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PURPOSE: Many patients with early breast cancer (eBC) undergoing neoadjuvant chemotherapy do not achieve pathological complete response (pCR), which is a prognostic factor. We examined the role of HER2-low expression in predicting pCR and prognosis in HER2-negative eBC. METHODS: We evaluated patients with stage I-III HER2-negative BC, treated between 2013 and 2023 at The Royal Marsden NHS Foundation Trust, London. Tumors were classified based on estrogen receptor (ER) status and into HER2-low and HER2-zero subgroups. We analyzed pCR rates, relapse-free survival (RFS) and overall survival (OS). RESULTS: 754 patients were included in the analysis. pCR rate was 8.9% in the ER+ /HER2-low, 16.5% in the ER+ /HER2-zero, 38.9% in the ER- ER-/HER2-low and 35.9% in the ER-/HER2-zero eBC (p < 0.001). Multivariable analysis showed a significantly lower pCR rate in HER2-low compared to HER2-zero BC in the ER+ subgroup. At a median follow-up of 63.8 months (59.9-67.4), we observed longer OS in HER2-low compared to HER2-zero patients in the overall and in the ER+ population. There was no predictive or prognostic impact of HER2-low status in the ER- population. CONCLUSION: This study supports the interpretation of HER2 status as a possible prognostic and predictive biomarker for HER2-negative eBC, especially among patients with ER+ disease.
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Biomarcadores Tumorais , Neoplasias da Mama , Estadiamento de Neoplasias , Receptor ErbB-2 , Receptores de Estrogênio , Humanos , Receptor ErbB-2/metabolismo , Receptor ErbB-2/genética , Feminino , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Neoplasias da Mama/metabolismo , Neoplasias da Mama/genética , Neoplasias da Mama/terapia , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Biomarcadores Tumorais/metabolismo , Biomarcadores Tumorais/genética , Adulto , Idoso , Receptores de Estrogênio/metabolismo , Terapia Neoadjuvante/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
INTRODUCTION: Adequate reporting of data specific to older populations enrolled to breast cancer trials is critical, given the high incidence of the disease among this demographic. This study aimed to examine the completeness of reporting of older subgroups among patients recruited to registration clinical trials investigating systemic treatments for breast cancer. METHODS: Clinical trials leading to a US food and drug administration (FDA) approval in breast cancer between 2012 and 2021 were included. Primary study reports and and all available secondary publications were systematically and objectively assessed with regard to the availability of data regarding efficacy, baseline characteristics, safety, and health-related quality of life (HRQOL) outcomes among older subgroups. RESULTS: 27 trials and 216 publications were assessed. 20.3% of patients were aged ≥65. 70.0% of patients had an eastern cooperative oncology group (ECOG) performance status of 0. Although complete reporting of primary endpoints was adequate (72.7%), most protocol-defined primary endpoints were surrogate endpoints (84.8%). Overall survival data among older populations was unavailable in 50.0% of studies. Reporting was poor for secondary efficacy endpoints (81.8% unreported), baseline characteristics (70.4% unreported), toxicity (55.6% unreported), and health-related quality of life outcomes (87.5% unreported). CONCLUSION: The findings underline significant deficits in the reporting of age-specific data in breast cancer registration trials. The underreporting of key efficacy, safety, and HRQOL outcomes highlights the need for mandatory reporting standards and a dedicated emphasis on older populations' priorities and needs in the reporting of registration clinical trials.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Qualidade de VidaRESUMO
BACKGROUND: Frailty negatively affects the outcomes of patients with cancer, and its assessment might vary widely in the real world. The objective of this study was to explore awareness and use of frailty screening tools among the ONCOassist healthcare professionals (HCPs) users. MATERIALS AND METHODS: We sent 2 emails with a cross-sectional 15-item survey in a 3-week interval between April and May 2021. Differences in the awareness and use of tools according to respondents' continents, country income, and job types were investigated. RESULTS: Seven hundred thirty-seven HCPs from 91 countries (81% physicians, 13% nurses, and 5% other HCPs) completed the survey. Three hundred and eighty-five (52%) reported assessing all or the majority of their patients; 518 (70%) at baseline and before starting a new treatment. Three hundred and four (43%) HCPs were aware of performance status (PS) scores only, 309 (42%) age/frailty/comorbidity (AFC) screening, and 102 (14%) chemotoxicity predictive tools. Five hundred and thirty-seven (73%) reported using tools; 423 (57%) just PS, 237 (32%) AFC, and 60 (8%) chemotoxicity ones. Reasons for tools non-use (485 responders) were awareness (70%), time constraints (28%), and uselessness (2%). There were significant differences in awareness and use of screening tools among different continents, country income, job types, and medical specialties (P < .001 for all comparisons). CONCLUSION: Among selected oncology HCPs, there is still a worldwide lack of knowledge and usage of frailty screening tools, which may differ according to their geography, country income, and education. Targeted initiatives to raise awareness and education are needed to implement frailty assessment in managing patients with cancer.
