ABSTRACT
BACKGROUND AND OBJECTIVES: Bexarotene has been approved to treat advanced stage cutaneous T-cell lymphomas (CTCL) since 1999. However, very few data have been published on its long-term safety and efficacy profile. The aim of this study is to determine the tolerability to bexarotene and outcomes by collecting the 2nd largest case series to date on its long-term use vs CTCL. MATERIAL AND METHOD: This was a multicenter retrospective review of 216 patients with mycosis fungoides (174), or Sézary syndrome (42) on a 10-year course of bexarotene alone or in combination with other therapies at 19 tertiary referral teaching hospitals. RESULTS: A total of 133 men (62%) and 83 women (38%) were included, with a mean age of 63.5 year (27-95). A total of 45% were on bexarotene monotherapy for the entire study period, 22% started on bexarotene but eventually received an additional therapy, 13% were on another treatment but eventually received bexarotene while the remaining 20% received a combination therapy since the beginning. The median course of treatment was 20.78 months (1-114); and the overall response rate, 70.3%. Complete and partial response rates were achieved in 26% and 45% of the patients, respectively. Treatment was well tolerated, being the most common toxicities hypertriglyceridemia (79%), hypercholesterolemia (71%), and hypothyroidism (52%). No treatment-related grade 5 adverse events were reported. CONCLUSIONS: Our study confirms bexarotene is a safe and effective therapy for the long-term treatment of CTCL.
Subject(s)
Bexarotene , Mycosis Fungoides , Sezary Syndrome , Skin Neoplasms , Tetrahydronaphthalenes , Humans , Bexarotene/therapeutic use , Male , Female , Aged , Retrospective Studies , Middle Aged , Aged, 80 and over , Skin Neoplasms/drug therapy , Adult , Tetrahydronaphthalenes/therapeutic use , Tetrahydronaphthalenes/adverse effects , Mycosis Fungoides/drug therapy , Sezary Syndrome/drug therapy , Spain , Lymphoma, T-Cell, Cutaneous/drug therapy , Treatment Outcome , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effectsABSTRACT
BACKGROUND AND OBJECTIVES: Bexarotene has been approved to treat advanced stage cutaneous T-cell lymphomas (CTCL) since 1999. However, very few data have been published on its long-term safety and efficacy profile. The aim of this study is to determine the tolerability to bexarotene and outcomes by collecting the 2nd largest case series to date on its long-term use vs CTCL. MATERIAL AND METHOD: This was a multicenter retrospective review of 216 patients with mycosis fungoides (174), or Sézary syndrome (42) on a 10-year course of bexarotene alone or in combination with other therapies at 19 tertiary referral teaching hospitals. RESULTS: A total of 133 men (62%) and 83 women (38%) were included, with a mean age of 63.5 year (27-95). A total of 45% were on bexarotene monotherapy for the entire study period, 22% started on bexarotene but eventually received an additional therapy, 13% were on another treatment but eventually received bexarotene while the remaining 20% received a combination therapy since the beginning. The median course of treatment was 20.78 months (1-114); and the overall response rate, 70.3%. Complete and partial response rates were achieved in 26% and 45% of the patients, respectively. Treatment was well tolerated, being the most common toxicities hypertriglyceridemia (79%), hypercholesterolemia (71%), and hypothyroidism (52%). No treatment-related grade 5 adverse events were reported. CONCLUSIONS: Our study confirms bexarotene is a safe and effective therapy for the long-term treatment of CTCL.
Subject(s)
Bexarotene , Mycosis Fungoides , Sezary Syndrome , Skin Neoplasms , Tetrahydronaphthalenes , Humans , Bexarotene/therapeutic use , Male , Female , Aged , Retrospective Studies , Middle Aged , Aged, 80 and over , Skin Neoplasms/drug therapy , Adult , Tetrahydronaphthalenes/therapeutic use , Tetrahydronaphthalenes/adverse effects , Mycosis Fungoides/drug therapy , Sezary Syndrome/drug therapy , Spain , Lymphoma, T-Cell, Cutaneous/drug therapy , Treatment Outcome , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effectsABSTRACT
BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was 34,214 per patient. The corresponding costs by stage were 11,952.47 for stageI disease, 23,506.21 for stageII disease, 38,771.81 for stageIII disease, and 72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at 78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.
