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1.
Nat Commun ; 15(1): 5931, 2024 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-39013870

RESUMO

This open-label, non-comparative, 2:1 randomized, phase II trial (NCT03275506) in women with stage IIIC/IV high-grade serous carcinoma (HGSC) for whom upfront complete resection was unachievable assessed whether adding pembrolizumab (200 mg every 3 weeks) to standard-of-care carboplatin plus paclitaxel yielded a complete resection rate (CRR) of at least 50%. Postoperatively patients continued assigned treatment for a maximum of 2 years. Postoperative bevacizumab was optional. The primary endpoint was independently assessed CRR at interval debulking surgery. Secondary endpoints were Completeness of Cytoreduction Index (CCI) and peritoneal cancer index (PCI) scores, objective and best response rates, progression-free survival, overall survival, safety, postoperative morbidity, and pathological complete response. The CRR in 61 pembrolizumab-treated patients was 74% (one-sided 95% CI = 63%), exceeding the prespecified ≥50% threshold and meeting the primary objective. The CRR without pembrolizumab was 70% (one-sided 95% CI = 54%). In the remaining patients CCI scores were ≥3 in 27% of the standard-of-care group and 18% of the investigational group and CC1 in 3% of the investigational group. PCI score decreased by a mean of 9.6 in the standard-of-care group and 10.2 in the investigational group. Objective response rates were 60% and 72%, respectively, and best overall response rates were 83% and 90%, respectively. Progression-free survival was similar with the two regimens (median 20.8 versus 19.4 months in the standard-of-care versus investigational arms, respectively) but overall survival favored pembrolizumab-containing therapy (median 35.3 versus 49.8 months, respectively). The most common grade ≥3 adverse events with pembrolizumab-containing therapy were anemia during neoadjuvant therapy and infection/fever postoperatively. Pembrolizumab was discontinued prematurely because of adverse events in 23% of pembrolizumab-treated patients. Combining pembrolizumab with neoadjuvant chemotherapy is feasible for HGSC considered not completely resectable; observed activity in some subgroups justifies further evaluation to improve understanding of the role of immunotherapy in HGSC.


Assuntos
Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Carboplatina , Terapia Neoadjuvante , Humanos , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Feminino , Pessoa de Meia-Idade , Idoso , Terapia Neoadjuvante/métodos , Carboplatina/uso terapêutico , Carboplatina/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Paclitaxel/uso terapêutico , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Quimioterapia Adjuvante/métodos , Adulto , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/cirurgia , Neoplasias Ovarianas/mortalidade , Cistadenocarcinoma Seroso/tratamento farmacológico , Cistadenocarcinoma Seroso/patologia , Cistadenocarcinoma Seroso/cirurgia , Cistadenocarcinoma Seroso/mortalidade , Intervalo Livre de Progressão , Procedimentos Cirúrgicos de Citorredução , Estadiamento de Neoplasias
2.
Anticancer Res ; 43(2): 653-662, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36697069

RESUMO

BACKGROUND/AIM: Olaparib was approved in 2014 by the European Medicines Agency (EMA) as maintenance treatment for patients with breast cancer gene (BRCA)-mutated platinum-sensitive relapsed high-grade epithelial ovarian cancer (EOC) following the results of the Study 19. We present the results of a national real-world study on the effectiveness of olaparib in relapsed BRCA-mutated EOC patients. PATIENTS AND METHODS: Patients with EOC, peritoneal, and/or fallopian-tube cancer treated with olaparib in a French Center between May 2014 and March 2017 were included. The primary end-point of the study was progression-free survival. RESULTS: Of the 128 patients analyzed, 89 were treated according to the EMA label. The median progression-free survival was 17.0 months. The most common treatment-related toxicity was fatigue. Treatment-related myelodysplastic syndrome (n=5) and a second cancer (n=1) were diagnosed. CONCLUSION: In this real-life setting, olaparib confirmed its efficacy and safety profile, as previously shown in clinical trials.


Assuntos
Antineoplásicos , Neoplasias Ovarianas , Humanos , Feminino , Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/genética , Antineoplásicos/uso terapêutico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/genética , Estudos de Coortes , Ftalazinas/efeitos adversos , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/genética
3.
Int J Antimicrob Agents ; 27 Suppl 1: 25-30, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16713193

RESUMO

The use of antifungal combination therapy is a new clinical approach for combating fungal infections. Although few conclusive clinical studies have been performed to date, data exist that strongly suggest that combination therapy would benefit specific patient subgroups (e.g. stem-cell transplant recipients). This paper examines the evidence available from in vitro, experimental, and clinical studies, and seeks to discover viable clinical strategies for this promising new therapeutic approach.


Assuntos
Anfotericina B/uso terapêutico , Antifúngicos/uso terapêutico , Peptídeos Cíclicos/uso terapêutico , Fosfatidilcolinas/uso terapêutico , Fosfatidilgliceróis/uso terapêutico , Anfotericina B/efeitos adversos , Animais , Antifúngicos/efeitos adversos , Aspergilose/tratamento farmacológico , Caspofungina , Ensaios Clínicos como Assunto , Combinação de Medicamentos , Quimioterapia Combinada , Equinocandinas , Previsões , Humanos , Técnicas In Vitro , Lipopeptídeos , Peptídeos Cíclicos/efeitos adversos , Fosfatidilcolinas/efeitos adversos , Fosfatidilgliceróis/efeitos adversos
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