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1.
BMC Cancer ; 21(1): 1292, 2021 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-34856936

RESUMEN

INTRODUCTION: Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no predictive biomarkers for pathological complete response (pCR) are currently validated in clinical practice. Studies evaluating immune checkpoint inhibitors in the peri-operative setting are emerging with promising results. Clinical trials are clearly required in the neoadjuvant setting in order to improve therapeutic strategies. METHODS AND ANALYSIS: Oncodistinct 004 - AURA is an ongoing multicenter phase II randomized trial assessing the efficacy and safety of avelumab single-agent or combined to different NAC regimens in patients with non-metastatic MIBC. Patients are enrolled in two distinct cohorts according to their eligibility to receive cisplatin-based NAC. In the cisplatin eligible cohort, patients are randomized in a 1:1 fashion to receive avelumab combined with cisplatin-gemcitabine or with dose-dense methotrexate-vinblastine-doxorubicin-cisplatin. In the cisplatin ineligible cohort, patients are randomized at a 1:1 ratio to paclitaxel-gemcitabine associated to avelumab or avelumab alone. Primary endpoint is pCR. Secondary endpoints are pathological response and safety. ETHICS AND DISSEMINATION: The study is approved by ethics committee from all participating centers. All participants provide informed consent prior inclusion to the study. Once completed, results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03674424).


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antineoplásicos Inmunológicos/uso terapéutico , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Terapia Neoadyuvante/métodos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Anticuerpos Monoclonales Humanizados/efectos adversos , Antineoplásicos/uso terapéutico , Antineoplásicos Inmunológicos/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioterapia Adyuvante/métodos , Cisplatino/administración & dosificación , Cisplatino/uso terapéutico , Desoxicitidina/administración & dosificación , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapéutico , Doxorrubicina/administración & dosificación , Doxorrubicina/uso terapéutico , Humanos , Metotrexato/administración & dosificación , Metotrexato/uso terapéutico , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Neoplasias de la Vejiga Urinaria/patología , Vinblastina/administración & dosificación , Vinblastina/uso terapéutico , Gemcitabina
2.
J Oncol Pharm Pract ; 27(1): 216-219, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32397905

RESUMEN

INTRODUCTION: Abiraterone acetate is an inhibitor of androgens biosynthesis, approved as first-line treatment in castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. Abiraterone has been rarely associated with severe rhabdomyolysis, but the mechanism of muscle toxicity is unknown. CASE REPORT: We hereby present a case of severe rhabdomyolysis resulting in acute on chronic kidney injury following abiraterone initiation in a patient previously under rosuvastatin. MANAGEMENT AND OUTCOME: Rhabdomyolysis was resolutive after rosuvastatin and abiraterone discontinuation, and kidney function recovered. There was no recurrence of muscle toxicity after re-initiation of abiraterone alone. DISCUSSION: Abiraterone selectively inhibits CYP17 as well as the hepatic transporter OATP1B1. OATP1B1 is an efflux transporter, whose function is to extract several drugs from the portal blood, allowing them to undergo hepatic metabolism. We hypothesize that abiraterone-induced inhibition of plasmatic uptake of rosuvastatin by OATP1B1 increased plasmatic concentration of rosuvastatin, leading to toxicity on muscle cells. We therefore suggest that the association between rosuvastatin and abiraterone should be avoided.


Asunto(s)
Acetato de Abiraterona/efectos adversos , Lesión Renal Aguda/inducido químicamente , Rabdomiólisis/inducido químicamente , Rosuvastatina Cálcica/efectos adversos , Anciano , Humanos , Transportador 1 de Anión Orgánico Específico del Hígado/antagonistas & inhibidores , Masculino , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico
3.
Urol Int ; 94(4): 485-7, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25531760

RESUMEN

Non-clear cell renal cell carcinoma accounts for about 20% of all kidney cancers. Tubulocystic carcinoma of the kidney (TCK) is a newly described entity with distinct molecular, genetic and clinical features. In 2013, it was one of five new renal tumors to be recognized by the International Society of Urological Pathology Vancouver Classification of Renal Neoplasia. We describe here a case of TCK with a rare genetic signature, unusual metastases and limited response to an anti-vascular endothelial growth factor inhibitor in what we believe is the youngest patient on record to date.


