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1.
Support Care Cancer ; 29(1): 387-396, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32372176

RESUMEN

PURPOSE: To evaluate the efficacy of testosterone supplementation for improving aromatase inhibitor musculoskeletal symptoms (AIMSS). METHODS: Postmenopausal women experiencing moderate-to-severe arthralgias while taking adjuvant aromatase inhibitors for breast cancer were enrolled in this trial. Initially, patients were randomly allocated to receive either a subcutaneous testosterone pellet versus a placebo pellet. Due to slow accrual, the protocol was modified such that additional participants were randomized to receive either a topical testosterone gel or a placebo gel. Changes in patient-reported joint pain were compared between patients receiving testosterone and those receiving placebo using a two-sample t test. Changes in hot flashes and other vasomotor symptoms were also analyzed. Further analyses were conducted to evaluate whether 27 single nucleotide polymorphisms (SNPs) in 14 genes previously associated with AIMSS were associated with testosterone supplementation benefit. RESULTS: While 64% of patients reported an improvement in joint pain at 3 months, there were no significant differences in average pain or joint stiffness at 3 or 6 months between testosterone and placebo arms. Patients receiving testosterone did report improvements in strength, lack of energy, urinary frequency, and stress incontinence (p < 0.05). The subset of patients receiving subcutaneous testosterone also experienced improvements in hot flashes and mood swings. An inherited variant (rs7984870 CC genotype) in TNFSF11 was more likely to be associated with improvements in hot flashes in patients receiving testosterone. CONCLUSION: The doses of testosterone supplementation used in this study did not significantly improve AIMSS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01573442.


Asunto(s)
Inhibidores de la Aromatasa/efectos adversos , Artralgia/tratamiento farmacológico , Sofocos/tratamiento farmacológico , Dolor Musculoesquelético/tratamiento farmacológico , Testosterona/uso terapéutico , Administración Tópica , Artralgia/inducido químicamente , Neoplasias de la Mama/tratamiento farmacológico , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Dolor Musculoesquelético/inducido químicamente , Polimorfismo de Nucleótido Simple/genética , Posmenopausia , Calidad de Vida/psicología , Ligando RANK/genética , Testosterona/administración & dosificación , Resultado del Tratamiento
2.
Support Care Cancer ; 26(2): 643-650, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-28921241

RESUMEN

BACKGROUND: Women with estrogen deficiencies can suffer from vaginal symptoms that negatively impact sexual health. This study evaluated vaginal dehydroepiandrosterone (DHEA) for alleviation of vaginal symptoms. METHODS: This three-arm randomized, controlled trial evaluated DHEA 3.25 mg and DHEA 6.5 mg, each compared to a plain moisturizer (PM) over 12 weeks, to improve the severity of vaginal dryness or dyspareunia, measured with an ordinal scale, and overall sexual health using the Female Sexual Function Index (FSFI). Postmenopausal women with a history of breast or gynecologic cancer who had completed primary treatment, had no evidence of disease, and reported at least moderate vaginal symptoms were eligible. The mean change from baseline to week 12 in the severity of vaginal dryness or dyspareunia for each DHEA dose was compared to PM and analyzed by two independent t tests using a Bonferroni correction. RESULTS: Four hundred sixty-four women were randomized. All arms reported improvement in either dryness or dyspareunia. Neither DHEA dose was statistically significantly different from PM at 12 weeks (6.25 mg, p = .08; 3.25 mg, p = 0.48), although a significant difference at 8 weeks for 6.5 mg DHEA was observed (p = 0.005). Women on the 6.5 mg arm of DHEA reported significantly better sexual health on the FSFI (p < 0.001). There were no significant differences in provider-graded toxicities and few significant differences in self-reported side effects. CONCLUSION: PM and DHEA improved vaginal symptoms at 12 weeks. However, vaginal DHEA, 6.5 mg, significantly improved sexual health. Vaginal DHEA warrants further investigation in women with a history of cancer.


