Cost-Effectiveness Analysis: Selective Use of Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer.

BACKGROUND: Locally advanced rectal cancer has high cure rates with trimodal therapy. Studies sparing neoadjuvant chemoradiation in selected patients show comparable outcomes. OBJECTIVE: This study aimed to determine the cost-effectiveness of selective use of neoadjuvant chemoradiation in this population. DESIGN: A cost-effectiveness analysis model compared selective and blanket use chemoradiation for locally advanced rectal cancer. SETTINGS: Literature review, expert consensus, and a prospective database populated the model. Health care utilization costs were based on information from the Centers for Medicare and Medicaid Services. PATIENTS: Adult patients with stage II and III rectal cancer were selected. MAIN OUTCOMES MEASURES: Primary outcomes were cost, effectiveness in quality-adjusted disease-free life years, net monetary benefit, and incremental cost-effectiveness ratios in dollars per quality-adjusted disease-free life years. Base-case 5-year disease-free survival for both strategies was 65%. One-way sensitivity analysis found the probability of 5-year disease-free survival for selective ranged between 40% and 65%. Probabilistic sensitivity analysis assessed second-order variability. RESULTS: Base-case 5-year disease-free survival demonstrated selective use is dominant with lower cost and higher quality-adjusted disease-free life years. For selective use, cost is $153,176, effectiveness is 2.71 quality-adjusted life years, and net monetary benefit is -$17,564 and for blanket use cost is $176,362, effectiveness is 2.64 quality-adjusted life years, and net monetary benefit is -$44,217. One-way sensitivity analysis shows selective use is dominant for disease-free survival above 61.25% and is preferred for disease-free survival above 53.7%. Probabilistic sensitivity analysis shows selective use is optimal in 88% of the iterations for a population of 10,000 patients. LIMITATIONS: Model was based on data from the literature, prospective database, and expert consensus. CONCLUSION: In a population of patients with locally advanced rectal cancer with base-case disease-free survival of 65%, selective use of neoadjuvant chemoradiation is the superior strategy as long as disease-free survival in this group remains above 53%. See Video Abstract at http://links.lww.com/DCR/C199. ANLISIS DE COSTOEFECTIVIDAD USO SELECTIVO DE QUIMIORRADIACIN NEOADYUVANTE EN CNCER DE RECTO LOCALMENTE AVANZADO: ANTECEDENTES:El cáncer de recto localmente avanzado tiene altas tasas de curación con la terapia trimodal. Los estudios que evitan la quimiorradiación neoadyuvante en pacientes seleccionados muestran resultados comparables.OBJETIVO:Determinar la relación costo-efectividad del uso selectivo de quimiorradiación neoadyuvante en esta población.DISEÑO:Un modelo de análisis de costo-efectividad comparó la quimiorradiación selectiva y de uso general para el cáncer de recto localmente avanzado.AJUSTES:Revisión de literatura, consenso de expertos y una base de datos prospectiva poblaron el modelo. Los costos de utilización de la atención médica se basaron en los Centros de Servicios de Medicare y Medicaid.PACIENTES:Se seleccionaron pacientes adultos con cáncer de recto en estadio II y III.PRINCIPALES MEDIDAS DE RESULTADOS:Los resultados primarios fueron el costo, efectividad en años de vida sin enfermedad ajustados por calidad, el beneficio monetario neto y la relación costo-efectividad incremental en $/años de vida sin enfermedad ajustados por calidad. La supervivencia libre de enfermedad a 5 años del caso base para ambas estrategias fue del 65%. El análisis de sensibilidad unidireccional varió la probabilidad de supervivencia libre de enfermedad a 5 años para uso selectivo entre 40%-65%. El análisis de sensibilidad probabilístico evaluó la variabilidad de segundo orden.RESULTADOS:El caso base de 5 años de supervivencia libre de enfermedad demostró que el uso selectivo es dominante con menor costo y años de vida libre de enfermedad ajustados de mayor calidad. El costo, la efectividad y el beneficio monetario neto para el uso selectivo y general fueron ($153 176; 2,71 QALY; -$17 564) y ($176 362; 2,64 QALY; -$44 217). El análisis de sensibilidad unidireccional demostró que el uso selectivo es dominante para la supervivencia sin enfermedad por encima del 61,25% y se prefiere para la supervivencia sin enfermedad por encima del 53,7%. El análisis de sensibilidad probabilístico demostró que el uso selectivo es óptimo en el 88% de las iteraciones para una población de 10 000 pacientes.LIMITACIONES:Modelo basado en datos de literatura, base de datos prospectiva y consenso de expertos.CONCLUSIÓN:En una población de pacientes con cáncer de recto localmente avanzado con caso base de supervivencia libre de enfermedad del 65%, el uso selectivo de quimiorradiación neoadyuvante para el cáncer de recto localmente avanzado es la estrategia superior, siempre y cuando la supervivencia libre de enfermedad en este grupo se mantenga por encima del 53%. Consulte Video Resumen en http://links.lww.com/DCR/C199. (Traducción-Dr. Fidel Ruiz Healy).