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Fragilidade , Neoplasias , Estudos Transversais , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Neoplasias/complicações , Neoplasias/epidemiologia , Inquéritos e QuestionáriosRESUMO
Breast cancer is increasingly prevalent in older adults and is a substantial part of routine oncology practice. However, management of breast cancer in this population is challenging because the disease is highly heterogeneous and there is insufficient evidence specific to older adults. Decision making should not be driven by age alone but should involve geriatric assessments plus careful consideration of life expectancy, competing risks of mortality, and patient preferences. A multidisciplinary taskforce, including members of the European Society of Breast Cancer Specialists and International Society of Geriatric Oncology, gathered to expand and update the previous 2012 evidence-based recommendations for the management of breast cancer in older individuals with the endorsement of the European Cancer Organisation. These guidelines were expanded to include chemotherapy toxicity prediction calculators, cultural and social considerations, surveillance imaging, genetic screening, gene expression profiles, neoadjuvant systemic treatment options, bone-modifying drugs, targeted therapies, and supportive care. Recommendations on geriatric assessment, ductal carcinoma in situ, screening, primary endocrine therapy, surgery, radiotherapy, adjuvant systemic therapy, and secondary breast cancer were updated.
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Neoplasias da Mama/terapia , Oncologia/normas , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/mortalidade , Tomada de Decisão Clínica , Consenso , Técnicas de Apoio para a Decisão , Feminino , Avaliação Geriátrica , Humanos , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de RiscoRESUMO
BACKGROUND: Chemotherapy improves outcomes for high risk early breast cancer (EBC) patients but is infrequently offered to older individuals. This study determined if there are fit older patients with high-risk disease who may benefit from chemotherapy. METHODS: A multicentre, prospective, observational study was performed to determine chemotherapy (±trastuzumab) usage and survival and quality-of-life outcomes in EBC patients aged ≥70 years. Propensity score-matching adjusted for variation in baseline age, fitness and tumour stage. RESULTS: Three thousands four hundred sixteen women were recruited from 56 UK centres between 2013 and 2018. Two thousands eight hundred eleven (82%) had surgery. 1520/2811 (54%) had high-risk EBC and 2059/2811 (73%) were fit. Chemotherapy was given to 306/1100 (27.8%) fit patients with high-risk EBC. Unmatched comparison of chemotherapy versus no chemotherapy demonstrated reduced metastatic recurrence risk in high-risk patients(hazard ratio [HR] 0.36 [95% CI 0.19-0.68]) and in 541 age, stage and fitness-matched patients(adjusted HR 0.43 [95% CI 0.20-0.92]) but no benefit to overall survival (OS) or breast cancer-specific survival (BCSS) in either group. Chemotherapy improved survival in women with oestrogen receptor (ER)-negative cancer (OS: HR 0.20 [95% CI 0.08-0.49];BCSS: HR 0.12 [95% CI 0.03-0.44]).Transient negative quality-of-life impacts were observed. CONCLUSIONS: Chemotherapy was associated with reduced risk of metastatic recurrence, but survival benefits were only seen in patients with ER-negative cancer. Quality-of-life impacts were significant but transient. TRIAL REGISTRATION: ISRCTN 46099296.