Subject(s)
Lymphoma, T-Cell, Cutaneous , Mycosis Fungoides , Sezary Syndrome , Skin Neoplasms , Adult , Humans , Male , Middle Aged , Female , Quality of Life , Spain/epidemiology , Skin Neoplasms/therapy , Skin Neoplasms/pathology , Lymphoma, T-Cell, Cutaneous/epidemiology , Lymphoma, T-Cell, Cutaneous/therapy , Lymphoma, T-Cell, Cutaneous/pathology , Mycosis Fungoides/therapy , Mycosis Fungoides/pathology , Sezary Syndrome/therapy , Sezary Syndrome/pathologyABSTRACT
BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was 34,214 per patient. The corresponding costs by stage were 11,952.47 for stageI disease, 23,506.21 for stageII disease, 38,771.81 for stageIII disease, and 72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at 78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.
Subject(s)
Lymphoma, T-Cell, Cutaneous , Mycosis Fungoides , Sezary Syndrome , Skin Neoplasms , Adult , Humans , Male , Middle Aged , Female , Quality of Life , Spain/epidemiology , Skin Neoplasms/therapy , Skin Neoplasms/pathology , Lymphoma, T-Cell, Cutaneous/therapy , Lymphoma, T-Cell, Cutaneous/pathology , Mycosis Fungoides/therapy , Mycosis Fungoides/pathology , Sezary Syndrome/therapy , Sezary Syndrome/pathologyABSTRACT
Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, is characterized by proliferation of malignant skin-tropic T cells. Progression from early-stage disease (skin patches and/or plaques) to more advanced stages (cutaneous tumours, erythroderma or extracutaneous involvement) occurs slowly and can be discontinuous. Prognosis is poor for the ~25% of patients who progress to advanced disease. Patients at any stage of MF may experience reduced health-related quality of life (QoL) via a spectrum of physically and psychologically debilitating symptoms that can impact many aspects of daily life. Allogeneic stem-cell transplantation is a curative treatment option for some patients with advanced disease, but otherwise there is currently no cure for MF; patients are often refractory to several treatments and require lifelong management. The goals of therapy are symptom control, prevention of disease progression, avoidance of treatment-related toxicity and maintenance/improvement of QoL. Although treatment regimens exist it can be difficult to know how to prioritize them, hence therapies are tailored according to patient needs and drug availabilities, following clinical recommendations. International consensus guidelines recommend skin-directed therapies (SDTs) as first-line treatment for early-stage disease, and SDTs combined with systemic therapy for advanced stages. Chlormethine (CL), also known as mechlorethamine, chlorethazine, mustine, HN2, caryolysine and embichin, is a synthetic deoxyribonucleic acid-alkylating agent that was used as a chemical weapon (mustard gas) during the First World War. Subsequent investigation revealed that survivors of mustard gas exposure had lymphocytopenia, and that CL could inhibit rapidly proliferating malignant T cells. CL has since been developed as a topical treatment for MF and prescribed as such for over 70 years. This review aims to summarize the current knowledge regarding the mechanism of action of CL in the cutaneous micro-environment, in the specific context of MF treatment.