Asunto(s)
Deshidroepiandrosterona/uso terapéutico , Enfermedades Vaginales/tratamiento farmacológico , Administración Intravaginal , Supervivientes de Cáncer , Deshidroepiandrosterona/farmacología , Femenino , Humanos , Persona de Mediana Edad , Posmenopausia
3.
Support Care Cancer ; 26(4): 1335-1343, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29164377

RESUMEN

BACKGROUND: Dehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history. METHODS: Postmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3.25 versus 6.5 mg/day of DHEA versus a plain moisturizer (PM) control. Sex steroid hormone levels, biomarkers of bone formation, vaginal pH, and maturation index were collected at baseline and 12 weeks. Analysis included independent t tests and Wilcoxon rank tests, comparing each DHEA arm with the control. RESULTS: Three hundred forty-five women contributed evaluable blood and 46 contributed evaluable cytology and pH values. Circulating DHEA-S and testosterone levels were significantly increased in those on vaginal DHEA in a dose-dependent manner compared to PM. Estradiol was significantly increased in those on 6.5 mg/day DHEA but not in those on 3.25 mg/day DHEA (p < 0.05 and p = 0.05, respectively), and not in those on AIs. Biomarkers of bone formation were unchanged in all arms. Maturation of vaginal cells was 100% (3.25 mg/day), 86% (6.5 mg/day), and 64% (PM); pH decreased more in DHEA arms. CONCLUSION: DHEA resulted in increased hormone concentrations, though still in the lowest half or quartile of the postmenopausal range, and provided more favorable effects on vaginal cytology, compared to PM. Estrogen concentrations in women on AIs were not changed. Further research on the benefit of vaginal DHEA is warranted in hormone-dependent cancers.


Asunto(s)
Deshidroepiandrosterona/administración & dosificación , Vagina/efectos de los fármacos , Administración Intravaginal , Inhibidores de la Aromatasa/administración & dosificación , Neoplasias de la Mama/sangre , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Sulfato de Deshidroepiandrosterona/sangre , Estradiol/sangre , Femenino , Neoplasias de los Genitales Femeninos/sangre , Neoplasias de los Genitales Femeninos/tratamiento farmacológico , Neoplasias de los Genitales Femeninos/patología , Hormonas Esteroides Gonadales/sangre , Humanos , Persona de Mediana Edad , Osteogénesis/efectos de los fármacos , Posmenopausia , Tamoxifeno/administración & dosificación , Testosterona/sangre , Vagina/patología
4.
Cancer ; 120(22): 3575-83, 2014 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-25043153

RESUMEN

BACKGROUND: Despite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy (HEC). METHODS: Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by gabapentin 300 mg twice a day and dexamethasone (dex) or placebo and dex after HEC. Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle, whereas dex was titrated down on days 2-4. The primary end point was complete response (CR), defined as no emesis and no use of rescue medications on days 2-6, using an NV diary. The percentages of those in each group with a CR were compared by Fisher's exact test. RESULTS: Four hundred thirty patients were enrolled in this study. Forty-seven percent of patients in the gabapentin arm and 41% in the placebo arm had a CR (P = .23). Mean number of emesis episodes was <0.5 daily, and mean nausea severity was < 2 (mild). In both arms, patient satisfaction with NV control was greater than 8 (with 10 being perfectly satisfied). There were no significant differences in unwanted side effects. CONCLUSIONS: In this study, gabapentin did not significantly improve delayed NV. Patients were satisfied with the control of their nausea and vomiting irrespective of arm. The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients.


Asunto(s)
Aminas/uso terapéutico , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Ácidos Ciclohexanocarboxílicos/uso terapéutico , Náusea/prevención & control , Neoplasias/tratamiento farmacológico , Vómitos/prevención & control , Ácido gamma-Aminobutírico/uso terapéutico , Adulto , Anciano , Aminas/administración & dosificación , Aminas/efectos adversos , Ácidos Ciclohexanocarboxílicos/administración & dosificación , Ácidos Ciclohexanocarboxílicos/efectos adversos , Método Doble Ciego , Esquema de Medicación , Femenino , Gabapentina , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Satisfacción del Paciente , Factores de Tiempo , Vómitos/inducido químicamente , Ácido gamma-Aminobutírico/administración & dosificación , Ácido gamma-Aminobutírico/efectos adversos
5.
Maturitas ; 144: 37-44, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33358206

RESUMEN

PURPOSE: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO2 laser therapy in gynecologic cancer survivors. METHODS: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO2 laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6). RESULTS: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events. CONCLUSIONS: Fractional CO2 laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).