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Antraciclinas/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Hidrocarbonetos Aromáticos com Pontes/uso terapêutico , Qualidade de Vida/psicologia , Taxoides/uso terapêutico , Trastuzumab/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antraciclinas/efeitos adversos , Neoplasias da Mama/psicologia , Hidrocarbonetos Aromáticos com Pontes/efeitos adversos , Tratamento Farmacológico , Feminino , Humanos , Satisfação do Paciente/estatística & dados numéricos , Pontuação de Propensão , Estudos Prospectivos , Análise de Sobrevida , Taxoides/efeitos adversos , Trastuzumab/efeitos adversos , Resultado do TratamentoRESUMO
PURPOSE: Trastuzumab improves survival in patients with HER2+ early breast cancer. However, cardiotoxicity remains a concern, particularly in the curative setting, and there are limited data on its incidence outside of clinical trials. We retrospectively evaluated the cardiotoxicity rates [left ventricular ejection fraction (LVEF) decline, congestive heart failure (CHF), cardiac death or trastuzumab discontinuation] and assessed the performance of a proposed model to predict cardiotoxicity in routine clinical practice. METHODS: Patients receiving curative trastuzumab between 2011 and 2018 were identified. Demographics, treatments, assessments and toxicities were recorded. Fisher's exact test, Chi-squared and logistic regression were used. RESULTS: 931 patients were included in the analysis. Median age was 54 years (range 24-83) and Charlson comorbidity index 0 (0-6), with 195 patients (20.9%) aged 65 or older. 228 (24.5%) were smokers. Anthracyclines were given in 608 (65.3%). Median number of trastuzumab doses was 18 (1-18). The HFA-ICOS cardiovascular risk was low in 401 patients (43.1%), medium in 454 (48.8%), high in 70 (7.5%) and very high in 6 (0.6%). Overall, 155 (16.6%) patients experienced cardiotoxicity: LVEF decline ≥ 10% in 141 (15.1%), falling below 50% in 55 (5.9%), CHF NYHA class II in 42 (4.5%) and class III-IV in 5 (0.5%) and discontinuation due to cardiac reasons in 35 (3.8%). No deaths were observed. Cardiotoxicity rates increased with HFA-ICOS score (14.0% low, 16.7% medium, 30.3% high/very high; p = 0.002). CONCLUSIONS: Cardiotoxicity was relatively common (16.6%), but symptomatic heart failure on trastuzumab was rare in our cohort. The HFA-ICOS score identifies patients at high risk of cardiotoxicity.
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Neoplasias da Mama , Insuficiência Cardíaca , Trastuzumab , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/tratamento farmacológico , Cardiotoxicidade , Feminino , Insuficiência Cardíaca/induzido quimicamente , Humanos , Incidência , Pessoa de Meia-Idade , Receptor ErbB-2 , Estudos Retrospectivos , Medição de Risco , Volume Sistólico , Trastuzumab/efeitos adversos , Trastuzumab/uso terapêutico , Função Ventricular Esquerda , Adulto JovemRESUMO
PURPOSE OF REVIEW: In this review, we describe the evidence on the efficacy and the safety of systemic treatments for the management of early breast cancer (EBC) in older individuals. RECENT FINDINGS: Chemotherapy has a temporary impact on quality of life (QoL) for older EBC patients and improves survival outcomes for those with oestrogen receptor (ER)-negative disease. Benefits were seen also in the context of comorbidities, although these may be influenced by selection bias. The Cancer and Aging Research Group-Breast Cancer tool can predict the risk of severe toxicities on chemotherapy in older patients. Gene expression profiling is less frequently used in older adults although it holds promise to better inform patient selection also in this age group.Postneoadjuvant systemic therapy and novel agents remain poorly described in older patients with EBC. No disease-free survival benefits were seen in older patients receiving abemaciclib plus adjuvant endocrine therapy. SUMMARY: Chemotherapy is beneficial for selected older patients with high-risk, ER-negative EBC. Although its impact on QoL is temporary, preferences, higher risk of toxicity and competing risks need to be carefully considered. Open questions remain on novel therapeutic approaches and gene expression profile in older EBC patients and more real-world evidence is warranted.
