Practice-Changing Use of the 21-Gene Test for the Management of Patients With Early-Stage Breast Cancer in Latin America.

PURPOSE: We present a physician survey of the impact of 21-gene Breast Recurrence Score test results on treatment decisions in clinical practice in Latin America. METHODS: This prospective survey enrolled consecutive patients at 14 sites in Argentina, Colombia, Mexico, and Peru who had routine 21-gene testing. Physician surveys captured patient and tumor characteristics and treatment decisions before and after 21-gene test results. The survey spanned the period before and after Trial Assigning Individualized Options for Treatment (TAILORx) results reported (June 2018). Overall net percent change in adjuvant chemotherapy recommendations was estimated, and asymptotic 95% CIs with continuity correction were calculated. The proportion with a change between pretest treatment recommendation and actual treatment received was calculated overall and by Recurrence Score groups per TAILORx. RESULTS: Between March 2015 and December 2019, the survey was completed for 647 patients; 20% were node-positive. The mean patient age was 54 years (24-85 years); 55% were postmenopausal; 17%, 63%, and 20% had grade 1, 2, and 3 tumors, respectively; and 30% had tumors > 2 cm. Recurrence Score (RS) results were as follows: 20% RS 0-10, 56% RS 11-25, and 24% RS 26-100. Overall, chemotherapy recommendations fell by a relative proportion of 39% (95% CI, 33.4 to 44.3) after 21-gene testing (33% decrease in node-negative and 55% decrease in node-positive). Among node-negative patients, the relative decrease in chemotherapy recommendations was 28% (95% CI, 18.9 to 39.5) before TAILORx and 36% (95% CI, 28.4 to 43.7) after. CONCLUSION: To our knowledge, this large survey of 21-gene test practice patterns was the first conducted in Latin America and showed the relevance of 21-gene testing in low- and medium-resource countries to minimize chemotherapy overuse and underuse in breast cancer. The results showed substantial reductions in chemotherapy use overall-especially after TAILORx reported-indicating the practice-changing potential of that study.

Real-World Effectiveness and Tolerability of Pazopanib as First Targeted Therapy in Metastatic Renal Cell Carcinoma: A Retrospective Chart Review in Latin America.

INTRODUCTION: Pazopanib is approved in Latin America as first targeted therapy for patients with metastatic renal cell carcinoma (mRCC). METHODS: A retrospective chart review of adult patients with mRCC who initiated pazopanib as first targeted therapy between January 2011 and March 2016 was conducted among oncology care centers in Argentina, Brazil, Chile, Colombia, and Mexico. Patient characteristics, treatment patterns, overall survival (OS), progression-free survival (PFS), and adverse events were summarized. RESULTS: A total of 156 charts of patients with mRCC receiving first-line pazopanib were reviewed (29, 54, 27, 28, and 18 patients from Argentina, Brazil, Chile, Colombia, and Mexico, respectively). The mean age at initial mRCC diagnosis was 61.6 years, 73.7% were male, and 51.3% were Hispanic. The median dose of pazopanib was 800 mg and the median time from initial mRCC diagnosis to pazopanib start was 2.2 months. The median time on treatment was 10.0 months. At the time of data extraction, 16.7% of patients remained on pazopanib, with clinical progression listed as the main reason for discontinuation. Subsequent therapy was received by 25.6% of patients; the most common were everolimus (9.6%) and axitinib (5.8%). Overall, median PFS and OS were 10.8 and 16.9 months, respectively, and varied across countries. The most common all-grade adverse events were diarrhea (44.9%), asthenia/fatigue (43.6%), and nausea (28.8%). CONCLUSIONS: Pazopanib was used for first-line mRCC treatment in a clinically diverse patient population across Latin America. Real-world PFS and tolerability were similar to clinical studies of pazopanib. FUNDING: Novartis Pharmaceuticals Corporation, Inc.

Diagnóstico y tratamiento multidisciplinario de melanoma temprano y localmente avanzado. Consenso de expertos. Asociación Colombiana de Hematología y Oncología (ACHO) / Diagnosis and multidisciplinary treatment of early-stage and locally advanced melanoma: Expert consensus, Colombian Association of Hemato-Oncology (ACHO)

Resumen Introducción: El melanoma ocasiona el 75% de las muertes por cáncer de piel. Según GLOBOCAN, en 2018 se presentaron 287.723 casos nuevos de melanoma, con una mortalidad de 60.712 casos, que equivale al 20% del total de los casos incidentes. Las alternativas para el tratamiento del melanoma se fundamentan en la estatificación de la enfermedad, y en las características moleculares de la enfermedad. Objetivo: Consensuar, por común acuerdo de expertos, sugerencias para el diagnóstico y manejo de melanoma temprano basadas en la evidencia y ajustadas al contexto colombiano. Métodos: Se llevó a cabo un consenso de expertos multidisciplinario, constituido por 19 oncólogos clínicos, 2 cirujanos de mama y tejidos blandos, 2 dermatólogos, 2 patólogos y 2 radioterapeutas, miembros activos de la Asociación Colombiana de Hemato Oncología (ACHO). Este consenso se realizó en 4 etapas: 1. Estructuración de 29 preguntas, que se calificaron de 1 a 9. 2. Reenvío de las preguntas no consensuadas. 3. Análisis y discusión de las respuestas. 4. Las respuestas no consensuadas se llevaron a un consenso nominal. Resultados: Se discutieron 29 preguntas relacionadas con el diagnóstico y tratamiento de melanoma temprano, se construyeron sugerencias basadas en evidencia utilizada por los expertos y en guías de manejo de oncología reconocidas internacionalmente, adaptadas al contexto y realidad colombianos. Conclusiones: Se presentan sugerencias multidisciplinarias para el diagnóstico y tratamiento de melanoma temprano, las cuales debe considerarse para orientar la toma de decisiones y homogenizar la práctica clínica de acuerdo al contexto colombiano y a las características propias del sistema de salud del país. Este es un documento académico y no regulatorio.

Abstract Introduction: Melanoma causes 75% of deaths from skin cancer. In 2018, according to GLOBOCAN, 287,723 new melanoma cases were registered, with a mortality of 60,712 cases, which is equivalent to 20% of all incident cases. Alternatives for the treatment of melanoma are based on disease staging and the molecular characteristics of the disease. Objective: To establish a consensus by common agreement of experts and construct suggestions for the diagnosis and management of early-stage melanoma based on evidence and adjusted to the Colombian context. Methods: A multidisciplinary expert consensus was established, wth the participation of 19 clinical oncologists, 2 soft tissue surgeons, 2 dermatologists, 2 pathologists, and 2 radiotherapists, active members of the Colombian Association of Hemato-Oncology (ACHO). This consensus was carried out in four stages: 1) Structuring of 29 questions, which were scored from 1 to 9; 2) Resubmission of non-consensual questions; 3) Analysis and discussion of responses; and 4) Validation of non-consensual responses by nominal consensus. Results: Twenty-nine questions related to the diagnosis and treatment of early-stage melanoma were discussed in order to construct suggestions based on evidence proven by experts, as well as on internationally recognized oncology management guidelines adapted to the Colombian context and reality. Conclusions: Multidisciplinary suggestions are offered for the diagnosis and treatment of early-stage melanoma, which should be considered in order to guide decision-making and homogenize clinical practice according to the Colombian context and the characteristics of the Colombian health care system. This is an academic and non-regulatory document.