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BACKGROUND: Patch tests (PTs) are recommended to identify the culprit drug in non-immediate cutaneous adverse drug reactions (NICADRs). We recently reported that, in patients with NICADRs, a unique reading of PTs at day (D)2 compared with an additional second late reading at D4 missed almost half (45.3%) of the positive PTs. OBJECTIVES: To assess the change in sensitivity of the PT reading on D4 compared with the reading on D3. METHODS: We performed a retrospective (July 2020-June 2023) monocentric study of patients who had PTs with two readings for a NICADR. We compared reading on D3 and the second reading on D4 for the suspected drug (primary outcome) and for the related drugs tested simultaneously (secondary outcome). RESULTS: During the study period, 249 patients underwent patch testing with D3 and D4 readings. Regarding the primary outcome, the first reading at D3 was positive for 13.7% of patients, and the reading at D4 for 24.9% of patients (p < 0.0001). Regarding the secondary outcome, only 9.6% of patients had all their positive PT at D3 compared with 24.9% of patients at D4 (p < 0.0001). Considering the evaluated drug classes, no statistical difference was observed. However, we highlight that D3 reading detected all positive carbamazepine PTs (n = 3) while positive clindamycin PTs (n = 4) were identified only with the help of the second reading on D4. CONCLUSION: This study showed that, an additional D4 reading compared with a single D3 reading enhanced the sensitivity of PTs to identify culprit drugs and related. Further studies should replicate these findings and evaluate the medico-economic balance and safety of a single reading of PTs on D4.
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BACKGROUND: Patch tests (PTs) with two readings have been used for decades to identify the culprit drug in nonimmediate cutaneous adverse drug reactions (NICADRs), followed more recently by late reading of intradermal tests (IDTs). Some teams tend to perform PTs with only one reading before IDTs or even directly perform IDTs. OBJECTIVES: To evaluate the relevance of a late PT reading on day 4 (D4) in NICADRs. METHODS: We retrospectively selected patients who had a PT for an NICADR between July 2014 and March 2020. RESULTS: During the study period, 328 patients had a PT with available results. Among the 75 positive-PT patients with available data for the two readings, 41 (54.7%) had positive results on D2 and D4 and 34 (45.3%) had negative results on D2 but positive results on D4. No patient had positive results on D2 and negative results on D4. CONCLUSION: This study shows that a D4 reading enhanced the PT-positive results. A positive PT result allows for reducing the number of IDTs, which are more difficult and costly to perform. Our series suggests that a late PT reading at D4 should be performed for exploring NICADRs.
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Hipersensibilidad a las Drogas/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Hipersensibilidad Tardía/diagnóstico , Pruebas del Parche/métodos , Femenino , Humanos , Masculino , Preparaciones Farmacéuticas , Estudios RetrospectivosRESUMEN
BACKGROUND: To evaluate the efficacy and toxicity of irinotecan and oxaliplatin plus 5-fluorouracil (FU) and leucovorin (FOLFIRINOX) as second-line therapy in metastatic pancreatic adenocarcinoma (MPA). PATIENTS AND METHODS: We retrospectively analyzed the medical records of 27 patients with MPA treated with FOLFIRINOX as second-line therapy between January 2003 and November 2009 in our hospital. The recommended schedule was oxaliplatin 85 mg/m(2) on day 1 + irinotecan 180 mg/m(2) on day 1 + leucovorin 400 mg/m(2) on day 1 followed by FU 400 mg/m(2) as a bolus on day 1 and 2,400 mg/m(2) as 46-hour continuous infusion biweekly. RESULTS: The median age of the 27 patients (13 males and 14 females) was 63 years (45-83). All patients had progressive disease after first-line chemotherapy by gemcitabine. A total of 167 cycles were administered, with a median number of 6 cycles (1-29) per patient. One toxic death occurred (sepsis). Tolerance of treatment was acceptable, and the relative dose density delivered per patient was 92.8% for oxaliplatin, 89.1% for irinotecan and 96.4% for FU. Grade 3-4 neutropenia occurred in 55.6% of the patients, including 1 febrile neutropenia. The other toxicities were manageable. Regarding efficacy, 22 of the 27 patients were evaluable (WHO and RECIST criteria). Five patients had partial responses and 12 stable disease, resulting in an overall disease control rate of 63%. Median time to progression was 5.4 months (0.7-25.48), and median event-free survival was 3 months (0.5-24.9). Median overall survival was 8.5 months (0-26). A clinical benefit was reported for 55% of the patients. CONCLUSIONS: These results confirmed the good safety profile and the efficacy of the FOLFIRINOX regimen as second-line treatment of MPA.
