Application of the ASCO value framework to evaluate the clinical and economic value of enzalutamide and apalutamide in the early stages of prostate cancer in Colombia.

Introduction: Prostate cancer has increased in recent years, increasing the costs associated with its treatment. Second-generation oral antiandrogens have emerged as an attractive therapeutic option. Objective: To compare the health value provided by enzalutamide and apalutamide, by evaluating two stages of prostate cancer: non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Methods: To establish, through the American Society of Clinical Oncology (ASCO) value framework, a contrast between two technologies in two stages of prostate cancer. The monthly cost of the two technologies was calculated according to the current price regulation norm in Colombia. Results: Enzalutamide showed a higher net health benefit score compared to apalutamide for both nmCRPC (48.33 versus 33.46) and mHSPC (52.0 versus 40.75). The cost per net health benefit point for the nmCRPC stage was $214,723 Colombian Pesos (COP) ($54.84 USD) with enzalutamide compared to $291,925 COP ($74.56 USD) with apalutamide, and for the mHSPC stage was $199,692 COP ($51.00 USD) with enzalutamide and $239,701 COP ($61.22 USD) with apalutamide. Conclusion: After comparing enzalutamide versus apalutamide in the nmCRPC and mHSPC stages through the ASCO value framework, enzalutamide showed a more prominent net clinical benefit and a lower investment per point awarded.

Inverted urethral flap reconstruction after partial penectomy: Long-term oncological and functional outcomes.

INTRODUCTION: Penile aesthetics after partial penectomy (PP) for penile cancer (PC), significantly affect a patient's health-related quality of life (HRQoL), self-esteem, and sexual function. Satisfactory reconstruction has become a major milestone in the treatment of these patients. METHODS: Clinical charts of all patients that underwent PP and reconstruction with an inverted urethral flap (IUF) were reviewed. The primary endpoints were recurrence-free survival (RFS), overall survival (OS), and progression-free survival (PFS) which were graphically represented by Kaplan-Meier estimates. The key secondary endpoints were Health-related quality of life (HRQoL), erectile function, and lower urinary tract symptoms. RESULTS: Between May 2007 and December 2019, 74 patients with PC underwent PP and IUF reconstruction. The median age was 62 years (IQR 52-76), median follow-up was 72 months (IQR 38-121). Twenty-nine patients (39.2%) underwent inguinal lymph node dissection, 62 (83.8%) underwent dynamic sentinel lymph node biopsy. Kaplan-Meier estimates of OS, RFS, and PFS showed a 6-year OS of 86.5%, 6-year RFS of 90.5%, and a 6-year PFS of 85.1%. Regarding functional outcomes, we found a mean global health score of 84.6% ± 10.4 at the EQ-5D-3L-VAS. The mean Voiding score of the ICIQ-MLUTS was 1.7 ± 3.2 and a mean IIEF-5 score of 17.3 ± 7. CONCLUSIONS: To the best of our knowledge, we report the largest cohort in the literature of PP with IUF reconstruction. These results are important since early-stage PC is the most common stage at diagnosis. In carefully selected patients' preservation of a longer urethral stump to allow for the inverted flap is safe and does not compromise oncological outcomes while preserving HRQoL.

Inguinal lymph node density as a powerful predictor of cancer specific survival in patients with node-positive penile cancer.

