RESUMEN
BACKGROUND: Claudin 18.2 (CLDN18.2) is contained within normal gastric mucosa epithelial tight junctions; upon malignant transformation, CLDN18.2 epitopes become exposed. Zolbetuximab, a chimeric monoclonal antibody, mediates specific killing of CLDN18.2-positive cells through immune effector mechanisms. PATIENTS AND METHODS: The FAST study enrolled advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients (aged ≥18 years) with moderate-to-strong CLDN18.2 expression in ≥40% tumour cells. Patients received first-line epirubicin + oxaliplatin + capecitabine (EOX, arm 1, n = 84) every 3 weeks (Q3W), or zolbetuximab + EOX (loading dose, 800 mg/m2 then 600 mg/m2 Q3W) (arm 2, n = 77). Arm 3 (exploratory) was added after enrolment initiation (zolbetuximab + EOX 1000 mg/m2 Q3W, n = 85). The primary endpoint was progression-free survival (PFS) and overall survival (OS) was a secondary endpoint. RESULTS: In the overall population, both PFS [hazard ratio (HR) = 0.44; 95% confidence interval (CI), 0.29-0.67; P < 0.0005] and OS (HR = 0.55; 95% CI, 0.39-0.77; P < 0.0005) were significantly improved with zolbetuximab + EOX (arm 2) compared with EOX alone (arm 1). This significant PFS benefit was retained in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells (HR = 0.38; 95% CI, 0.23-0.62; P < 0.0005). Significant improvement in PFS was also reported in the overall population of arm 3 versus arm 1 (HR = 0.58; 95% CI, 0.39-0.85; P = 0.0114) but not in high CLDN18.2-expressing patients; no significant improvement in OS was observed in either population. Most adverse events (AEs) related to zolbetuximab + EOX (nausea, vomiting, neutropenia, anaemia) were grade 1-2. Grade ≥3 AEs showed no substantial increases overall (zolbetuximab + EOX versus EOX alone). CONCLUSIONS: In advanced gastric/gastro-oesophageal junction and oesophageal adenocarcinoma patients expressing CLDN18.2, adding zolbetuximab to first-line EOX provided longer PFS and OS versus EOX alone. Zolbetuximab + EOX was generally tolerated and AEs were manageable. Zolbetuximab 800/600 mg/m2 is being evaluated in phase III studies based on clinical benefit observed in the overall population and in patients with moderate-to-strong CLDN18.2 expression in ≥70% of tumour cells.
Asunto(s)
Adenocarcinoma , Neoplasias Esofágicas , Neoplasias Gástricas , Adenocarcinoma/tratamiento farmacológico , Adolescente , Adulto , Anticuerpos Monoclonales/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Capecitabina/uso terapéutico , Claudinas/genética , Claudinas/uso terapéutico , Neoplasias Esofágicas/tratamiento farmacológico , Unión Esofagogástrica , Humanos , Neoplasias Gástricas/tratamiento farmacológicoRESUMEN
Recent advances of cancer treatment resulted in the increase of patient survival rate. Treatment for Hodgkin's lymphoma (HL) may impair reproductive function, which leads to a decrease of the quality of life of cancer survival. Today different approaches have been developed for fertility preservation, one of which is the cryopreservation of ovarian tissue with subsequent orthotopic transplantation. We have described a recovery of reproductive function in patient of 28 years with acute ovarian failure, which was induced after cancer treatment. After the orthotopic transplantation cryopreserved ovarian tissue ongoing pregnancy was achieved in the natural cycle after IVF insemination. We have described the first live birth in Russia after the orthotopic transplantation cryopreserved ovarian tissue in cancer patient. This approach has resulted in the recovery of endocrine function without replacement hormonal therapy and possibility for a woman to have her own biological baby. It suggests that cryopreservation of ovarian tissue should be offered to all young women diagnosed with cancer.
