Assuntos
Neoplasias da Mama , Neoplasias de Mama Triplo Negativas , Albuminas , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Capecitabina/efeitos adversos , Feminino , Humanos , Paclitaxel/efeitos adversos , Neoplasias de Mama Triplo Negativas/tratamento farmacológicoRESUMO
BACKGROUND: NEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle. METHODS: In this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2-4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined. RESULTS: Of the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65-0.50 for no CINV events on cycles 3 and 4). CONCLUSION: The high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle. TRIAL REGISTRATION: This trial was retrospectively registered at Clinicaltrials.gov identifier (NCT03862144) on 05/Mar/2019.
Assuntos
Antraciclinas/efeitos adversos , Antieméticos/uso terapêutico , Antineoplásicos Alquilantes/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Ciclofosfamida/efeitos adversos , Dexametasona/uso terapêutico , Antagonistas dos Receptores de Neurocinina-1/uso terapêutico , Palonossetrom/uso terapêutico , Piridinas/uso terapêutico , Vômito/induzido quimicamente , Vômito/prevenção & controle , Adulto , Idoso , Antraciclinas/uso terapêutico , Antieméticos/administração & dosagem , Antineoplásicos Alquilantes/uso terapêutico , Quimioterapia Adjuvante , Ciclofosfamida/uso terapêutico , Dexametasona/administração & dosagem , Combinação de Medicamentos , Feminino , Humanos , Pessoa de Meia-Idade , Antagonistas dos Receptores de Neurocinina-1/administração & dosagem , Palonossetrom/administração & dosagem , Piridinas/administração & dosagemRESUMO
BACKGROUND: Fatigue is one of the most distressing symptoms of cancer patients. Its characteristics and impact on quality of life have not been fully explored and treatment of cancer-related fatigue in Italian oncological centers has not been codified. METHODS: A cross-sectional study was carried out on all patients attending for any reason the 24 participating centers in two non-consecutive days. Patients with fatigue filled out the Brief Fatigue Inventory (BFI) questionnaire and reported any pharmacological or non-pharmacological treatment for fatigue. RESULTS: From October 2014 to May 2015, 1394 cancer patients agreed to participate in the study. Fatigue was referred by 866 (62.1%) of patients; its duration was > 4 months in 441 patients (50.9%). In the investigators' opinion, the most important (probable or almost sure) determinants of fatigue were reduced physical activity (271 patients), anxiety (149), pain (131), insomnia (125), anemia (123), and depression (123). Fatigue of moderate/severe intensity was reported by 43%/29.2% of patients, while usual fatigue in the last 24 h by 45%/33.1%, and the worst fatigue in the last 24 h by 33%/54.8%, respectively. Concerning the impact on quality of life, fatigue interfered moderately/severely with general activity in 30.8%/38.6% of patients, with mood in 26.1%/32.8%, with the ability to work in 27.9%/35.6%, with normal work in 26.7%/38.9%, with relationships with others in 21%/23.4% and with the ability to amuse themselves in 22.2%/33.1%. Only 117/866 patients (13.5%) received a pharmacological treatment represented by a corticosteroid in 101 patients (86.3%) while 188 patients (21.7%) received a non-pharmacological treatment such as physical exercise (120 patients, 63.8%) and various alimentary supplements (52 patients, 27.6%). CONCLUSIONS: Cancer-related fatigue is frequently reported by oncological patients; its intensity and impact on quality of life is relevant.
Assuntos
Fadiga/epidemiologia , Fadiga/etiologia , Neoplasias/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Ansiedade/complicações , Dor do Câncer/complicações , Estudos Transversais , Depressão/complicações , Exercício Físico/psicologia , Terapia por Exercício , Fadiga/terapia , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Qualidade de Vida , Inquéritos e Questionários , Adulto JovemRESUMO
PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes. METHODS: Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression. RESULTS: The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, "significant nausea," and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90). CONCLUSIONS: CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.