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Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Fatores Etários , Feminino , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Immunotherapy with checkpoint inhibitors against programmed cell death receptor (PD-1) and programmed cell death ligand (PD-L1) has been implemented in the treatment pathway of patients with non-small cell lung cancer (NSCLC) from locally advanced disease to the metastatic setting. This approach has resulted in improved survival and a more favourable toxicity profile when compared with chemotherapy. Following the successful introduction of single-agent immunotherapy, current clinical trials are focusing on combination treatments with chemotherapy or radiotherapy or even other immunotherapeutic agents. However, most of the data available from these trials are derived from, and therefore might be more applicable to younger and fitter patients rather than older and often frail lung cancer real-world patients. This article provides a detailed review of these immunotherapy agents with a focus on the data available regarding older NSCLC patients and makes recommendations to fill evidence gaps in this patient population.
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Carcinoma Pulmonar de Células não Pequenas/terapia , Inibidores de Checkpoint Imunológico/uso terapêutico , Imunoterapia/métodos , Neoplasias Pulmonares/terapia , Radioimunoterapia/métodos , Antineoplásicos/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Ensaios Clínicos como Assunto , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Imunossenescência , Neoplasias Pulmonares/mortalidadeRESUMO
PURPOSE: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) for breast cancer predicts the risk of recurrence and increasingly may indicate the need for additional therapy postoperatively. METHODS: We identified non-metastatic breast cancer patients receiving NACT during 2013-2017. Patients' and disease characteristics, rates of pCR (ypT0-is ypN0), toxicities, dose delays and reductions, and survival outcomes were recorded. RESULTS: 789 patients had median age of 50 years. 67.8% had stage II disease, 71.1% had grade 3 , and 91.8% had ductal histopathology. 32.8% had estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative, 25.5% had triple-negative (TN), and 38.0% HER2-positive disease. 6.8% received platinum. 48.2% of the HER2-positive patients received trastuzumab and pertuzumab and 51.8% received trastuzumab. Overall pCR rate was 33.5% and differed according to disease subtype, receptor status, grade, histology, and early discontinuation, but not according to age, dose reductions/delays, or year of treatment. The addition of pertuzumab to trastuzumab marginally improved the pCR rates. Survival outcomes were better following pCR. CONCLUSIONS: In our analysis, pCR rates are consistent with the published data. Even with contemporary therapies, many patients have residual disease following NACT, suggesting a significant risk of recurrence, and may benefit from additional postoperative systemic therapy.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Trastuzumab/uso terapêutico , Adulto , Idoso , Antineoplásicos Imunológicos/uso terapêutico , Neoplasias da Mama/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Gradação de Tumores , Estadiamento de Neoplasias , Estudos Retrospectivos , Análise de Sobrevida , Resultado do TratamentoRESUMO
PURPOSE OF REVIEW: Decision-making for systemic treatments in older patients with cancer is difficult because of concerns for decreased organ function, risk of toxicity, limited life expectancy due to comorbidities and the lack of evidence available to guide its management in this population. Here, we review the data on the role of systemic agents for the treatment of common malignancies in this age group. RECENT FINDINGS: Evidence on the use of systemic treatments for older patients with cancer is increasing, especially for newer options including immune checkpoint inhibitors and targeted agents that provide comparable benefit in older and younger patients. Nonetheless, the risks for short- and long-term toxicities need to be considered. More research is warranted and represents a unique opportunity to increase the knowledge on cancer treatment for older adults. Healthy, older individuals should be considered for standard systemic treatment options, whereas those at risk based on geriatric assessments require adjusted plans. Geriatric assessments are key for decision-making.