Asunto(s)
Criopreservación , Enfermedad de Hodgkin/cirugía , Ovario/trasplante , Recuperación de la Función , Reproducción , Adulto , Femenino , Humanos , Trasplante AutólogoRESUMEN
The purpose of this study was to determine the prognostic significance of dynamics of C-reactive protein concentration in blood plasma as a marker for the progression of squamous cell carcinoma of the oral cavity mucosa. From January 2014 to August 2014 there were under the observation 35 patients with squamous cell carcinoma of the oral cavity mucosa. All patients were divided into 2 groups: group 1 - primary patients who had been diagnosed with malignant lesions of the oral cavity mucosa for the first time (17 people); group 2 - patients with recurrent disease (18 people). All 17 patients of group 1 received induction polychemotherapy by PF scheme and 18 patients of group 2 - curative polychemotherapy by the following schemes: PF, DCF, TC. In all patients there was performed an assessment of the level of C-reactive protein in blood serum at the stage prior to drug treatment and before each subsequent cycle of chemotherapy. An assessment of the level of C-reactive protein before treatment showed that in 17 patients of group 1 its level was in the normal range. Patients of group 2 had an increased concentration of C-reactive protein in blood plasma. Analysis of obtained data allows concluding that the level of C-reactive protein may be effectively used as a prognostic marker in patients with this pathology.
Asunto(s)
Biomarcadores de Tumor/sangre , Proteína C-Reactiva/genética , Pronóstico , Carcinoma de Células Escamosas de Cabeza y Cuello/sangre , Adulto , Anciano , Biomarcadores de Tumor/genética , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Boca/patología , Mucosa Bucal/patología , Índice de Severidad de la Enfermedad , Carcinoma de Células Escamosas de Cabeza y Cuello/genética , Carcinoma de Células Escamosas de Cabeza y Cuello/patologíaRESUMEN
The article analyzed the results of surgical treatment of 153 patients with soft tissue sarcomas. The surgery was complemented by preoperative embolization of vessels, which supplied the tumor, cryotherapy on the tumor and postoperative wound in 72 patients of main group. The control group consisted of 81 patients and there weren't any perioperative actions. It was shown, that more than 80% of soft tissue sarcomas had the main and mixed type of tumor blood supply. Partial and full reduction of blood flow could be obtained by embolization of the tumor in more than 50% patients. Combination of surgical and preoperative embolization of vessels and cryotherapy decreased the rate of local recurrence and increased the quantity of organosafe interventions.
Asunto(s)
Crioterapia/métodos , Embolización Terapéutica/métodos , Sarcoma/terapia , Adulto , Anciano , Anciano de 80 o más Años , Angiografía , Femenino , Estudios de Seguimiento , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Sarcoma/irrigación sanguínea , Sarcoma/diagnóstico , Resultado del Tratamiento , Adulto JovenRESUMEN
There are presented results of treatment of 347 patients with colorectal cancer. Laparoscopic surgery had been planned for 92 (26.5%) patients (study group). In 79 (85.9%) patients surgery was performed completely by laparoscopy, 13 (14.1%) patients underwent conversion. In 255 (73.5%) patients surgery was carried out from an open access (control group). The authors showed the effectiveness of the use of minimally invasive techniques in treatment for colorectal cancer.
Asunto(s)
Colectomía/métodos , Neoplasias del Colon/cirugía , Laparoscopía , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias del Colon/patología , Neoplasias Colorrectales/cirugía , Conversión a Cirugía Abierta/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Resultado del TratamientoRESUMEN
The article presents the results of surgery outcomes in 127 elderly patients with colon cancer. The patients were divided into two groups: the main group (prospective, n = 52) and control group (retrospective, n = 75). The combined preoperative nutritive status assessment by BMI and a prognostic hypotrophy index were used. It included the optimization of nutritive support on all stages and an early tube removal, an enteral feeding during postoperative period. It was stated, that it significantly reduced the level of complications, period of intensive care unit stay on 2 days and a hospital stay on 4 days in main group. All the patients of the main group improved the quality of life during 7 days (EORTC QIQ CR29). Proposed nutritive support program allowed improvement of the quality of life and positive treatment outcomes in elderly patients with colon cancer.
