RESUMO
BACKGROUND: Belantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies. METHODS: In this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status. RESULTS: In total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved. CONCLUSIONS: As compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Bortezomib , Dexametasona , Mieloma Múltiplo , Intervalo Livre de Progressão , Humanos , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/mortalidade , Bortezomib/efeitos adversos , Bortezomib/administração & dosagem , Bortezomib/uso terapêutico , Dexametasona/efeitos adversos , Dexametasona/uso terapêutico , Dexametasona/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Adulto , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais/administração & dosagem , Neoplasia Residual , Estimativa de Kaplan-Meier , Análise de SobrevidaRESUMO
Background: The COVID-19 social distancing guidelines resulted in a dramatic transition to telephone and video technologies to deliver substance use disorder (SUD) treatment. Before COVID-19, the question was "Will telehealth ever take hold for SUD services?" Now that social distancing guidelines have been lifted, the question is "Will telehealth remain a commonly used care modality?" Objective: The principal purpose of this investigation was to examine the extent to which telehealth use in SUD service settings persisted following the lifting of COVID-19 safety distancing recommendations. Additionally, the study aimed to explore practitioners' perceptions of telehealth convenience and value after its regular implementation during the pandemic. Specifically, the goal of this study was to compare telehealth activity between time intervals: May-August 2020 (during peak COVID-19 safety distancing recommendations) and October-December 2022 (following discontinuation of distancing recommendations). Specifically, we compared (1) telehealth technologies and services, (2) perceived usefulness of telehealth, (3) ease of use of telephone- and video-based telehealth services, and (4) organizational readiness to use telehealth. Methods: An online cross-sectional survey consisting of 108 items was conducted to measure the use of telehealth technologies for delivering a specific set of SUD services in the United States and to explore the perceived readiness for use and satisfaction with telephonic and video services. The survey took approximately 25-35 minutes to complete and used the same 3 sets of questions and 2 theory-driven scales as in a previous cross-sectional survey conducted in 2020. Six of 10 Regional Addiction Technology Transfer Centers funded by the Substance Abuse and Mental Health Services Administration distributed the survey in their respective regions, collectively spanning 37 states. Responses of administrators and clinicians (hereafter referred to as staff) from this 2022 survey were compared to those obtained in the 2020 survey. Responses in 2020 and 2022 were anonymous and comprised two separate samples; therefore, an accurate longitudinal model could not be analyzed. Results: A total of 375 staff responded to the 2022 survey (vs 457 in 2020). Baseline organizational characteristics of the 2022 sample were similar to those of the 2020 sample. Phone and video telehealth utilization rates remained greater than 50% in 2022 for screening and assessment, case management, peer recovery support services, and regular outpatient services. The perceived usefulness of phone-based telehealth was higher in 2022 than in 2020 (mean difference [MD] -0.23; P=.002), but not for video-based telehealth (MD -0.12; P=.13). Ease of use of video-based telehealth was perceived as higher in 2022 than in 2020 (MD-0.35; P<.001), but no difference was found for phone-based telehealth (MD -0.12; P=.11). From the staff's perspective, patients had greater readiness for using telehealth via phone than video, but the staff perceived their personal and organizational readiness for using telehealth as greater for video-based than for phone-based telehealth. Conclusions: Despite lower telephone and video use in 2022 for telehealth services than in 2020, both modalities continue to be perceived positively. Future research may further determine the relative cost and clinical effectiveness of video-based services and thereby help to address some sources of the noted challenges to implementation by SUD organizations.
Assuntos
COVID-19 , Transtornos Relacionados ao Uso de Substâncias , Telemedicina , Humanos , COVID-19/prevenção & controle , COVID-19/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Estudos Transversais , Distanciamento Físico , Inquéritos e Questionários , Masculino , Adulto , FemininoRESUMO
BACKGROUND: Social distancing guidelines for COVID-19 have caused a rapid transition to telephone and video technologies for delivering treatment for substance use disorders (SUDs). OBJECTIVE: This study examined the adoption of these technologies across the SUD service continuum, acceptance of these technologies among service providers, and intent of providers to use these technologies after the pandemic. Additional analysis using the validated technology acceptance model (TAM) was performed to test the potential applications of these technologies after the pandemic. The study objectives were as follows: (1) to assess the use of telehealth (telephone and video technologies) for different SUD services during COVID-19 in May-June 2020, (2) to assess the intended applications of telehealth for SUD services beyond COVID-19, (3) to evaluate the perceived ease of use and value of telehealth for delivering SUD services, and (4) to assess organizational readiness for the sustained use of telehealth services. METHODS: An online survey on the use of telephonic and video services was distributed between May and August 2020 to measure the current use of these services, perceived organizational readiness to use these services, and the intent to use these services after COVID-19. In total, 8 of 10 regional Addiction Technology Transfer Centers representing 43 states distributed the survey. Individual organizations were the unit of analysis. RESULTS: In total, 457 organizations responded to the survey. Overall, the technology was widely used; >70% (n>335) of organizations reported using telephone or video platforms for most services. The odds of the intent of organizations to use these technologies to deliver services post COVID-19 were significantly greater for all but two services (ie, telephonic residential counseling and buprenorphine therapy; mean odds ratio 3.79, range 1.87-6.98). Clinical users preferred video technologies to telephone technologies for virtually all services. Readiness to use telephone and video technologies was high across numerous factors, though telephonic services were considered more accessible. Consistent with the TAM, perceived usefulness and ease of use influenced the intent to use both telephone and video technologies. CONCLUSIONS: The overall perceived ease of use and usefulness of telephonic and video services suggest promising post-COVID-19 applications of these services. Survey participants consistently preferred video services to telephonic services; however, the availability of telephonic services to those lacking easy access to video technology is an important characteristic of these services. Future studies should review the acceptance of telehealth services and their comparative impact on SUD care outcomes.