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Adenocarcinoma/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Pancreáticas/tratamiento farmacológico , Adenocarcinoma/secundario , Adenocarcinoma/cirugía , Anciano , Anciano de 80 o más Años , Antimetabolitos Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Camptotecina/administración & dosificación , Camptotecina/análogos & derivados , Quimioterapia Adyuvante , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapéutico , Progresión de la Enfermedad , Esquema de Medicación , Femenino , Fluorouracilo/administración & dosificación , Humanos , Irinotecán , Leucovorina/administración & dosificación , Masculino , Registros Médicos , Persona de Mediana Edad , Estadificación de Neoplasias , Compuestos Organoplatinos/administración & dosificación , Oxaliplatino , Neoplasias Pancreáticas/patología , Neoplasias Pancreáticas/cirugía , Estudios Retrospectivos , Insuficiencia del Tratamiento , Resultado del Tratamiento , GemcitabinaRESUMEN
INTRODUCTION: Rituximab is a standard treatment for gastric mucosa-associated lymphoid tissue (MALT) lymphoma (GML). We sought to compare the effectiveness and safety of subcutaneous and intravenous rituximab in a retrospective case-control study. PATIENTS AND METHODS: All consecutive patients with GML treated with subcutaneous rituximab between January 2017 and December 2018 were included and compared to 3 matched control patients (based on Ann Arbor classification, presence of t(11;18) translocation, history of treatment, and type of current treatment) treated with intravenous rituximab between January 2000 and December 2018. Patients with t(11;18) translocation were treated with rituximab in combination with chlorambucil; the other patients were treated with rituximab alone. Effectiveness was assessed at week 52, and safety was assessed through weeks 0 to 52 and compared by the chi-square test. RESULTS: Twenty-five patients were included in the subcutaneous rituximab group and 75 in the intravenous group. There was no difference between the groups in complete remission (78% vs. 76%, P = .99) or overall response rates (91% vs. 89%, P = .99) at week 52. Safety profiles were similar in both groups, with a significant decrease in postinduction grade 2 injection-related reactions and outpatient hospital length of stay in the subcutaneous rituximab group. CONCLUSION: In a small case-control study, we did not find any difference in the effectiveness or safety profiles between subcutaneously and intravenously delivered rituximab for the treatment of patients with GML. We found a decrease in postinduction grade 2 injection-related reactions and outpatient hospital length of stay in the subcutaneous rituximab group.
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Administración Intravenosa/métodos , Antineoplásicos Inmunológicos/uso terapéutico , Inyecciones Subcutáneas/métodos , Linfoma de Células B de la Zona Marginal/tratamiento farmacológico , Rituximab/uso terapéutico , Antineoplásicos Inmunológicos/farmacología , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Rituximab/farmacología , Resultado del TratamientoRESUMEN
AIM OF THE REVIEW: The aim of this work was first to define which antineoplastic agents with sufficiently long stability could be eligible in the circuit of home-based therapy (centralised preparation, transport to the patient's home and administration by nurses) and, second, to propose a standardisation of the stability data of anticancer drugs in use for home hospitalisation. METHOD: A survey carried out in six hospital pharmacies of the Assistance Publique-Hôpitaux de Paris (AP-HP) hospitals, with important activity in oncology, listed the stability data used locally by each site. The final goal is to reach a consensus for the stability of cytotoxic drugs, which was the result of an original collaboration between the pharmacists of the compounding unit and the quality control unit. These results were compared to marketing authorisation data. RESULTS: The survey showed that eight antineoplastic agents of 34 were prepared under identical conditions (infusion diluent, concentration range, protection from light, temperature) by all hospitals (3 < or = n < or = 6): the stability was identical between each site for only two cytotoxic drug preparations (fotemustine and gemcitabine) and varied by up to 168 h or 7 days for the preparations of dacarbazine, epirubicine and cisplatin. Stability validated by pharmacists and those provided by marketing authorisation ranged respectively from "extemporaneously prepared" at 1,344 h (median = 168 h) to "extemporaneously prepared" at 720 h (median = 4 h). For 11 antineoplastic drugs, no information about the stability after compounding was specified in the marketing authorisation. Of all cytotoxic drugs used in the Hospital at Home of AP-HP, stability after compounding validated by pharmacists was less than 30 h for six of them, between 30 and 78 h for four and exceeding 78 h for the remaining 24. CONCLUSION: Considering the lack of data about cytotoxic drugs stability provided by the pharmaceutical companies and the difficulties in retrieving and interpreting the literature data, a consensus on the stability of cytotoxic drug preparations is essential for the current practice. With this approach, initiated for home hospitalisation, we propose in this study an initiative of the standardisation of stability data which offers a decision support for other centres.
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Antineoplásicos/química , Composición de Medicamentos/normas , Estabilidad de Medicamentos , Terapia de Infusión a Domicilio/normas , Química Farmacéutica , Etiquetado de Medicamentos , Encuestas de Atención de la Salud , Humanos , Servicio de Farmacia en Hospital/normas , Control de Calidad , Estudios de Validación como AsuntoRESUMEN
BACKGROUND: Current first-line cisplatin-based combination chemotherapy regimens provide interesting response rates but limited impact on survival for patients with metastatic transitional cell carcinoma of the urothelium. Such results leave a significant patient population in need of salvage therapy. PATIENTS AND METHODS: As the epidermal growth factor receptors 1 and 2 (EGFR and HER2) are frequently overexpressed in urothelial carcinoma, we explored the feasibility of a combination of paclitaxel (80 mg/m(2)/week) and lapatinib (1,500 mg orally daily) for six patients who were treated after failure of first-line platinum-based chemotherapy. RESULTS: Only one out of six patients was able to receive the full doses during the first six weeks of treatment, while grade 2 or 3 diarrhea events required lapatinib dose reduction (one patient) or discontinuation (five patients), despite loperamide support. CONCLUSION: This combination is not recommended for this population of patients.