Factors predicting reclassification of variants of unknown significance.

Genetic variants of unknown significance (VUS) are an increasingly common result of genetic testing. VUS present dilemmas for treatment and surveillance. Family history may play a role in VUS reclassification over time. METHODS: All genetic tests performed at a tertiary referral center 2006-2015 were evaluated for the presence of VUS. Patients with VUS were evaluated for demographics, clinical characteristics, family history, and gene characteristics. RESULTS: In total, 2291 individuals were tested from 1639 families; 150 VUS were identified. Twenty-eight VUS reclassified, 21 to benign and 7 to pathogenic. Logistic regression demonstrated the number of family members with associated phenotypic disease was a significant predictor of reclassification. CONCLUSION: The likelihood of VUS reclassification can be predicted by increased positive family history of disease. Most VUS reclassify to benign, but one-fourth reclassify to pathogenic. The actual risk of a VUS should be assessed based on family history and routinely checked for reclassification.

Robotic Colorectal Surgery Learning Curve and Case Complexity.

PURPOSE: To understand the role of case complexity in the learning curve for robotic colorectal surgery. MATERIALS AND METHODS: Sixty-two patients who underwent robot-assisted colorectal surgery were retrospectively reviewed. Each case was assigned a category of complexity ranging from I to IV. Overall, groups and categories of segmental colectomy, rectopexy, and proctectomy for cancer were analyzed according to case volume. Forty-eight patients who underwent similar laparoscopic cases during the same period were also reviewed for comparison. RESULTS: Level I complexity cases were identified in 30% of the first 15 cases compared to 3% after the first 15 cases (P < .01). Level IV complexity cases were identified in 10% of the first 15 cases and 34% after 15 cases (P = .03). Mean operative time for the overall group was 426 minutes (range 178-766, standard deviation [SD] = 152) in the first 15 cases and 373 minutes (range 190-593, SD = 109) after more than 15 cases (P = NS). Mean operative time for rectal cancer procedures decreased from 518 minutes (range 425-752, SD = 88) to 410 minutes (range 220-593, SD = 98) after 15 cases (P = .02). Mean operative time for rectopexy decreased from 361 minutes (range 276-520, SD = 85) to 258 minutes (range 215-318, SD = 34) after 15 cases (P = .03). Overall complications were reduced after 15 cases (6.3%) compared with the first 15 cases (27%) (P = .04). When comparing laparoscopic and open cases, laparoscopic cases were associated with a significant shorter operative time (P = < .00001) as well as overall cost (P = < .00001). CONCLUSION: Complex robotic colorectal surgery can be performed early in the experience, with reduced operative time. Overall complications are reduced after 15 robotic cases. This study shows that improvement in robotic surgery operating time and surgical outcomes occur along with application of the technology to more difficult cases, not as a function of choosing less complex cases.