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Antineoplásicos/uso terapêutico , Avaliação Geriátrica , Neoplasias/tratamento farmacológico , Idoso , Antineoplásicos/efeitos adversos , Humanos , Imunoterapia , Terapia de Alvo Molecular , Neoplasias/terapiaRESUMO
PURPOSE: Agents targeting the human epidermal growth factor receptor 2 (HER2) have improved outcomes of advanced HER2-positive breast cancer with durable responses. We evaluated first-line therapy long-term outcomes in patients responding for more than 1 year. METHODS: We retrospectively identified patients on first-line anti-HER2 therapy at The Royal Marsden Hospital for at least 1 year from 2001 to 2016. Demographics, disease characteristics, treatments and adverse events were recorded. Simple statistics, Fisher's, Chi squared and log-rank tests were used. RESULTS: 208 patients on treatment for at least 1 year had a median age of 54 years (31-88). 38.0% had de novo metastatic disease and 55.9% were ER positive. Of the relapsed cases, 54.4% previously had trastuzumab. At the time of presentation of metastatic disease, 27.4% of the entire cohort had pulmonary, 43.7% liver and 10.6% brain involvement. 97.1% received trastuzumab and 1.44% lapatinib; 33.2% pertuzumab and trastuzumab. 82.7% received chemotherapy (usually taxanes). 47.6% received maintenance endocrine therapy. Median progression-free survival was 39.5 months and overall survival 81.0 months. Overall response rate was 87.5%. Cardiotoxicity occurred in 4.8% of cases. Seven patients stopped treatment electively after 17-87 months and, so far, all remain in complete remission. CONCLUSIONS: First-line anti-HER2 treatment is associated with median overall survival longer than 6 years in half of the patients free from disease progression after a year, but most still relapse eventually. Response prediction would be key to inform trial design and treatment decisions in this setting.
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Biomarcadores Tumorais , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/etiologia , Receptor ErbB-2/genética , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Terapia Combinada , Gerenciamento Clínico , Feminino , Humanos , Pessoa de Meia-Idade , Gradação de Tumores , Metástase Neoplásica , Estadiamento de Neoplasias , Receptor ErbB-2/metabolismo , Estudos RetrospectivosRESUMO
PURPOSE: Palbociclib is approved in 1st line for hormone receptor (HR)-positive HER2-negative advanced breast cancer (ABC). A Compassionate Access Programme previously allowed patients to receive it in 4th line. However, Palbociclib has not been specifically tested in this population. We aimed to determine the safety and efficacy profile of Palbociclib within the Programme across ten institutions in the United Kingdom. METHODS: We retrospectively identified HR-positive HER2-negative ABC patients on the Programme between December 2015 and September 2017. Demographics, disease characteristics, prior treatments, blood tests, toxicities, treatment delays and responses were recorded. Simple statistics, Fisher's exact test, χ2 method and Cox regression were used. RESULTS: 118 patients identified had a median age of 59. 82.2% were postmenopausal and 92.4% performance status 0-1. 81.4% had visceral involvement and 6.8% bone-only disease after a median of 5 prior treatments and 3 prior chemotherapies. Clinical benefit rate was 47.5%, overall response rate 15.8%, median PFS 4.5 months and median OS 15.8 months. Longer progression-free survival on prior endocrine therapy was a predictor of longer PFS and OS. 89.7% developed neutropenia (grade ≥ 3 in 56.8%). 5.1% experienced febrile neutropenia. 48.3% had dose reductions and 3.4% discontinued Palbociclib following toxicity. No statistically significant difference in grade ≥ 3 neutropenia was observed according to metastatic sites nor previous treatments. CONCLUSIONS: This is the most extensive analysis of palbociclib in ≥ 4th-line setting. Clinical benefit was confirmed particularly for endocrine-sensitive, predominantly bony disease and in earlier lines of treatment. Safety was similar to PALOMA trials with higher febrile neutropenia rate.
