RESUMO
PURPOSE: 5-aminolevulinic acid (5-ALA) fluorescence-guided resection (FGR) has been an essential tool in the 'standard of care' of malignant gliomas. Over the last two decades, its indications have been extended to other neoplasms, such as metastases and meningiomas. However, its availability and cost-benefit still pose a challenge for widespread use. The present article reports a retrospective series of 707 cases of central nervous system (CNS) tumors submitted to FGR with pharmacological equivalent 5-ALA and discusses financial implications, feasibility and safeness. METHODS: From December 2015 to February 2024, a retrospective single institution series of 707 cases of 5-ALA FGR were analyzed. Age, gender, 5-ALA dosage, intraoperative fluorescence finding, diagnosis and adverse effects were recorded. Financial impact in the surgical treatment cost were also reported. RESULTS: there was an additional cost estimated in $300 dollars for each case, increasing from 2,37 to 3,28% of the total hospitalization cost. There were 19 (2,69%) cases of asymptomatic photosensitive reaction and 2 (0,28%) cases of photosensitive reaction requiring symptomatic treatment. 1 (0,14%) patient had a cutaneous rash sustained for up to 10 days. No other complications related to the method were evident. In 3 (0,42%) cases of patients with intracranial hypertension, there was vomiting after administration. CONCLUSION: FGR with pharmacological equivalent 5-ALA can be considered safe and efficient and incorporates a small increase in hospital expenses. It constitutes a reliable solution in avoiding prohibitive costs worldwide, especially in countries where commercial 5-ALA is unavailable.
Assuntos
Ácido Aminolevulínico , Neoplasias do Sistema Nervoso Central , Análise Custo-Benefício , Estudos de Viabilidade , Humanos , Ácido Aminolevulínico/economia , Feminino , Masculino , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Adulto , Neoplasias do Sistema Nervoso Central/cirurgia , Neoplasias do Sistema Nervoso Central/economia , Procedimentos Neurocirúrgicos/economia , Procedimentos Neurocirúrgicos/métodos , Cirurgia Assistida por Computador/economia , Cirurgia Assistida por Computador/métodos , Adulto Jovem , Idoso de 80 Anos ou mais , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/uso terapêutico , Adolescente , Criança , Fluorescência , Imagem Óptica/economiaRESUMO
INTRODUCTION: Basal cell carcinoma is the most common cancer. Excisional surgery is associated with a high clearance rate, at the expense of significant functional and aesthetic morbidity, especially within the T-zone or for extensive lesions. We report five-year follow-up outcomes for carbon dioxide laser extirpation of cutaneous basal cell carcinoma, assisted by immediate methyl aminolevulinate photodynamic therapy and cost-benefit considerations. MATERIALS AND METHODS: Retrospective cohort database analysis of adult patients with biopsy-proven primary cutaneous basal cell carcinoma, completing five years of follow-up. Direct per-lesion cost was compared with conventional wide local excision. Patients with morphoeic basal cell carcinoma were excluded. RESULTS: Treated lesions were up to 1% total body surface area and up to 3.8mm (1.38 ± 0.695cm, mean ± standard deviation) in biopsy-proven depth. At the five-year follow-up mark, 93.6% of treated areas remained free of recurrence. Nodular basal cell carcinoma was the most common subtype (41.5%). A mean tumour depth greater than 2 ± 0.872mm was significantly associated with recurrence (Mann-Whitney, p = 0.0487). For a service delivered through the NHS at 2015 prices, we report a 43% saving, equating to a saving of £235 per basal cell carcinoma or a national annualised saving of £70 million by 2025 for the NHS. CONCLUSION: Our results suggest that CO2-assisted photodynamic therapy is non-inferior to excision but may offer better functional and cosmetic preservation at a fraction of the direct like for like cost of operative surgery. Investigation of this method by randomised controlled methodology is warranted.
