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INTRODUCTION: The safety and efficacy of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in peritoneal metastasis in palliative settings remain poorly investigated and understood. Chemotherapy-refractory patients often present with symptomatic disease. This study investigated the safety and survival outcomes of optimal CRS/HIPEC performed primarily for palliation. METHODS: Palliative CRS/HIPEC was defined as asymptomatic patients who did not respond to three or more lines of chemotherapy, progression on current chemotherapy, and/or any symptomatic disease progression, including ascites, bowel obstruction, and pain. Data collected included demographics, histology, length of stay (LOS), perioperative complications, perioperative mortality, adjuvant chemotherapy use, peritoneal recurrence, overall recurrence, and overall survival. RESULTS: The median number of lines of chemotherapy received prior to CRS/HIPEC was 3.2, and 81% of patients were symptomatic. There were no postoperative deaths and the major complication rate was 22%. Ostomy creation and abdominal wall reconstruction were performed in 24% and 21% of patients, respectively. The median LOS was 11 days and successful palliation was achieved in 97% of patients. Overall survival was 13.5 months and factors associated with prolonged survival included optimal CRS (R1/R2a; p < 0.01) and the use of adjuvant chemotherapy (p < 0.001). Synchronous liver metastasis in the colon cancer subset did not negatively impact survival. CONCLUSION: CRS/HIPEC was performed safely in the palliative setting in patients with symptomatic progressive disease receiving multiple lines of chemotherapy. Median survival exceeded 1 year and factors associated with longer survival were optimal CRS and adjuvant chemotherapy. Liver metastasis did not preclude survival benefit in colon cancer patients. CRS/HIPEC can be considered for palliation but should be performed at high-volume centers.
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Neoplasias do Colo , Hipertermia Induzida , Neoplasias Hepáticas , Neoplasias Peritoneais , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias do Colo/tratamento farmacológico , Terapia Combinada , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Humanos , Quimioterapia Intraperitoneal Hipertérmica , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Peritoneais/secundário , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
PURPOSE: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. METHODS: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D3 4,000 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. RESULTS: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6- and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. CONCLUSIONS: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional efforts to improve the outcomes of these challenging injuries are still needed. LEVEL OF EVIDENCE: Therapeutic Level II.
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Fraturas do Colo Femoral , Fraturas do Quadril , Adolescente , Adulto , Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Projetos Piloto , Qualidade de Vida , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients. DESIGN: A pilot factorial randomized controlled trial. SETTING: Fifteen North American clinical sites. PARTICIPANTS: Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation. INTERVENTION: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months). MAIN OUTCOME MEASUREMENTS: The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing. RESULTS: Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92). CONCLUSIONS: These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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Fraturas do Colo Femoral , Fraturas do Quadril , Adulto , Fraturas do Colo Femoral/diagnóstico por imagem , Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas , Humanos , Projetos Piloto , Resultado do TratamentoRESUMO
OBJECTIVES: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. DESIGN: Pilot trial. SETTING: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. PATIENTS/PARTICIPANTS: Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. INTERVENTION: Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. MAIN OUTCOME MEASUREMENTS: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). RESULTS: Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. CONCLUSIONS: Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.