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PURPOSE: Given the infancy and evolving complexity of medicinal marijuana, an evolving political landscape, and the growing frequency of its use in cancer care, it is important for oncologists to be actively engaged in developing and successfully implementing clinical trials focusing on medical marijuana. The purpose of this study was to analyze and evaluate trends in clinical trials focused on medical marijuana in oncology. PATIENTS AND METHODS: Using 3 web-based registries, Clinicaltrials.gov, European Union Clinical Trials Register (EU-CTR), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), we queried for search terms related to marijuana and oncology. This search identified approximately 48 oncology clinical trials involving medical marijuana. We restricted our selection to clinical trials registered between January 2002 and May 2019. Data were summarized using descriptive statistics, and qualitative data were represented as frequency and percentage. RESULTS: A total of 474,043 trials were queried in the databases and the search strategy returned 48 trials since 2002 that met criteria for analysis in the current study: 36 from ClinicalTrials.gov, 8 from EU CTR, and 4 from ICTRP. Mean trial enrollment was 370 participants, median 53, with range of 6-10000 participants. In total, 25 % trials were phase I, 12.5 % were phase I/II, 27.1 % were phase II, 4 % were phase II/III, 18.8 % were phase III, and 12.5 % were unknown. The recruitment status were "not yet recruiting", "recruiting", "active, not recruiting", "completed", "terminated/withdrawn", and "unknown" in 6 (12.5 %), 14 (29.2 %), 0 (0 %), 20 (41.7 %), 5 (10.4 %), and 3 (6.3 %) trials, respectively. The trial start years were "2002-2005â³, 2006-2009, 2010-2013, 2014-2017, and 2018-Present in 4 (8.3 %), 5 (10.4 %), 10 (20.8 %), 15 (31.3 %), and 14 (29.2 %) of trials, respectively. Lastly, synthetic or branded compounds were investigated in 26 (54.2 %) of trials since 2002. CONCLUSION: Our results indicate that across oncology, there is growing interest in clinical research in the use of medical marijuana.
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Marihuana Medicinal/uso terapéutico , Oncología Médica/tendencias , Neoplasias/terapia , Proyectos de Investigación/tendencias , Ensayos Clínicos como Asunto , Humanos , Sistema de RegistrosRESUMEN
PURPOSE: Prior authorization (PA) has been widely implemented for proton beam therapy (PBT). We sought to determine the association between PA determination and patient characteristics, practice guidelines, and potential treatment delays. METHODS AND MATERIALS: A single-institution retrospective analysis was performed of all patients considered for PBT between 2015 and 2018 at a National Cancer Institute-designated Comprehensive Cancer Center. Differences in treatment start times and denial rates over time were compared, and multivariable logistic regression was used to identify predictors of initial denial. RESULTS: A total of 444 patients were considered for PBT, including 396 adult and 48 pediatric patients. The American Society for Radiation Oncology model policy supported PBT coverage for 77% of the cohort. Of adult patients requiring PA, 64% were initially denied and 32% remained denied after appeal. In patients considered for reirradiation or randomized phase 3 trial enrollment, initial denial rates were 57% and 64%, respectively. Insurance coverage was not related to diagnosis, reirradiation, trial enrollment, or the American Society for Radiation Oncology model policy guidelines, but it was related to insurance category on multivariable analysis (P < .001). Over a 3-year timespan, initial denial rates increased from 55% to 74% (P = .034). PA delayed treatment start by an average of 3 weeks (and up to 4 months) for those requiring appeal (P < .001) and resulted in 19% of denied patients abandoning radiation treatment altogether. Of pediatric patients, 9% were initially denied, all of whom were approved after appeal, and PA requirement did not delay treatment start (P = .47). CONCLUSIONS: PA requirements in adults represent a significant burden in initiating PBT and cause significant delays in patient care. Insurance approval is arbitrary and has become more restrictive over time, discordant with national clinical practice guidelines. Payors and providers should seek to streamline coverage policies in alignment with established guidelines to ensure appropriate and timely patient care.