Asunto(s)
Carcinoma de Células Renales/secundario , Neoplasias Renales/patología , Adolescente , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Biomarcadores de Tumor/análisis , Biopsia , Carcinoma de Células Renales/química , Carcinoma de Células Renales/clasificación , Carcinoma de Células Renales/cirugía , Cisplatino/uso terapéutico , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapéutico , Progresión de la Enfermedad , Resultado Fatal , Humanos , Indoles/uso terapéutico , Neoplasias Renales/química , Neoplasias Renales/clasificación , Neoplasias Renales/cirugía , Masculino , Nefrectomía , Neoplasias Pleurales/tratamiento farmacológico , Neoplasias Pleurales/secundario , Inhibidores de Proteínas Quinasas/uso terapéutico , Pirroles/uso terapéutico , Sunitinib , Factores de Tiempo , Resultado del Tratamiento , Gemcitabina
4.
Clin Cancer Res ; 26(1): 61-70, 2020 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-31801732

RESUMEN

PURPOSE: Patients with advanced urothelial carcinoma who fail platinum-containing chemotherapy (treatment fails) have a poor prognosis and limited treatment options. Recent approvals of immune-checkpoint inhibitors confirmed the value of immunomodulatory therapy in urothelial carcinoma. Tremelimumab is a selective human immunoglobulin G2 (IgG2) monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4 with demonstrated durable response rate in metastatic melanoma. This is the first study to report the efficacy and safety of tremelimumab in urothelial carcinoma. PATIENTS AND METHODS: We report the results of the urothelial carcinoma cohort from a phase II, open-label, multicenter study of patients with advanced solid tumors (NCT02527434). Patients with locally advanced/metastatic urothelial carcinoma were treated with tremelimumab monotherapy (750 mg via intravenous infusion every 4 weeks for seven cycles, then every 12 weeks for two additional cycles) for up to 12 months or until disease progression, initiation of other anticancer therapy, unacceptable toxicity, or consent withdrawal. RESULTS: In 32 evaluable patients with metastatic urothelial carcinoma, objective response rate was 18.8% (95% confidence interval, 7.2-36.4), including complete response (CR) in 2 (6.3%), and partial response in 4 patients (12.5%). Median duration of response has not been reached. Stable disease of ≥12 months was reported in 1 patient (3.1%), yielding a disease control rate at 12 months of 21.9%. Overall, tremelimumab was generally well tolerated; safety results were consistent with the known safety profile. CONCLUSIONS: Tremelimumab monotherapy demonstrated clinical activity and durable responses in patients with metastatic urothelial carcinoma. This study is the first in which CR has been observed with tremelimumab as a single agent in urothelial carcinoma.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Carcinoma de Células Transicionales/tratamiento farmacológico , Resistencia a Antineoplásicos/efectos de los fármacos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Compuestos Organoplatinos/farmacología , Terapia Recuperativa , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/secundario , Femenino , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Seguridad del Paciente , Tasa de Supervivencia , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/patología
5.
Expert Opin Pharmacother ; 19(16): 1797-1804, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30311804

