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1.
Support Care Cancer ; 25(11): 3407-3416, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28551844

RESUMO

PURPOSE: Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Given that extensive animal data suggest that minocycline may prevent chemotherapy-induced neurotoxicity, the purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and the P-APS. METHODS: Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks and were randomized to receive minocycline 200 mg on day 1 followed by 100 mg twice daily or a matching placebo. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy to measure P-APS and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment, to measure CIPN. RESULTS: Forty-seven patients were randomized. There were no remarkable differences noted between the minocycline and placebo groups for the overall sensory neuropathy score of the EORTC QLQ-CIPN20 or its individual components, which evaluate tingling, numbness and shooting/burning pain in hands and feet. However, patients taking minocycline had a significant reduction in the daily average pain score attributed to P-APS (p = 0.02). Not only were no increased toxicities reported with minocycline, but there was a significant reduction in fatigue (p = 0.02). CONCLUSIONS: Results of this pilot study do not support the use of minocycline to prevent CIPN, but suggest that it may reduce P-APS and decrease fatigue; further study of the impact of this agent on those endpoints may be warranted.


Assuntos
Antibacterianos/uso terapêutico , Minociclina/uso terapêutico , Paclitaxel/efeitos adversos , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Antibacterianos/farmacologia , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Minociclina/farmacologia , Projetos Piloto
2.
Support Care Cancer ; 18(3): 321-8, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19468757

RESUMO

PURPOSE: The purpose of this study is to test the ability of risedronate and estradiol, alone or in combination, to prevent bone loss associated with androgen deprivation therapy in men with prostate cancer. MATERIALS AND METHODS: This is a randomized placebo-controlled trial of risedronate and estradiol, alone or in combination, in men with prostate cancer receiving androgen deprivation therapy. The primary outcome was change in hip bone mineral density at 1 year. RESULTS: No statistical difference was found among the groups for bone mineral density changes. The only side effects of note were increased gynecomastia and breast tenderness associated with estrogen therapy. The study was limited by poor accrual and subsequent lack of statistical power. CONCLUSIONS: Men receiving androgen deprivation therapy for prostate cancer are at risk for bone loss and should receive appropriate bone density monitoring and preventive advice about calcium, vitamin D, exercise, and fall prevention. Prescription drugs proven in this patient population should be used when the risk of fracture is high.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Conservadores da Densidade Óssea/uso terapêutico , Estradiol/uso terapêutico , Ácido Etidrônico/análogos & derivados , Osteoporose/induzido quimicamente , Osteoporose/prevenção & controle , Neoplasias da Próstata/tratamento farmacológico , Idoso , Método Duplo-Cego , Ácido Etidrônico/uso terapêutico , Hormônio Liberador de Gonadotropina/agonistas , Ginecomastia/induzido quimicamente , Humanos , Masculino , Ácido Risedrônico
3.
Breast Cancer Res Treat ; 117(3): 603-9, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19214743

RESUMO

Postmenopausal women with breast cancer (BC) are at increased risk for bone loss. Bisphosphonates improve bone mineral density (BMD) in normal postmenopausal women. The purpose of this study was to determine if immediate treatment with zoledronic acid preserves BMD in postmenopausal women with BC starting letrozole after tamoxifen. Postmenopausal women with BC completing tamoxifen were treated with daily letrozole 2.5 mg/vitamin D 400 I.U., calcium 500 mg twice daily and were randomized to upfront or delayed zoledronic acid 4 mg every 6 months. Patients in the delayed arm were only given zoledronic acid if they developed a post-baseline BMD T score <-2.0 or had a fracture. The primary endpoint was the mean percent change in lumbar spine (LS) BMD at 1 year. About 558 women enrolled; 395 provided 1 year BMD data. The upfront arm experienced a mean change of +3.66% in LS BMD versus -1.66% for the delayed group (P < 0.001). Changes at the femoral neck/total hip were also greater for the upfront versus delayed arms (P < 0.001; P < 0.001) with differences persisting at 2 years. Patients in the delayed arm were more likely to experience a clinically meaningful 5% loss of BMD at all sites versus the upfront zoledronate group. Patients in the upfront arm were slightly more likely to report limb edema, fatigue, fever, nausea and jaw osteonecrosis(1%). Upfront zoledronic acid prevents bone loss in postmenopausal women with BC starting letrozole after tamoxifen.