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Antineoplásicos Hormonais/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Piperazinas/administração & dosagem , Inibidores de Proteínas Quinases/administração & dosagem , Piridinas/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Hormonais/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/metabolismo , Feminino , Humanos , Pessoa de Meia-Idade , Piperazinas/efeitos adversos , Inibidores de Proteínas Quinases/efeitos adversos , Piridinas/efeitos adversos , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Estudos Retrospectivos , Análise de Sobrevida , Resultado do Tratamento , Reino UnidoRESUMO
BACKGROUND: There are over half a million women with a previous breast cancer diagnosis living in the UK. It is important to establish their level of unmet physical and psychosocial needs, as many are not routinely seen for follow-up under current models of care. METHODS: We conducted a retrospective analysis of early breast cancer survivors entering an Open Access Follow-Up (OAFU) programme in 2015. Unmet needs were assessed using the Holistic Needs Assessment (HNA) or extracted directly from the electronic patient record (EPR), when the HNA had not been completed. RESULTS: Six hundred and twenty-five patients were eligible. Sixty-one per cent of the survivors had at least one unmet need and 18% had ⩾5 needs. Consistently higher levels of unmet needs were identified using the formal HNA checklist as opposed to extraction from EPR (P<0.001). Physical and emotional needs were the most frequently reported (55 and 24% respectively). Patients receiving endocrine therapy and those who had received chemotherapy were more likely to report unmet needs (both P<0.001). CONCLUSIONS: Unmet physical and emotional needs are common in breast cancer survivors. It is vital that the services are available for these patients as they transition from hospital-based follow-up to patient-led self-management models of care.
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Neoplasias da Mama/fisiopatologia , Avaliação das Necessidades , Sobreviventes , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Antineoplásicos Hormonais/uso terapêutico , Ansiedade/psicologia , Neoplasias da Mama/patologia , Neoplasias da Mama/psicologia , Neoplasias da Mama/terapia , Depressão/psicologia , Registros Eletrônicos de Saúde , Fadiga/fisiopatologia , Feminino , Fogachos/fisiopatologia , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Dor/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Transtornos do Sono-Vigília/fisiopatologia , Apoio Social , Inquéritos e Questionários , Reino UnidoAssuntos
Neoplasias da Mama , Fulvestranto , Aminopiridinas , Benzimidazóis , Quinase 4 Dependente de Ciclina , Feminino , Humanos , TrastuzumabRESUMO
As the global population ages, so does the number of older people being diagnosed, treated and surviving cancer. Challenges to providing appropriate healthcare management stem from the heterogeneity common in this population. Although malnutrition is highly prevalent in older people with cancer, ranging between 30 % and 80 % according to some analyses, is associated with frailty, and has been shown to be a major risk factor for poor treatment response and worse overall survival, addressing nutrition status is not always a priority among oncology healthcare providers. Evaluation of nutritional status is a two-step process: screening identifies risk factors for reduced nutritional intake and deficits that require more in-depth assessment. Screening activities can be as simple as taking weight and BMI measurements or using short nutritional questionnaires and asking the patient about unintentional weight loss to identify potential nutritional risk. Using geriatric assessment, deficits in the nutritional domain as well as in others reveal potentially reversible geriatric and medical problems to guide specific therapeutic interventions. The authors of this paper are experts in the fields of geriatric medicine, oncology, and nutrition science and believe that there is not only substantial evidence to support regularly performing screening and assessment of nutritional status in older patients with cancer, but that these measures lead to the planning and implementation of patient-centered approaches to nutrition management and thus enhanced geriatric-oncology care. This paper presents rationale for systematic nutrition screening and assessment in older adults with cancer.