RESUMEN

INTRODUCTION: Prostate cancer is the second most common cause of cancer worldwide and is the most frequently detected cancer in the European Union in men over 50 years of age. Androgen deprivation therapy remains the cornerstone of treatment for recurrent or metastatic disease. Unfortunately, nearly all patients will develop resistance to androgen blockade leading to castration-resistant prostate cancer (CRPC). Over the last 10 years, new treatments have dramatically improved overall survival of men with mCRPC. Current therapies are based on AR-axis inhibitors and taxane-based chemotherapies, as well as radiopharmaceuticals and Sipuleucel T. AREAS COVERED: The authors provide a review of the current field of systemic therapy in metastatic CRPC. This is followed by an in-depth analysis of recent developments in treatment, and the biological rationale behind these therapies. EXPERT OPINION: Since several trials with docetaxel or novel hormonal agents showed improvement in overall survival in metastatic castration-sensitive prostate cancer, as well as in non-metastatic castration-resistant patients, it is expected that a growing subgroup of patients will be exposed earlier to chemotherapy and to AR targeted agents. It becomes then fundamental to find novel strategies to overcome drug resistance and further improve survival.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Próstata Resistentes a la Castración/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/farmacología , Humanos , Masculino , Persona de Mediana Edad , Metástasis de la Neoplasia
6.
Bull Cancer ; 105(2): 140-145, 2018 Feb.
Artículo en Francés | MEDLINE | ID: mdl-29290331

RESUMEN

Treatments for patients with metastatic or advanced urothelial carcinomas on progression after first line chemotherapy or unfit for cisplatin are currently limited. Atezolizumab (Tecentriq®) is a monoclonal antibody targeting PD-L1. The first of IMVIGOR 210 phase II trial (NCT02951767) investigated atezolizumab as front line treatment among 119 patients with metastatic urothelial cancer unfit for cisplatin. Response rate was 23% and median overall survival 15.9 months. The second cohort (NCT02108652) included 310 patients whose tumors were progressing after first line platinum-based chemotherapy. Response rate was 15% and median overall survival 7.9 months. Among patients with high PD-L1 expression on infiltrating immune cells (ICs), response rate was 26% and median overall survival 11 months. Atezolizumab was well-tolerated in both cohorts with 66% of treatment-related toxicities including 12% (cohort 1) and 7% (cohort 2) of grade 3-4 adverse events. These results led to an approval by the FDA in United States and the EMA in Europe. In France, atezolizumab was available through an early access agreement by the French National Agency for Medicines and Health Products (ANSM) for patients with metastatic or advanced urothelial carcinomas on progression after first line chemotherapy or unfit for cisplatin. So far, its avaibility in France within the EMA approval is pending its pricing.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Antineoplásicos/uso terapéutico , Carcinoma de Células Transicionales/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/farmacocinética , Anticuerpos Monoclonales Humanizados , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Antineoplásicos/farmacocinética , Antígeno B7-H1/metabolismo , Carcinoma de Células Transicionales/metabolismo , Carcinoma de Células Transicionales/mortalidad , Carcinoma de Células Transicionales/patología , Cisplatino/efectos adversos , Ensayos Clínicos Fase I como Asunto , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Contraindicaciones de los Medicamentos , Humanos , Neoplasias de la Vejiga Urinaria/metabolismo , Neoplasias de la Vejiga Urinaria/mortalidad , Neoplasias de la Vejiga Urinaria/patología
7.
Eur J Cancer ; 69: 151-157, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27821318

RESUMEN

BACKGROUND: Patients with germ cell tumours (GCT) receiving cisplatin-based chemotherapy are at high risk of thromboembolic events (TEE). Previously, we identified serum lactate dehydrogenase (LDH) and body surface area (BSA) as independent predictive factors for TEE. The aim of this study was to validate these predictive factors and to assess the impact of thromboembolism prophylaxis in patients at risk of deep venous thrombosis (DVT). METHODS: Between 2001 and 2014, 295 patients received first-line cisplatin-based chemotherapy for GCT. Preventive anticoagulation with low-molecular-weight heparin (LMWH) was progressively implemented in patients with predictive factors. Sixteen patients with evidence of TEE before starting chemotherapy were excluded from the analysis. RESULTS: Among 279 eligible patients, a TEE occurred in 38 (14%) consisting of DVT (n = 26), arterial thrombosis (n = 2), and superficial thrombophlebitis (n = 10). DVT occurred in 26 (12.7%) of 204 patients with risk factors versus two (2.6%) of 75 patients with no risk factors (p = 0.01). After a prevention protocol was progressively implemented from 2005, primary thromboprophylaxis was administered to 104 patients (68%) with risk factors. Among patients at risk (n = 151), the incidence of DVT decreased by roughly half when they received a LMWH: 9/97 (9.2%) and 9/54 (16.6%), respectively (p = 0.23). CONCLUSION: Patients with GCT who receive cisplatin-based chemotherapy are at risk of developing a TEE which can be predicted by elevated serum LDH. To our knowledge this is the first study exploring LMWH as thromboprophylaxis in GCT patients. A prospective trial testing prophylactic anticoagulation is warranted.