INTRODUCTION: Penile cancer (PC) is an aggressive malignancy in which the most important prognostic factor for cancer specific survival (CSS) is the involvement of regional lymph nodes (LNs). Lymph node density (LND) could become a superior prognostic tool for CSS, by accounting for both extent of dissection and nodal disease burden. We aim to validate LND as a prognostic factor for CSS in a contemporary series of patients with PC treated and followed at a single high-volume center, treating more than 25 PC patients per year, over a 13-year period. METHODS: Clinical charts of all patients with PC who underwent surgical treatment between 2007 and 2020 were reviewed. Clinicopathological data was collected and analyzed retrospectively. We only included patients with ≥ 8 LNs removed in a unilateral ILND or ≥16 LNs when a bilateral approach was used. We attempted to find an optimal threshold for LND, capable of maximizing effect difference in terms of CSS and RFS between dichotomized groups. To determine this threshold, we used the chi-squared and the Mann-Whitney tests, and it was required to fulfill the proportional hazards assumption. We assessed different thresholds previously reported in the literature. In our study the optimal threshold for LND was determined to be ≤ 20% Descriptive statistics were used to summarize patient characteristics, CSS and RFS were graphically represented by Kaplan-Meier estimates. Harrell's C index for CSS and RFS were calculated for LND and pN stage, to determine which variable has a superior predictive capacity RESULTS: We identified 110 patients with PC who underwent ILND at our institution, of these, 87 were node-positive and were included in the final analysis. Overall estimates of CSS showed a 3-year CSS of 43% (95% CI: 32-54), the estimated 3-year CSS for the patients with a LND ≤ 20% was 69% (95% CI: 50-82) and 26% (95% CI: 14-39) in the group with a LND >20% (Log-rank P = 0.001). The estimated 3-year RFS for the patients with LND ≤ 20% was 61% (95% CI: 42-76) and 30% (95% CI: 16-44) in the group with a LND >20% (Log-rank P = 0.009). The results of univariate analysis indicate that in patients with a LND >20% the risk for cancer specific mortality was increased (HR 2.68; 95% CI: 1.45-4.98, P =  0.002) compared with LND ≤ 20%. In the and Cox multivariate analysis after Adjusting for age and pN stage the association increased (HR 2.73; 95%, CI 1.38-5.40, P = 0.004). Harrell´s C index for CSS was 0.63 for LND vs. 0.54 for pN stage, suggesting a 9% higher concordance for LND and CSS. CONCLUSIONS: Lymph node density stands as a promising tool for risk-stratifying patients with node-positive PC after ILND. In this retrospective study, LND was a significant predictor of CSS and RFS when using a LND >20% threshold, and also showed a superior predictive ability than pN stage. These results support the use of the LND parameter in clinical practice with a final goal to improve risk stratification, and individualized adjuvant treatment decision-making to patients with high-risk of cancer specific mortality.

Real World Data of Penile Cancer Treatment at a High-Volume Center in South America: Insights and Survival Trends.

OBJECTIVE: To report survival trends and oncological outcomes of penile cancer surgically treated patients, at a high-volume center, treating more than 25 patients each year, in a high incidence country. METHODS: Clinical charts of all patients that underwent surgical management for penile cancer were reviewed. The primary end points were cancer specific survival (CSS), progression-free survival, and local recurrence free survival. Kaplan-Meier plots were used for survival analyses. Multivariate analysis was performed using cox proportional hazard age-adjusted models to determine the effect of pN, pT, lymphovascular invasion for CSS. RESULTS: A total of 209 patients were identified, with a median follow up of 96 months (IQR 49-133). Organ-sparing surgerywas performed in 72.7%, 56.9% underwent dynamic sentinel lymph node biopsy, 110 patients underwent inguinal lymph node dissection, and 45 (21.5%) pelvic lymph node dissection. A total of 75 (35.8%) of patients relapsed, median time to relapse of 12 months (IQR 6-25). Overall estimates of CSS showed an 8-year CSS of 68.9%. Eight-year CSS was 90.5% for N0, and 32.8% in pN3 (P <.001). The Cox proportional hazard model showed that pN1-3, pT2-4, lymphovascular invasion and positive dynamic sentinel lymph node biopsy were the variables associated with worse 8-year CSS. CONCLUSION: To the best of our knowledge, we report one of the largest cohorts on the survival outcomes of penile cancer surgical treatment, in a single institution, over a long period of time, were most patients are referred with high-risk, locally advanced or nodal disease.

Renal fossa recurrence with synchronous port site and appendicular metastases after laparoscopic nephrectomy: Role of metastases and abdominal wall en bloc resection.

Isolated renal fossa recurrence and port site metastasis after laparoscopic nephrectomy are two different entities, and despite being rare, in selected cases would benefit from surgical resection. We report the case of a 61-year-old male with local renal fossa recurrence with synchronous metastasis involving the port site, the abdominal wall and the appendix, which was successfully treated with open surgical resection and is free of metastasis or recurrence. To conclude opportune treatment of similar cases, remain a safe and curative option, and should be considered after reviewing the case within a multidisciplinary team.