Asunto(s)
Neoplasias del Colon , Apoyo Nutricional/métodos , Complicaciones Posoperatorias/prevención & control , Desnutrición Proteico-Calórica , Anciano , Anciano de 80 o más Años , Colectomía/efectos adversos , Colectomía/métodos , Colon/patología , Colon/cirugía , Neoplasias del Colon/complicaciones , Neoplasias del Colon/patología , Neoplasias del Colon/cirugía , Femenino , Evaluación Geriátrica/métodos , Humanos , Tiempo de Internación , Masculino , Estadificación de Neoplasias , Evaluación Nutricional , Estado Nutricional , Atención Perioperativa/métodos , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/psicología , Desnutrición Proteico-Calórica/complicaciones , Desnutrición Proteico-Calórica/diagnóstico , Desnutrición Proteico-Calórica/terapia , Calidad de Vida , Resultado del TratamientoRESUMEN
AIM: AZD8931 is an oral equipotent inhibitor of EGFR (erbB1), HER2 (erbB2) and HER3 (erbB3) signaling. This Phase I, open-label study evaluated the safety, tolerability, and pharmacokinetics of multiple ascending doses of AZD8931 in patients with advanced solid tumors (NCT00637039). METHODS: Patients received AZD8931 as a single oral dose followed by 4 days of observation, then twice-daily dosing for 21 consecutive days. Using a standard 3 + 3 design, AZD8931 doses were escalated from 40 mg bid until the maximum tolerated dose (MTD) was established. RESULTS: Twenty-eight patients received AZD8931 (n = 5, 40 mg bid; n = 8, 80 mg bid; n = 6, 160 mg bid; n = 6, 240 mg bid; n = 3, 300 mg bid). Ovary (n = 8) and breast (n = 5) were the most common primary tumor types. The most frequent adverse events were treatment-emergent cutaneous (n = 27) and diarrhea (n = 21). Dose-limiting toxicities (DLTs) were identified in one patient in the 240 mg bid cohort (Grade 3 rash) and two patients in the 300 mg bid cohort (Grade 3 and 4 diarrhea). The pharmacokinetic profile of AZD8931 supported twice-daily dosing. AZD8931 was rapidly absorbed (median tmax 1-3 h), was well distributed and had moderate to high clearance with an elimination half-life of approximately 11 h. Exposure appeared to increase approximately proportionally with dose up to 160 mg. Of 21 patients evaluable for response at day 21, 12 had stable disease and nine had disease progression. CONCLUSION: The MTD of AZD8931 determined from the 21-day DLT period was 240 mg bid, although more long-term data are needed to confirm a dose of AZD8931 suitable for chronic treatment.
Asunto(s)
Receptores ErbB/antagonistas & inhibidores , Neoplasias/tratamiento farmacológico , Neoplasias/metabolismo , Inhibidores de Proteínas Quinasas/uso terapéutico , Quinazolinas/uso terapéutico , Receptor ErbB-2/antagonistas & inhibidores , Receptor ErbB-3/antagonistas & inhibidores , Transducción de Señal , Adulto , Anciano , Demografía , Relación Dosis-Respuesta a Droga , Receptores ErbB/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias/patología , Inhibidores de Proteínas Quinasas/administración & dosificación , Inhibidores de Proteínas Quinasas/sangre , Inhibidores de Proteínas Quinasas/farmacocinética , Quinazolinas/administración & dosificación , Quinazolinas/sangre , Quinazolinas/farmacocinética , Receptor ErbB-2/metabolismo , Receptor ErbB-3/metabolismo , Resultado del Tratamiento , Carga TumoralRESUMEN
BACKGROUND: This phase 2 study evaluated trebananib (AMG 386), an investigational peptide-Fc fusion protein that neutralises the interaction between angiopoietins-1/2 and the Tie2 receptor, plus FOLFIRI as second-line treatment for patients with metastatic colorectal cancer. METHODS: Patients had adenocarcinoma of the colon or rectum with progression within 6 months of receiving only one prior fluoropyrimidine/oxaliplatin-based chemotherapy regimen for metastatic disease. All patients received FOLFIRI and were randomised 2:1 to also receive intravenous trebananib 10 mg kg(-1) once weekly (QW) (Arm A) or placebo QW (Arm B). The primary end point was investigator-assessed progression-free survival (PFS). RESULTS: One hundred and forty-four patients were randomised (Arms A/B, n=95/49). Median PFS in Arms A and B was 3.5 and 5.2 months (hazard ratio (HR) 1.23; 95% CI, 0.81-1.86; P=0.33) and median overall survival (OS) was 11.9 and 8.8 months, respectively (HR 0.90; 95% CI; 0.53-1.54; P=0.70). Objective response rate (ORR) was 14% and 0% in Arms A and B, respectively. Incidence of grade ≥3 adverse events was similar between treatment arms (Arm A, 61%; Arm B, 65%) and included pulmonary embolism (1%/4%), deep vein thrombosis (5%/2%), and hypertension (1%/0%). CONCLUSION: Administration of trebananib plus FOLFIRI did not prolong PFS compared with placebo plus FOLFIRI. Toxicities were manageable and consistent with those known for FOLFIRI and trebananib.