Assuntos
Ácido Aminolevulínico/análogos & derivados , Carcinoma Basocelular/terapia , Procedimentos Cirúrgicos Dermatológicos/métodos , Lasers de Gás/uso terapêutico , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/uso terapêutico , Neoplasias Cutâneas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/economia , Ácido Aminolevulínico/uso terapêutico , Carcinoma Basocelular/economia , Terapia Combinada , Análise Custo-Benefício , Procedimentos Cirúrgicos Dermatológicos/economia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Estudos Retrospectivos , Neoplasias Cutâneas/economia , Resultado do Tratamento , Reino UnidoRESUMO
Importance: The EVEREST II trial showed that for patients with polypoidal choroidal vasculopathy (PCV), intravitreal ranibizumab in combination with verteporfin photodynamic therapy improves visual acuity relative to ranibizumab monotherapy. However, whether combination therapy is incrementally cost-effective relative to monotherapy during a lifetime is unclear. Objective: To assess the incremental cost-effectiveness of combination therapy compared with ranibizumab monotherapy in patients with PCV. Design, Setting, and Participants: This model-based, economic evaluation used 2018 unit cost data from a tertiary eye hospital in Singapore, first- and second-year outcomes and resource use data from a multicenter trial across various Asian countries (EVEREST II) to model a hypothetical cohort of patients with symptomatic PCV. Scenario analyses and deterministic and probabilistic sensitivity analyses were performed to examine uncertainty. Data were collected from October 2018 through April 2019 and analyzed from March through October 2019. Interventions: This model used data from the EVEREST II trial, in which all participants were given 0.5 mg of intravitreal ranibizumab once every 4 weeks for the first 3 months. Subsequent administration occurred as needed. For participants receiving combination therapy, standard fluence (50 J/cm3) photodynamic therapy with 6-mg/m2 verteporfin was administered once during the first 3 months and thereafter as needed. Main Outcomes and Measures: Incremental cost per quality-adjusted life-year (QALY) gained for combination therapy relative to monotherapy for patients with PCV. Results: In this model based on a cohort of 1000 patients aged 68 years, a patient with PCV incurred a total cost in Singapore dollars (SGD) of 92â¯327 (US $67â¯399) with combination therapy and SGD 92â¯371 (US $67â¯431) with monotherapy during a lifetime horizon, generating a modest cost savings of SGD 44 (US $32) per patient undergoing combination therapy. Lifetime QALYs were estimated to be 7.87 for combination therapy and 7.85 for monotherapy, for an incremental gain of 0.02 QALYs. Combination therapy remained cost-saving or cost-effective in all lifetime scenarios modeled, but during shorter time horizons and at lower monotherapy costs, it may not be cost-effective. Conclusions and Relevance: This study found combination therapy to be a dominant (more effective and less costly) strategy, being similar in costs and slightly more effective than ranibizumab monotherapy during a lifetime horizon. However, decreasing the time horizon to less than 10 years and/or reductions in the cost of monotherapy may result in combination therapy no longer being cost-effective.
Assuntos
Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/economia , Neovascularização de Coroide/tratamento farmacológico , Neovascularização de Coroide/economia , Custos de Medicamentos , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/administração & dosagem , Fármacos Fotossensibilizantes/economia , Ranibizumab/administração & dosagem , Ranibizumab/economia , Verteporfina/administração & dosagem , Verteporfina/economia , Idoso , Inibidores da Angiogênese/efeitos adversos , Ásia , Neovascularização de Coroide/diagnóstico , Neovascularização de Coroide/fisiopatologia , Redução de Custos , Análise Custo-Benefício , Feminino , Humanos , Injeções Intravítreas , Masculino , Fotoquimioterapia/efeitos adversos , Fármacos Fotossensibilizantes/efeitos adversos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Ranibizumab/efeitos adversos , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento , Verteporfina/efeitos adversos , Acuidade Visual/efeitos dos fármacosRESUMO
INTRODUCTION: Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective. METHODS AND ANALYSIS: PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime. ETHICS AND DISSEMINATION: Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.
Assuntos
Cistectomia/economia , Técnicas de Diagnóstico Urológico/economia , Fármacos Fotossensibilizantes/economia , Neoplasias da Bexiga Urinária/economia , Neoplasias da Bexiga Urinária/cirurgia , Técnicas de Diagnóstico Urológico/normas , Custos de Cuidados de Saúde , Humanos , Recidiva Local de Neoplasia/economia , Recidiva Local de Neoplasia/cirurgia , Fármacos Fotossensibilizantes/uso terapêutico , Medicina Estatal , Resultado do Tratamento , Reino Unido , Bexiga Urinária/patologia , Neoplasias da Bexiga Urinária/diagnósticoRESUMO
BACKGROUND: 5-Aminolevulinic acid (5-ALA) has become an important assistant in glioblastoma (GB) surgery. Unfortunately, its price affects its widespread use. OBJECTIVE: The aim of this study was to compare commercial 5-ALA with the pharmacy-compounded solution. METHODS: Using first an in vitro experimental approach, different concentrations of the pharmacy-compounded solution and commercial 5-ALA were tested in U87MG, LN229, U373, and T98G commercial glioblastoma cell lines. Fluorescence intensity was compared for each concentration by flow cytometry. Mean fluorescence of culture supernatant and lysate samples were analyzed. In a second phase, both preparations were used for surgical glioblastoma resection and tumor samples were analyzed by confocal microscopy. Mean fluorescence intensity was analyzed for each preparation and compared. RESULTS: There was a high variability of fluorescence intensity between cell lines, but each cell line showed similar fluorescence for both preparations (compounded preparation and commercial 5-ALA). In the same way, both preparations had similar fluorescence intensity in glioblastoma samples. CONCLUSION: Both, compounded and commercial 5-ALA preparations produce equivalent fluorescent responses in human glioblastoma cells. Fluorescence intensity is cell line specific, but fluorescent properties of both preparations are undistinguishable.
