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1.
BJU Int ; 133 Suppl 3: 57-67, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37986556

RESUMEN

OBJECTIVE: To evaluate the efficacy of sequential treatment with ipilimumab and nivolumab following progression on nivolumab monotherapy in individuals with advanced, non-clear-cell renal cell carcinoma (nccRCC). MATERIALS AND METHODS: UNISoN (ANZUP1602; NCT03177239) was an open-label, single-arm, phase 2 clinical trial that recruited adults with immunotherapy-naïve, advanced nccRCC. Participants received nivolumab 240 mg i.v. two-weekly for up to 12 months (Part 1), followed by sequential addition of ipilimumab 1 mg/kg three-weekly for four doses to nivolumab if disease progression occurred during treatment (Part 2). The primary endpoint was objective tumour response rate (OTRR) and secondary endpoints included duration of response (DOR), progression-free (PFS) and overall survival (OS), and toxicity (treatment-related adverse events). RESULTS: A total of 83 participants were eligible for Part 1, including people with papillary (37/83, 45%), chromophobe (15/83, 18%) and other nccRCC subtypes (31/83, 37%); 41 participants enrolled in Part 2. The median (range) follow-up was 22 (16-30) months. In Part 1, the OTRR was 16.9% (95% confidence interval [CI] 9.5-26.7), the median DOR was 20.7 months (95% CI 3.7-not reached) and the median PFS was 4.0 months (95% CI 3.6-7.4). Treatment-related adverse events were reported in 71% of participants; 19% were grade 3 or 4. For participants who enrolled in Part 2, the OTRR was 10%; the median DOR was 13.5 months (95% CI 4.8-19.7) and the median PFS 2.6 months (95% CI 2.2-3.8). Treatment-related adverse events occurred in 80% of these participants; 49% had grade 3, 4 or 5. The median OS was 24 months (95% CI 16-28) from time of enrolment in Part 1. CONCLUSIONS: Nivolumab monotherapy had a modest effect overall, with a few participants experiencing a long DOR. Sequential combination immunotherapy by addition of ipilimumab in the context of disease progression to nivolumab in nccRCC is not supported by this study, with only a minority of participants benefiting from this strategy.


Asunto(s)
Carcinoma de Células Renales , Nivolumab , Adulto , Humanos , Nivolumab/uso terapéutico , Nivolumab/efectos adversos , Ipilimumab/efectos adversos , Carcinoma de Células Renales/tratamiento farmacológico , Carcinoma de Células Renales/patología , Progresión de la Enfermedad , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos
2.
BMC Health Serv Res ; 23(1): 1023, 2023 Sep 22.
Artículo en Inglés | MEDLINE | ID: mdl-37740170

RESUMEN

BACKGROUND: The majority of cancer patients and cancer care clinicians-CCCs (e.g., oncologists) believe that exercise is an important adjunct therapy that should be embedded in standard practice. Yet, CCCs do not routinely discuss exercise with their patients, nor do they regularly refer them to exercise professionals (e.g., exercise physiologists-EPs). This study evaluated the feasibility and acceptability of an evidence-based approach to improving exercise communication between CCCs and their patients, including an exercise referral pathway. METHODS: Implementation and testing of the Exercise Communication and Referral Pathway (ECRP) occurred in Sydney, Australia. The ECRP included a brief oncology-initiated communication exchange with patients, CCC exercise referral to an EP, followed by EP-initiated telephone consultation with patients concerning tailored exercise advice. Participant perceptions concerning the feasibility and applicability of the ECPR were evaluated. Semi-structured interviews were conducted with CCCs (n = 3), cancer patients (n = 21), and an EP (n = 1). Inductive thematic analysis was undertaken. RESULTS: Analysis generated three themes: (1) Navigating the role of CCCs in the ECRP, suggesting that oncology-initiated communication is a cue to action, however there was a lack of role clarity regarding exercise referral; (2) Implementing Patient-Orientated Care within a Standardised Pathway, highlighting the need for tailored information and advice for patients that reflects individual disease, socio-cultural, and environmental factors, and; (3) Taking Steps Towards Action, revealing the need for structural (e.g., EP initiated contact with patients) and policy changes (i.e., changes to Medicare, direct oncologist referral) to engage patients and better integrate exercise as part of standard care. CONCLUSIONS: Findings provide important insights into improving oncology-patient exercise communication and developing an exercise referral pathway to increase engagement and patient reach. However, individual (e.g., experience, knowledge) and contextual factors (e.g., time, resources) need consideration when implementing an ECRP. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical (#ACTRN12620000358943) on March 13, 2020.