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Avaliação Geriátrica , Desnutrição , Neoplasias , Avaliação Nutricional , Estado Nutricional , Humanos , Avaliação Geriátrica/métodos , Neoplasias/terapia , Neoplasias/diagnóstico , Neoplasias/complicações , Idoso , Desnutrição/diagnóstico , Desnutrição/terapia , Oncologia/métodos , Idoso de 80 Anos ou mais , Fatores de RiscoRESUMO
Immune checkpoint inhibitors (ICI) have transformed the management of cancer, particularly for older adults, who constitute a majority of the global cancer patient population. This study aimed to assess the inclusion, characteristics, and reporting of older adults enrolled in Food and Drug Administration (FDA) registration clinical trials of ICI between 2018 and 2022. Clinical trials of ICI leading to an FDA approval in solid tumor oncology between 2018 and 2022 were included. Primary study reports and all available secondary publications were assessed. The availability and completeness of older subgroup data for protocol-defined clinical efficacy endpoints, health-related quality of life (HRQOL) and toxicity outcomes, and baseline characteristics were assessed according to predefined criteria which categorized reporting completeness hierarchically in relation to the availability of published data, including effect size, sample size, and measures of precision. 53 registration trials were included, involving a total of 37,094 participants. Most trials (64.2%) were of ICI combination therapy. 42.3% of patients were aged≥65 years; 11.1% were aged≥75. No trials specified an upper age limit for eligibility. 98.1% of trials excluded patients with European Cooperative Oncology Group performance status>1. 87.2% of primary efficacy endpoints and 17.9% of secondary efficacy endpoints were reported completely for older adults. Five studies (9.4%) reported baseline characteristics, three (6.1%) reported HRQOL assessments, and four (7.5%) reported toxicity outcomes completely among older subgroups. No trials conducted baseline geriatric assessments or reported geriatric-specific symptoms or quality of life scales. This analysis highlights significant deficits in the enrollment and reporting of older subgroups in pivotal trials of ICI therapy. The findings highlight an urgent need for improved reporting and inclusion standards in clinical trials of ICI to better inform treatment decisions for older adults.
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Imunoterapia , United States Food and Drug Administration , Humanos , Idoso , Estados Unidos , Imunoterapia/métodos , Masculino , Feminino , Idoso de 80 Anos ou mais , Qualidade de Vida , Neoplasias/tratamento farmacológico , Inibidores de Checkpoint Imunológico/uso terapêutico , Inibidores de Checkpoint Imunológico/efeitos adversos , Ensaios Clínicos como Assunto , Fatores EtáriosRESUMO
BACKGROUND: Though cancer is more prevalent in the older population, this patient group are underrepresented in phase I oncology trials. AIMS: We evaluated the use of a geriatric screening tool (SAOP3) in patients of 70 years of age or older who attended a Phase I Clinical Trials Unit, with the aim of assessing the feasibility of the tool and identifying potential unmet needs in this patient group. METHODS: Twenty-two patients over the age of 70 completed the SAOP3 questionnaire. Geriatric impairments and needs were analysed with descriptive statistics. Qualitative responses were grouped in themes using structured thematic analysis. RESULTS: All of patients triggered at least 1 geriatric domain, most commonly mobility. Six core themes were identified as being important to the patient including family, friends and positivity. On cognition assessment over 20% of patients triggered as requiring further cognitive assessment. The group had a relatively high screen fail risk. CONCLUSION: In conclusion, routine geriatric screening withSAOP3 was feasible and identified areas of patient need. Results highlight the prevalence of psychological distress and cognitive impairment. Geriatric screening offers an opportunity for prehabilitation prior to trial and support during trial participation to optimise safety and improve trial access.