Assuntos
Ácido Aminolevulínico/farmacocinética , Neoplasias Encefálicas/metabolismo , Glioblastoma/metabolismo , Fármacos Fotossensibilizantes/farmacocinética , Ácido Aminolevulínico/economia , Ácido Aminolevulínico/normas , Linhagem Celular Tumoral , Custos e Análise de Custo , Humanos , Neurônios/metabolismo , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/normasRESUMO
BACKGROUND: Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK). OBJECTIVES: To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs. METHODS: This nonsponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy. RESULTS: In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0·008). In total, BF-200 ALA cleared 299/375 AKs (79·7%) and MAL 288/392 (73·5%) (P = 0·041). The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven on the MAL side and 23 displayed no difference (P = 0·001). The cosmetic outcome was excellent or good in > 90% of cases with both photosensitizers (P = 1·000). The cost-effectiveness plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA. CONCLUSIONS: Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL.
Assuntos
Ácido Aminolevulínico/análogos & derivados , Ceratose Actínica/tratamento farmacológico , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/administração & dosagem , Ácido Aminolevulínico/efeitos adversos , Ácido Aminolevulínico/economia , Análise Custo-Benefício , Feminino , Humanos , Ceratose Actínica/diagnóstico , Masculino , Pessoa de Meia-Idade , Fotoquimioterapia/efeitos adversos , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/efeitos adversos , Fármacos Fotossensibilizantes/economia , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The cost of topical treatments for actinic keratosis (AK) has never been evaluated with respect to the actual cancerization field treated and the corresponding lesion response rate. Traditionally, evaluation in AK has been done in the context of patient response rate alone. The current study aimed to develop an economic model assessing the cost of topical treatments for the management of AK in Italy. METHODS: Data from Italian patients (N.=100) with five or more mild/moderate lesions on the face and/or scalp was used. The efficacy of the topical treatments which are available for the treatment of AK in Italy was considered. The outcome of interest was lesion response rates at three months and was based on published literature. The cost of each treatment was estimated according to the approval status of the drug and the cancerization area that required treatment. The analysis was replicated for four other European countries. RESULTS: The average costs of treatment with c-PDT, DL PDT, DHA, InMeb and IMQ were 364.2, 255.5, 848.7, 1039.1, and 628.3, respectively. Taking into account the number of lesions cleared per patient, the cancerization area treated, and the number of visits required with each treatment, the total costs per lesion treated per patient were estimated at 37.9, 29, 264.7, 103.5, and 115.4, respectively. The analysis produced consistent results when it was replicated for other countries. CONCLUSIONS: Daylight therapy with methyl aminolevulinate (DL PDT) is an effective treatment option for AK management with a favourable value for money profile.