Assuntos
Antineoplásicos/uso terapêutico , Conservadores da Densidade Óssea/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Difosfonatos/administração & dosagem , Imidazóis/administração & dosagem , Osteoporose Pós-Menopausa/prevenção & controle , Adulto , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/efeitos dos fármacos , Difosfonatos/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Imidazóis/efeitos adversos , Letrozol , Pessoa de Meia-Idade , Nitrilas/administração & dosagem , Nitrilas/efeitos adversos , Osteoporose Pós-Menopausa/induzido quimicamente , Tamoxifeno/uso terapêutico , Triazóis/administração & dosagem , Triazóis/efeitos adversos , Ácido Zoledrônico
4.
J Clin Oncol ; 29(4): 421-7, 2011 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-21189381

RESUMO

PURPOSE: Cumulative sensory neurotoxicity (sNT) is the dose-limiting toxicity of oxaliplatin, which commonly leads to early discontinuation of oxaliplatin-based therapy in the palliative and adjuvant settings. In a nonrandomized, retrospective study, intravenous (IV) calcium/magnesium (Ca/Mg) was associated with reduced oxaliplatin-induced sNT. METHODS: Patients with colon cancer undergoing adjuvant therapy with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) were randomly assigned to Ca/Mg (1g calcium gluconate plus 1g magnesium sulfate pre- and post-oxaliplatin) or placebo, in a double-blinded manner. The primary end point was the percentage of patients with grade 2 or greater sNT at any time during or after oxaliplatin-based therapy by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3) criteria. An oxaliplatin-specific sNT scale and patient questionnaires were also used to assess sNT. After 104 of 300 planned patients were enrolled, the study was closed. This was due to preliminary reports from another trial that suggested that Ca/Mg decreased treatment efficacy; these data were subsequently found to be incorrect. RESULTS: Overall, 102 patients were available for analysis. Ca/Mg decreased the incidence of chronic, cumulative, grade 2 or greater sNT, as measured by NCI CTCAE (P = .038) and also by the oxaliplatin-specific sNT scale (P = .018). In addition, acute muscle spasms associated with oxaliplatin were significantly reduced (P = .01) No effect on acute, cold-induced sNT was found. No substantial differences in adverse effects were noted between Ca/Mg and placebo. CONCLUSION: Despite early termination and decreased statistical power, this study supports IV Ca/Mg as an effective neuroprotectant against oxaliplatin-induced cumulative sNT in adjuvant colon cancer.


Assuntos
Adenocarcinoma/tratamento farmacológico , Antineoplásicos/efeitos adversos , Gluconato de Cálcio/administração & dosagem , Neoplasias do Colo/tratamento farmacológico , Sulfato de Magnésio/administração & dosagem , Fármacos Neuroprotetores/administração & dosagem , Síndromes Neurotóxicas/prevenção & controle , Compostos Organoplatínicos/efeitos adversos , Transtornos de Sensação/prevenção & controle , Idoso , Quimioterapia Adjuvante , Distribuição de Qui-Quadrado , Método Duplo-Cego , Combinação de Medicamentos , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Infusões Intravenosas , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Síndromes Neurotóxicas/diagnóstico , Síndromes Neurotóxicas/etiologia , Oxaliplatina , Estudos Prospectivos , Transtornos de Sensação/induzido quimicamente , Transtornos de Sensação/diagnóstico , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
5.
J Clin Oncol ; 28(5): 853-8, 2010 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-20048179