Asunto(s)
Antineoplásicos/uso terapéutico , Superficie Corporal , Cisplatino/uso terapéutico , L-Lactato Deshidrogenasa/sangre , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Seminoma/tratamiento farmacológico , Neoplasias Testiculares/tratamiento farmacológico , Tromboflebitis/epidemiología , Trombosis de la Vena/epidemiología , Adolescente , Adulto , Anticoagulantes/uso terapéutico , Quimioprevención , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Incidencia , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tromboflebitis/sangre , Tromboflebitis/prevención & control , Trombosis/sangre , Trombosis/epidemiología , Trombosis/prevención & control , Trombosis de la Vena/sangre , Trombosis de la Vena/prevención & control , Adulto Joven
8.
Expert Rev Anticancer Ther ; 15(5): 499-507, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25907705

RESUMEN

Axitinib is the most recent targeted therapy approved by the US FDA and EMA in the treatment of metastatic renal cell carcinoma (mRCC). It is a second-generation, orally available, potent tyrosine kinase inhibitor targeting selectively VEGF receptor (VEGFR)-1, -2 and -3, resulting in inhibition of angiogenesis, metastasis and tumor growth. Based on the results of a randomized pivotal Phase III clinical trial, axitinib stands as one of the two recommended agents for patients with mRCC who progressed after first-line tyrosine kinase inhibitor therapy. Its potent and selective inhibition of VEGFR was the rationale for its development in the second-line setting after failure of prior cytokines or sunitinib. Here we examine the preclinical and clinical data of axitinib for mRCC, and its use in the treatment algorithm.


Asunto(s)
Carcinoma de Células Renales/tratamiento farmacológico , Imidazoles/uso terapéutico , Indazoles/uso terapéutico , Neoplasias Renales/tratamiento farmacológico , Algoritmos , Axitinib , Carcinoma de Células Renales/patología , Progresión de la Enfermedad , Humanos , Imidazoles/farmacología , Indazoles/farmacología , Neoplasias Renales/patología , Terapia Molecular Dirigida , Metástasis de la Neoplasia , Inhibidores de Proteínas Quinasas/farmacología , Inhibidores de Proteínas Quinasas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Receptores de Factores de Crecimiento Endotelial Vascular/antagonistas & inhibidores
9.
Oncol Res Treat ; 38(6): 286-8, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26045025

RESUMEN

INTRODUCTION: Over the past 3 decades, the appropriate management of metastatic germ cell tumours (GCT) has been defined by several phase III trials. Many follow-up recommendations have been published based on expert consensus. However, common clinical scenarios can still be vexing for clinicians who are less experienced at managing patients with testicular cancer. CASE REPORT: We highlight the arduous diagnostic work-up of a suspected late relapsing metastatic GCT in a patient suffering from fatigue, weight loss and prominent retroperitoneal lymph nodes, 4 years after first-line chemotherapy for metastatic seminoma. The various explorations finally led to the diagnosis of Whipple's disease. CONCLUSION: This unusual clinical case strongly highlights the need to perform an exhaustive evaluation, with a biopsy, if a late recurrent GCT is suspected to avoid pointless and potentially harmful treatment.


Asunto(s)
Recurrencia Local de Neoplasia/patología , Seminoma/patología , Neoplasias Testiculares/patología , Tropheryma/aislamiento & purificación , Enfermedad de Whipple/diagnóstico , Adulto , Biopsia , Histiocitos/microbiología , Humanos , Laparoscopía/métodos , Ganglios Linfáticos/microbiología , Masculino , Mesenterio , Reacción en Cadena de la Polimerasa , Saliva/microbiología
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