Assuntos
Ácido Aminolevulínico/análogos & derivados , Ceratose Actínica/tratamento farmacológico , Modelos Econômicos , Fotoquimioterapia/métodos , Administração Cutânea , Ácido Aminolevulínico/administração & dosagem , Ácido Aminolevulínico/economia , Europa (Continente) , Humanos , Itália , Ceratose Actínica/economia , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/administração & dosagem , Fármacos Fotossensibilizantes/economia , Resultado do TratamentoAssuntos
Terapia a Laser/economia , Fotoquimioterapia/economia , Dermatopatias/tratamento farmacológico , Ácido Aminolevulínico/administração & dosagem , Ácido Aminolevulínico/economia , Humanos , Terapia a Laser/métodos , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/administração & dosagem , Fármacos Fotossensibilizantes/economiaRESUMO
PURPOSE: To evaluate the cost effectiveness of corneal collagen crosslinking (CXL) for progressive keratoconus from the healthcare payer's perspective. DESIGN: A probabilistic Markov-type model using data from published clinical trials and cohort studies. PARTICIPANTS: Two identical cohorts, each comprising 1000 virtual patients with progressive bilateral keratoconus, were modeled; one cohort underwent CXL and the other cohort received no intervention. METHODS: Both cohorts were modeled and evaluated annually over a lifetime. Quality-adjusted life years (QALYs), total cost, disease progression, and the probability of corneal transplantation, graft failure, or both were calculated based on data from published trials and cohort studies. These outcomes were compared between the 2 cohorts. In our base scenario, the stabilizing effect of CXL was assumed to be 10 years; however, longer durations also were analyzed. One-way sensitivity analyses were performed to test the robustness of the outcomes. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio (ICER), defined as euros per QALY. RESULTS: Assuming a 10-year effect of CXL, the ICER was 54 384/QALY ($59 822/QALY). When we adjusted the effect of CXL to a lifelong stabilizing effect, the ICER decreased to 10 149/QALY ($11 163/QALY). Other sensitivity and scenario analyses that had a relevant impact on ICER included the discount rate, visual acuity before CXL, and healthcare costs. CONCLUSIONS: Corneal collagen crosslinking for progressive keratoconus is cost effective at a willingness-to-pay threshold of 3 times the current gross domestic product (GDP) per capita. Moreover, a longer stabilizing effect of CXL increases cost effectiveness. If CXL had a stabilizing effect on keratoconus of 15 years or longer, then the ICER would be less than the 1 × GDP per capita threshold and thus very cost effective.
Assuntos
Colágeno/metabolismo , Substância Própria/metabolismo , Análise Custo-Benefício , Reagentes de Ligações Cruzadas/economia , Ceratocone/economia , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Adulto , Transplante de Córnea , Progressão da Doença , Seguimentos , Custos de Cuidados de Saúde , Humanos , Ceratocone/tratamento farmacológico , Ceratocone/metabolismo , Cadeias de Markov , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Riboflavina/economia , Raios Ultravioleta , Acuidade Visual/fisiologia , Adulto JovemRESUMO
PURPOSE: To use patient-level microsimulation models to evaluate the comparative cost-effectiveness of early corneal cross-linking (CXL) and conventional management with penetrating keratoplasty (PKP) when indicated in managing keratoconus in Canada. DESIGN: Cost-utility analysis using individual-based, state-transition microsimulation models. PARTICIPANTS: Simulated cohorts of 100 000 individuals with keratoconus who entered each treatment arm at 25 years of age. Fellow eyes were modeled separately. Simulated individuals lived up to a maximum of 110 years. METHODS: We developed 2 state-transition microsimulation models to reflect the natural history of keratoconus progression and the impact of conventional management with PKP versus CXL. We collected data from the published literature to inform model parameters. We used realistic parameters that maximized the potential costs and complications of CXL, while minimizing those associated with PKP. In each treatment arm, we allowed simulated individuals to move through health states in monthly cycles from diagnosis until death. MAIN OUTCOME MEASURES: For each treatment strategy, we calculated the total cost and number of quality-adjusted life years (QALYs) gained. Costs were measured in Canadian dollars. Costs and QALYs were discounted at 5%, converting future costs and QALYs into present values. We used an incremental cost-effectiveness ratio (ICER = difference in lifetime costs/difference in lifetime health outcomes) to compare the cost-effectiveness of CXL versus conventional management with PKP. RESULTS: Lifetime costs and QALYs for CXL were estimated to be Can$5530 (Can$4512, discounted) and 50.12 QALYs (16.42 QALYs, discounted). Lifetime costs and QALYs for conventional management with PKP were Can$2675 (Can$1508, discounted) and 48.93 QALYs (16.09 QALYs, discounted). The discounted ICER comparing CXL to conventional management was Can$9090/QALY gained. Sensitivity analyses revealed that in general, parameter variations did not influence the cost-effectiveness of CXL. CONCLUSIONS: CXL is cost-effective compared with conventional management with PKP in the treatment of keratoconus. Our ICER of Can$9090/QALY falls well below the range of Can$20 000 to Can$100 000/QALY and below US$50 000/QALY, thresholds generally used to evaluate the cost-effectiveness of health interventions in Canada and the United States. This study provides strong economic evidence for the cost-effectiveness of early CXL in keratoconus.