Asunto(s)
Adenocarcinoma/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Terapia Recuperativa , Adenocarcinoma/mortalidad , Adenocarcinoma/secundario , Adulto , Anciano , Biomarcadores de Tumor/análisis , Camptotecina/administración & dosificación , Neoplasias Colorrectales/mortalidad , Neoplasias Colorrectales/patología , Método Doble Ciego , Femenino , Fluorouracilo/administración & dosificación , Humanos , Agencias Internacionales , Leucovorina/administración & dosificación , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana Edad , Pronóstico , Proteínas Recombinantes de Fusión/administración & dosificación , Tasa de Supervivencia , Adulto JovenRESUMEN
Colorectal cancer (CRC) is one of the commonest malignancies of Western countries, with approximately half the incidence occurring in patients > 70 years of age. Elderly CRC patients, however, are insufficient to fully examined, therefore, they receive inadequate treatment and underrepresented in clinical trials. The International Society of Geriatric Oncology created a task force with a view to assessing potential for developing guidelines for the treatment of elderly (geriatric) patients. A review of the evidence presented by the task force members confirmed the paucity of clinical trial data in elderly people and the lack of evidence-based guidelines. However, recommendations have been proposed on the basis of the available data and on the emerging evidence that treatment outcomes for fit, elderly CRC patients can be similar to those of younger patients. This gives hoped that such efforts will pave the way for formal treatment guidelines based upon solid scientific evidence in the future.
Asunto(s)
Neoplasias Colorrectales/terapia , Geriatría/normas , Oncología Médica/normas , Guías de Práctica Clínica como Asunto , Factores de Edad , Anciano , Anciano de 80 o más Años , Terapia Combinada/normas , HumanosRESUMEN
The comparative analysis of the main life quality parameters for patients with locally advanced operated gastric cancer was carried out using the EORTC QLQ-C30, STO-22 version 3.0. at stages of chemotherapeutic treatment. All patients (n = 47) have been divided into 2 groups depending on application of chemotherapy (cisplatin + 5-fluorouracil) prevention by hemo-immunostimulation ("Glutoxim"). The changes in functional state, symptoms and general health status of patients were evaluated. It is revealed that application of Glutoxim significantly improves functional state and insignificantly influences disease symptoms.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Oligopéptidos/uso terapéutico , Sustancias Protectoras/uso terapéutico , Calidad de Vida , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/psicología , Adulto , Anciano , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Femenino , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Gastrectomía , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Gástricas/patología , Neoplasias Gástricas/cirugía , Encuestas y CuestionariosRESUMEN
PURPOSE: The primary objective of this study was to access the potential effects of trabectedin on the QT/QTc interval in patients with locally advanced or metastatic solid tumors. METHODS: Patients (n = 75) who had received ≤3 previous lines of chemotherapy and had either relapsed or had progressive disease were enrolled. Patients were administered 3-h intravenous infusions of placebo (saline) on day 1 and trabectedin (1.3 mg/m(2)) on day 2. Time-matched serial triplicate ECG recordings and pharmacokinetic blood samples were collected over 24 h on both days. Heart rate corrected mean QT intervals and changes from predose baseline in QTc (ΔQTc) were assessed. The difference in ΔQTc between trabectedin and placebo was calculated at each time point (ΔΔQTc). RESULTS: The upper limits of the 90% confidence interval for ΔΔQTcF and ΔΔQTcB at all time points were less than the prespecified noninferiority margin of 10 ms (≤6.65 ms). No patient had a QTc > 500 ms or a time-matched increase from baseline in QTc > 60 ms at any time point. Regression analyses indicated ΔΔQTc was poorly correlated with trabectedin concentration. No adverse events suggestive of proarrhythmic potential were reported. CONCLUSION: Trabectedin did not prolong the QTc interval. Safety and pharmacokinetic profiles of trabectedin were similar to that observed in other ovarian and breast cancer studies.