Subject(s)
Mustard Gas , Mycosis Fungoides , Skin Neoplasms , Humans , Mechlorethamine/therapeutic use , Quality of Life , Mustard Gas/therapeutic use , Mycosis Fungoides/pathology , Skin Neoplasms/pathology , Tumor MicroenvironmentABSTRACT
Antecedentes RECAP es un cuestionario de siete ítems diseñado para capturar la experiencia del control del eccema atópico en todas las edades y severidades. El control a largo plazo del eccema es uno de los cuatro dominios de resultados principales para los ensayos de eccema atópico. Ha sido desarrollado en el Reino Unido y traducido al chino, al alemán, al holandés y al francés. Objetivos El propósito fue generar una versión española del cuestionario RECAP, y como objetivo secundario, validarlo lingüísticamente y probar su validez de contenido en la población española con eccema atópico. Material y métodos Llevamos a cabo un proceso de 7 pasos. El cuestionario se tradujo dos veces hacia delante y una hacia atrás. Se celebraron dos reuniones de consenso entre expertos para obtener una versión en español del RECAP. Entrevistamos a 15 pacientes adultos con eccema atópico para evaluar los criterios de comprensibilidad, exhaustividad y relevancia. Al mismo tiempo, proporcionamos a los pacientes los cuestionarios ADCT, DLQI y POEM para realizar la correlación entre ellos y el RECAP, con las herramientas informáticas adecuadas utilizando Stata v.16. Resultados Los participantes en el estudio consideraron que la versión española del RECAP era comprensible y fácil de responder. Encontramos una fuerte correlación entre la versión española del cuestionario RECAP y la ADCT, y una correlación muy significativa con el DLQI y el POEM, respectivamente. Conclusiones La versión española del RECAP y su adaptación transcultural es lingüísticamente equivalente a la versión original. Muestra una alta correlación con otros PROM existentes (AU)
Background The 7-item RECAP (Recap of Atopic Eczema) questionnaire is used to assess the control of different degrees of eczema severity in patients of all ages. Long-term control of eczema is one of the 4 core outcome domains to be assessed in clinical trials of eczema therapies. After the RECAP was developed in the United Kingdom, it was translated into Chinese, German, Dutch, and French. Objectives To produce a validated Spanish version of the RECAP questionnaire and, secondarily, to test its content validity in a group of Spanish patients with atopic eczema. Material and methods In a 7-step process we produced 2forward translations and 1back translation of the RECAP questionnaire. Experts then held two meetings to reach consensus and draft a Spanish version of the questionnaire. Fifteen adult patients with atopic eczema were interviewed to evaluate the comprehensibility, comprehensiveness, and relevance of the drafted items. These patients also completed the Atopic Dermatitis Control Tool (ADCT), the Dermatology Life Quality Index (DLQI), and the Patient-Oriented Eczema Measure (POEM). Stata software (version 16) was then used to explore the correlations between the patients scores on these tools and the RECAP. Results The patients found the Spanish version of the RECAP to be comprehensible and easy to answer. We observed a strong correlation between results on the Spanish RECAP and the ADCT, and highly significant correlations between the RECAP and the DLQI and POEM tools. Conclusions The culturally adapted Spanish version of the RECAP is linguistically equivalent to the original version of the questionnaire. RECAP scores correlate highly with other patient-reported outcome measures (AU)
Subject(s)
Humans , Male , Female , Adolescent , Young Adult , Adult , Middle Aged , Surveys and Questionnaires , Cross-Cultural Comparison , Dermatitis, Atopic/therapy , Reproducibility of Results , Translating , SpainABSTRACT
Background The 7-item RECAP (Recap of Atopic Eczema) questionnaire is used to assess the control of different degrees of eczema severity in patients of all ages. Long-term control of eczema is one of the 4 core outcome domains to be assessed in clinical trials of eczema therapies. After the RECAP was developed in the United Kingdom, it was translated into Chinese, German, Dutch, and French. Objectives To produce a validated Spanish version of the RECAP questionnaire and, secondarily, to test its content validity in a group of Spanish patients with atopic eczema. Material and methods In a 7-step process we produced 2forward translations and 1back translation of the RECAP questionnaire. Experts then held two meetings to reach consensus