Assuntos
Colágeno/metabolismo , Substância Própria/metabolismo , Análise Custo-Benefício , Reagentes de Ligações Cruzadas/economia , Ceratocone/economia , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Adulto , Canadá , Simulação por Computador , Humanos , Ceratocone/tratamento farmacológico , Ceratocone/metabolismo , Ceratoplastia Penetrante/economia , Modelos Econômicos , Fármacos Fotossensibilizantes/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Riboflavina/economia , Riboflavina/uso terapêutico , Raios UltravioletaRESUMO
OBJECTIVE: This analysis estimated the cost-effectiveness of intravitreal aflibercept injection(s) (IAI) for wet age-related macular degeneration (wAMD) compared with other treatments in Japan. METHODS: This was a cost-utility analysis based on published data. A state-transition cohort model was constructed with six health states based on best-corrected visual acuity in the better-seeing eye. The cycle time was 4 weeks, and the time horizon was 12 years. The model compared IAI 2 mg every 8 weeks (2q8) for 2 years after three initial monthly injections, ranibizumab as needed, ranibizumab 0.5 mg every 4 weeks (0.5q4), pegaptanib sodium 0.3 mg every 6 weeks, verteporfin photodynamic therapy (PDT), and best supportive care, assumed to include medical management and monitoring, but no active therapy. Costs (expressed as Japanese yen [JPY]) and quality-adjusted life years (QALYs) gained were estimated for each treatment and discounted at 2.0%. Input data were obtained from clinical studies, the Japanese drug tariff and social insurance reimbursement schedule, and expert opinion. The analysis was conducted from the societal perspective, including medical costs as well as costs of blindness. RESULTS: IAI 2q8 was dominant (i.e. more effective in terms of QALYs and less costly) to all other comparators (ranibizumab as needed, ranibizumab 0.5q4, pegaptanib sodium, PDT, and best supportive care), as shown by the incremental cost-utility ratio (i.e. cost per QALY gained). LIMITATIONS: The strengths of the analysis include the wide range of comparators evaluated and the use of Japanese-specific utility data. The limitations include the use of one eye, inclusion of published data up to 2 years only, and assumptions on disease course over 5 years. CONCLUSIONS: IAI 2q8 was more effective in terms of QALYs and less costly compared with other treatments for wAMD in Japan.
Assuntos
Análise Custo-Benefício , Injeções Intravítreas , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/economia , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Inibidores da Angiogênese/administração & dosagem , Inibidores da Angiogênese/economia , Custos de Medicamentos/estatística & dados numéricos , Feminino , Gastos em Saúde , Humanos , Japão , Masculino , Fármacos Fotossensibilizantes/administração & dosagem , Fármacos Fotossensibilizantes/economia , Anos de Vida Ajustados por Qualidade de Vida , Triazenos/administração & dosagem , Triazenos/economiaRESUMO
Some basal cell carcinomas (BCCs) are indistinguishable from nevi based on clinical manifestations. Therefore, it is often difficult for the excision margins of the initial surgical treatment to achieve radical removal of the malignancy. This study was a comparative analysis of the clinical results of aminolevulinic acid (ALA)-photodynamic therapy (PDT) or secondary surgery after the primary excision. In total, 20 patients with preoperative clinical diagnoses of nevi underwent in situ resection. The postoperative pathological diagnoses confirmed all cases were BCC. Ten patients received PDT twice after the primary excision, and 10 cases received extended resection after the primary excision. Patients were followed up for 8 months at least, and the 2 groups did not show statistically significant differences in the recurrence rate, while the PDT group had better results in terms of economic burden, healing period, and cosmetic satisfaction than the group with secondary surgery. Our study demonstrates that ALA-PDT can sever as a considerable remedial treatment for the BCC patients who have not accepted radical resection due to primary clinical misdiagnosis.
Assuntos
Ácido Aminolevulínico/uso terapêutico , Carcinoma Basocelular/terapia , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/uso terapêutico , Neoplasias Cutâneas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/economia , Carcinoma Basocelular/cirurgia , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/cirurgia , CicatrizaçãoRESUMO
Tissue penetration depth is a major challenge in practical photodynamic therapy (PDT). A biocompatible and highly effective near infrared (NIR)-light-absorbing carbazole-substituted BODIPY (Car-BDP) molecule is reported as a class of imaging-guidable deep-tissue activatable photosensitizers for PDT. Car-BDP possesses an intense, broad NIR absorption band (600-800 nm) with a remarkably high singlet oxygen quantum yield (ΦΔ = 67%). After being encapsulated with biodegradable PLA-PEG-FA polymers, Car-BDP can form uniform and small organic nanoparticles that are water-soluble and tumor-targetable. Rather than using laser light, such nanoparticles offer an unprecedented deep-tissue, tumor targeting photodynamic therapeutic effect by using an exceptionally low-power-density and cost-effective lamp light (12 mW cm-2). In addition, these nanoparticles can be simultaneously traced in vivo due to their excellent NIR fluorescence. This study signals a major step forward in photodynamic therapy by developing a new class of NIR-absorbing biocompatible organic nanoparticles for effective targeting and treatment of deep-tissue tumors. This work also provides a potential new platform for precise tumor-targeting theranostics and novel opportunities for future affordable clinical cancer treatment.