Asunto(s)
Dioxoles/uso terapéutico , Frecuencia Cardíaca/efectos de los fármacos , Neoplasias/tratamiento farmacológico , Tetrahidroisoquinolinas/uso terapéutico , Adolescente , Adulto , Anciano , Antineoplásicos Alquilantes/efectos adversos , Antineoplásicos Alquilantes/farmacocinética , Antineoplásicos Alquilantes/uso terapéutico , Astenia/inducido químicamente , Dioxoles/administración & dosificación , Dioxoles/farmacocinética , Electrocardiografía/efectos de los fármacos , Femenino , Humanos , Infusiones Intravenosas , Masculino , Tasa de Depuración Metabólica , Persona de Mediana Edad , Náusea/inducido químicamente , Neoplasias/patología , Neoplasias/fisiopatología , Método Simple Ciego , Tetrahidroisoquinolinas/administración & dosificación , Tetrahidroisoquinolinas/farmacocinética , Trabectedina , Resultado del Tratamiento , Vómitos/inducido químicamente , Adulto JovenRESUMEN
The authors present an analysis of specific features of transfusions of erythrocyte containing media in oncological patients. Special attention was given to necessary selection of donor erythrocytes in performing operations with massive intraoperative blood loss. It considerably contributes to a decreased number of posttransfusional reactions and complications. For the recent five years transfusions of erythrocyte containing media to more than 15 thousand patients with surgical treatment were analyzed. Among them the individual selection of donor blood was fulfilled in 2047 cases. Compatible erythrocytes could not be selected in five cases only. In these patients infusions of Perftoran were used as an oxygen carrier both during operation and at the postoperative period.
Asunto(s)
Anemia , Transfusión de Componentes Sanguíneos/métodos , Incompatibilidad de Grupos Sanguíneos/prevención & control , Pérdida de Sangre Quirúrgica , Prueba de Histocompatibilidad , Neoplasias/complicaciones , Adulto , Anemia/sangre , Anemia/etiología , Anemia/terapia , Transfusión de Componentes Sanguíneos/normas , Donantes de Sangre , Antígenos de Grupos Sanguíneos/análisis , Sustitutos Sanguíneos/administración & dosificación , Eritropoyetina/administración & dosificación , Femenino , Fluorocarburos/administración & dosificación , Antígenos HLA/análisis , Hematínicos/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico , Neoplasias/cirugía , Mejoramiento de la Calidad , Proteínas Recombinantes , Estudios RetrospectivosAsunto(s)
Antineoplásicos Hormonales/uso terapéutico , Biomarcadores de Tumor/metabolismo , Neoplasias de la Mama/tratamiento farmacológico , Ciclina D1/metabolismo , Neoplasias Hormono-Dependientes/tratamiento farmacológico , Anciano , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/patología , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Hormono-Dependientes/metabolismo , Neoplasias Hormono-Dependientes/patología , Posmenopausia , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Tamoxifeno/uso terapéuticoRESUMEN
Ninety-six patients with unresectable or metastatic colorectal cancer received first-line chemotherapy plus bevacizumab. The purpose of our study was to evaluate the safety and efficacy of the therapy. Median relapse-free survival lasted 10.4 months. Addition of bevacizumab was well tolerated and may be recommended for clinical use.
Asunto(s)
Inhibidores de la Angiogénesis/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias Colorrectales/tratamiento farmacológico , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales Humanizados , Bevacizumab , Neoplasias Colorrectales/patología , Femenino , Enfermedades Hematológicas/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Debilidad Muscular/inducido químicamente , Náusea/inducido químicamente , Estadificación de Neoplasias , Calidad de Vida , Estomatitis/inducido químicamente , Resultado del Tratamiento , Vómitos/inducido químicamenteAsunto(s)
Antineoplásicos Hormonales/uso terapéutico , Inhibidores de la Aromatasa/uso terapéutico , Neoplasias Endometriales/tratamiento farmacológico , Nitrilos/uso terapéutico , Sarcoma Estromático Endometrial/tratamiento farmacológico , Triazoles/uso terapéutico , Anciano , Anastrozol , Neoplasias Endometriales/diagnóstico por imagen , Neoplasias Endometriales/patología , Femenino , Humanos , Inducción de Remisión , Sarcoma Estromático Endometrial/diagnóstico por imagen , Sarcoma Estromático Endometrial/patología , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
Four categories of patients with advanced gastric cancer treated with different regimens of chemotherapy: (1) PF cisplatin 100 mg/m2/day+5-fluorouracil 1000 mg/m2/day intravenous infusion (100 hrs); (2) carboplatin (AUC5)+5-fluorouracil 500 mg/m2/day intravenous infusion (2 hrs), days 1-3; (3) DCF, and (4) bevacizumab+PF.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Gástricas/tratamiento farmacológico , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bevacizumab , Instituciones Oncológicas , Carboplatino/administración & dosificación , Cisplatino/administración & dosificación , Docetaxel , Esquema de Medicación , Fluorouracilo/administración & dosificación , Humanos , Infusiones Intravenosas , Federación de Rusia , Neoplasias Gástricas/patología , Taxoides/administración & dosificación , Resultado del TratamientoRESUMEN
