RESUMEN
This manuscript reports the consensus statements regarding recurrent ovarian cancer (ROC), reached at the fifth Ovarian Cancer Consensus Conference (OCCC), which was held in Tokyo, Japan, in November 2015. Three important questions were identified: (i) What are the subgroups for clinical trials in ROC? The historical definition of using platinum-free interval (PFI) to categorise patients as having platinum-sensitive/resistant disease was replaced by therapy-free interval (TFI). TFI can be broken down into TFIp (PFI), TFInp (non-PFI) and TFIb (biological agent-free interval). Additional criteria to consider include histology, BRCA mutation status, number/type of previous therapies, outcome of prior surgery and patient reported symptoms. (ii) What are the control arms for clinical trials in ROC? When platinum is considered the best option, the control arm should be a platinum-based therapy with or without an anti-angiogenic agent or a poly (ADP-ribose) polymerase (PARP) inhibitor. If platinum is not considered the best option, the control arm could include a non-platinum drug, either as single agent or in combination. (iii) What are the endpoints for clinical trials in ROC? Overall survival (OS) is the preferred endpoint for patient cohorts with an expected median OS < or = 12 months. Progression-free survival (PFS) is an alternative, and it is the preferred endpoint when the expected median OS is > 12 months. However, PFS alone should not be the only endpoint and must be supported by additional endpoints including pre-defined patient reported outcomes (PROs), time to second subsequent therapy (TSST), or time until definitive deterioration of quality of life (TUDD).
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Recurrencia Local de Neoplasia/terapia , Neoplasias Ováricas/patología , Neoplasias Ováricas/terapia , Proyectos de Investigación , Femenino , HumanosRESUMEN
PURPOSE OF INVESTIGATION: The objective of this retrospective multicenter study was to assess the prognostic relevance of histologic type in uterine sarcomas. METHODS: The hospital reports of 249 patients with uterine sarcomas were reviewed. Surgery was the initial therapy for all patients. Histologic type was leiomyosarcoma in 95 cases, low-grade endometrial stromal sarcoma (ESS) in 19, high-grade ESS in 34, and carcinosarcoma in 101. Postoperative treatment was given without well-defined protocols. Median follow-up of survivors was 97 months. RESULTS: In the whole series 2-year, 5-year, and 10-year survival rates were 53.5%, 41.6%, and 35.8%, respectively, and median survival was 31 months. At univariate analysis survival was significantly related to stage (p = 0.0001), mitotic count (p = 0.0001), and histologic type (low-grade ESS vs leiomyosarcoma vs carcinosarcoma vs high-grade ESS, median: not reached vs 27 months vs 21 months vs 16.5 months, p = 0.0011), but not to postoperative therapy and patient age. The Cox model revealed that tumor stage, mitotic count and histologic type were independent prognostic variables for survival. In detail, the risk of death was significantly lower for low-grade ESS (risk ratio [RR] = 0.257; 95% confidence interval [CI] = 0.071-0.931) and carcinosarcoma (RR = 0.509; 955 CI = 0.324-0.799) when compared to leiomyosarcoma. Conversely, no significant difference in survival was found between leiomyosarcoma and high-grade ESS. CONCLUSIONS: Histologic type is an independent prognostic variable for survival in uterine sarcomas. Low-grade ESS has the best clinical outcome, whereas leiomyosarcoma has the poorest one. It is noteworthy that, when adjusting for stage and mitotic count, leiomyosarcoma has a significantly worse prognosis than carcinosarcoma.
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Neoplasias Uterinas/mortalidad , Neoplasias Uterinas/patología , Adulto , Anciano , Anciano de 80 o más Años , Carcinosarcoma/etiología , Carcinosarcoma/mortalidad , Carcinosarcoma/patología , Femenino , Humanos , Italia/epidemiología , Leiomiosarcoma/etiología , Leiomiosarcoma/mortalidad , Leiomiosarcoma/patología , Registros Médicos , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Sarcoma Estromático Endometrial/etiología , Sarcoma Estromático Endometrial/mortalidad , Sarcoma Estromático Endometrial/patología , Análisis de Supervivencia , Neoplasias Uterinas/etiologíaRESUMEN
The Authors present two cases of fetal alcohol syndrome, in an infant 15 months old and in a child 10 years old. In both cases were present a growth deficiency, many dysmorphic features and a psycho-motor impairment. The Authors emphasize the importance of this disease and its present high frequency among the population.
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Anomalías Inducidas por Medicamentos , Anomalías Múltiples , Alcoholismo/complicaciones , Enfermedades Fetales , Trastornos del Crecimiento/etiología , Complicaciones del Embarazo , Trastornos Psicomotores/etiología , Adulto , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Masculino , EmbarazoRESUMEN
This multicenter retrospective study is based on 192 patients with advanced ovarian cancer in pathological complete response at second-look surgery. Ninety-four (48.9%) patients developed recurrent disease after a median time of 18 months (range, 4-89 months) from surgical reassessment. The recurrence involved the pelvis in 45 (47.9%) cases, the abdomen in 42 (44.7%), the retroperitoneal lymph nodes in 13 (13.8%), and distant sites in 20 (21.2%). On the whole series, 5- and 7-year disease-free survival rates after negative second-look were 47.4 and 44.5%, respectively. By log-rank test the disease-free survival rate was related to FIGO stage (P = 0.008), tumor grade (P = 0.0021), size of residual disease after initial surgery (P = 0.0038), and type of second-look (laparoscopy vs laparotomy, P = 0.0061), but not to histological type and first-line chemotherapy. Cox proportional hazard model showed that tumor grade, size of residual disease, and type of second-look were independent prognostic variables for disease-free survival. The risk ratio of relapse was 2.386 (95% CI, 1.140-4.990) for grade 2 and 3.118 (95% CI, 1.515-6.416) for grade 3 compared to grade 1 disease. For patients with residual disease 1-2 cm and > 2 cm the risk ratio was, respectively, 1.877 (95% CI, 1.117-3.156) and 2.156 (95% CI, 1.324-3.511) compared to patients with residual disease < 1 cm. The risk ratio was 1.826 (95% CI, 1.121-2.973) for patients who were submitted to a laparoscopic second-look compared to those who underwent a laparotomic reassessment. Poorly differentiated grade and large residual disease after initial surgery are the strongest prognostic variables for recurrence after a negative second-look.