Assuntos
Fotoquimioterapia/métodos , Radioterapia/métodos , Bioensaio , Compostos de Boro/química , Sobrevivência Celular , Células HeLa , Humanos , Raios Infravermelhos , Estrutura Molecular , Imagem Óptica , Fármacos Fotossensibilizantes/química , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/farmacologia , Água/químicaAssuntos
Substância Própria/metabolismo , Reagentes de Ligações Cruzadas/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Ceratocone/economia , Fotoquimioterapia/economia , Colágeno/metabolismo , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Custos de Medicamentos , Feminino , Humanos , Ceratocone/tratamento farmacológico , Ceratocone/metabolismo , Masculino , Fármacos Fotossensibilizantes/economia , Riboflavina/economia , Raios Ultravioleta , Acuidade Visual/fisiologia , Adulto JovemRESUMO
Actinic keratoses (AK) occur frequently; however, real-life clinical data on personalized treatment choice and costs are scarce. This multicentre one-year observational study investigated patient-characteristics, cost and effectiveness of methylaminolaevulinate photodynamic therapy (MAL-PDT), imiquimod (IMI) and 5-fluorour-acil (5-FU) in patients with AKs on the face/scalp. A total of 104 patients preferred MAL-PDT, 106 preferred IMI and 110 preferred 5-FU. At baseline, significant differences between treatment groups were found; most patients were severely affected (mean 32.5 AK in PDT-group, 20.2 in IMI-group, 22.8 in 5-FU-group). A mean reduction in lesions of 81% after MAL-PDT, 82% after IMI and 88% after 5-FU was found after one year. Annual costs were 1,950 for MAL-PDT, 877 for IMI and 738 for 5-FU. These results show that, compared with clinical trials, in the real-life clinical setting AK patients are usually more severely affected and treatment costs are much higher. Furthermore, patient characteristics are important factors in treatment choice.
Assuntos
Ácido Aminolevulínico/análogos & derivados , Aminoquinolinas/economia , Aminoquinolinas/uso terapêutico , Fármacos Dermatológicos/economia , Fármacos Dermatológicos/uso terapêutico , Custos de Medicamentos , Fluoruracila/economia , Fluoruracila/uso terapêutico , Ceratose Actínica/tratamento farmacológico , Ceratose Actínica/economia , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/economia , Ácido Aminolevulínico/uso terapêutico , Análise Custo-Benefício , Feminino , Humanos , Imiquimode , Masculino , Pessoa de Meia-Idade , Países Baixos , Preferência do Paciente , Fotoquimioterapia/métodos , Indução de Remissão , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: To explore the cost impact on Swedish healthcare of incorporating one instillation of hexaminolevulinate hydrochloride (HAL) blue-light cystoscopy into transurethral resection of bladder tumour (TURBT) in patients with suspected new or recurrent non-muscle-invasive bladder cancer (NMIBC). MATERIALS AND METHODS: A decision tree model was built based on European Association of Urology guidelines for the treatment and management of NMIBC. Input data were compiled from two recent studies comparing recurrence rates of bladder cancer in patients undergoing TURBT with either the current standard of care (SOC) of white-light cystoscopy, or with the SOC and HAL blue-light cystoscopy. Using these published data with clinical cost data for surgical and outpatient procedures and pharmaceutical costs, the model reported on the clinical and economic differences associated with the two treatment options. RESULTS: This model demonstrates the significant clinical benefits likely to be observed through the incorporation of HAL blue-light cystoscopy for TURBT in terms of reductions in recurrences of bladder cancer. Analysis of economic outputs of the model found that the use of one instillation of HAL for TURBT in all Swedish patients with NMIBC is likely to be cost-neutral or cost-saving over 5 years relative to the current SOC of white-light cystoscopy. CONCLUSIONS: The results of this analysis provide additional health economic rationale for the incorporation of a single instillation of HAL blue-light cystoscopy for TURBT in the treatment of patients with NMIBC in Sweden.