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Cobertura del Seguro/estadística & datos numéricos , Reembolso de Seguro de Salud/estadística & datos numéricos , Neoplasias/radioterapia , Autorización Previa/estadística & datos numéricos , Terapia de Protones/economía , Tiempo de Tratamiento/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Femenino , Humanos , Revisión de Utilización de Seguros/estadística & datos numéricos , Masculino , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Terapia de Protones/estadística & datos numéricos , Análisis de Regresión , Estudios Retrospectivos , Estados Unidos , Adulto JovenRESUMEN
Women newly diagnosed with stage 1 breast cancer have an early-stage disease that can be effectively treated. Evidence provides little justification for performing imaging to exclude metastasis in asymptomatic women with stage I breast cancer. No differences have been found in survival or quality of life in women regardless of whether they underwent initial workup for metastatic disease. These women generally prefer intensive follow-up to detect an early recurrence. However, survival rates do not differ between women who obtain intensive screening and surveillance, with imaging and laboratory studies, and women who undergo testing only as a result of development of symptoms or findings on clinical examinations. In addition, quality of life is similar for women who undergo intensive surveillance compared with those who do not. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients. Additional imaging may be needed if the patient has locoregional symptoms. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review by the panel include extensive analysis of current medical literature from peer-reviewed journals and application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures. When evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.
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Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/patología , Detección Precoz del Cáncer/normas , Mamografía/normas , Metástasis de la Neoplasia/diagnóstico por imagen , Recurrencia Local de Neoplasia/diagnóstico por imagen , Enfermedades Asintomáticas , Medicina Basada en la Evidencia , Femenino , Humanos , Oncología Médica/normas , Metástasis de la Neoplasia/patología , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Guías de Práctica Clínica como Asunto , Radiología/normas , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Vigilancia de Guardia , Estados UnidosRESUMEN
Stereotactic body radiation therapy (SBRT) delivers large doses of radiation with great accuracy, but is known to have deleterious effects on the vascular compartment of irradiated tissues. Combining SBRT with targeted anti-angiogenesis agents, while able to increase therapeutic efficacy, may unexpectedly precipitate vascular-based toxicities. In this report, we describe a patient with colon cancer who developed transverse myelopathy from regorafenib 2 years after receiving SBRT for three metastatic liver lesions. Regorafenib (Stivarga), formerly BAY 73-4506, (Bayer HealthCare Pharmaceuticals, Montville, NJ) is a multiple receptor tyrosine kinase inhibitor with anti-angiogenic effects used in metastatic colon cancer. Its most common side effects are fatigue, diarrhea and hypertension. However, severe neurologic toxicity has not been previously recognized. Here, we illustrate a case in which the patient developed hyperalgesia and radicular pain 2 weeks after starting regorafenib. Several studies report an increased neurological toxicity when angiogenesis inhibitors are given after radiation therapy, and we postulate that the angioinhibitory effects of regorafenib accelerated subclinical microvascular injury from SBRT. This unexpected toxicity may be clinically relevant when giving targeted angiogenesis inhibitors after SBRT.
RESUMEN
Women newly diagnosed with stage 1 breast cancer have an early-stage disease that can be effectively treated. Evidence provides little justification for performing imaging to exclude metastasis in asymptomatic women with stage I breast cancer. No differences have been found in survival or quality of life in women regardless of whether they underwent initial workup for metastatic disease. These women generally prefer intensive follow-up to detect an early recurrence. However, survival rates do not differ between women who obtain intensive screening and surveillance, with imaging and laboratory studies, and women who undergo testing only as a result of development of symptoms or findings on clinical examinations. In addition, quality of life is similar for women who undergo intensive surveillance compared with those who do not. American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients. Additional imaging may be needed if the patient has locoregional symptoms. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 3 years by a multidisciplinary expert panel. The guideline development and review by the panel include extensive analysis of current medical literature from peer-reviewed journals and application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures. When evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.