Asunto(s)
Dióxido de Carbono/uso terapéutico , Enfermedades Urogenitales Femeninas/cirugía , Terapia por Láser , Láseres de Gas , Adulto , Anciano , Supervivientes de Cáncer , Femenino , Humanos , Menopausia , Persona de Mediana Edad , Proyectos Piloto , Método Simple Ciego , Síndrome , Vagina/cirugía
6.
Gynecol Oncol ; 116(3): 419-23, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19896181

RESUMEN

OBJECTIVES: To investigate treatment outcomes of patients with carcinosarcoma of the uterus and to identify parameters predictive of survival. Secondary objectives included (a) the assessment of treatment failures as a function of histologic subtypes and (b) the impact of the new FIGO staging classification system. METHODS: This is a retrospective outcomes analysis of 121 patients diagnosed with primary carcinosarcoma of the uterus. Clinical, surgical and pathological data were reviewed and patients were classified according to the new 2009 FIGO staging system for endometrial carcinoma. Survivorship curves were evaluated with the log-rank test and associations between events and variables with Cox proportional hazards model. RESULTS: In the multivariate analyses for disease-specific survival (DSS) and disease-free survival (DFS), the only independent factors were FIGO stage, adjuvant chemotherapy after surgery and the presence of clear cell histology in the tumor. The 5-year DSS for stages I-II, III and IV was 59%, 22% and 9%, respectively. The administration of platin-based chemotherapy provided a significant benefit with regard to both DFS (OR=0.28; p=0.001) and DSS (OR=0.35; p=0.01). While radiotherapy (RT) appeared to control vaginal failures in all stages, pelvic RT did not impact DSS. Of importance, the epithelial component was the predominant histology in both the primary extrauterine metastases (94%) and the distant failure sites (82%). CONCLUSIONS: This highly aggressive uterine malignancy warrants comprehensive surgical staging to assess tumor dissemination followed by systemic therapy in patients with both early and advanced stage disease.


Asunto(s)
Carcinosarcoma/terapia , Neoplasias Uterinas/terapia , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma Endometrioide/patología , Carcinoma Endometrioide/terapia , Carcinosarcoma/patología , Terapia Combinada , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Estudios Retrospectivos , Resultado del Tratamiento , Neoplasias Uterinas/patología , Adulto Joven
7.
JCO Precis Oncol ; 2: 1-12, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-35135120

RESUMEN

INTRODUCTION: Precision oncology (PO) is a growing treatment approach in the era of next-generation sequencing (NGS) and matched therapies. Effective delivery of PO in the community has not been extensively studied. Our program developed a virtual molecular tumor board (MTB) strategy to help guide PO care. MATERIALS AND METHODS: Over 18 months, eligible adult patients with advanced, incurable solid tumor malignancies were enrolled in a molecular profiling (MP) study using the Foundation Medicine NGS panel. Results were reviewed through a weekly, videoconferenced MTB conducted across our largely rural integrated health system. Recommendations from the MTB were used to identify actionable alterations (AAs). Feasibility of PO care delivery was assessed as the primary outcome. Secondary outcomes included the frequency of AAs, genomic matched treatments, genomic matched clinical trial enrollment, and clinical outcomes. RESULTS: A total of 120 participants with a variety of advanced tumor types were enrolled. Of these, 109 (90.8%) had successful MP. Treatment on the basis of an AA was recommended by the MTB in 58% of patients (63 of 109) who had a successful MP result. For those completing MP, treatments included enrollment in a genomic matched clinical trial (n = 16; 14.6%) and genomic matched treatment with a Food and Drug Administration-approved agent (n = 23; 21.1%). Response and survival data were similar regardless of the matched treatment option chosen. CONCLUSION: A video-conferenced MTB-facilitated NGS testing and treatment delivery system was implemented in our integrated community oncology program. Continued use of this model aims to increase understanding of the impact of PO in this setting.