Asunto(s)
Neoplasias , Derivación y Consulta , Humanos , Anciano , Estudios de Factibilidad , Australia , Teléfono , Programas Nacionales de Salud , Comunicación , Neoplasias/terapia
3.
Cancers (Basel) ; 14(6)2022 Mar 09.
Artículo en Inglés | MEDLINE | ID: mdl-35326557

RESUMEN

Angiogenesis inhibitors have been adopted into the standard armamentarium of therapies for advanced-stage renal cell carcinomas (RCC), but more recently, combination regimens with immune checkpoint inhibitors have demonstrated better outcomes. Despite this, the majority of affected patients still eventually experience progressive disease due to therapeutic resistance mechanisms, and there remains a need to develop novel therapeutic strategies. This article will review the synergistic mechanisms behind angiogenesis and immunomodulation in the tumor microenvironment and discuss the pre-clinical and clinical evidence for both clear-cell and non-clear-cell RCC, exploring opportunities for future growth in this exciting area of drug development.

4.
Asia Pac J Clin Oncol ; 18(6): 625-633, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-35098655

RESUMEN

AIMS: This study aimed to (1) explore the perceptions of people living with cancer about exercise in general and exercise as an adjunct form of cancer care, (2) explore their perceptions regarding exercise counselling needs and preferences, and (3) investigate how these perceptions of exercise as an adjunct form of cancer care shape survivors exercise levels postcancer diagnosis. METHODS: A cross-sectional design and online survey were used to recruit cancer survivors via cancer-related networks throughout Australia. Two factor analyses were conducted to examine the structure and reduce the number of variables pertaining to exercise during and after the cancer treatment. Extracted components were used in one-way analysis of variance to compare differences in physical activity levels postcancer diagnosis. RESULTS: Participants (N = 288) had very positive perceptions of exercise, yet only 50% of participants would prefer to receive exercise counselling. Those who were more active postcancer diagnosis had higher exercise beliefs than those who were similarly active (p = 0.04, r = 0.27) and less active (p = 0.03, r = 0.24) postdiagnosis. Those who were less active also had lower exercise knowledge than those who were similarly active (p = 0.01, r = 0.31) and more active (p = 0.03, r = 0.26). Safety beliefs did not significantly differ between cancer survivors' activity levels (p = 0.16) CONCLUSION: This survey highlights the potential benefits of a concentrated effort in connecting survivors to relevant services and resources, and utilizing cancer clinicians to communicate with survivors about the role of exercise in cancer care.


Asunto(s)
Supervivientes de Cáncer , Neoplasias , Humanos , Estudios Transversales , Australia , Ejercicio Físico , Sobrevivientes , Neoplasias/terapia
5.
Patient Educ Couns ; 105(7): 2489-2496, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34823926

RESUMEN

OBJECTIVE: This study aimed to 1) understand factors impacting the implementation of exercise communication and referral, and 2) explore integrated clinical approaches to exercise communication and referral in cancer care. METHODS: Seven focus groups (N = 53) were conducted with clinicians and exercise professionals throughout Sydney, Australia. A sub-sample of participants (n = 9) attended a half-day workshop to identifying best practice approaches for moving forward. Data were analysed using thematic content analysis. RESULTS: Two themes emerged: 1) Factors impacting the knowledge-to-action gap, inclusive of limited exercise specific knowledge and training opportunities, funding structure, and current referral process, and 2) Recommendations for a consistent and efficient way forward, detailing the need for oncologist-initiated communication, distribution of cancer-exercise resources, and access to exercise professionals with cancer expertise. CONCLUSIONS: This study identified factors (e.g., cancer-exercise specific training, integration of exercise physiologists) influencing exercise counselling and referral. A potential implementation-referral approach accounting for these factors and how to incorporate exercise into a standard model of cancer care, is described. Future testing is required to determine feasibility and practicality of these approaches. PRACTICAL IMPLICATIONS: A pragmatic model is provided to guide implementation-referral, inclusive of oncologist-initiated communication exchange, relevant resources, and access to exercise professionals with cancer expertise.