BACKGROUND: This is a phase II randomized study to evaluate the efficacy and safety of bortezomib and pemetrexed alone or in combination, in patients with previously treated advanced non-small-cell lung cancer (NSCLC). The primary end point was assessment of response rate. METHODS: A total of 155 patients were randomized (1:1:1) to pemetrexed (500mg/m(2)) on day 1 plus bortezomib (1.6mg/m(2)) on days 1 and 8 (Arm A) or pemetrexed (500mg/m(2)) on day 1 (Arm B) or bortezomib (1.6mg/m(2)) on days 1 and 8 (Arm C) of a 21 day cycle. Response rate was assessed by investigators using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and toxicity assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system. RESULTS: Response rate was 7% in Arm A, 4% in Arm B, and 0% in Arm C; disease control rates were 73%, 62%, and 43%, respectively. Median overall survival was 8.6 months in Arm A, 12.7 months in Arm B, and 7.8 months in Arm C; time to progression was 4.0 months, 2.9 months, and 1.4 months, respectively. Most common reported adverse events >/=grade 3 were neutropenia (19%), thrombocytopenia (15%), and dyspnea (13%) in Arm A, neutropenia (10%) in Arm B, and dyspnea (13%) and fatigue (10%) in Arm C. CONCLUSION: In previously treated NSCLC the addition of bortezomib to pemetrexed was well tolerated but offered no statistically significant response or survival advantage versus pemetrexed alone, while bortezomib alone showed no clinically significant activity.
Asunto(s)
Ácidos Borónicos/administración & dosificación , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Glutamatos/administración & dosificación , Guanina/análogos & derivados , Neoplasias Pulmonares/tratamiento farmacológico , Pirazinas/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Ácidos Borónicos/efectos adversos , Bortezomib , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/fisiopatología , Progresión de la Enfermedad , Quimioterapia Combinada , Disnea/etiología , Femenino , Glutamatos/efectos adversos , Guanina/administración & dosificación , Guanina/efectos adversos , Humanos , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/fisiopatología , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neutropenia/etiología , Pemetrexed , Pirazinas/efectos adversos , Análisis de Supervivencia , Trombocitopenia/etiologíaRESUMEN
Our investigation was carried out on an assumption that end results among patients radically-treated for colorectal cancer might be improved by use of enteroabsorption. The study group included 17, controls--13 patients with diagnostically verified stage I-III tumors. Mixed sorbent (microcellulose + polysorb) (6g) was administered, once a week, on the average of 20 days after operation. Immunological vigor was assayed 3 weeks after surgery: immunoglobulin levels--by turbodimetric method, cellular profile of lymphocytes--monoclonal antibodies to cell markers CD3, CD4, CD8, CD16 and CD22. As a result of adjuvant treatment CD22 (B-lymphocytes) concentration increased significantly--from 17.70 to 21.66 (22%), while CD16 (innate killers) both in absolute numbers (19%) and by percentage points (9%). Circulating immunocomplex levels in the sorbent-treatment group were significantly lower (37.44 ths units) than in control (48 ths units) (average 28%). No relapse or metastases were reported in either group.
Asunto(s)
Celulosa/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/inmunología , Enteroadsorción , Polímeros/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antígenos CD/efectos de los fármacos , Linfocitos B/efectos de los fármacos , Complejo CD3/efectos de los fármacos , Antígenos CD4/efectos de los fármacos , Antígenos CD8/efectos de los fármacos , Quimioterapia Adyuvante , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/radioterapia , Neoplasias Colorrectales/cirugía , Complemento C3/efectos de los fármacos , Complemento C4/efectos de los fármacos , Femenino , Humanos , Inmunoglobulinas/efectos de los fármacos , Células Asesinas Naturales/efectos de los fármacos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Radioterapia Adyuvante , Receptores de IgG/efectos de los fármacos , Lectina 2 Similar a Ig de Unión al Ácido Siálico/efectos de los fármacosRESUMEN
The study is concerned with the effects of non-specific blocking gap junction communication with oleamide as well as genesis and spreading of melanoma B16 metastases to the lung in mice C57B1. The blocking exerted no distinct influence on primary tumorigenesis but had a marked effect on metastatic spread. Oleamide treatment during tumor growth led to an increase in area covered by metastases. A correlation was established between metastatic frequency and dosage: 1 mg/kg was followed by an upsurge in frequency of secondary lung tumors while 10 mg/kg--by a drop.