Assuntos
Antraciclinas/efeitos adversos , Antieméticos/uso terapêutico , Neoplasias da Mama/complicações , Ciclofosfamida/efeitos adversos , Náusea/induzido quimicamente , Vômito/induzido quimicamente , Adulto , Idoso , Neoplasias da Mama/tratamento farmacológico , Feminino , Humanos , Incidência , Itália , Pessoa de Meia-Idade , Estudos ProspectivosAssuntos
Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/etiologia , Hiperaldosteronismo/complicações , Hiperaldosteronismo/diagnóstico , Neoplasias do Córtex Suprarrenal/complicações , Neoplasias do Córtex Suprarrenal/patologia , Neoplasias do Córtex Suprarrenal/cirurgia , Adrenalectomia , Adenoma Adrenocortical/complicações , Adenoma Adrenocortical/patologia , Adenoma Adrenocortical/cirurgia , Feminino , Humanos , Hiperaldosteronismo/etiologia , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
The neurofibromatosis type 1 (NF1) is characterized by specific cutaneous features (neurofibromas, "café-au-lait" spots of the skin) and alterations of several tissue (nervous, vascular) and bone deformities, such as scoliosis, congenital pseudoarthrosis and bone dysplasia of tibia. Moreover, several studies have shown systemic involvement of bone tissue in NF1 patients, leading to reduced bone mass. The aim of our study was to evaluate some bone mineral metabolism parameters before and after calcium and vitamin D supplementation in NF1 patients. We evaluated in 70 NF1 consecutive patients the mineral metabolism and bone mineral density compared with 40 normal subjects. We showed bone alterations in 35% of patients and the increase of bone formation markers, such as bone isoenzyme of alkaline phosphatase (41.2 ± 15.5 vs. 25.6 ± 8.7 UI; P < 0.05, respectively) and osteocalcin (18.1 ± 5.6 vs. 7.6 ± 1.9 ng/ml; P < 0.05) and reduction of circulating levels of (25OH)-vitamin D (21.8 ± 12.3 ng/ml) with an high percentage of hypovitaminosys D (>60%). Moreover, we revealed a significant reduction of bone mass density at spine (L1-L4) (0.935 ± 0.13 vs. 1.110 ± 0.17 g/cm(2); P < 0.001) and femoral neck side (0.765 ± 0.09 vs. 0.839 ± 0.12 g/cm(2); P < 0.02), with high prevalence of osteopenia (44%) and osteoporosis (18%). After 12 months of calcium (1,200 mg/die) and cholecalciferol (800 UI/die) supplementation, we found a significant increase of (25) OH-vitamin D level (21.8 ± 12.3 vs. 35 ± 13 ng/ml; P < 0.01), without changes in bone mass density. In conclusion, NF1 patients may present a mineral bone involvement, with vitamin D deficiency; calcium and vitamin D supplementation is necessary to restore these bone mineral metabolic alterations.
Assuntos
Densidade Óssea , Remodelação Óssea , Osso e Ossos/metabolismo , Minerais/metabolismo , Neurofibromatose 1/metabolismo , Adulto , Densidade Óssea/efeitos dos fármacos , Osso e Ossos/patologia , Calcificação Fisiológica/efeitos dos fármacos , Cálcio/administração & dosagem , Cálcio/deficiência , Suplementos Nutricionais , Feminino , Humanos , Masculino , Neurofibromatose 1/patologia , Neurofibromina 1/genética , Osteoporose , Vitamina D/administração & dosagem , Deficiência de Vitamina D/metabolismoRESUMO
This paper aimed to investigate the role played by key psychological factors in the experience of pain in cancer. One hundred and eight consecutive cancer patients were administered validated scales for pain, alexithymia, coping with cancer, and illness behavior. Two groups of patients with (n=45, 42%) and without (n=63, 58%) current pain were compared. Pain was associated to tumor sites and status, poor adjustment to cancer, and higher disease conviction and perception, but not to global alexithymia. However, the component of difficulty identifying feelings (DIF) of the alexithymia construct was significantly higher in pain patients compared to pain-free patients (t=2.88, p<0.01), constituted one of the independent predictors of pain (r=0.37; beta=0.27, p<0.01), and correlated with quality descriptors of pain (r=0.33, p<0.05). The present findings showed for the first time that although alexithymia was not globally related to cancer pain, the DIF component was however associated to pain dimensions, thus suggesting it might be involved in the way patients describe their pain experience, together with maladaptive coping and abnormal illness behavior. Cancer patients experiencing pain should be helped to adopt a more adaptive coping with the disease by identifying more accurately the source of their feelings.