and draft a Spanish version of the questionnaire. Fifteen adult patients with atopic eczema were interviewed to evaluate the comprehensibility, comprehensiveness, and relevance of the drafted items. These patients also completed the Atopic Dermatitis Control Tool (ADCT), the Dermatology Life Quality Index (DLQI), and the Patient-Oriented Eczema Measure (POEM). Stata software (version 16) was then used to explore the correlations between the patients scores on these tools and the RECAP. Results The patients found the Spanish version of the RECAP to be comprehensible and easy to answer. We observed a strong correlation between results on the Spanish RECAP and the ADCT, and highly significant correlations between the RECAP and the DLQI and POEM tools. Conclusions The culturally adapted Spanish version of the RECAP is linguistically equivalent to the original version of the questionnaire. RECAP scores correlate highly with other patient-reported outcome measures (AU)
Antecedentes RECAP es un cuestionario de siete ítems diseñado para capturar la experiencia del control del eccema atópico en todas las edades y severidades. El control a largo plazo del eccema es uno de los cuatro dominios de resultados principales para los ensayos de eccema atópico. Ha sido desarrollado en el Reino Unido y traducido al chino, al alemán, al holandés y al francés. Objetivos El propósito fue generar una versión española del cuestionario RECAP, y como objetivo secundario, validarlo lingüísticamente y probar su validez de contenido en la población española con eccema atópico. Material y métodos Llevamos a cabo un proceso de 7 pasos. El cuestionario se tradujo dos veces hacia delante y una hacia atrás. Se celebraron dos reuniones de consenso entre expertos para obtener una versión en español del RECAP. Entrevistamos a 15 pacientes adultos con eccema atópico para evaluar los criterios de comprensibilidad, exhaustividad y relevancia. Al mismo tiempo, proporcionamos a los pacientes los cuestionarios ADCT, DLQI y POEM para realizar la correlación entre ellos y el RECAP, con las herramientas informáticas adecuadas utilizando Stata v.16. Resultados Los participantes en el estudio consideraron que la versión española del RECAP era comprensible y fácil de responder. Encontramos una fuerte correlación entre la versión española del cuestionario RECAP y la ADCT, y una correlación muy significativa con el DLQI y el POEM, respectivamente. Conclusiones La versión española del RECAP y su adaptación transcultural es lingüísticamente equivalente a la versión original. Muestra una alta correlación con otros PROM existentes (AU)
Subject(s)
Humans , Male , Female , Adolescent , Young Adult , Adult , Middle Aged , Surveys and Questionnaires , Cross-Cultural Comparison , Dermatitis, Atopic/therapy , Reproducibility of Results , Translating , SpainABSTRACT
BACKGROUND: The 7-item RECAP (Recap of Atopic Eczema) questionnaire is used to assess the control of different degrees of eczema severity in patients of all ages. Long-term control of eczema is one of the 4 core outcome domains to be assessed in clinical trials of eczema therapies. After the RECAP was developed in the United Kingdom, it was translated into Chinese, German, Dutch, and French. OBJECTIVES: To produce a validated Spanish version of the RECAP questionnaire and, secondarily, to test its content validity in a group of Spanish patients with atopic eczema. MATERIAL AND METHODS: In a 7-step process we produced 2forward translations and 1back translation of the RECAP questionnaire. Experts then held two meetings to reach consensus and draft a Spanish version of the questionnaire. Fifteen adult patients with atopic eczema were interviewed to evaluate the comprehensibility, comprehensiveness, and relevance of the drafted items. These patients also completed the Atopic Dermatitis Control Tool (ADCT), the Dermatology Life Quality Index (DLQI), and the Patient-Oriented Eczema Measure (POEM). Stata software (version 16) was then used to explore the correlations between the patients' scores on these tools and the RECAP. RESULTS: The patients found the Spanish version of the RECAP to be comprehensible and easy to answer. We observed a strong correlation between results on the Spanish RECAP and the ADCT, and highly significant correlations between the RECAP and the DLQI and POEM tools. CONCLUSIONS: The culturally adapted Spanish version of the RECAP is linguistically equivalent to the original version of the questionnaire. RECAP scores correlate highly with other patient-reported outcome measures.
