RESUMO
PURPOSE: Desmoid fibromatosis (DF) is a locally aggressive tumor with low mortality but significant morbidity. There is a lack of standard of care, and existing therapies are associated with significant barriers including access, cost, and toxicities. This study aimed to explore the efficacy and safety of the metronomic therapy (MT) in DF in a large, homogenous cohort from India. PATIENTS AND METHODS: This study involved histologically confirmed DF cases treated with MT comprising vinblastine (6 mg) and methotrexate (15 mg) both once a week, and tamoxifen (40 mg/m2) in two divided doses once daily between 2002 and 2018. RESULTS: There were 315 patients with a median age of 27 years; the commonest site was extremity (142 of 315; 45.0%). There were 159 (50.1%) male patients. Of the 123 (39.0%) prior treated patients, 119 had surgery. Of 315 patients, 263 (83.5%) received treatment at our institute (MT-151, 77-local treatment, 9-tyrosine kinase inhibitor, and 26 were observed). Among the MT cohort (n = 163, 61.2%), at a median follow-up of 36 (0.5-186) months, the 3-year progression-free and overall survival were 81.1% (95% CI, 74.3 to 88.4) and 99.2% (95% CI, 97.6 to 100), respectively. There were 35% partial responses. Ninety-two patients (56.4%) completed 1-year therapy, which was an independent prognosticator (P < .0001; hazard ratio, 0.177 [95% CI, 0.083 to 0.377]). MT was well tolerated. Predominant grade ≥3 toxicities were febrile neutropenia, 12 (7.4%) without any chemotoxicity-related death. The annual cost of MT was $130 US dollars. CONCLUSION: The novel, low-cost MT qualifies as one of the effective, less toxic, sustainable, standard-of-care options for the treatment of DF with global reach and merits wide recognition.
Assuntos
Administração Metronômica , Fibromatose Agressiva , Metotrexato , Centros de Atenção Terciária , Humanos , Masculino , Feminino , Adulto , Fibromatose Agressiva/tratamento farmacológico , Fibromatose Agressiva/mortalidade , Fibromatose Agressiva/economia , Índia , Centros de Atenção Terciária/estatística & dados numéricos , Adulto Jovem , Pessoa de Meia-Idade , Adolescente , Metotrexato/administração & dosagem , Metotrexato/uso terapêutico , Metotrexato/economia , Padrão de Cuidado , Criança , Vimblastina/administração & dosagem , Vimblastina/uso terapêutico , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Tamoxifeno/administração & dosagem , Tamoxifeno/economia , Tamoxifeno/uso terapêutico , Estudos RetrospectivosRESUMO
BACKGROUND AND AIMS: Ultrasonography (USG) is used to evaluate gastric residual volume (GRV); however, this technique may have inter-assessor variability. This study aimed to measure GRV in three groups of fasted patients 2 h after they received 200 mL of water, clear apple juice or apple-flavoured oral rehydration solution (ORS) and to determine inter-assessor reliability of USG-guided GRV measurement. METHODS: We randomised 90 adult patients planned for elective cancer surgery, with no risk factors for delayed gastric emptying, to receive 200 mL of water, clear apple juice or apple-flavoured ORS after overnight fasting. Two hours later, two blinded assessors (a trained anaesthesiologist and a radiologist) independently determined USG-guided GRV. The primary outcome was GRV measured by the radiologist. The secondary outcome was inter-assessor correlation and agreement in GRV measurements. RESULTS: There was no statistically significant difference in median GRV between groups (apple-flavoured ORS 74.8 mL, apple juice 63.7 mL, and water 62.1 mL, P = 0.11). We found poor correlation between measurements of radiologist and anaesthesiologist (Intra-class correlation coefficient 0.3, 95% confidence intervals 0.09 to 0.48, P value 0.002). The average (mean) bias was 5.4 mL (standard deviation 42.3 mL) and the 95% limits of agreement were -79.2 ml to +90 ml. CONCLUSION: Patients receiving 200 mL of water, clear apple juice or apple-flavoured ORS had comparable GRV after 2 h. There was poor correlation and agreement between GRV measurements of different assessors, indicating that more training may be required for anaesthesiologists to attain proficiency in the quantitative assessment of GRV.