What happens after a failed LIFT for anal fistula?

BACKGROUND: Ligation of the intersphincteric fistula tract (LIFT) was developed to treat transsphincteric anal fistulas. The aftermath of a failed LIFT has not been well documented. METHODS: Retrospective chart review of LIFT procedure for transsphincteric anal fistula between March 2012 and September 2016. RESULTS: 53 patients with LIFT procedure were identified, 20 (37.7%) had persistent fistula with median followup of 4 months. Following LIFT, recurrence of fistula was transsphincteric (75%) or intersphincteric (25%) (p = NS). Persistent transsphincteric fistulas after LIFT were treated with seton (71.4%) followed by advancement flap (20%) or fistulotomy (50%). Of the recurrent intersphincteric fistulas, 50% underwent seton placement followed by fistulotomy, or advancement flap. Of the patients who underwent surgery after failed LIFT, 50% have had resolution of the fistula; 31.7% are still undergoing treatment. CONCLUSION: Patients who underwent surgery after failed LIFT had 50% healing with placement of seton followed by fistulotomy or rectal advancement flap.

Risk of late bleeding following hemorrhoidal banding in patients on antithrombotic prophylaxis.

BACKGROUND: The risk of bleeding following rubber band ligation of internal hemorrhoids is 1%-2%. This risk may be increased in patients taking antithrombotic therapy. The goal of the current study was to find a safer approach to banding without increasing the risk of bleeding. METHODS: This retrospective review identified patients undergoing banding while on antithrombotic therapy. These medications were held for 7-10 days following the procedure. The number of bands placed while on antithrombotic therapy and their post band complications were recorded. RESULTS: There were 605 bands placed on 364 patients taking antithrombotic medications. There were 23 complications involving bleeding, a value that was not statistically different from those not taking antithrombotic therapy. Patients on clopidogrel experienced 50% of the significant bleeding episodes and 18% of the insignificant bleeding episodes. CONCLUSIONS: Holding antithrombotic medication following banding appears to equalize the risk of bleeding to that of patients not taking antithrombotic medications. Patients taking clopidogrel may be at higher risk for bleeding complications.

Response to preoperative chemoradiation in stage II and III rectal cancer.

PURPOSE: The purpose of this study was to determine whether a complete pathologic response after neoadjuvant therapy in rectal cancer patients improves disease control and survival. METHODS: The study reviewed Stage II and III rectal cancer patients treated with preoperative chemoradiation and resected for cure. Complete pathologic response was defined as no cancer in the resected specimen. The main outcome measures were cancer-specific and disease-free survival in patients achieving a complete pathologic response and a noncomplete pathologic response. Kaplan-Meier curves were evaluated using log-rank analysis. RESULTS: Eighty-nine rectal cancer patients received neoadjuvant chemoradiation followed by radical resection for cure. Twenty-one patients (24 percent) achieved a complete pathologic response. Median follow-up for the complete pathologic response group was 23.5 months and 31 months for the noncomplete pathologic response group. There were more Stage III patients in the noncomplete pathologic response group than the complete pathologic response group (P = 0.005). Complete pathologic response patients were less likely to receive postoperative adjuvant chemotherapy than noncomplete pathologic response patients (P = 0.004). Cancer-specific and disease-free survival were not statistically different between the two groups. However, a trend was noted toward improved survival and decreased recurrence in association with a complete pathologic response. CONCLUSION: Stage III patients were less likely to be in the complete pathologic response group than Stage II patients. Complete pathologic response patients were less likely to receive postoperative adjuvant chemotherapy than noncomplete pathologic response patients. Complete pathologic response after neoadjuvant chemoradiation for rectal cancer patients demonstrated a trend toward improved survival and decreased recurrence compared with noncomplete pathologic response patients.