Subject(s)
Dermatitis, Atopic , Eczema , Adult , Humans , Dermatitis, Atopic/therapy , Quality of Life , Surveys and Questionnaires , Patient Reported Outcome Measures , Severity of Illness IndexABSTRACT
BACKGROUND AND OBJECTIVE: Primary cutaneous lymphomas (PCL) are uncommon. Observations based on the first year of data from the Spanish Registry of Primary Cutaneous Lymphomas (RELCP, in its Spanish abbreviation) of the Spanish Academy of Dermatology and Venereology (AEDV) were published in February 2018. This report covers RELCP data for the first 5 years. PATIENTS AND METHODS: RELCP data were collected prospectively and included diagnosis, treatments, tests, and the current status of patients. We compiled descriptive statistics of the data registered during the first 5 years. RESULTS: Information on 2020 patients treated at 33 Spanish hospitals had been included in the RELCP by December 2021. Fifty-nine percent of the patients were men; the mean age was 62.2 years. The lymphomas were grouped into 4 large diagnostic categories: mycosis fungoides/Sézary syndrome, 1112 patients (55%); primary B-cell cutaneous lymphoma, 547 patients (27.1%); primary CD30+lymphoproliferative disorders, 222 patients (11%), and other T-cell lymphomas, 116 patients (5.8%). Nearly 75% of the tumors were registered in stage I. After treatment, 43.5% achieved complete remission and 27% were stable at the time of writing. Treatments prescribed were topical corticosteroids (1369 [67.8%]), phototherapy (890 patients [44.1%]), surgery (412 patients [20.4%]), and radiotherapy (384 patients [19%]). CONCLUSION: The characteristics of cutaneous lymphomas in Spain are similar to those reported for other series. The large size of the RELCP registry at 5 years has allowed us to give more precise descriptive statistics than in the first year. This registry facilitates the clinical research of the AEDV's lymphoma interest group, which has already published articles based on the RELCP data.
Subject(s)
Dermatology , Lymphoma, T-Cell, Cutaneous , Mycosis Fungoides , Skin Neoplasms , Venereology , Male , Humans , Middle Aged , Female , Lymphoma, T-Cell, Cutaneous/diagnosis , Lymphoma, T-Cell, Cutaneous/epidemiology , Lymphoma, T-Cell, Cutaneous/therapy , Skin Neoplasms/diagnosis , Skin Neoplasms/epidemiology , Skin Neoplasms/therapy , Registries , Mycosis Fungoides/pathologySubject(s)
Humans , Female , Aged, 80 and over , Antiprotozoal Agents/adverse effects , Meglumine Antimoniate/adverse effects , Long QT Syndrome/chemically induced , Antiprotozoal Agents/therapeutic use , Electrocardiography , Injections, Intralesional , Leishmaniasis, Cutaneous/drug therapy , Meglumine Antimoniate/therapeutic useSubject(s)
Humans , Female , Aged, 80 and over , Antiprotozoal Agents/adverse effects , Meglumine Antimoniate/adverse effects , Long QT Syndrome/chemically induced , Antiprotozoal Agents/therapeutic use , Electrocardiography , Injections, Intralesional , Leishmaniasis, Cutaneous/drug therapy , Meglumine Antimoniate/therapeutic useABSTRACT
BACKGROUND AND OBJECTIVE: Accurate information on the incidence of melanoma by stage and a better understanding of transition between stages are important for determining the burden of disease and assessing the impact of new adjuvant therapies on recurrence and survival. The aim of this study was to estimate the incidence rates of the various stages of melanoma in Spain and to estimate the number of patients with stage III disease who are eligible for adjuvant systemic therapies. MATERIALS AND METHOD: We built an epidemiological model using prospectively collected data from patients diagnosed with de novo or recurrent melanoma between 2012 and 2016 in the melanoma units of 4 public hospitals. RESULTS: The estimated crude incidence rates for stage I and II melanoma were 7 and 2.9 cases per 100,000 person-years, respectively. The corresponding rates for stage III and IV melanoma were 1.9 and 1.3 cases per 100,000 person-years; 25.8% of patients with stage III melanoma were stage IIIA, 47% were stage IIIB, and 27.3% were stage IIIC. The respective estimated incidence rates for recurrent stage III and IV melanoma were 1.1 and 0.9 cases per 100,000 person-years. Overall, 54% of patients with recurrent stage III melanoma had progressed from stage I or II; the other cases corresponded to changes in substage. Of the patients with stage III melanoma, 85% of those with a de novo diagnosis and 80% of those who had relapsed had resectable disease, meaning they were eligible for adjuvant therapy; 47% of these patients had a BRAF mutation. CONCLUSIONS: The above estimates could have a major impact on health care resource planning. Assessing the number of patients with melanoma who are eligible for adjuvant therapies in melanoma could help decision-makers and clinicians anticipate future needs for the management of this disease.