Factores asociados a la histología de masa residual retroperitoneal post quimioterapia en tumor testicular de células germinales / Factors Associated with the Histology of Retroperitoneal Residual Mass Post Chemotherapy in Testicular Germ Cell Tumo

Objetivo El objetivo de este estudio es describir las características y factores relacionados con la histología de la masa residual postquimioterapia en pacientes con tumor de células germinales de origen testicular sometidos a linfadenectomía retroperitoneal durante 12 años de seguimiento. Métodos Retrospectivamente se recolectaron datos clínicos, quirúrgicos y patológicos de la historia clínica de los pacientes en un centro de referencia de manejo de cáncer durante un periodo de 12 años. Se estimó la asociación entre los datos recolectados con la histología del tumor residual post quimioterapia. Resultados Se incluyeron 64 pacientes, la edad promedio fue 28.1 años, el tamaño promedio de masa residual fue de 6.7 cm. La histología de la masa residual fue teratoma en 60.9%, necrosis 26.5% y tumor viable 12.5%. El grupo pronóstico tiene asociación con la histología de la masa retroperitoneal. Las masas con histología de necrosis tuvieron menor tamaño con media 6.5 cm mientras que otras histologías tuvieron tamaño promedio de la masa residual de 10.4 cm. Conclusiones La LNDRP-PC es el estándar de tratamiento en masas residuales retroperitoneales después de quimioterapia y puede generar sobre-tratamiento hasta en 50% de los casos. El teratoma en la histología testicular está relacionado mayor tamaño de la masa residual retroperitoneal. Las características histológicas de la masa residual son comparables con otras series.

Objective The aim of the study is to describe factors and characteristics related with the post-chemotherapy residual mass histology in patients who undergoing RPLND. Methods Clinical, surgical and pathological data were retrospectively recorded from medical records of patients with diagnosis of germ cell tumor and post-chemotherapy residual retroperitoneal tumor in a cancer referral center over a period of 12 years. The association between the data collected and the post-chemotherapy residual tumor histology was assessed. Results Sixty-four patients were included with average age of 28.1 years. The mean residual mass size was 6.7 cm. The histology of the mass was teratoma in 60.9%, necrosis 26.5% and viable tumor 12.5%. Prognostic group was associated with the mass histology. Mass with necrosis histology was smaller with mean size of 6.5 cm, while other histologies had an average mass size of 10.4 cm. Conclusion PC-RPLND is the standard of management of retroperitoneal residual mass after chemotherapy and could over treat in up to 50% of cases. Teratoma component in testicular histology is related to increase size of the residual mass. Histology findings of the retroperitoneal mass are comparable with other series.

Prognostic Factors for Inguinal Lymph Node Involvement and Tumor Recurrence in Squamous Cell Carcinoma of the Penis / Factores pronósticos de compromiso ganglionar inguinal y recaída tumoral en carcinoma escamocelular de pene

Zoom Image Abstract Introduction Penile carcinoma is an aggressive disease with catastrophic consequences that frequently lead to death. Therefore, further knowledge on the prognostic factors that can help identify patients in need of more aggressive treatments becomes essential. Objective To identify the prognostic factors for lymph node (LN) involvement and tumor recurrence in patients diagnosed with squamous cell carcinoma of the penis (SCCP). Methods A retrospective cohort study was conducted. Patients diagnosed and treated for SCCP at Instituto Nacional de Cancerología between 2008 and 2015 were included in the sample. Cases in which no information on recurrence was available for the follow-up were excluded, as well as patients with no initial pathology and those getting penile reconstructions after cancer. Relevant data was retrieved from the medical records of each patient, and a descriptive analysis was performed. Subsequently, this data was used to apply a logistic regression model to determine the potential clinical and histopathological prognostic factors. Results A total of 104 patients were included in the present study. The average age of the sample was 59 years, while the follow-up averaged 24 months per patient. Inguinal lymphadenectomy was performed on 61 patients (59%) during the follow-up. The logistic regression model showed that lymphovascular invasion (odds ratio [OR]: 6.7; 95% confidence interval [95%CI]: 1.2­35) and poor tumor differentiation (OR: 17; 95%CI: 3.2­92) were associated with tumor recurrence. Likewise, the lymphadenectomy procedures showed that lymphovascular invasion was associated with LN involvement (OR: 3.3; 95%CI: 1.1­10). Conclusion Lymphovascular invasion was the strongest prognostic factor observed in our sample, aiding in the prediction of inguinal LN involvement and tumor recurrence in SCCP patients