Asunto(s)
Neoplasias , Derivación y Consulta , Actitud del Personal de Salud , Australia , Consejo , Ejercicio Físico , Humanos , Neoplasias/terapia , Investigación Cualitativa
6.
Immunotherapy ; 14(7): 511-520, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35321560

RESUMEN

Immune checkpoint inhibitors have been incorporated into the treatment of various malignancies. An increasing body of literature is reporting rare but potentially fatal adverse events associated with these agents. In this case series, the authors report the clinical features and outcomes of seven patients who received immune checkpoint inhibitors for different solid organ malignancies and developed a tetrad of immune-related myocarditis, myositis, myasthenia gravis and transaminitis. Herein the authors review the literature and describe the current diagnostic and management approach for this overlapping syndrome. The authors' series highlights the importance of a high index of clinical suspicion, prompt comprehensive investigations, early multidisciplinary team involvement and initiation of immunosuppressive therapy when immune-related adverse events are suspected.


Cancer immunotherapy is used in the treatment of different cancer types. Immunotherapy activates the immune system to detect and attack cancer cells, but side effects may arise from the immune system inadvertently attacking normal tissues and organs. The increased use of immunotherapy has led to an increase in the reporting of rare but potentially life-threatening treatment-related side effects. In this case series, the authors report the clinical features and outcomes of seven patients who developed inflammation of the heart, muscles, nerve and muscle junctions and liver following treatment with immunotherapy. The authors review the scientific literature and discuss the current understanding of and management approach to this rare syndrome. The authors' report highlights the importance of a high degree of clinical suspicion, prompt comprehensive testing to confirm diagnosis, early involvement of experts from different specialties and early initiation of treatment in the management of this unique syndrome.


Asunto(s)
Miastenia Gravis , Miocarditis , Miositis , Neoplasias , Humanos , Inhibidores de Puntos de Control Inmunológico/efectos adversos , Miastenia Gravis/inducido químicamente , Miocarditis/inducido químicamente , Miocarditis/diagnóstico , Miocarditis/tratamiento farmacológico , Miositis/inducido químicamente , Miositis/diagnóstico , Neoplasias/tratamiento farmacológico
7.
Eur J Cancer ; 47(9): 1343-54, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21550229

RESUMEN

BACKGROUND: In the setting of metastatic colorectal cancer (CRC), anti-EGFR antibodies are not currently recommended for individuals with KRAS mutant tumours. This is based on subgroup analyses of individual clinical trials rather than a formal synthesis of evidence for KRAS status as a predictive biomarker, while newer trials report no benefit for anti-EGFR antibodies irrespective of KRAS status. This study systematically reviewed the evidence for KRAS mutation status as a treatment effect modifier of response to anti-EGFR antibodies and the influence of partner chemotherapy. METHODS: Medline (1966-2010), EMBASE and American and European oncology meeting abstracts were searched for randomised controlled trials reporting the influence of KRAS status on effectiveness of anti-EGFR antibodies in metastatic CRC. The treatment efficacy was summarised by KRAS status using hazard ratios (HR) for progression-free survival (PFS) and risk differences (RD) for objective response. For each study, a measure of effect modification was calculated, and aggregated using random effects meta-analysis to assess the interaction between KRAS and treatment effect. FINDINGS: Eleven studies (8924 patients) were selected from 198 reports. Two studies assessed anti-EGFR antibodies as monotherapy and nine their use with chemotherapy. KRAS status was reported in 7555 cases. In subgroup analysis, the progression HR for KRAS wild patients assigned to anti-EGFR antibodies was 0.80 (4436 patients 95%CI: 0.64, 0.99) and for mutant cases 1.11 (3119 patients, 95%CI: 0.97, 1.27). A significant treatment effect interaction between KRAS status and addition of anti-EGFR antibodies to standard treatment was found for PFS (ratio of HRs 0.71, 95%CI: 0.57, 0.90 p=0.005) and response rate difference (difference in RDs 15%, 95%CI: 8, 22%, p<0.001). There was no evidence that the extent of effect modification differed between chemotherapeutic partners for both PFS (p=0.3) and response rate (p=0.6). INTERPRETATION: KRAS mutation status is a treatment effect modifier for anti-EGFR antibodies in metastatic CRC. Further evidence is needed to determine whether this is true for all chemotherapy partners and all clinical circumstances.


Asunto(s)
Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/inmunología , Receptores ErbB/inmunología , Antineoplásicos/farmacología , Neoplasias Colorrectales/patología , Análisis Mutacional de ADN , Progresión de la Enfermedad , Supervivencia sin Enfermedad , Genes ras/genética , Humanos , Mutación , Metástasis de la Neoplasia , Ensayos Clínicos Controlados Aleatorios como Asunto , Riesgo , Resultado del Tratamiento , Proteínas ras/metabolismo
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