RESUMO

PURPOSE Prior trials have shown that surgery followed by hepatic artery infusion (HAI) of floxuridine (FUDR) alternating with systemic fluorouracil improves survival rates. Oxaliplatin combined with capecitabine has demonstrated activity in advanced colorectal cancer. Based on this observation a trial was conducted to assess the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR. The primary end point was 2-year survival. PATIENTS AND METHODS Patients with liver-only metastases from colorectal cancer amenable to resection or cryoablation were eligible. HAI and systemic therapy was initiated after metastasectomy. Alternating courses of HAI consisted of 0.2 mg/m(2)/d FUDR and dexamethasone, day 1 through 14 weeks 1 and 2. Systemic therapy included oxaliplatin 130 mg/m(2) day 1 with capecitabine at 1,000 mg/m(2) twice daily, days 1 through 14, weeks 4 and 5. Two additional 3-week courses of systemic therapy were given. Capecitabine was reduced to 850 mg/m(2) twice daily after interim review of toxicity. Results Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median follow-up of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. CONCLUSION Alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and was clinically tolerable. However, the merits of this approach need to be established with a phase III trial.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Ablação por Cateter , Neoplasias Colorretais/patologia , Criocirurgia , Hepatectomia , Neoplasias Hepáticas/tratamento farmacológico , Administração Oral , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Capecitabina , Quimioterapia Adjuvante , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Dexametasona/administração & dosagem , Esquema de Medicação , Estudos de Viabilidade , Feminino , Floxuridina/administração & dosagem , Fluoruracila/administração & dosagem , Fluoruracila/análogos & derivados , Artéria Hepática , Humanos , Infusões Intra-Arteriais , Infusões Intravenosas , Estimativa de Kaplan-Meier , Neoplasias Hepáticas/mortalidade , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/cirurgia , Masculino , Pessoa de Meia-Idade , Compostos Organoplatínicos/administração & dosagem , Oxaliplatina , Modelos de Riscos Proporcionais , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
6.
J Clin Oncol ; 24(7): 1079-89, 2006 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-16505427

RESUMO

PURPOSE: To compare maintenance epoetin alfa administered once every 3 weeks with continued weekly epoetin alfa for patients with cancer-associated anemia. PATIENTS AND METHODS: Eligible patients were randomly assigned at enrollment to receive three weekly doses of epoetin alfa 40,000 U subcutaneously (SC), followed by either standard weekly epoetin alfa (40K arm) or 120,000 U of epoetin alfa (120K arm) SC every 3 weeks for 18 additional weeks. RESULTS: Three hundred sixty-five patients were enrolled. One hundred eighty-three patients were assigned to the 40K arm, and 182 were assigned to the 120K arm. There was no difference in the proportion of patients requiring transfusions during the study (23% in 40K arm and 18% in 120K arm, P = .22) or specifically during the maintenance phase (13% in 40K arm v 15% in 120K arm, P = .58). Patients randomly assigned to the 40K arm were more likely to have a > or = 2 or > or = 3 g/dL hemoglobin (Hb) increment, were more likely to have a drug dose held because of high Hb, and had higher mean end-of-study Hb levels. Toxicities, including thromboembolism, and overall survival were similar. Patients in the 40K arm had a higher global quality of life (QOL) at baseline for unclear reasons, whereas patients in the 120K arm had a greater global QOL improvement during the study, so end-of-study QOL was equivalent. CONCLUSION: After three weekly doses of epoetin alfa 40,000 U, a dose of 120,000 U can be administered safely once every 3 weeks without increasing transfusion needs or sacrificing QOL. The Hb increment is somewhat greater with continued weekly epoetin alfa. Lack of blinding as a result of different treatment schedules may have confounded results.


Assuntos
Anemia Hipocrômica/tratamento farmacológico , Antineoplásicos/efeitos adversos , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia Hipocrômica/induzido quimicamente , Antineoplásicos/administração & dosagem , Fatores de Confusão Epidemiológicos , Esquema de Medicação , Epoetina alfa , Feminino , Hemoglobinas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Proteínas Recombinantes , Projetos de Pesquisa , Resultado do Tratamento
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