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1.
Int J Cancer ; 150(1): 100-111, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-34449877

RESUMO

Ipilimumab was the first treatment that improved survival in advanced melanoma. Efficacy and toxicity in a real-world setting may differ from clinical trials, due to more liberal eligibility criteria and less intensive monitoring. Moreover, high costs and lack of biomarkers have raised cost-benefit concerns about ipilimumab in national healthcare systems and limited its use. Here, we report the prospective, interventional study, Ipi4 (NCT02068196), which aimed to investigate the toxicity and efficacy of ipilimumab in a real-world population with advanced melanoma. This national, multicentre, phase IV trial included 151 patients. Patients received ipilimumab 3 mg/kg intravenously and were followed for at least 5 years or until death. Treatment interruption or cessation occurred in 38%, most frequently due to disease progression (19%). Treatment-associated grade 3 to 4 toxicity was observed in 28% of patients, and immune-related toxicity in 56%. The overall response rate was 9%. Median overall survival was 12.1 months (95% CI: 8.3-15.9); and progression-free survival 2.7 months (95% CI: 2.6-2.8). After 5 years, 20% of patients were alive. In a landmark analysis from 6 months, improved survival was associated with objective response (HR 0.16, P = .001) and stable disease (HR 0.49, P = .005) compared to progressive disease. Poor performance status, elevated lactate dehydrogenase and C-reactive protein were identified as biomarkers. This prospective trial represents the longest reported follow-up of a real-world melanoma population treated with ipilimumab. Results indicate safety and efficacy comparable to phase III trials and suggest that the use of ipilimumab can be based on current cost-benefit estimates.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Ipilimumab/uso terapêutico , Melanoma/tratamento farmacológico , Neoplasias Cutâneas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Melanoma/patologia , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Neoplasias Cutâneas/secundário , Taxa de Sobrevida
3.
Tidsskr Nor Laegeforen ; 124(19): 2498-500, 2004 Oct 07.
Artigo em Nor | MEDLINE | ID: mdl-15477890

RESUMO

BACKGROUND: The introduction of high-dose treatment with autologous stem cell support (HMAS) in Norwegian regional hospitals in the early 1990s was controversial. Concerns that low numbers of patients would lead to unacceptably low quality were expressed. MATERIAL AND METHODS: We present treatment results in the health region of Middle Norway, based on nearly 10 years of experience and 100 treated patients. Myeloma results are compared to the results from other Norwegian regional hospitals. RESULTS AND INTERPRETATION: Overall survival for multiple myeloma after HMAS (median 6.8 years) was not significantly different in middle Norway compared to the rest of the country, and comparable with published results. Treatment-related mortality was low (1.2%). Results and complications in malignant lymphoma, breast cancer or germ cell tumours are described. HMAS can be satisfactorily given in a regional hospital with relatively few patients.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Neoplasias/terapia , Adulto , Idoso , Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Feminino , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/métodos , Transplante de Células-Tronco Hematopoéticas/normas , Humanos , Linfoma/tratamento farmacológico , Linfoma/mortalidade , Linfoma/terapia , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/terapia , Neoplasias/tratamento farmacológico , Neoplasias/mortalidade , Noruega , Indicadores de Qualidade em Assistência à Saúde , Estudos Retrospectivos , Neoplasias Testiculares/tratamento farmacológico , Neoplasias Testiculares/mortalidade , Neoplasias Testiculares/terapia
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