversos , Anilidas/efectos adversos , Antineoplásicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Docetaxel/efectos adversos , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Nitrilos/efectos adversos , Supervivencia sin Progresión , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/sangre , Calidad de Vida , Riesgo , Compuestos de Tosilo/efectos adversos , Pamoato de Triptorelina/efectos adversosRESUMEN
INTRODUCTION: Research has suggested a high level of satisfaction following beauty and well-being care in oncology. We aimed to assess perception of beauty and well-being care in a large sample of patients affected by cancer. METHODS: From June through August, 2017, a physical and online survey was conducted recruiting patients affected by cancer and their relatives. A questionnaire, established in a collaborative manner with healthcare providers and patients, collected general demographic and medical data, awareness and knowledge data, the experience of beauty and well-being care and perceived benefits. RESULTS: At baseline, 1263 people were recruited (online, n=485; others, n=778) with 1254 usable replies. After excluding caregivers (n=88), the analysis was made on 1166 patients (mean age=51.7). This sample included 1080 women (92.6 %) and breast cancer was prominent (n=827; 70.9%). Among the 481 patients, who had received beauty and well-being care, 405 stated them as a relaxing time (84 %) and the average ranking was 8,1/10. Mean number of sessions was 2.8. A combined scheme of beauty and well-being care (individual and collective) and a greater number of sessions were statistically associated with a higher perceived benefit (P=0.02 and P<0.001) and a higher level of recommendation (P=0.039 and P=0.05). DISCUSSION: This large national survey confirms the high level of satisfaction associated with beauty and well-being care. The type and number of sessions seem to be positively correlated with a greater benefit.