Subject(s)
Melanoma , Skin Neoplasms , Adjuvants, Immunologic , Combined Modality Therapy , Humans , Melanoma/diagnosis , Melanoma/epidemiology , Melanoma/therapy , Skin Neoplasms/epidemiology , Skin Neoplasms/therapy , Spain/epidemiology , Melanoma, Cutaneous MalignantABSTRACT
Antecedentes y objetivo: Para estimar la carga real del melanoma y el impacto de las nuevas terapias adyuvantes sobre las recaídas y la supervivencia, se precisa conocer con mayor exactitud la incidencia por estadios y analizar la transición entre ellos. Este estudio pretende estimar dicha incidencia y determinar el número de pacientes en estadio III que podrían beneficiarse del tratamiento sistémico adyuvante en España. Materiales y método: Se elaboró un modelo epidemiológico basado en datos de pacientes diagnosticados de melanoma o en recaída, recogidos prospectivamente durante 2012-2016 por cuatro unidades de melanoma de centros sanitarios públicos. Resultados: Las tasas brutas de incidencia estimadas para estadios I y II se situaron en 7 y 2,9 casos por 100.000 personas-año, respectivamente. Para estadio III se estimó en 1,9 (25,8% en IIIA, 47% en IIIB, y 27,3% en IIIC), siendo la de estadio IV de 1,3. La tasa de recaídas en estadio III se estimó en 1,1, siendo para estadio IV de 0,9. El 54% de recaídas a estadio III procedían de estadios I/II, mientras que el resto progresaban desde subestadios III. En estadio III, un 85% de nuevos diagnósticos y un 80% de recaídas fueron resecables, por tanto, candidatos a adyuvancia, de los cuales el 47% presentaba mutación en BRAF. Conclusiones: Estas estimaciones podrían tener un impacto importante en la planificación de los recursos sanitarios. La proyección en el número de potenciales candidatos a adyuvancia puede ayudar a decisores y clínicos a anticiparse a futuras necesidades en el manejo del melanoma (AU)
Background and objective: Accurate information on the incidence of melanoma by stage and a better understanding of transition between stages are important for determining the burden of disease and assessing the impact of new adjuvant therapies on recurrence and survival. The aim of this study was to estimate the incidence rates of the various stages of melanoma in Spain and to estimate the number of patients with stage III disease who are eligible for adjuvant systemic therapies. materials and method: We built an epidemiological model using prospectively collected data from patients diagnosed with de novo or recurrent melanoma between 2012 and 2016 in the melanoma units of 4 public hospitals. Results: The estimated crude incidence rates for stage I and II melanoma were 7 and 2.9 cases per 100,000 person-years, respectively. The corresponding rates for stage III and IV melanoma were 1.9 and 1.3 cases per 100,000 person-years; 25.8% of patients with stage III melanoma were stage IIIA, 47% were stage IIIB, and 27.3% were stage IIIC. The respective estimated incidence rates for recurrent stage III and IV melanoma were 1.1 and 0.9 cases per 100,000 person-years. Overall, 54% of patients with recurrent stage III melanoma had progressed from stage I or II; the other cases corresponded to changes in substage. Of the patients with stage III melanoma, 85% of those with a de novo diagnosis and 80% of those who had relapsed had resectable disease, meaning they were eligible for adjuvant therapy; 47% of these patients had a BRAF mutation. Conclusions: The above estimates could have a major impact on health care resource planning. Assessing the number of patients with melanoma who are eligible for adjuvant therapies in melanoma could help decision-makers and clinicians anticipate future needs for the management of this disease (AU)
