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Métodos Terapêuticos e Terapias MTCI
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1.
PLoS One ; 8(4): e59981, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23577077

RESUMO

PURPOSE: Neuropathic pain is commonly associated with cancer. Current treatments include combination opioid and adjuvant therapies, but no guidelines are available for dose escalation strategies. This phase II study compared the efficacy and tolerability of two dose escalation strategies for oxycodone and pregabalin combination therapy. METHODS: Patients (N = 75) with oncological neuropathic pain, previously untreated with pregabalin, were recruited in 5 Italian institutions between 2007 and 2010. Patients were randomised to two different dose escalation strategies (arm A; N = 38) oxycodone at a fixed dose with increasing pregabalin doses; (arm B; N = 37) pregabalin at a fixed dose with increasing oxycodone doses. Patients were evaluated from daily diaries and follow-ups at 3, 7, 10, and 14 days after beginning treatment with a numerical rating scale (NRS), neuropathic pain scale (SDN), and well-being scale (ESAS). The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects. The study had a 90% probability of detecting the best strategy for a true difference of at least 15%. RESULTS: More patients in arm A (76%) than arm B (64%) achieved ≥1/3 overall pain reduction even after controlling for baseline factors (gender, baseline pain). Group A reported fewer side effects than group B; constipation 52.8% vs. 66.7%; nausea: 27.8% vs. 44.4%; drowsiness: 44.4% vs. 55.6%; confusion: 16.7% vs. 27.8%; itching: 8.3% vs. 19.4%. CONCLUSIONS: Both strategies effectively controlled neuropathic pain, but according to the adopted selection design arm A is preferable to arm B for pain control. TRIAL REGISTRATION: ClinicalTrials.gov NCT00637975.


Assuntos
Neoplasias/complicações , Neuralgia/complicações , Neuralgia/tratamento farmacológico , Oxicodona/efeitos adversos , Oxicodona/uso terapêutico , Ácido gama-Aminobutírico/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neuralgia/genética , Polimorfismo de Nucleotídeo Único , Pregabalina , Resultado do Tratamento , Ácido gama-Aminobutírico/efeitos adversos , Ácido gama-Aminobutírico/uso terapêutico
2.
Cancer Chemother Pharmacol ; 66(5): 837-44, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20041325

RESUMO

PURPOSE: Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity. METHODS: Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days. RESULTS: All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities. CONCLUSIONS: Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Hepatocelular/tratamento farmacológico , Neoplasias Hepáticas/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Benzenossulfonatos/administração & dosagem , Carcinoma Hepatocelular/fisiopatologia , Diarreia/induzido quimicamente , Progressão da Doença , Feminino , Humanos , Hipertensão/induzido quimicamente , Neoplasias Hepáticas/fisiopatologia , Masculino , Pessoa de Meia-Idade , Niacinamida/análogos & derivados , Octreotida/administração & dosagem , Compostos de Fenilureia , Piridinas/administração & dosagem , Sorafenibe , Sobrevida , Resultado do Tratamento
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