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Ácido Aminolevulínico/análogos & derivados , Cistoscopia/economia , Fármacos Fotossensibilizantes/economia , Neoplasias da Bexiga Urinária/economia , Ácido Aminolevulínico/administração & dosagem , Ácido Aminolevulínico/economia , Orçamentos , Custos e Análise de Custo , Cistoscopia/métodos , Cistoscopia/estatística & dados numéricos , Progressão da Doença , Humanos , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/economia , Recidiva Local de Neoplasia/cirurgia , Fármacos Fotossensibilizantes/administração & dosagem , Suécia , Neoplasias da Bexiga Urinária/diagnóstico , Neoplasias da Bexiga Urinária/cirurgiaRESUMO
BACKGROUND: A recent noninferiority randomized trial showed that in terms of clinical effectiveness imiquimod was superior and topical fluorouracil noninferior to methylaminolaevulinate photodynamic therapy (MAL-PDT) for treatment of superficial basal-cell carcinoma (sBCC). Although it was expected that MAL-PDT would be more costly than either cream, a full cost-effectiveness analysis is necessary to determine the balance between effectiveness and costs. OBJECTIVE: To determine whether imiquimod or topical fluorouracil are cost-effective treatments for sBCC compared with MAL-PDT. METHODS: An economic evaluation was performed from a healthcare perspective. Data on resource use and costs were collected alongside the randomized clinical trial. The incremental cost-effectiveness ratio was expressed as the incremental costs per additional patient free of tumour recurrence. RESULTS: At 12 months follow-up, the total mean costs for MAL-PDT were 680, for imiquimod cream 526 and for topical fluorouracil cream 388. Both imiquimod and topical fluorouracil were cost-effective treatments compared with MAL-PDT. Comparing costs and effectiveness of both creams led to a incremental investment of 4451 to achieve an additional patient free of tumour recurrence. The acceptability curve showed that, for a threshold value of 4451, the probability of imiquimod being more cost-effective than topical fluorouracil was 50%. CONCLUSION: Based on the 12 months follow-up results, imiquimod and topical fluorouracil cream are more cost-effective than MAL-PDT for treatment of sBCC. Hence, substituting MAL-PDT with either imiquimod or topical fluorouracil results in cost savings; these savings will be larger for topical fluorouracil. Long-term follow-up effectiveness data are necessary to confirm the cost-effectiveness of imiquimod vs. topical 5-fluorouracil cream.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Basocelular/tratamento farmacológico , Fotoquimioterapia/economia , Neoplasias Cutâneas/tratamento farmacológico , Administração Cutânea , Ácido Aminolevulínico/análogos & derivados , Ácido Aminolevulínico/economia , Ácido Aminolevulínico/uso terapêutico , Aminoquinolinas/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Carcinoma Basocelular/economia , Redução de Custos , Análise Custo-Benefício , Fluoruracila/administração & dosagem , Seguimentos , Humanos , Imiquimode , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/uso terapêutico , Neoplasias Cutâneas/economiaRESUMO
BACKGROUND: A gel containing diclofenac and hyaluronic acid (DHA) and photodynamic therapy with methyl aminolaevulinate (MAL-PDT) are widely used treatments for actinic keratoses (AKs). OBJECTIVES: The aim of this single-centre, open-label, prospective, nonsponsored, randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA. METHODS: Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA. After 90 days, the overall complete remission (CR) rate of patients and the CR rate of lesions according to thickness score were assessed, and patients and an investigator scored the cosmetic outcome. In addition, patients scored their overall satisfaction with the treatment. Patients with CR of all lesions were followed up for 12 months. RESULTS: Two hundred patients with a total of 1674 AKs were enrolled. The lesion CR rates at 3 months were 85·9% with MAL-PDT and 51·8% with DHA (P < 0·0001). AKs of all thicknesses were significantly more responsive to MAL-PDT. The patient CR rates at 3 months were 68% with MAL-PDT and 27% with DHA. At the 12-month examination, the number of patients with CR reduced to 37 with MAL-PDT and seven with DHA. Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments. The analysis of cost-effectiveness showed that the costs per patient with CR at 3 months and at 12 months are 566·7 and 1026·2, respectively, with MAL-PDT and 595·2 and 2295·6, respectively, with DHA. CONCLUSIONS: Efficacy, cosmetic outcome and patients' overall satisfaction with MAL-PDT are superior in comparison with DHA. MAL-PDT is more expensive but it is more cost-effective.