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Ensaios Clínicos Fase I como Assunto , Avaliação Geriátrica , Neoplasias , Humanos , Idoso , Feminino , Masculino , Avaliação Geriátrica/métodos , Idoso de 80 Anos ou mais , Neoplasias/psicologia , Inquéritos e Questionários , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/psicologia , Estudos de Viabilidade , Programas de Rastreamento/métodosRESUMO
INTRODUCTION: Despite significant evidence supporting the benefits of comprehensive oncogeriatric assessment in the management of older patients with cancer, the adoption of specialised geriatric oncology programs in the United Kingdom remains limited. Descriptions of clinic structure and models, patient demographics and baseline characteristics, resource utilisation, and predictors of resource utilisation are lacking in this population, which may complicate or impede the planning, resourcing, and development of further services in this subspecialty on a national and regional basis. MATERIALS AND METHODS: Between November 2021 and April 2023, 244 patients commencing systemic anticancer treatment at the Royal Marsden Hospital, London underwent geriatric screening using the Senior Adult Oncology Programme-3 (SAOP3) screening tool. Baseline clinical factors (sex, age, Charlson Comorbidity Index score, Cumulative Illness Rating Scale-Geriatric [CIRS-G] score, Katz Index score, Barthel Index score, treatment intent, and Eastern Cooperative Oncology Group Performance Status [ECOG-PS]) were assessed as predictors of geriatric impairments and need for multidisciplinary referral and intervention using a negative binomial regression analysis. Referral rates to multidisciplinary teams were assessed against ECOG-PS score using point-biserial correlation, as well as against a historical control using descriptive statistics. RESULTS: The median age of participants was 77; 75.8% were female. Breast cancer was the most prevalent diagnosis (61.9%). Most patients (67.6%) were undergoing treatment in the palliative setting. Two hundred eleven (86.5%) patients were identified as having at least one geriatric impairment. Six hundred forty-nine multidisciplinary referrals were made, of which 583 (86.7%) were accepted by the referred patient. Higher ECOG PS was positively associated with geriatric impairments in physiotherapy, occupational therapy, dietetics, pharmacy, and welfare rights domains, as well as with the overall number of geriatric impairments. DISCUSSION: The Royal Marsden Senior Adult Oncology Programme represents the first geriatric oncology service in a tertiary cancer centre in the United Kingdom. Following implementation of SAOP3 screening, we observed a substantial increase in referrals to all multidisciplinary teams, suggestive of previously underrecognized needs among this population. The need for multidisciplinary intervention was strongly correlated with baseline ECOG-PS score, but not with other measured clinical variables, including comorbidity or functional indices.
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Neoplasias da Mama , Neoplasias , Humanos , Feminino , Idoso , Masculino , Neoplasias/terapia , Neoplasias/epidemiologia , Oncologia , Neoplasias da Mama/epidemiologia , Comorbidade , Avaliação Geriátrica , HospitaisRESUMO
The worldwide population is ageing, alongside an increase in cancer incidence rates. Over the past 10 years, there has been huge progress in the field of oncology with earlier diagnosis and an expansion of treatment options, leading to a growing number of older people living with cancer. That has meant that caring for older patients with cancer is now part of day-to-day oncology practices. This cohort often has geriatric syndromes and a higher prevalence of frailty and complex needs and preparing our clinical services to optimise care for these patients is essential. Whilst it is widely accepted that comprehensive geriatric assessments are of benefit to patients, only a small proportion of patients can access these through specialised teams during their cancer care. In the past few years there has been significant progress in this field throughout the United Kingdom (UK). The goal of this review is to inform other health care systems how to learn from what has been done in the UK. This paper provides an update from our previous review in 2020, detailing the new services being implemented and made available to patients and an expansion in the number of new pilot teams and research projects/trials throughout the four nations of the UK.