8.
J Clin Oncol ; 32(18): 1941-67, 2014 Jun 20.
Artículo en Inglés | MEDLINE | ID: mdl-24733808

RESUMEN

PURPOSE: To provide evidence-based guidance on the optimum prevention and treatment approaches in the management of chemotherapy-induced peripheral neuropathies (CIPN) in adult cancer survivors. METHODS: A systematic literature search identified relevant, randomized controlled trials (RCTs) for the treatment of CIPN. Primary outcomes included incidence and severity of neuropathy as measured by neurophysiologic changes, patient-reported outcomes, and quality of life. RESULTS: A total of 48 RCTs met eligibility criteria and comprise the evidentiary basis for the recommendations. Trials tended to be small and heterogeneous, many with insufficient sample sizes to detect clinically important differences in outcomes. Primary outcomes varied across the trials, and in most cases, studies were not directly comparable because of different outcomes, measurements, and instruments used at different time points. The strength of the recommendations is based on the quality, amount, and consistency of the evidence and the balance between benefits and harms. RECOMMENDATIONS: On the basis of the paucity of high-quality, consistent evidence, there are no agents recommended for the prevention of CIPN. With regard to the treatment of existing CIPN, the best available data support a moderate recommendation for treatment with duloxetine. Although the CIPN trials are inconclusive regarding tricyclic antidepressants (such as nortriptyline), gabapentin, and a compounded topical gel containing baclofen, amitriptyline HCL, and ketamine, these agents may be offered on the basis of data supporting their utility in other neuropathic pain conditions given the limited other CIPN treatment options. Further research on these agents is warranted.


Asunto(s)
Analgésicos/uso terapéutico , Antineoplásicos/efectos adversos , Neoplasias/tratamiento farmacológico , Neuralgia/prevención & control , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/prevención & control , Sobrevivientes , Tiofenos/uso terapéutico , Adulto , Aminas/uso terapéutico , Amitriptilina/administración & dosificación , Anticonvulsivantes/uso terapéutico , Antidepresivos Tricíclicos/uso terapéutico , Antineoplásicos/administración & dosificación , Baclofeno/administración & dosificación , Comorbilidad , Ácidos Ciclohexanocarboxílicos/uso terapéutico , Quimioterapia Combinada , Clorhidrato de Duloxetina , Medicina Basada en la Evidencia , Gabapentina , Geles , Humanos , Incidencia , Ketamina/administración & dosificación , Neuralgia/tratamiento farmacológico , Neuralgia/etiología , Enfermedades del Sistema Nervioso Periférico/complicaciones , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/fisiopatología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Estados Unidos , Ácido gamma-Aminobutírico/uso terapéutico
9.
Expert Rev Anticancer Ther ; 6(6): 921-30, 2006 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-16761936

RESUMEN

In the USA, colorectal cancer is the fourth most prevalent cancer and is the second leading cause of cancer death after lung cancer. In 2006, 148,610 colorectal cancer cases are expected in the USA, with 55,170 deaths expected from this disease. After years of stagnation, the treatment of metastatic colorectal cancer has recently made dramatic advances. The previous standard of care, 5-fluorouracil, is the now the backbone of combination regimens with oxaliplatin or irinotecan. The addition of biological agents, such as the vascular endothelial growth factor inhibitor, bevacizumab, and the epidermal growth factor receptor inhibitors, cetuximab and panitumumab, have further enhanced the activity of conventional chemotherapy. These advances have increased the overall survival of advanced colorectal cancer patients, which was once 6 months with best supportive care, to over 2 years if all active agents are used in the course of the disease.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Colorrectales/patología , Esquema de Medicación , Receptores ErbB/antagonistas & inhibidores , Fluorouracilo/administración & dosificación , Humanos , Neoplasias Hepáticas/secundario , Neoplasias Hepáticas/cirugía , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
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