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Dermatoses Faciais/tratamento farmacológico , Ceratose Actínica/tratamento farmacológico , Fotoquimioterapia/métodos , Dermatoses do Couro Cabeludo/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Ácido Aminolevulínico/administração & dosagem , Ácido Aminolevulínico/análogos & derivados , Ácido Aminolevulínico/economia , Análise Custo-Benefício , Diclofenaco/administração & dosagem , Diclofenaco/economia , Combinação de Medicamentos , Dermatoses Faciais/economia , Feminino , Géis , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/economia , Ceratose Actínica/economia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/administração & dosagem , Fármacos Fotossensibilizantes/economia , Estudos Prospectivos , Dermatoses do Couro Cabeludo/economia , Resultado do TratamentoRESUMO
AIM: To compare effectiveness, safety, and cost of photodynamic therapy (PDT) and radiofrequency ablation (RFA) in treatment of Barrett's dysplasia (BD). METHODS: Consecutive case series of patients undergoing either PDT or RFA treatment at single center by a single investigator were compared. Thirty-three patients with high-grade dysplasia (HGD) had treatment with porfimer sodium photosensitzer and 630 nm laser (130 J/cm), with maximum of 3 treatment sessions. Fifty-three patients with BD (47 with low-grade dysplasia -LGD, 6 with HGD) had step-wise circumferential and focal ablation using the HALO system with maximum of 4 treatment sessions. Both groups received proton pump inhibitors twice daily. Endoscopic biopsies were acquired at 2 and 12 mo after enrollment, with 4-quadrant biopsies every 1 cm of the original BE extent. A complete histological resolution response of BD (CR-D) was defined as all biopsies at the last endoscopy session negative for BD. Fisher's exact test was used to assess differences between the two study groups for primary outcomes. For all outcomes, a two-sided P value of less than 0.05 was considered to indicate statistical significance. RESULTS: Thirty (91%) PDT patients and 39 (74%) RFA were men (P = 0.05). The mean age was 70.7 ± 12.2 and 65.4 ± 12.7 (P = 0.10) year and mean length of BE was 5.4 ± 3.2 cm and 5.7 ± 3.2 cm (P = 0.53) for PDT and RFA patients, respectively. The CR-D was (18/33) 54.5% with PDT vs (47/53) 88.7% with RFA (P = 0.001). One patient with PDT had an esophageal perforation and was managed with non-surgical measures and no perforation was seen with RFA. PDT was five times more costly than RFA at our institution. The two groups were not randomized and had different BD grading are the limitations of the study. CONCLUSION: In our experience, RFA had higher rate of CR-D without any serious adverse events and was less costly than PDT for endoscopic treatment of BD.
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Esôfago de Barrett/terapia , Ablação por Cateter , Custos de Cuidados de Saúde , Fotoquimioterapia , Idoso , Idoso de 80 Anos ou mais , Esôfago de Barrett/diagnóstico , Esôfago de Barrett/economia , Biópsia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/economia , Redução de Custos , Análise Custo-Benefício , Éter de Diematoporfirina/economia , Éter de Diematoporfirina/uso terapêutico , Esquema de Medicação , Custos de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fotoquimioterapia/efeitos adversos , Fotoquimioterapia/economia , Fármacos Fotossensibilizantes/economia , Fármacos Fotossensibilizantes/uso terapêutico , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/economia , Estudos Retrospectivos , Texas , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Our previous study has shown a prolonged retention and accumulation of Zn-pheophorbide a, a water-soluble derivative of chlorophyll a, in tumor tissue (Szczygiel et al. [19]). This prompted us to further evaluate the phototherapeutic potential of this photosensitizer of excellent physicochemical properties. METHODS: Cellular uptake of Zn-pheophorbide, its localization in cells, cytotoxicity, phototoxicity and cell death mechanisms were studied in human adenocarcinoma cell lines: A549, MCF-7 and LoVo. The PDT efficacy was tested against A549 tumors growing in nude mice. RESULTS: Zn-pheophorbide a even at very low concentrations (â¼1×10(-6)M) and at low light doses (5J/cm(2)) causes a strong photodynamic effect, leading to 100% cell mortality. Confocal microscopy showed that in contrast to most derivatives of chlorophyll, Zn-pheophorbide a does not localize to mitochondria. The photodynamic effects and the cell death mechanisms of Zn-pheophorbide a, its Mg analog (chlorophyllide a) and Photofrin were compared on the A549 cells. Zn-pheophorbide a showed the strongest photodynamic effect, at low dose killing all A549 cells via apoptosis and necrosis. The very high anti-cancer potential of Zn-pheophorbide was confirmed in a photodynamic treatment of the A549 tumors. They either regressed or were markedly inhibited for up to 4 months after the treatment, resulting, on average, in a 5-fold decrease in tumor volume. CONCLUSION: These results show that Zn-pheophorbide a is a very promising low-cost, synthetically easily accessible, second generation photosensitizer against human cancer.