Introduccion El cáncer de pene es una enfermedad agresiva con consecuencias catastróficas que frecuentemente llevan a la muerte. Por lo tanto, es esencial un mayor conocimiento sobre los factores pronósticos que pueden ayudar a identificar a los pacientes que necesitan tratamientos más agresivos. Objetivo Identificar los factores pronósticos patológicos de compromiso ganglionar inguinal y recaída tumoral en pacientes con carcinoma escamocelular de pene. Métodos Se realizó un estudio de cohorte retrospectivo. Se incluyeron en la muestra pacientes diagnosticados y tratados por carcinoma escamocelular de pene (SCCP) en el Instituto Nacional de Cancerología entre 2008 y 2015. Los casos en los que no había información sobre la recurrencia en el seguimiento fueron excluidos, así como los pacientes sin patología inicial y aquellos que reciben reconstrucciones del pene después del cáncer. Se recuperaron los datos relevantes de los registros médicos de cada paciente, y una descripción fue realizada. Posteriormente, estos datos se utilizaron para aplicar un modelo de regresión logística para determinar los posibles factores pronósticos clínicos e histopatológicos. Resultados Un total de 104 pacientes fueron incluidos en el estudio. La edad promedio de la muestra fue de 59 años, mientras que el seguimiento promedió fue de 24 meses por paciente. La linfadenectomía inguinal se realizó en 61 pacientes (59%) durante el seguimiento. El modelo de regresión logística mostró que la invasión linfovascular (odds ratio [OR]: 6,7; intervalo de confianza del 95% [IC 95%]: 1,2­35) y la pobre diferenciación tumoral (OR: 17; IC 95%: 3,2­92) se asociaron con recurrencia tumoral. Así mismo, los procedimientos de linfadenectomía mostraron que la invasión linfovascular se asoció con afectación de LN. (OR: 3,3; IC 95%: 1,1-10). Conclusión La invasión linfovascular es el factor pronóstico independiente más importante que se asocia de manera independiente con compromiso ganglionar inguinal positivo y recaída tumoral.

Metastasectomy of Abdominal Wall Lesions due to Prostate Cancer Detected Through PET/CT Gallium 68-PMSA: First Case Report.

Introducing the topic of abdominal wall metastasis secondary to prostate cancer with a reminder of the disease's rarity, being the first published case. This article is about a 66 year old patient diagnosed with prostate cancer [cT2aNxMx iPSA: 5,6 ng/ml Gleason 3+3, (Grade 1 Group)], treated with radical prostatectomy as well as accompanied with amplified pelvic lymphadenectomy, who subsequently presented metastatic lesions to the abdominal wall diagnosed with PET/CT Gallium 68-PMSA technique and treated with abdominal metastasectomy with adequate short term results.

Tax secretion from peripheral blood mononuclear cells and Tax detection in plasma of patients with human T-lymphotropic virus-type 1-associated myelopathy/tropical spastic paraparesis and asymptomatic carriers.

Human T-lymphotropic virus-type 1 (HTLV-1) is the etiologic agent of the neurologic disease HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP). Tax viral protein plays a critical role in viral pathogenesis. Previous studies suggested that extracellular Tax might involve cytokine-like extracellular effects. We evaluated Tax secretion in 18 h-ex vivo peripheral blood mononuclear cells (PBMCs) cultures from 15 HAM/TSP patients and 15 asymptomatic carriers. Futhermore, Tax plasma level was evaluated from other 12 HAM/TSP patients and 10 asymptomatic carriers. Proviral load and mRNA encoding Tax were quantified by PCR and real-time RT-PCR, respectively. Intracellular Tax in CD4(+)CD25(+) cells occurred in 100% and 86.7% of HAM/TSP patients and asymptomatic carriers, respectively. Percentage of CD4(+)CD25(+) Tax+, proviral load and mRNA encoding Tax were significantly higher in HAM/TSP patients. Western blot analyses showed higher secretion levels of ubiquitinated Tax in HAM/TSP patients than in asymptomatic carriers. In HTLV-1-infected subjects, Western blot of plasma Tax showed higher levels in HAM/TSP patients than in asymptomatic carriers, whereas no Tax was found in non-infected subjects. Immunoprecipitated plasma Tax resolved on SDS-PAGE gave two major bands of 57 and 48 kDa allowing identification of Tax and Ubiquitin peptides by mass spectrometry. Relative percentage of either CD4(+)CD25(+) Tax+ cells, or Tax protein released from PBMCs, or plasma Tax, correlates neither with tax mRNA nor with proviral load. This fact could be explained by a complex regulation of Tax expression. Tax secreted from PBMCs or present in plasma could potentially become a biomarker to distinguish between HAM/TSP patients and asymptomatic carriers.