Subject(s)
Humans , Melanoma/therapy , Melanoma/epidemiology , Skin Neoplasms/epidemiology , Skin Neoplasms/therapy , Prospective Studies , Chemotherapy, Adjuvant , Combined Modality Therapy , Spain/epidemiology , Neoplasm Recurrence, Local , Neoplasm Staging , IncidenceABSTRACT
Background and objective: Accurate information on the incidence of melanoma by stage and a better understanding of transition between stages are important for determining the burden of disease and assessing the impact of new adjuvant therapies on recurrence and survival. The aim of this study was to estimate the incidence rates of the various stages of melanoma in Spain and to estimate the number of patients with stage III disease who are eligible for adjuvant systemic therapies. materials and method: We built an epidemiological model using prospectively collected data from patients diagnosed with de novo or recurrent melanoma between 2012 and 2016 in the melanoma units of 4 public hospitals. Results: The estimated crude incidence rates for stage I and II melanoma were 7 and 2.9 cases per 100,000 person-years, respectively. The corresponding rates for stage III and IV melanoma were 1.9 and 1.3 cases per 100,000 person-years; 25.8% of patients with stage III melanoma were stage IIIA, 47% were stage IIIB, and 27.3% were stage IIIC. The respective estimated incidence rates for recurrent stage III and IV melanoma were 1.1 and 0.9 cases per 100,000 person-years. Overall, 54% of patients with recurrent stage III melanoma had progressed from stage I or II; the other cases corresponded to changes in substage. Of the patients with stage III melanoma, 85% of those with a de novo diagnosis and 80% of those who had relapsed had resectable disease, meaning they were eligible for adjuvant therapy; 47% of these patients had a BRAF mutation. Conclusions: The above estimates could have a major impact on health care resource planning. Assessing the number of patients with melanoma who are eligible for adjuvant therapies in melanoma could help decision-makers and clinicians anticipate future needs for the management of this disease (AU)
Antecedentes y objetivo: Para estimar la carga real del melanoma y el impacto de las nuevas terapias adyuvantes sobre las recaídas y la supervivencia, se precisa conocer con mayor exactitud la incidencia por estadios y analizar la transición entre ellos. Este estudio pretende estimar dicha incidencia y determinar el número de pacientes en estadio III que podrían beneficiarse del tratamiento sistémico adyuvante en España. Materiales y método: Se elaboró un modelo epidemiológico basado en datos de pacientes diagnosticados de melanoma o en recaída, recogidos prospectivamente durante 2012-2016 por cuatro unidades de melanoma de centros sanitarios públicos. Resultados: Las tasas brutas de incidencia estimadas para estadios I y II se situaron en 7 y 2,9 casos por 100.000 personas-año, respectivamente. Para estadio III se estimó en 1,9 (25,8% en IIIA, 47% en IIIB, y 27,3% en IIIC), siendo la de estadio IV de 1,3. La tasa de recaídas en estadio III se estimó en 1,1, siendo para estadio IV de 0,9. El 54% de recaídas a estadio III procedían de estadios I/II, mientras que el resto progresaban desde subestadios III. En estadio III, un 85% de nuevos diagnósticos y un 80% de recaídas fueron resecables, por tanto, candidatos a adyuvancia, de los cuales el 47% presentaba mutación en BRAF. Conclusiones: Estas estimaciones podrían tener un impacto importante en la planificación de los recursos sanitarios. La proyección en el número de potenciales candidatos a adyuvancia puede ayudar a decisores y clínicos a anticiparse a futuras necesidades en el manejo del melanoma (AU)
