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1.
Ann Oncol ; 33(12): 1250-1268, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36228963

RESUMO

BACKGROUND: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. PATIENTS AND METHODS: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. RESULTS: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Δ 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. CONCLUSION: With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals.


Assuntos
Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/genética , Ftalazinas/efeitos adversos , Células Germinativas/patologia , Proteína BRCA1/genética
2.
Clin Transl Oncol ; 22(8): 1364-1377, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32052382

RESUMO

PURPOSE: Hormone receptor (HR)-positive, Human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) requires a therapeutic approach that takes into account multiple factors, with treatment being based on anti-estrogen hormone therapy (HT). As consensus documents are valuable tools that assist in the decision-making process for establishing clinical strategies and optimize the delivery of health services, this consensus document has been created with the aim of developing recommendations on cretiera for hormone sensitivity and resistance in HER2-negative luminal MBC and facilitating clinical decision-making. METHODS: This consensus document was generated using a modification of the RAND/UCLA methodology, which included the definition of the project and identification of issues of interest, a non-exhaustive systematic review of the literature, an analysis and synthesis of the scientific evidence, preparation of recommendations, and external evaluation with a panel of 64 medical oncologists specializing in breast cancer. RESULTS: A Spanish panel of experts reached consensus on 32 of the 32 recommendations/conclusions presented in the first round and were accepted with an approval rate of 100% about definition of metastatic disease not susceptible to local curative treatment, definition of hormone sensitivity and hormone resistance in metastatic luminal disease and therapeutic decision-making. CONCLUSION: We have developed a consensus document with recommendations on the treatment of patients with HER2-negative luminal MBC that will help to improve therapeutic benefits.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Tomada de Decisão Clínica , Consenso , Receptor ErbB-2 , Idoso , Biomarcadores Tumorais/sangue , Biópsia , Mama/patologia , Neoplasias da Mama/genética , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Resistencia a Medicamentos Antineoplásicos , Feminino , Expressão Gênica , Humanos , Imuno-Histoquímica , Antígeno Ki-67/análise , Menopausa/metabolismo , Pessoa de Meia-Idade , Terapia de Alvo Molecular , Recidiva Local de Neoplasia/metabolismo , Neoplasias Hormônio-Dependentes/diagnóstico , Ovário/efeitos dos fármacos , Guias de Prática Clínica como Assunto , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo
3.
Clin. transl. oncol. (Print) ; 20(9): 1136-1144, sept. 2018. ilus, tab
Artigo em Inglês | IBECS | ID: ibc-173698

RESUMO

Cyclin-dependent kinases (CDKs) play a key role in cell cycle regulation, which makes them a clear therapeutic target to interfere with cell division and proliferation in cancer patients. Palbociclib, a specific inhibitor of CDK4/6 with outstanding clinical efficacy data and limited toxicity, has been recently approved for the treatment of hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, either in combination with an aromatase inhibitor or in combination with fulvestrant in women who have received prior endocrine therapy. This review describes the mechanism of action, preclinical experiences and clinical data of palbociclib, with a special focus on integrating this data with the positioning of palbociclib in the current clinical guidelines for advanced HR-positive/HER2-negative breast cancer. Aspects of the ongoing major studies are also presented, as well as future prospects in the development of palbociclib


No disponible


Assuntos
Humanos , Animais , Inibidor p16 de Quinase Dependente de Ciclina/farmacocinética , Quinase 4 Dependente de Ciclina/antagonistas & inibidores , Neoplasias da Mama/tratamento farmacológico , Inibidores da Aromatase/uso terapêutico , Ensaios Clínicos como Assunto , Biomarcadores Tumorais/análise , Piperazinas/uso terapêutico
4.
Clin. transl. oncol. (Print) ; 20(6): 753-760, jun. 2018. tab
Artigo em Inglês | IBECS | ID: ibc-173624

RESUMO

Background: Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. Patients and methods: Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain. Results: Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE. Conclusion: The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Everolimo/uso terapêutico , Androstadienos/uso terapêutico , Receptor ErbB-2/isolamento & purificação , Neoplasias da Mama/patologia , Segurança do Paciente/estatística & dados numéricos , Receptores de Estrogênio/isolamento & purificação , Receptores de Progesterona/isolamento & purificação , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Invasividade Neoplásica/patologia , Metástase Neoplásica/tratamento farmacológico
5.
Clin Transl Oncol ; 20(6): 753-760, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29116433

RESUMO

BACKGROUND: Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. PATIENTS AND METHODS: Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain. RESULTS: Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE. CONCLUSION: The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Adulto , Idoso , Idoso de 80 Anos ou mais , Androstadienos/administração & dosagem , Neoplasias da Mama/patologia , Everolimo/administração & dosagem , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Invasividade Neoplásica , Metástase Neoplásica , Prognóstico , Segurança , Taxa de Sobrevida
8.
Oncología (Barc.) ; 26(2): 85-88, feb. 2003. ilus
Artigo em Es | IBECS | ID: ibc-24240

RESUMO

La actitud tradicional ante un carcinoma no microcítico de pulmón con diseminación extratorácica era la abstención quirúrgica. Actualmente, en el caso de las metástasis suprarrenales, se ha visto que es posible obtener supervivencias prolongadas en algunos pacientes tras la resección del tumor primario y la metástasis. Presentamos el caso de un paciente de 62 años con una metástasis única suprarrenal derecha de un cáncer de pulmón resecado (neumonectomía izquierda) 5 meses antes. Se trató con quimioterapia neoadyuvante y suprarrenalectomía, y sigue libre de enfermedad 27 meses después. Se discuten las opciones de tratamiento y las indicaciones (AU)


Assuntos
Masculino , Pessoa de Meia-Idade , Humanos , Neoplasias Pulmonares/complicações , Neoplasias das Glândulas Suprarrenais/secundário , Intervalo Livre de Doença , Neoplasias das Glândulas Suprarrenais/cirurgia , Metástase Neoplásica/terapia
9.
Oncología (Barc.) ; 25(4): 235-238, abr. 2002. ilus
Artigo em Es | IBECS | ID: ibc-13814

RESUMO

Propósito: Describir una complicación infrecuente de los catéteres venosos centrales permanentes, así como su tratamiento. Material y métodos: Paciente de 78 años, en tratamiento por adenocarcinoma de pulmón, que requiere recolocación quirúrgica del catéter venoso central por migración del mismo a yugular interna. Se analizan las posibles causas y consecuencias de esta situación, así como las opciones terapéuticas. Conclusiones: La migración del catéter es una complicación infrecuente, de causa desconocida y tratamiento relativamente sencillo, que se diagnostica en la radiografía de tórax, y que puede originar otras complicaciones mayores, principalmente trombosis venos (AU)


Assuntos
Idoso , Masculino , Humanos , Cateterismo Venoso Central/efeitos adversos , Cateteres de Demora/efeitos adversos , Adenocarcinoma/tratamento farmacológico , Migração de Corpo Estranho/complicações , Veias Jugulares , Neoplasias Pulmonares/tratamento farmacológico , Migração de Corpo Estranho/cirurgia
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